Executive Profile Expert View Mistaken Acquisitions Dim Earnings Vice president of global R&D at Sanofi Opportunities to develop new Fourth-quarter earnings from and leader of Sunrise talks about living therapies beyond checkpoint companies missed on sales but low sales through biotech companies (p16) inhibitors remain in IO (p20) from acquisitions contributed to missed expectations (p21)

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Scripscrip.pharmamedtechbi.com Pharma intelligence | informa launched under the direction of the Swiss biotech’s current R&D hierarchy. J&J gets a 16% interest in the spinout, which will be directed by CEO Jean-Paul Clozel, and the right to acquire an additional 16% interest through con- vertible notes. The new company also will begin with roughly $1bn in cash to fund its operations. Actelion chair Jean-Pierre Garnier told a same-day conference call the deal structure may offer a way to provide immediate value creation – through the portfolio acquisitions by J&J and the sales price to Actelion – with- out the longer-term value destruction that sometimes occurs when a large pharma acquires a biotech. With the R&D spinout, “there will not be any loss of momentum,” Shutterstock: rangizzz Shutterstock: Garnier said, while the ongoing relationship with J&J provides a “preferred partner” for the new company. J&J’s $30bn For Actelion Buys The deal resulted from a long negotiation process, in which J&J walked away at one point – leaving the door open for Sanofi Immediate And Longer-Term Value to start negotiating with Actelion in De- In this tale of two companies, it’s the best of times and the best of times. J&J gets cember. A few weeks later, Actelion’s nego- immediate value by acquiring Actelion’s blockbuster PAH franchise and its late- tiations with the French pharma reached a stage pipeline, while its stake in an Actelion spinout offers longer-term potential. standstill, with J&J re-entering the picture. JOSEPH HAAS [email protected] J&J execs largely were mum about the deal’s prospects during their fourth quarter and full-year 2016 earnings calls on Jan. 24, ome analysts are quibbling with the The transaction is an all-cash tender but said it would be immediately accretive price tag, but no one doubts that for all outstanding shares in Actelion at to earnings if it happened. The company Johnson & Johnson will get an imme- $280 per share, contingent upon at least S guided that acquiring Actelion should in- diate return from its $30bn bid for Actelion 67% of Actelion’s shares being tendered. crease its long-term revenue growth pros- Pharmaceuticals Ltd., a deal transferring a The companies, whose boards both pects by at least 1% and its long-term earn- blockbuster respiratory franchise and a pair unanimously approved the deal, expect ings growth rate by 1.5%-2%. of promising Phase III assets. Perhaps just the sale to close before the end of the As an added benefit, J&J is financing the as importantly, the Jan. 26 deal includes a second quarter, at which time a new, as- deal with its offshore cash, which since it spinout of Actelion’s R&D engine into a new yet unnamed R&D company comprising is being used to buy an ex-US asset means company, with J&J holding a 16% share and Actelion’s Phase II and earlier pipeline as- there will be zero US taxation of the deal, an option to double that stake. sets plus its discovery capabilities will be CONTINUED ON PAGE 7

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Sanofi’s Science J&J Pledges Investment Scout

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COVER / J&J’s $30bn For Actelion Buys Immediate from the editor And Longer-Term Value [email protected] 3 GSK US Pharma President On A “Dynamic” 2017 4 Fresh From The White House, J&J’s Gorsky Talks Policy, It’s been a busy year so far for Johnson & Johnson’s Drug Pricing . Only eight days after joining President Trump at the White House with 11 other leaders of 5 ’s Humira Biosim EU First US mega-corporations to discuss red tape, tax cuts 6 Can Slow Selling Heart Drug Entresto Perk Up In 2017? and keeping it all in America, he was back there this 8 Under Fire, Bristol Plans To Pick Up The IO Pieces week with an elite group of pharma leaders. Once 9 Patent Pool For ’s abandoned TB Drug again red tape, tax cuts and keeping it all in America were on the agenda, as well as drug pricing. 10 Policy & Regulation Briefs Gorsky wasn’t twiddling his thumbs between trips 11 Neuroscience Reaches A New Inflection Point to the White House. He expounded on policy at the 12 How To Help Women Move Into The Biopharma C-Suite company’s annual earnings event (see p 4) before an- nouncing the acquisition of Swiss firm Actelion (see 14 Pharmas Pursue Tech Deals To Speed Drug Development cover story) two days later. 15 R&D Bites As that $30bn foreign acquisition demonstrates, 16 Exectutive Profile:Katherine Bowdish, Trump’s drive to bring everything onto US soil is go- Sanofi’s Early Science Investment Scout ing to be tricky for big pharma, despite PhRMA’s up- beat message that Trump reforms can create 350,000 18 Business Bulletin US biopharma jobs. Pharma has a huge footprint 19 Lenvatinib Measures Up In HCC But Prospects Limited? across the world and relies on global talent; moving 20 Expert View: How To Get Ahead In The Trendy World jobs to the US will come at a cost not only for workers Of IO elsewhere, but for the companies themselves. 21 Stockwatch: Mistaken Acquisitions Dim Earnings Season 22 Pipeline Watch 23 Appointments

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2 | Scrip intelligence | 3 February 2017 © Informa UK Ltd 2017 HEADLINE NEWS

GSK US Pharma President On A “Dynamic” 2017 With new US President Trump in place, new corporate CEO Walmsley to take the reins in April and the opportunity for four US drug launches in 2017, GSK’s president of US Pharmaceuticals says he is preparing for an “intense” year.

JESSICA MERRILL [email protected]

laxoSmithKline PLC’s US Pharma- “Some of the pricing pressure from ceuticals president Jack Bailey is several years ago obviously has col- Gbracing for a year of transitions, lapsed what is likely to be any pricing launches and one big potential generic loss. differential … or it certainly eliminates or When it comes to big changes, GSK is facing reduces the opportunity for broad price a lot: new US President Trump, new corpo- disparity between the generic and the rate CEO Emma Walmsley, the potential for brand,” he said. four new US drug launches and the chance And GSK is turning its attention to new the first generic rival to Advair Diskus could launches, both new respiratory drugs that be approved by the FDA. have launched in the last three years like “The headline is 2017 is going to be an Breo Ellipta, Anoro Ellipta and Nucala for incredibly dynamic year, driven by environ- eosinophilic asthma, as well as upcoming mental forces and changes, but also some launches anticipated in 2017. specific ones [impacting GSK],” Bailey said in an interview Jan. 10 at the J.P. Morgan SHINGRIX MAY BE A STAR Healthcare Conference in San Francisco. Jack Bailey The company is gearing up for four poten- On the leadership transition from long- tial approvals in 2017. The shingles vaccine time CEO Andrew Witty to former Con- Shingrix, filed with FDA in October, is con- GSK is one of the big pharmas that has sumer Healthcare CEO Walmsley on Apr. 1, sidered the biggest near-term commercial experienced some of the most significant Bailey said the transition is on track to be a opportunity for GSK. payer pushback on drug pricing, given its smooth one. GSK expanded its position in vaccines leadership position in respiratory disease, “She’s really sharp, brings great leader- through the 2014 asset swap with a competitive therapy area that has been ship and obviously proven results,” Bailey AG. Now, Bailey said the company is well targeted by payers. Its blockbuster asthma said of Walmsley. “She has a very clear positioned for the commercial launch of and chronic obstructive pulmonary dis- strategy that Andrew of course laid out, Shingrix. ease drug Advair has experienced pricing and we continue to be focused on ex- “We feel good about how we are sized,” pressure that has resulted in declining ecuting that.” he said of the sales team. There may be sales, so that GSK has absorbed about 50% Nonetheless, GSK announced another some tweaking, he said, but the company of the effective economic impact of a ge- already has a presence in the adult vaccines high-profile leadership change Jan. 17, after neric launch. market through vaccines for pertussis and the interview, which could result in more The first generic versions of the block- flu, which it will look to build on. “We aren’t transition shakeout. The company said buster could be approved by the FDA in President of Global Pharmaceuticals Abbas early 2017. NV and Hikma Pharma- starting from scratch,” he said. Hussain will leave the company and be re- ceuticals PLC have ANDAs pending at the Among the other anticipated launches placed by AstraZeneca PLC’s Luke Miels. FDA with March 28 and May 10 user fee this year are the first closed triple combi- As far as the broader pharma industry dates, respectively. It remains unclear if nation for COPD, made up of the inhaled and health care sector, Bailey said 2017 the FDA will grant the drugs a first-round corticosteroid fluticasone, the long-acting has the potential to be “more intense” approval, however, given the complexities beta2-adrenergic agonist vilanterol and a than previous years, given the uncertainty around development, namely a drug com- long-acting muscarinic antagonist umecli- about what might come under the Trump bination delivered to the lungs through a dinium in one device. administration, the ongoing national device. If a generic is approved it would be If approved, GSK will be the company dialogue on drug pricing, the potential one of the biggest generic opportunities in with the broadest respiratory portfolio for repeal of the Affordable Care Act and PD- 2017 and a major blow to GSK. Advair gen- COPD with a range of products all adminis- UFA reauthorization. erated £1.87bn ($2.35bn) in the US in 2015. tered using the same Ellipta device, Bailey “We try to go into that as a responsible But Bailey said the company is prepared said. Currently, about one-third of patients player. Under Andrew’s leadership you for a generic entry and echoed comments are on triple therapy, but there is not an ap- have seen a company that has pressed for previously made by Witty that there re- proved therapy delivered in a single device. greater transparency,” he said, noting the mains a lot of uncertainty around if and “If you are going to deal in respiratory, transparency extends to all aspects of the when a generic will launch, how many you are probably going to have to deal business from clinical trials to commercial- generics might the market and the with GSK,” Bailey said. ization strategy and pricing. level of impact on the brand. Published online 23 January 2017

scrip.pharmamedtechbi.com 3 February 2017 | Scrip intelligence | 3 HEADLINE NEWS

Fresh From The White House, J&J’s Gorsky Talks Policy, Drug Pricing Prior to its Actelion takeover bid, J&J’s CEO pledged transparency and responsible pricing of its drugs during the company’s earnings call, while outlining its goals for US health care and tax reform. Fourth quarter performance was unspectacular, although J&J’s oncology and immunology portfolios showed sales growth. JOSEPH HAAS [email protected]

ohnson & Johnson seized the moment pharma companies. “Our process to then quarter will issue the first of what Gorsky of the company’s full-year earnings set the prices for those products includes said will be annual US pharmaceutical Jcall to get out front on the US policy extensive research and collecting diverse transparency reports. debate, with CEO Alex Gorsky detailing his stakeholder input, in order to ensure they “This annual report will highlight existing recent conversation with President Don- are both accessible and representative of disclosures of Johnson & Johnson’s clinical ald Trump, outlining the firm’s priorities the outcomes and value they ultimately trial data and compassionate use, as well as for health care reform and announcing a deliver,” Gorsky continued. “We have main- Janssen’s transfer of value to US health care business transparency plan that includes a tained a responsible approach to pharma- providers, and support for patient access,” pledge for “responsible pricing.” ceutical pricing, generally limiting aggre- he explained. “Additionally, it will include expanded disclosures on US pricing and value, as well as R&D and sales and market- ing expenses. We recognize that this is one step towards demonstrating how serious we are about responsible pricing. In the long term, we know it will take all parts of the health care system working together to address the challenges we are facing.” Referring to his meeting with Trump, Gorsky noted the main focus was on how to accelerate domestic job growth, and added that it is too soon to speculate about specific changes to the Affordable Care Act or the US tax code. The exec called for a bi- partisan approach, citing how both parties worked together for the 21st Century Cures Act, which he termed a “significant invest- ment in innovation.” Gorsky said J&J is advocating that any replacement of the ACA include measures Alex Gorsky for increased health care access and retains the Act’s language mandating that insur- ers cover pre-existing conditions and that Gorsky, one of several US business lead- gate annual price increases to single-digit young adults can continue to be covered ers who met with Trump Jan. 23 to discuss percentages, below those of our competi- under their parents’ coverage. economic policy, gave an overview of his tive set. Furthermore, in our pharmaceuti- In addition, “any ACA replacement must comments during the pharma’s Jan. 24 cal business, we invest more in R&D than support a competitive market for individual earnings call by pointing out that health we do in sales and marketing. And cumu- health insurance,” he said. “We will continue care is an issue that affects all, and that the latively since 2010, we’ve invested more to advocate for models that encourage in- business of health care accounts for 18% of incremental dollars in R&D than we have novation and value, continuing the move to- US gross domestic product. Pharmaceuti- realized from US net price increases.” wards value-based care and payment for im- cal spending, he noted, comprises approxi- That messaging is straight out of the proved patient outcomes. Finally, we support mately 14% of US health care spending. playbook for major R&D-based pharma reforms that emphasize wellness and inter- J&J’s first priority, the exec said, is to in- companies. But J&J is taking another step cepting disease before it happens. Preventa- vest in innovation that produces differenti- that could go further. The firm is undertak- tive care, more latitude for employer wellness ated drugs which extend and improve lives ing an effort to “consolidate and expand programs, and incentives for healthy behav- – a common promise for J&J and other upon” its disclosures, and later in the first iors are great ways to embody this focus.”

4 | Scrip intelligence | 3 February 2017 © Informa UK Ltd 2017 HEADLINE NEWS

Disease interception and prevention is a medical devices added to momentum major business focus for J&J, as its Janssen and the consumer division was seeing Amgen’s Humira Pharmaceuticals Inc. division unveiled its to improve profitability. Pharmaceuticals Biosim EU First Disease Interception Accelerator initiative posted sales of $8.2bn for the fourth quar- this past March. ter, up 2.1% globally, with US sales rising Amgen’s biosimilar version of the anti-TNF Gorsky also issued a call for moderniza- 1.9% and ex-US sales up 2.4%. adalimumab has become the first to receive tion of the US tax code, saying the current Oncology brought in $1.46bn on the an EU positive opinion but the company has one is outdated and makes the US a “more quarter, up 14.8% from fourth quarter 2015 no plans to launch the product this year. costly place to do business.” “We are very performance, while immunology had the The EU’s CHMP has granted a posi- encouraged by the proposals currently in highest total sales among the five pharma tive opinion on marketing ABP 501, discussion, and will support business tax divisions, with $2.94bn, up 6.0%. Neurosci- Amgen Inc.’s biosimilar version of policy that is competitive with most de- ence dropped 8.2% to $1.47bn, while in- AbbVie Inc.’s multi-blockbusting anti- veloped countries, and encourages inno- fectious diseases declined 5.0% to $761m TNF Humira (adalimumab), under two vation and growth,” he said. “This includes and cardiovascular/metabolism/other fell trade names for its full complement of a system based on territorial taxation in 0.9% to $1.60bn. indications. line with most economically developed The cancer division performance was The opinion, which generally paves nations. We also believe there should be propelled by solid growth from Imbruvica the way for approval within three incentives for innovation such as research (), up 47% to $346m, and Darza- months, technically puts it in the lead of and development, and the cash currently lex (), which brought in a wave of biosimilar products hoping to gain a slice of Humira’s sales pie. It fol- held abroad should be allowed to be $200m on the quarter, the pharma not- lows its approval last year by the US FDA brought back into the US at a more com- ed. Imbruvica hit the blockbuster sales on Sept. 23, as Amjevita (adalimumab- petitive tax rate.” mark for the full year at $1.25bn, while atto), but don’t expect it to be launched A November analysis by ISI Evercore es- Darzalex tallied $572m for its first full year any time soon in either the US or EU. timates that at least four US biopharmas on the market. Outside of oncology, the The Amgen biosimilar is being kept – Amgen Inc., Inc., Merck other top grower was the anticoagulant from the market by ongoing patent & Co. Inc. and Pfizer Inc. – could repatriate Xarelto () at $598m for the litigation. Amgen said that it intended $10bn or more if tax rates on cash held quarter, up 21.1%, and $2.29bn for the to “comply with our obligations under offshore by US-based businesses were re- year, up 22.5%. the regulatory scheme governing bio- duced. J&J actually has less to gain from Remicade (), facing biosimilar similars (the BPCIA)” and that in both such a policy than most of its big pharma competition from Pfizer’s Inflectra (inflix- markets it was “currently evaluating rivals, despite Gorsky’s advocacy. imab-dyyb), brought in just under $7bn for various launch scenarios” but did not Actelion took a hit Jan. 23 with the news the year, up 6.2% from 2015, but showed anticipate launching in 2017. AbbVie is that its Tracleer () follow-on prod- some sign of competitive pressure during putting up a robust defense of its flag- uct Opsumit () failed a Phase III the fourth quarter, earning $1.62bn, a 3.3% ship product and hopes to keep rivals study of pulmonary arterial hypertension decrease year-over-year. off the market for years yet, but com- due to Eisenmenger Syndrome. Overall, J&J’s quarterly performance led petitors are using various legal strate- Prior to the call, J&J revealed that it is two different analysts to use the word “tep- gies in a bid to get under its guard. assessing potential strategic options for id” as a descriptor. Leerink Partners’ Geoffrey The EU has given ABP 501 (as a 20 its diabetes care division, which consists Porges saw “not much encouragement” in mg and 40 mg solution for injection) of medtech firms LifeScan Inc., Animas his Jan. 24 note using that adjective, while a positive opinion under two different Corp. and Calibra Medical Inc., including Morningstar’s Damien Conover said the trade names, Amgevita and Solymbic, the possibility of joint ventures, operat- pharma’s pipeline probably isn’t sufficient each with subtly different indications. ing partnerships or a sell-off. Caruso said to offset biosimilar and generic competi- Together they encompass all the differ- the challenging pricing environment for tion, such as that that plagues the neuro- ent diseases that Humira has gained an diabetes care necessitated this strategy, science portfolio. EU label for. But Solymbic is missing adding that despite the unit’s best efforts “We continue to view J&J’s growth Amgevita’s polyarticular juvenile idi- “the level of profitability in that business prospects as challenged by heavy ge- opathic arthritis label. Amgen said that has declined.” neric competition and a pipeline that isn’t it had “decided on this strategy as we Overall, J&J reported sales of $18.1bn strong enough to offset patent losses, took into consideration a multitude of for the fourth quarter, a year-over-year in- resulting in our top-line annual growth commercial options that may be pre- crease of 1.7%, and of $71.9bn for the full projection of 2% over the next five years,” sent to us at time of launch.” year, up 2.6% from 2015. The company Conover wrote Jan. 24. “The tepid growth [email protected], 27 Jan 2017 guided for full-year 2017 sales of $74.1bn- is probably driving J&J to make acquisi- $74.8bn, with expected operational tions, and we view the acquisition of Acte- CLICK growth in the 4%-5% range. Pharmaceuti- lion at close to $28bn as giving most of the Read full story at: cals contributed to growth during the past deal’s value to Actelion shareholders.” http://bit.ly/2kFp7HQ year, the diversified company noted, while Published online 24 January 2017 scrip.pharmamedtechbi.com 3 February 2017 | Scrip intelligence | 5 HEADLINE NEWS

Can Slow Selling Heart Drug Entresto Perk Up In 2017? Sales of Novartis’ Entresto have been painfully slow and missed its 2016 target of $200m – but the big pharma hopes the heart failure drug’s sales momentum will take off this year and it remains confident the first-in-class therapy will eventually reach peak annual sales of around $5bn. STEN STOVALL [email protected]

ntresto is Novartis AG’s key pipeline growth driver, but has had additional data to support future label expansions to wider CHF very slow uptake commercially, falling far below early expec- patient populations. Taken together, these developments mean Etations thanks to US market access barriers by payers. Novartis Novartis’s management now sees what it says is true commercial is now confident those hurdles are starting to melt away, prompt- daylight for the drug in the key US market. ing the diversified Swiss group to predict that prescription sales of “Everything we’re seeing on Entresto is giving us confidence in the first-in-class ARNI therapy will triple over the coming year, as the the future for the drug,” Novartis CEO Joe Jimenez told reporters. group’s sales force is now fully in place and reimbursement coverage “For example prior authorizations are coming down in terms of re- in the US is more comprehensive. quirements, and so the access hurdles that were put up are coming Entresto, which combines the neprilysin inhibitor sacubitril down very quickly. And our field sales force that we initiated mid-year with the angiotensin receptor blocker valsartan, accumulated in 2016 is now up and running and is highly productive. People have full-year sales of $170m, below the company’s initial target of been trained and are in place. And we’re starting to see a depth of pre- $200m. But the company during its fourth-quarter and full-year scription among our biggest targets of cardiologists increase,” Jimenez presentation Jan. 25 forecast sales of the therapy, which won said, adding: “The early warning indicators on this brand make us very FDA approval in July 2015, will triple by the fourth-quarter 2017, bullish and we expect to triple scripts by the end of 2017.” to at least $500m. Initial uptake of the drug has been much low- er than expected due to reimbursement delays and challenges OTHERS REMAIN SKEPTICAL over its high yearly cost. But that forecast uptick in prescription sales for Entresto was under- But Novartis used its full-year update to say US access has im- whelming for some observers. proved for all channels for the heart failure therapy – particu- “Clearly, there has been some negotiation on price to achieve larly for the key Medicare population where access has hitherto this,” commented Jefferies analyst Jeffery Holford, who added in a been most difficult. In light of that trend, the Swiss group during note that “all things considered, we see the below consensus target a four-hour investor presentation reiterated that it is confident of $500m set for 2017 as a relatively low bar, though this makes the heart failure drug will gradually reach peak annual sales of sense given that 2016 revenue guidance was not met.” around $5bn. Roger Longman, CEO of Real Endpoints, an analytics com- There have been previous attempts to jump-start the therapy’s pany, said Novartis will need to navigate numerous barriers to commercial prospects. In late 2016 Novartis tried to boost senti- get better Medicare uptake and broader usage by cardiologists, ment by releasing data supporting Entresto in preventing costly who are loathe to switch heart patients on to different drugs if hospitalizations. their current ones are still working. Administrative paperwork is In November at the annual American Heart Association meeting another disincentive, he added. He noted that Medicare Part D it presented robust outcomes data in the PARADIGM-HF study, in plans don’t pay for hospitalization, so the outcomes data show- which it slashed the rate of death or hospitalization for heart failure ing fewer people end up in hospital when using Entresto is a – the primary endpoint – by 20% compared with the generic angio- moot point. That must be viewed in light of the fact stand-alone tensin converting enzyme inhibitor enalapril, in heart failure with reduced injection fraction. But despite positive cost-effectiveness prescription drug plans are only offered by private companies - analyses, the drug has struggled to get off the ground commercially. like Humana - that have a contract with Medicare to administer them. Each plan provides coverage for a specific drug list, called EVENTUAL ENTRESTO JUMP a formulary. Still, with Entresto now included on Medicare Part D and a num- “The most important thing about PDP plans is that they only ber of major commercial formularies, Informa’s Datamonitor cover drugs. So if you have a drug that reduces hospitalization Healthcare expects US sales to significantly increase over the which Entresto does, you as the administrator of the plan get no coming years. Entresto has also received the strongest class I rec- benefit – no offset – so you are paying for a much more expen- ommendation in both the US and European chronic heart failure sive drug than those you funded before – which are essentially treatment guidelines, which Datamonitor Healthcare believes generic,” Longman told Scrip. “Whereas if you were the owner of a will further enhance uptake of the drug in the chronic heart fail- Medicare Advantage Plan you could take a chance that the drug ure (CHF) indication. The new guidelines recommend Entresto as can reduce your medical expenses and offset the additional first-line treatment for CHF patients with reduced ejection frac- costs of the drug. But most of the people who would be pre- tion (HFrEF), with the drug expected to replace enalapril as the scribed Entresto are in these PDP plans. And that was one huge current standard of care. Also, Novartis has enrolled Entresto in problem for Novartis.” a large clinical trials program, FortiHFy, which is likely to provide Published online 25 January 2017

6 | Scrip intelligence | 3 February 2017 © Informa UK Ltd 2017 HEADLINE NEWS

CONTINUED FROM COVER J&J gains a pair of Phase III candidates conservative estimate for the franchise’s Johnson & Johnson chief financial officer from Actelion – ponesimod for relapsing earning potential. Dominic Caruso pointed out on the call. multiple sclerosis and cadazolid, a novel Welford was among several analysts who CEO Alex Gorsky indicated that the deal antibiotic for Clostridium difficile-associ- pointed out that J&J’s offer price of $280 leaves J&J with plenty of flexibility to pursue ated diarrhea – as well as a five-drug pul- per share for Actelion exceeds consensus further M&A activity in the near future, im- monary arterial hypertension (PAH) port- expectations closer to $250 per share. His portant since the pharma estimates roughly folio headlined by Tracleer (bosentan) Jefferies colleague Jeffrey Holford pointed 50% of its pharmaceutical innovation is ex- and its follow-on Opsumit (macitentan), out in a separate Jan. 26 note that the $30bn ternally sourced. “We think this [transaction] both endothelin receptor antagonists offer price equates to a 12.3x multiple of Ac- is very consistent with our approach and (ERA), along with complementary drugs telion’s projected 2017 sales revenues. would expect to continue that approach from the prostaglandin receptor an- going forward,” he said. “We’ll continue to tagonist class: Uptravi (), Veletri look for areas where there is a lot of unmet (epoprostenol for injection) and Ventavis medical need, great innovation, great tech- (inhaled ). nology, that at the end of the day makes financial sense and the right people and PAH PORTFOLIO cultural fit with J&J.” J&J exec VP-pharmaceuticals Joaquin Duato said this franchise – which faces generic RARE, BUT NOT UNIQUE competition to Tracleer and branded com- The deal structure, while unusual, in not petition from Pfizer Inc., Bayer AG, Gilead quite one-of-a-kind, even for J&J, Data- Sciences Inc. and United Therapeutics Corp. monitor analyst Amanda Micklus told – covers the full spectrum of PAH with oral, Scrip. The pharma bought privately held inhaled and intravenous therapy options. In cancer biotech Aragon Pharmaceuticals 2015, the five products served more than

Inc. in 2013 on the strength of prostate 65,000 patients globally and yielded sales in allstars Shutterstock: cancer candidate , currently excess of $2bn, he noted. in Phase III, and months later spun out J&J will take over Actelion’s effort to re- Gorsky indicated the deal the rest of firm’s pipeline as Seragon place Tracleer with Opsumit, based on the Pharmaceuticals Inc., later acquired by drug’s greater potency in clinical trials and leaves J&J with flexibility to Inc. the opportunity for earlier use and combi- Other recent pharma/biotech acquisi- nation therapy. Uptravi can delay disease pursue further M&A in the tions that resulted in the creation of new progression and reduce the risk of hospital- near term R&D-focused spinouts include Bristol-Myers ization due to PAH, Duato said. Squibb Co.’s 2011 takeout of Amira Pharma- “Uptravi is highly effective and well- ceuticals Inc. and Celgene Corp.’s purchase tolerated, and we anticipate that it will of Acetylon Pharmaceuticals Inc. accelerate worldwide growth of therapies In the last couple of years, this deal “What might be unique in J&J’s current targeting the pathway, largely is exceeded in sales price only by Shire case is the equity stake it keeps in the new through driving earlier use and in combi- PLC’s acquisition of Baxalta Inc. for $32bn Actelion spin-off, essentially a way for J&J nation regimens with ERAs,” the exec said. and Teva Pharmaceutical Industries Ltd.’s to also reap the benefits, long-term, of the “Based on extensive market research, only $40.5bn acquisition of PLC’s ge- early-stage development work Actelion is four out of 10 treated PAH patients in the neric drug business. In addition, it more doing that J&J isn’t directly acquiring,” Mick- US received a prostacyclin therapy. We than doubles the cost of Pfizer’s $14bn lus said. “And by directly acquiring Actelion’s foresee Uptravi becoming the go-to pros- buyout of Medivation Inc. more advanced candidates and marketed tacyclin therapy, garnering 50% share of “This is clearly a bolt-on, earnings-focused drugs, that gives J&J a more immediate that class by 2021.” deal, with few synergies in our view,” Holford benefit in terms of the near-term revenue, In a Jan. 26 note, Jefferies Equity Re- said. “Whilst it is expensive, we view it as a mainly from Tracleer … [and] if those newer search analyst Peter Welford offered a bull- higher-quality use of cash than share repur- PAH products to perform as forecasted.” ish perspective on the future prospects chases in the mid to long term.” Included in the deal are option rights for for Actelion’s post-Tracleer PAH franchise. BMO Capital Markets analyst Joanne J&J to the Actelion spinout’s pipeline assets, “We expect Opsumit and Uptravi together Wuensch said the deal fits well with J&J’s including the Phase II resistant hypertension to drive a treatment paradigm shift in the historic business development strategy. “The candidate ACT-132577. Other Phase II candi- PAH market as combination oral therapy company is very good at internally develop- dates going to the new company include lu- is adopted, driven by both drugs’ morbid- ing, making strategic acquisitions, and mak- cerastat for Fabry disease; DORA, a dual orexin ity-mortality benefits, supporting $2.3bn ing partnerships that build the path for the receptor antagonist for insomnia; cenerimod and $1.8bn peak worldwide sales, respec- future,” she said in a Jan. 26 note. “In this trans- for lupus and clazosentan for vasospasms re- tively,” he wrote. Factoring in lower sales action, it has checked all three boxes.” sulting from arterial hypertension. for Veletri and Ventavis, he said $4bn is a Published online 26 January 2017 scrip.pharmamedtechbi.com 3 February 2017 | Scrip intelligence | 7 HEADLINE NEWS

Under Fire, Bristol Plans To Pick Up The IO Pieces EMILY HAYES [email protected]

Facing analysts jittery about the pros- Keytruda is already approved as a mono- been impacted by the recent approval of pects for Opdivo/Yervoy in first-line therapy for first-line NSCLC, another sore Tecentriq in second-line NSCLC. Opdivo lung cancer, Bristol boasts breadth in its point for Bristol due to Opdivo’s failure in now has a 40% share of the second-line Phase III lung program, including IO/ that setting in the CheckMate 026 trial. Op- market. chemo studies, and the variety of tumor divo is approved as a monotherapy only in Gordon expects Opdivo sales will con- types targeted. second-line lung cancer. tinue to be affected in lung cancer, while Analysts have had some doubts that there will be rising use in other indications. esieged by questions during a Jan. 26 Merck’s combo filing was strong enough Bristol also noted that only 25% of the earnings call about the future for the for an accelerated approval. But during the market has been satisfied by Keytruda’s BYervoy/Opdivo combination in non- Jan. 25 call, Bristol execs said they expect- monotherapy first-line approval, which is small cell lung cancer, Bristol-Myers Squibb ed that Merck’s combination filing will be limited to patients with at least 50% PD-L1 Co. said it remained committed in this space cleared by the FDA. expression, and that a durable long-term while also stressing the dual checkpoint in- Bernstein Research analyst Tim Anderson benefit has still not been demonstrated with hibitor combination’s potential in other indi- observed in a Jan. 26 note that broad use the combination in the first-line setting. cations beyond lung cancer. of Merck’s Keytruda chemo combo across During the call, Bristol’s CEO Giovanni Bristol claimed an early lead in the im- all comers in first-line NSCLC “could essen- Caforio stressed the breadth of its first-line muno-oncology field and the significance tially wipe out” the second-line PD-1 mono- NSCLC development program, which in- of that business to the company as a whole therapy opportunities, which accounted for cludes four combination front-line studies, was underscored by its dominance on the about 60% of Opdivo’s sales in the fourth including Yervoy with Opdivo, immuno- earnings call, which was the first look at quarter. This could have implications in oth- therapy/chemotherapy and immunother- how damaged Bristol’s position has been er tumor types as well, the analyst added. apy with standard chemo and a short burst by a string of setbacks. Bristol’s stock price fell 5.51% to a close of of chemo on top. Optionality has been Oncology contributed 35% of the firm’s $46.82 on Jan. 26; the share price had fallen built into all studies, the exec noted. total sales of $19.4bn in 2016, or $6.8bn by 11.28% on Jan. 20 to a close of $49.23. The next big test will be a readout of data – and the immuno-oncology portfolio of for high PD-1 expressers from the Phase III Opdivo ($3.77bn) and Yervoy ($1.05bn) CHANGING DYNAMICS CheckMate 227 first-line NSCLC study of comprised 71% of that. In the fourth quar- These results had been highly anticipated Opdivo/Yervoy in the first quarter of 2018. ter, the company reported revenue of as the first real assessment of the impact The trial includes an arm that combines im- $5.2bn, an increase of 22% compared to of the Opdivo first-line failure as well as of munotherapy with chemotherapy. the same period last year. And while Opdi- new approvals like Roche’s PD-L1 inhibitor vo sales were up to $1.3bn, from $475m in Tecentriq (atezolizumab) and the first-line BRISTOL GRILLED 4Q 2015, the growth was driven by strong approval for Keytruda. Even though Bristol’s Jan. 19 announce- international performance. Bristol’s chief commercial officer Gordon ment about not filing the combination for The PD-1 inhibitor’s US sales of $715m Murdo explained that Opdivo sales have accelerated approval in first-line NSCLC was were flat from the third quarter of 2016, while Yervoy worldwide sales were $265m Tumor Phase 2 Phase 3 Expected Timing* in the fourth quarter, identical to the CM-227 – Opdivo + Yervoy (1L) NSCLC 1H 2018 $265m reported in the 2015 fourth quarter. CM-078 – Opdivo (2L / Asia) 1H 2018 Disappointing performance followed on CM-331– Opdivo (2L) 1H 2018 SCLC the heels of news Jan. 19 that the company CM-451 – Opdivo + Yervoy (1L) 1H 2018 was not going to seek accelerated approv- CM-511 – Opdivo + Yervoy (1L) 1H 2017 Melanoma al for the combination of its PD-1 inhibitor CM-238 – Opdivo (Adjuvant) 2H 2018 Opdivo (nivolumab) with its CTLA-4 inhibi- RCC CM-214 – Opdivo + Yervoy (1L) 2H 2017 tor Yervoy (ipilimumab) in first-line NSCLC, HCC CM-459 – Opdivo (1L) 2H 2017 contrary to prior suggestions that the ac- CM-143 – Opdivo (2L) 1H 2017 GBM celerated pathway was viable. CM-548 - Opdivo+SOC(1L) 1H 2018 This move gives Merck & Co. Inc. a clear H&N CM-651 – Opdivo + Yervoy (1L) 1H 2018 lead for its combination of the competing Bladder CM-275 – Opdivo (2L)** 4Q 2016 PD-1 inhibitor Keytruda (pembrolizumab) NHL CM-140 – Opdivo (2L) 1H 2017 with chemotherapy in first-line lung cancer, CM-602 – Opdivo + Elo+ SOC which was filed for accelerated approval un- Myeloma 2H 2018 expectedly early in January and has a May 14 Potential Registrational Trial Readouts in 10 Tumor Types in Next 24 Months 10 user fee date. *Trial readout per clinicaltrials.gov (CM-214 and CM-651 excluded) **CM-275Presented at ESMO 2016, US PDUFA Date 3/2/2017

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very brief, the company did not go into the and in Bristol’s ability to hold its ground in decision not to pursue accelerated approval immuno-oncology. Patent Pool during the earnings call. Analysts pressed “Given that Bristol now trails Merck in For Pfizer’s for more information, but the company de- launching an immuno-oncology drug in clined to comment. first-line NSCLC, the importance of catch- abandoned The lack of information frustrated ana- ing up through combination treatment lysts and the call was not reassuring. Gold- is more important. Despite the increased TB Drug man Sachs analyst Jami Rubin noted during challenges in NSCLC, Bristol remains well The Medicines Patent Pool (MPP) has a question on the call that the company ap- positioned in melanoma, renal, head and signed a license with Johns Hopkins pears to have gone from having the best neck, and small-cell lung cancer, which to- University to restart the clinical develop- immuno-oncology franchise and a signifi- gether represent a market potential close ment of tuberculosis (TB) drug candidate cant lead to handing that lead to Merck, to $10bn in annual peak sales,” Morning- sutezolid. star analyst Conover said. “squandering” its enviable market position. “The MPP-John Hopkins University Leerink Swann analyst Seamus Fernan- agreement is an extraordinary step as Analysts are impressed by dez said in a Jan. 26 note that near-term it seeks to jump-start currently stalled challenges will not abate until more is Opdivo’s potential across development on a compound that known about the CheckMate 227 study, showed promise in early stage trials,” the breadth of indications but that “Opdivo, Yervoy, and the burgeon- said Mario Raviglione, director of the ing IO pipeline at BMY is a high-value in- global TB program at the World Health dustry asset that cannot be ignored.” Organization (WHO). “If history teaches us anything in phar- Sutezolid is an oxazolidinone “While Bristol remains on solid footing ma, it is that companies suffering from antibiotic in the same class as the for long-term growth, management seem short-term missteps or surprises but with commercially-available drug linezolid to suggest less confidence in the combi- great assets are more likely than not to be- but in early-stage testing was shown to nation of Opdivo and Yervoy in first-line come vulnerable M&A targets over time be more potent and less toxic. Despite NSCLC. While the company is still commit- (e.g., Immunex, , Schering-Plough) positive early study results published in ted to the combination, we believe that if there isn’t either a reversal of fortune or 2014, the product stalled in Phase IIa more data reviewed internally suggests a series of value-added pipeline surprises,” development. less differentiated efficacy,” Morningstar Fernandez said. “The MPP has signed licenses for sev- analyst Damien Conover speculated in a eral products in late stage development Jan. 26 note. ALREADY BEHIND? (Phase III testing). However, this is our The company noted that after it got re- Caforio said that the competitive landscape first license for a product in Phase IIa sults from the failed CheckMate 026 study has changed in the last nine to 12 months trials, our first TB license and our first of Opdivo monotherapy in first-line NSCLC, and could very well change again based on worldwide license,” a spokesperson for the company looked at a range of biomark- future data readouts. Bristol will have early the MPP told Scrip. ers, including PD-L1 expression, and will be readouts of three new mechanisms this The rights to sutezolid are jointly publishing results later this year. Changes year: IDO, GITR and LAG3. held by Pfizer Inc. and Johns Hopkins. to the development strategy had been Bernstein’s Anderson noted during the Pfizer licensed all its rights to develop made quickly, including the CheckMate call that Merck was also ahead in terms and commercialize to Sequella in 227 protocol. of combining PD-1 with IDO, one of the 2013, but no new studies have been hottest emerging targets, as the com- conducted since that time. STRENGTH IN NUMBERS pany has five pivotal trials ongoing with Johns Hopkins is granting the MPP Bristol also stressed the strength Opdivo has Incyte Corp. an exclusive, royalty-free license cover- in other tumor types, with a good launch in Bristol execs responded that IDO is a very ing all countries that currently have head-and-neck cancer and strong perfor- interesting target, and is why the company patents issued or pending for a com- mance in renal cell carcinoma and the origi- bought Flexus Biosciences Inc. in 2015. bination therapy comprising sutezolid nal indication of melanoma – a role Merck Bristol will present IDO safety data at the and two additional compounds used to has played in previous quarters. American Association for Cancer Research treat TB such as pretomanid, dela- The company is looking to expand into meeting in April. If the data are good, it will manid, , rifampicin and hepatocellular carcinoma, first-line RCC and move the mechanism into registration and moxifloxacin. small-cell lung cancer and is committed to combination studies with Opdivo in several [email protected], 25 Jan 2017 developing the combination in a number of tumor types. tumor types. Fourteen registrational read- Caforio pointed out that when it comes outs in 10 tumor types will read out in the to new targets, Bristol has many in-house, CLICK next 24 months, Bristol noted (see chart). though it is very open to external collabo- Read full story at: Analysts are impressed by Opdivo’s po- rations as well. http://bit.ly/2jyfN6N tential across the breadth of indications, Published online 26 January 2017 scrip.pharmamedtechbi.com 3 February 2017 | Scrip intelligence | 9 POLICY & REGULATION BRIEFS

Biocon Chief Sees Bright Future In Trump Era Ajanta Explains FDA Sildenafil Action Biocon Ltd.’s chair and managing Shares in the Indian generic company, Ajanta Pharma Ltd, slumped in early director, Kiran Mazumdar-Shaw, ap- trade on Indian bourses on Jan. 24, amid confusion over an FDA import alert pears confident that Indian pharma- against its sildenafil citrate product seized in the US. The regulatory action ceutical firms will continue to have a pertained to the detention without physical examination (DWPE) of unap- key role to play in containing health- proved new drugs promoted in the US. News of the FDA alert pulled down care costs in the US, despite signs Ajanta’s shares by more than 12% in early trading on the Bombay Stock Ex- of emergence of a new protection- change (BSE), as some investors seemed also to interpret it as a regulatory ac- ist regime with US President Donald tion against the firm’s Indian site in Aurangabad, which was mentioned in the Trump at the helm. The Trump ad- agency’s posting. Ajanta, however, said that it appeared that “some unknown and unrelated entity/individual” had sent some sildenafil manufactured by the company and being sold in India or other emerging market to the US. “We have no relations or connection to this dispatch of sildenafil to the US. US authorities have seized this product as it is not approved by the FDA,” the Mumbai-based firmed said in a filing to the BSE. The company also stressed that there was no US FDA import alert on its facility or any of its products approved by the agency. Ajanta Pharma told Scrip that its sildenafil product was commercialized in over 25 markets around the world and this “suitcase export to US could have happened from any of these countries.” The product, which was said to be a significant contributor to sales several years ago, is now Shutterstock: Wolfilser Shutterstock: estimated to account for around just 1% of revenues, a company official said. ministration, she noted, is “very com- [email protected], 24 Jan 2017 mitted” to bringing down healthcare costs and India is a “strong partner” for the US in reining in these expens- all parts of the intended label for the es, especially drug costs because ge- drug. Neulasta is approved in the US nerics play a “huge role.” “He’s also Sandoz Sanguine On for the reduction in the incidence of made it very clear that the sort of pro- Biosimilar Neulasta Setback febrile neutropenia in patients receiv- tection that Medicaid had in the past ing myelosuppressive chemotherapy in terms of not being able to negotiate Delays for Sandoz International for malignancy (except chronic my- is now going to be done away with, be- GMBH could give competitors with elogenous leukemia and myelodys- cause he believes that large drug pro- rival biosimilar versions of Amgen plastic syndromes). But Sandoz’s BLA curement agencies must be in a posi- Inc.’s Neulasta (pegfilgrastim) an op- submission for its biosimilar version tion to get a better deal. And this in portunity to steal a march. Regulators was only based on efficacy and safety line with what generics are doing for have queried the Novartis AG-owned data from two comparative Phase III their country,” Mazumdar-Shaw told generics company’s biosimilar peg- studies in patients receiving (neo)- Scrip in a telephone interview after the filgrastim filing in Europe, prompt- adjuvant myelosuppressive chemo- company’s third-quarter results were ing it to withdraw its marketing ap- therapy for breast cancer. Sandoz told announced. Generic drugs account plication for the drug as a treatment Scrip it is still on track to launch five for 89% of prescriptions dispensed in for neutropenia. The committee for major new biosimilars by 2020 in the the US, bringing $227bn in savings in medicinal products for human use EU and US, including pegfilgrastim 2015, as per a report compiled by the (CHMP) said data provided by San- – which has not yet been approved in QuintilesIMS Institute on behalf of doz did not show that its biosimilar any country. The company plans to the US Generic Pharmaceutical Asso- pegfilgrastim product, Zioxtenzo, was submit more data to the EMA later ciation. Shaw maintained that Indian highly similar to Amgen’s origina- this year. As well as Neulasta, Sicor companies will not be impacted - nei- tor drug. This isn’t the first regula- Biotech has a product for neutrope- ther will biosimilars and generics, she tory stumble for Sandoz with this nia available in Europe; its drug Lon- emphasized, but she added that that product. In July 2016, the US FDA quex (lipegfilgrastim) won marketing the “carte blanche” pricing that many issued the company with a complete authorization from the EMA in 2013 of the innovator companies have en- response letter for biosimilar pegfil- when it was owned by Teva Pharma- joyed would be “something of a chal- grastim. Analysts at the time noted ceutical Industries Ltd. The drug was lenge” in the future. that the data provided by Sandoz transferred to Sicor in 2014. [email protected],25 Jan 2017 might not have been enough to cover [email protected], 27 Jan 2017

10 | Scrip intelligence | 3 February 2017 © Informa UK Ltd 2017 HEADLINE NEWS

Neuroscience Reaches A New Inflection Point Celgene and are investing in the challenging therapeutic area, fueled by advances in science, growing understanding of the role inflammation may play in neurodegenerative diseases and improved tools for measuring efficacy. JESSICA MERRILL [email protected]

new day is dawning for neurosci- companies occur in our industry when you now being studied aggressively for cancer, ence, at least according to some are correct about the inflection point,” he to potential improvements in inflammation Abig biotechs, who are investing ag- said. “The case is a scientific and clinical associated with neurodegeneration. gressively in the challenging therapeutic one where you say as I look at it, all these “It has become extremely apparent area despite investor reservations. Biogen signals are coming together.” through genetic studies that inflammation Inc. took on neuroscience as a core research Advances in genetics, imaging technolo- in the brain has a very important role in the area several years ago, and it appears the gies, the ability to access disease tissue and development of neurodegeneration, and company is as committed to the space as drug delivery to the brain are all factors that one of the core competencies of Celgene is ever under Exec VP-R&D Michael Ehlers, an could make drugs for some of the most immunology and inflammation,” Vessey said. experienced neuroscientist who took over challenging diseases a reality, Ehlers said. Biogen’s Ehlers echoed a similar refrain the role in April. Now Celgene Corp. also has about the company’s history in immunol- its eye on building a new neuroinflamma- NEUROINFLAMMATION ogy and inflammation and work in MS po- tion franchise. Executives at Celgene agreed during a me- sitioning it for success in neuroscience. Ehlers, Celgene CEO Mark Alles and oth- dia briefing the same day. Alles said the big Others drug makers also expressed ers talked at the J.P. Morgan Healthcare biotech wants to build a neuroinflammation growing interest in investigating inflam- Conference in San Francisco Jan. 9-12 franchise to add to its Immunology & Inflam- mation as it relates to neuroscience, in- about industry’s renewed enthusiasm for mation business. Celgene expects Phase III cluding Pfizer Inc. chief scientific officer of neuroscience, driven by scientific advanc- data on the potential best-in-class oral once- the Inflammation & Immunology Research es, a growing understanding of the role daily selective sphingosine 1 phosphate 1 Group Michael Vincent – who told Scrip inflammation may play in neurodegenera- and 5 receptor modulator (S1P) to read out “there is a huge interest now in the role of tive diseases and improved tools for mea- later this year for multiple sclerosis, a drug inflammation in neurodegeneration.” suring efficacy. the company acquired with the $7.2bn ac- Biogen’s Ehlers previously ran neurosci- The question remains if investors will quisition of Receptos Inc. in 2015. ence research at Pfizer. Vincent said Pfizer’s get behind the excitement. The therapeu- “We see ozanimod as almost a tunnel or inflammation, cardiovascular and metabol- tic area is high risk and littered with drug bridge to what Celgene’s future might be ic, neuroscience and rare disease research failures, but neurodegenerative diseases in the neuroinflammatory space,” Alles said. is all concentrated and closely connected also represent a significant unmet need Exec VP research and early development in Cambridge, Mass. and commercial opportunity for drugs Rupert Vessey said when it comes to in- Celgene might be in the market for more that succeed. Biogen has seen pipeline vesting in neuroscience, “conventional wis- business development in the therapy area setbacks, like the Phase II failure of anti-LIN- dom is falling apart.” as well. Vessey said the company recently GO-1 as a neuroreparative therapy for mul- “The genetic definition and the molecu- recruited neuroscientist Richard Harg- tiple sclerosis, highlighting the high stakes lar pathological definition of neurological reaves, who previously worked for Merck & for investors. Biogen also had a recent suc- diseases has really advanced in the last few Co. Inc. and Biogen. “He is actually here [at cess: the US FDA approval of the antisense years…so that it is much more reasonable J.P. Morgan] and taking plenty of meetings oligonucleotide Spinraza (nusinersen) for to subset patients with those disorders with neuroscience companies,” he said. the rare and deadly disease spinal muscu- rather in the way cancers have been subset.” The big opportunity for Biogen is the lar atrophy, a drug developed by partner Like Ehlers, Vessey also pointed to ad- Alzheimer’s hopeful aducanumab, which Ionis Pharmaceuticals Inc. vances in tools to measure the effect of is being studied in two Phase III studies, Some Biogen investors have been disap- drugs in the brain, including imaging and although data are years out and the beta pointed with the company’s limited late- other technologies. amyloid hypothesis was dealt another hit stage pipeline and focus on neuroscience. “We see, looking in a multi-year runway, when Eli Lilly & Co.’s solanezumab failed a The company’s former CEO George Scan- the science opening up such that there will third Phase III trial last year. gos announced plans to retire last year and be targeted opportunities we can take that Regardless, Ehlers said he remains hope- was succeeded recently by former chief have a better probability of success than ful about aducanumab’s chances for suc- commercial officer Michele Vounatsos. drugs have in the past,” he said. cess. “A big reason I came to Biogen was But in an interview Jan. 10, Ehlers reit- There is particularly growing interest because only Biogen had generated com- erated Biogen’s commitment to the field around the role of inflammation in the brain pelling clinical data modifying disease in of research and said the time to invest in and neurodegenerative disease. Preclinical Alzheimer’s disease,” he said. neuroscience is now. “Transformations in data has even linked checkpoint inhibitors, Published online 24 January 2017 scrip.pharmamedtechbi.com 3 February 2017 | Scrip intelligence | 11 HEADLINE NEWS

How To Help Women Move Into The Biopharma C-Suite Scrip decided to shake things up a bit for its third annual executive roundtable held during the J.P. Morgan Healthcare Conference by putting together an all-female panel to talk about the financing and dealmaking landscape as well as the state of women in the industry. MANDY JACKSON [email protected]

mma Walmsley’s elevation to the CEO The Liftstream report also found that Liftstream did a study and published it role at GlaxoSmithKline PLC – the first companies have a financial incentive – on about a year, maybe a little longer ago, that Efemale CEO of a big pharma company top of an interest in fairness – to recruit said that a number of women are saying it’s when she moves into the post later this more diverse boards: stock performance not that they’re not being offered higher year – is coming at a time when there’s a for companies with diverse boards was jobs, although that’s a problem too, but renewed focus on gender diversity in the 28% better than companies with all-male there are a number of women who are say- biopharmaceutical C-suite. And it is an issue boards during the years following an initial ing no to positions in smaller companies or that isn’t going away. public offering. in venture and they cite, “Why would I want After two years in a row of all-male “This study by Liftstream confirms the to work in that environment?” roundtable discussions at Scrip’s annual bi- gender diversity problem and highlights So there seems that there might be opharmaceutical executive roundtable at the need for active and intentionally something that we can do if the environ- the J.P. Morgan Healthcare Conference, this disruptive approaches for appointing ment is why people are saying “no.” You can year we put together an all-female panel. directors to biotech boards,” Third Rock fix that, not easily, but you can. I think it’s The relative lack of women in leadership Ventures Partner Abbie Celniker – one of harder for some of the other issues, like are positions became a hotter topic after the the Scrip roundtable participants – said women part of the network that’s doing J.P. Morgan conference in 2016 when LifeSci in Liftstream’s statement about its re- the hiring? Because you mentioned how Advisors hosted a party where it hired fe- port. “Venture capital firms and company hard it is to hire, but yet half the workforce male models to entertain male attendees. directors must plan more effectively to isn’t making themselves available. LifeSci Advisors, working with Women in increase their opportunity for recruiting Bio, has since launched a campaign to help directors from outside their customary JOCELYN JACKSON: I think your hiring women ascend to leadership positions at networks when meeting the changing comment is really important, because at biopharma companies. needs of the company.” Symic two out of three of our founders Also, an open letter about gender diver- What follows is the first part of a conversa- were women, so they were involved in the sity in the biopharma community was dis- tion that Scrip’s Mandy Jackson had on Jan. hiring from a very early stage and we have tributed during the 2017 J.P. Morgan con- 9 – the first day of this year’s J.P. Morgan con- consistently had about 50% women with- ference and signed by 116 executives and ference – with Celniker and five other female out ever talking about it, in every stage of counting. It lists five guiding principles for biopharma executives: Chromocell Corp. our organization, at the VP and the exec gender diversity in the industry as well as vice president of therapeutics Tina Garyantes, level, which is quite incredible. I really 10 best practices for being more inclusive Curis Inc. senior vice president and chief strat- think it all came down to hiring and hav- of women. egy officer Mani Mohindru, Symic Biomedi- ing a diverse group of people doing the Meanwhile, a report by the life science cal Inc. chief financial officer Jocelyn Jackson, hiring and then it just happens naturally. executive recruiting firm Liftstream re- Cerecor Inc. chief financial officer Mariam leased on Jan. 24 shows how far the indus- Morris, and Corbus Pharmaceuticals Hold- BARBARA WHITE: I actually had a try still has to go to reach gender parity. ings Inc. chief medical officer Barbara White. chuckle to myself about that, having Liftstream’s study of 177 public biopharma been in industry and big pharma for a company boards of directors found that: ABBIE CELNIKER: [Recruiting] is very long time. I once worked for a big pharma • Less than 8% of the companies had a relevant to the fact that you have all company and we took our leadership on woman CEO; women sitting here right now. Because the road, so they had t-shirts made and • Women occupied 10.9% of board posi- talent acquisition is hard; human capital, they put our pictures on the t-shirts. There tions; is really, really tough; and then, if you look were 16 gentlemen and one lady, myself, • Women chaired the board of directors at at the C-Suite level where all of us are, and those were the pictures and I said, less than 2% of the companies; it’s 9% to 10%? Right? It doesn’t matter “You really want us to wear those?” • Men are appointed to boards at twice which coast you’re on or whether you’re the rate of women; talking about the board level or at the TINA GARYANTES: [Sometimes] I’m • And at the current rate that women are C-Suite level. [By elevating mostly men] twice as good as this field and I’m the only appointed to biopharma boards of direc- you are only tapping half of your talent, woman in the room. tors, it will take 20 years for 30% of board so that is something that has to change, seats to be held by women and parity because there’s a lot of phenomenal tal- BW: But the other day, at a team meeting won’t be reached for another 40 years. ent out there. where were going to talk about our goals

12 | Scrip intelligence | 3 February 2017 © Informa UK Ltd 2017 HEADLINE NEWS

in the New Year … I walked in [and] I didn’t AC: I think that a lot of people have done TG: And it’s really a matter of having the see a male in the room! I said, “Where are research that says that in innovation en- men and the women talk to each other, the guys, somebody go find them!” vironments diversity is key – diversity of you know? I always tell this story of my thinking. [Diverse groups of] people think first job. There was the Israeli department, MANI MOHINDRU: You bring up a good outside the box and things can happen, so there was a Chinese department, the fe- point, because there are more women I think diversity of thinking, diverse expe- male department, whoever the head of in the workforce, I don’t think that’s the riences, diverse styles, all of those things the department was, they would look at question, but are they going up [into ex- translate into a more productive, innova- a resume and they would recognize the ecutive positions]? What happened? We tive environment, so that’s one thing. schools and this and that from the letter have more than 50% of our workforce are The other thing that is really interesting – it’s just naturally a human tendency that women, but then suddenly that attrition is that bias comes from who you know. It’s does hurt diversity and it hurts ideas and... happens. The representation is not appor- not necessarily that I’m going to be biased tioned. against somebody’s looks or accent, it’s just JJ: And I think enough studies have been [about] who I know, so the networking has done to show that it hurts the bottom line, TG: I think a part of it, what I’ve heard and got to change. [but] it’s difficult if you are the only woman it seems true to me, is that people tend Why do most of us come to J.P. Morgan? on the executive level and you’re hiring a to ... when there’s a position that opens To network, right? If you’re raising money, new person and you say, “Well, I want to up, they tend to think of male colleagues that’s a big part of it too, but even that is see a couple of female resumes, I just want first and the men are more willing to pro- networking to some extent. And if you to.” You could get some backlash, because, mote themselves and the women tend to have a conversation with a number of gen- you know, you’ll still get this feedback that, need to be identified. So, if we all, in this tlemen and you say, “When you’re network- “Well we just want the best person.” room, think about that when we’re being ing, do you look around and say, ‘My gosh, Well, yes, we just want the best person, why are there no women here?’” Most will asked to hire someone … just have an ex- but let’s make an effort to look at more re- say, “no.” Whereas if you’re talking to the tra thought on what women you know. I sumes, to look at more diversity and not women and you say, “Are you surprised think it’ll make a huge difference. just females, but other diversities. I think that we’re the only women here?” They’re it’s really important and we have to really not surprised, but they notice it. JJ: And I also think we need to start a demand it, if we’re in the executive level of So, we have been working, at least in the little bit earlier with women and teach our organizations, that we keep looking at Boston area, to try and figure out how we them that it’s OK to take risks and it’s OK it and keep talking about it. can catalyze not contrived, but natural net- to fail, and that if you fail today, you’ll get working – even if it has to be at the level back up tomorrow. I mean, look at the MOHINDRU: And actually, related to that, below the C-Suite, so that we’re working men around you failing and they don’t you’ve got a good point – it’s who you know. towards the future. How do we catalyze seem to worry, they just brush it off and The resumes that come to you are people that kind of networking so people actually go on. We really need to teach women who you know and then it just so happens – are thinking about that [female] counter- that it’s OK. I think there’s a little bit of an like men end up knowing more men – and part the next time they’re hiring? It’s not in- then if you find the right fit within the first intimidation factor if you’re one out of tuitive in terms of how you make that hap- two resumes, then that’s the person you 16 or if you don’t see anyone at the top pen without it being somewhat contrived. of your organization that looks like you, go with. But if you make up mandates on how to get [a diverse workforce] it is difficult but we really need to promote them to JJ: Well, do we change the way we net- conversation to have. So you extend your be gutsy and I think identifying them is work? I think about if women are un- search a little bit, extend it further, because really important also. comfortable with the standard form of I’m sure there are people out there that are networking, going to a cocktail party at equally or more capable. But we haven’t MOHINDRU: Also, get them to know that J.P. Morgan and introducing yourself to quite got there yet. it’s OK to ask. Get them to ask. It’s harder somebody next to you, if that’s not com- Published online 24 January 2017 for us to ask and it’s strange that I was with fortable, what else can we be doing? Can some other woman from a big pharma we change the dynamic? Can we have a Read full article here: http://bit.ly/2kkDNMW company and she had a very good point roundtable that is comfortable or smaller – women are more “we” people and men lunches or something else that would … For more J.P. Morgan Executive Roundtable tend to be more “me” people. see links below: MARIAM MORRIS: Without making it Women In Biopharma And The Path Forward: BW: So, in a clinical development group, uncomfortable for men. http://bit.ly/2kLlfV9 which we are, it is really terrific to have a Financing Is Difficult, But Available For Drugs bunch of “we” people. JJ: Exactly. That Provide Value: http://bit.ly/2kFBFzb How Do You Determine A Drug’s Value To MOHINDRU: There is nothing wrong MORRIS: Because then you organize these Patients, Payers, Partners?: about being “we” people, but it was an things that might be comfortable here, but http://bit.ly/2kJTv7k interesting perspective. are uncomfortable for the others, so ... scrip.pharmamedtechbi.com 3 February 2017 | Scrip intelligence | 13 HEADLINE NEWS

Pharmas Pursue Tech Deals To Speed Drug Development EMILY HAYES [email protected]

Deals for technology platforms allow Roche spent about $10bn annually on (alirocumab) to treat high LDL cholesterol. more of a multiple-shots-on-goal ap- R&D in 2016 and the parent company is These types of deals can range from really proach as opposed to taking a risk with committed to staying at the very cutting small to big-money partnerships, depend- one or two candidates. edge of drug discovery technology, both ing on the size of the companies involved for small molecules and large molecules. and how advanced their technologies are, ome pharmas are focusing in a highly One approach the company is interest- Micklus said. competitive R&D environment on do- ed in is the use of macrocycles, which are Merck KGAA on Jan. 12 announced a Sing more technology platform deals larger than a small molecule and smaller partnership with data analytics company to boost early-stage drug development and than an antibody, to interfere with protein- Palantir Technologies to develop and de- prove the value of their products. protein interactions. liver medicines more rapidly as well as im- Genentech Inc.’s Tom Zioncheck, senior The company also is getting very inter- prove patient outcomes. Deal terms were director of business development, com- ested in coopting the proteasome and not disclosed. mented in an interview during the J.P. Mor- ubiquitin system to target protein degra- Merck KGaA said in a statement that the gan Healthcare Conference in January that dation of intracellular targets, which have technology will be used initially in cancer after oncology, investing in research tools historically been very hard to drug. treatment and patient services, but the and technology is a high R&D priority. Roche inked a licensing deal with C4 plan is to deploy it across all three of the Therapeutics Inc. in January 2016 for the company’s business sectors – healthcare, development of Degronomids, which de- life science and performance materials. grade proteins through a cell’s ubiquitin/ Novartis AG has deals in place with Ceru- proteasome system. lean Pharma Inc. for the biotech’s Dynamic This followed a deal by Genentech with Tumor Targeting nanoparticle-drug conju- Arvinas Inc. to develop PROTACs, which tag gate technology platform and with Perlara proteins for degradation through the ubiq- PBC Perlara PBC to access a rare disease uitin/proteasome system. drug discovery platform based on CRISPR Genentech also announced an exclusive gene editing technology. [ drug discovery collaboration in June with Carmot Therapeutics Inc., gaining access DIGITAL TECH DRIVES to Carmot’s Chemotype Evolution lead- DATA COLLECTION identification technology. Genentech will Novartis also is thinking much more these manage lead optimization, preclinical and days about data collection in trials, using clinical development as well as manufac- digital technology or sensors, because the turing and commercialization. big challenge for value-based payments is how to measure outcomes and the industry Shutterstock: Sashkin Shutterstock: The company is using Carmot’s frag- ment-based screening technology to isn’t there yet, Chief Medical Officer Vasant The company has stressed develop- develop candidates against undisclosed Narasimhan commented in an interview ment of highly engineered therapeutics, targets it has been pursuing, with hopes during the J.P. Morgan meeting. including bispecific antibodies, that will of reaching targets that have been very dif- Pharma companies are under pressure allow Roche to design “fit for purpose” ficult to drug, Zioncheck said. from payers to provide information, but molecules aimed at a large number of po- Many deals regarding access to platform haven’t invested enough in digital data tential targets. technology that can generate multiple mining for insights, he said. That’s why Zioncheck also noted that Genentech candidates are being signed. This provides Novartis is investing in a number of dif- has grown out of just being an antibody companies with more shots on goal to ferent companies to help, for example, to therapeutics company and now has a potentially provide a long-term pipeline do remote clinical trials using telemedi- very active and mature small molecule ef- of drugs, as opposed to assuming the risk cine technology and to mine electronic fort. Most of the company’s investment in that comes with in-licensing one or two health records in order to find patients research and tools today revolves around compounds, commented Datamonitor suitable for clinical trials, Narasimhan drug discovery technologies for small mol- Healthcare analyst Amanda Micklus. said. He also noted that the company ecules as well as large molecules. Sanofi paid $85m up front in 2007 in continues to look at remote sensors and “This includes looking at novel chemical a collaboration with Regeneron Pharma- other technologies that will help devel- libraries with unique chemical structures, ceuticals Inc. to gain access to Regen- op novel endpoints. really trying to find new and interesting eron’s VelociSuite technologies for thera- “I think that is going to be really important ways to target what have historically been peutic antibodies, which resulted in the for us to be successful,” the exec said. undruggable targets,” he said. development of PCSK inhibitor Praluent Published online 25 January 2017

14 | Scrip intelligence | 3 February 2017 © Informa UK Ltd 2017 R&D BITES

Stem Cell Data Boosts Asterias In Spinal Injury Tourette’s Syndrome – Hit and Miss For US regenerative medicine company As- Psyadon and Neurocrine terias Biotherapeutics Inc. is planning a potentially pivotal Phase II trial of AST- Two mid-stage trials – one positive, one negative – for two first-in-class OPC1, its stem cell therapy for spinal therapies for Tourette’s syndrome from Neurocrine and Psyadon have cord injury, in patients in early 2018 fol- highlighted the complexities of treating this underserved condition. Neu- rocrine Biosciences Inc. has just reported disappointing results for Ingrezza lowing continuing evidence of efficacy (valbenazine), while private company Psyadon Pharmaceuticals Inc. had six and nine months after treatment in more positive data for its lead product, ecopipam. Current pharmacologi- its ongoing Phase I/II SCiStar trial. The cal treatments for Tourette’s include alpha2-adrenergic agonists (eg clo- new data are only from five participants nidine), muscle relaxants (eg baclofen and clonazepam) and dopamine but the study’s lead investigator stressed D2 antagonists, such as Abilify (aripiprazole) but many patients remain the value of the benefits seen to these pa- symptomatic despite treatment, or experience side effects such as weight tients who had at baseline no motor or gain or sedation that limit their use. No drugs with a novel mechanism of sensory function below their injury. “Re- action have been approved for three decades, but there is a raft of prod- covery of upper extremity motor func- ucts employing a range of targets currently in the clinic for the disease. tion is critically important to patients oth valbenazine and ecopipam act on dopamine, but in a different way with complete cervical spinal cord inju- to their predecessors. Valbenazine is a highly selective small molecule ve- ries, since this can dramatically improve sicular monoamine transporter 2 (VMAT2) inhibitor that modulates do- quality of life and their ability to live in- pamine release during nerve communication, and has very little affinity dependently,” said Dr. Richard Fessler for VMAT1, other receptors, transporters and ion channels. Meanwhile, of the Rush University Medical Center. ecopipam selectively blocks the actions of the neurotransmitter dopamine He added that the patients were “seeing at the D1 receptor, in contrast to the dopamine antagonists currently ap- what we believe are meaningful improve- proved for Tourette’s which act at D2 receptors. The data for valbenazine ments in their ability to use their arms, in the 124-patient placebo-controlled Phase II T-Forward study showed hands and fingers at six months and that it missed the primary endpoint of change from baseline in the Yale nine months following AST-OPC1 ad- Global Tic Severity Scale (YGTSS) at week eight (p=0.18). Management re- ministration.” During a conference call mained upbeat however, as the drug did show a significant improvement discussing the results, Asterias indicated in overall symptoms of Tourette’s syndrome as evidenced by the Clinical its intention to additionally pursue clini- Global Impression of Change (p=0.015), even though the YGTSS measure cal development of AST-OPC1 in part- is favored by the FDA. Neurocrine has released no further trial details for nership in Japan, where the company fear of biasing its ongoing, and commercially much more important, study considers more streamlined regulatory in pediatric patients, T-Force GREEN. processes exist for regenerative medicine [email protected], 23 Jan 2017 products. Asterias expects its planned Phase II trial to form a pivotal study in that market. [email protected], 27 Jan 2017 staggering price, even by rare disease testing as well as severe disease as dem- standards: $750,000 for the first year onstrated by genetic testing or onset of of treatment, dropping to $375,000 disease symptoms before six months Biogen’s Life-Transforming in subsequent years due to the lower of age. The decision apparently limits dosing schedule. The antisense oligo- treatment to Type 1 SMA, the form of Drug Spinraza nucleotide, developed in partnership the disease that is the most severe and Biogen Inc. guided investors to expect a with Ionis Pharmaceuticals Inc., was effects infants, even though the drug gradual launch of Spinraza (nusinersen) approved by the US FDA on Dec. 23. was approved by FDA for children and for the treatment of spinal muscular at- Some industry observers have won- adults. The approval was based on rophy (SMA) during its fourth quarter dered if the high price tag could result one Phase III double-blind controlled sales and earnings call Jan. 26. The cau- in payer pushback, which has so far clinical trial called ENDEAR in symp- tious outlook is notable because Spin- been relatively minimal for drugs that tomatic infantile-onset SMA patients raza is the first life-transforming medi- treat rare diseases.The insurer Anthem and supported by open-label clinical cine approved for the devastating rare recently said it will limit access to Spin- trials in pre-symptomatic and sympto- neurodegenerative disease – not a drug raza to patients for whom treatment is matic patients likely to develop Types entering a competitive therapeutic cat- considered “medically necessary” – con- 1, 2 or 3 SMA. egory. But Biogen priced the drug at a firmed diagnosis established by genetic [email protected], 26 Jan 2017 scrip.pharmamedtechbi.com 3 February 2017 | Scrip intelligence | 15 EXECUTIVE PROFILE

Katherine Bowdish, Sanofi’s Early Science Investment Scout Katherine Bowdish, vice president of global R&D at Sanofi and leader of Sunrise, the French big pharma’s early-stage investment arm, talks to Scrip about living vicariously through biotech companies whilst having the power and backing of a pharma major to advance important, innovative science.

LUCIE ELLIS [email protected]

atherine Bowdish, the founder of an immuno-oncology company over a Kdecade ago that was forced to shelve research due to lack of interest and buy- in from investors at the time, talks about Sanofi’s early investment initiative, Sunrise. In the latest installment of Scrip’s executive profile series, she highlights the impor- tance of pharma collaboration with early science designed to accelerate not impede development. Bowdish joined Sanofi in February 2013 to launch Sunrise, an investment initiative for the big pharma based in Cambridge, Massachusetts, and focused on early-stage R&D. But she started her biotech career in the 1990s by launching Prolifaron, a pri- vately held antibody discovery company, which was eventually acquired by Inc. Now, as vice president of global R&D and head of Sunrise at Sanofi, Bowdish gets to finance early, innovative science – an im- Katherine portant focus for her and a prior stumbling Bowdish block for past personal research projects. Bowdish also represents Sanofi on the boards of directors for two Sunrise portfo- LE: What has been the most interesting LE: What are your future goals for Sunrise? lio companies, Warp Drive Bio Inc. and Por- part of setting up Sunrise? KB: We are a small team that is very selec- tal Instruments Inc. KB: For me, I enjoy driving creative science tive about the opportunities we engage LUCIE ELLIS: Can you explain a bit more forward. It is different to early-stage biotech, in; and this allows us to pay very close at- about Sunrise and your current role? being in this large pharma environment, tention to the companies in our portfolio. but in this role I get to stay entrepreneurial. I It’s about quality not quantity. The down- KATHERINE BOWDISH: Sunrise is a unit get to live vicariously through the scientists side of this is that we see a lot of great sci- within R&D at Sanofi, where we are invest- and the companies we invest in but across ence that we don’t get to access or part- ing in the future of healthcare. We partner a multiple therapy areas and programs. ner with. Expanding the Sunrise team and with and invest in leading scientists who even doubling down on our approach is are working on what we think could be LE: What is different about this initiative? transformative opportunities to change a goal. how patients are treated in the future. Op- KB: There are many investment and col- LE: How has Sanofi changed during your erationally we do this through company laborative models across the life science time at the company? co-creation; but importantly our focus is ecosystem, but Sunrise focuses on the to align interests and nurture the science relationship between two companies. We KB: There have been many changes with- at the early stages. The goal is to accelerate are transparent and deeply collaborative in the company over the last four years high quality science through to applica- – we have each party doing what they including a lot of leadership changes. But tions that benefit patients. I joined Sanofi do best. Importantly we collaborate in a Sanofi has great new people on board to build and lead Sunrise four years ago, way that doesn’t impede innovation; and within leadership. As the company comes and I have been doing this role ever since. aligning interests is very important to us. out the other side of these changes, we

16 | Scrip intelligence | 3 February 2017 © Informa UK Ltd 2017 EXECUTIVE PROFILE are still a large pharma seeking the best knew T-cell technology and we outlined LE: What is the best piece of advice you’ve medical innovations for patients. I am also a series of experiments in this area that ever been given? pleased to be able to say that through gave us very strong data showing immu- KB: Stay curious. In this industry, the most these changes over the last four years, my no-oncology ought to work. There were important thing is to stay curious and to role hasn’t changed; I think I have the best other advancements in IO at the time, be bold and innovative. job at Sanofi. I get to focus on entrepre- mostly in academic centers, but it took a neurial science and work with world-class long time for investors to see the poten- LE: What R&D development have you innovators. It is nice to have great partners tial. I am proud we were there and leading been most excited about recently? around the table truly focused on bring- the charge at that time. KB: Science is advancing at such a rapid ing the best science forward. pace, as I look broadly across the indus- try I am excited by the recent approval for LE: You have risen to a leadership position ‘In this industry the Biogen’s Spinraza (nusinersen) for spinal in your field. What aspects of your person- muscular atrophy. This is such an exciting ality have helped you get here? most important thing treatment available for patients that have KB: I had a variety of experience while is to stay curious such a debilitating disease. It is a much- navigating science early on in my career needed treatment that will benefit these and I found that I was really interested and to be bold and patients and their families. in intricate biological pathways. There I also think it is remarkable that hepati- were no scientists in my family to help innovative’ tis C is now a curable disease, that’s amaz- chart the course, so before I started my ing. But within Sanofi, we have a new drug PhD I spent time exploring different coming out, dupilumab, a monoclonal an- LE: What has been the most difficult mo- scientific environments. including two tibody for atopic disease – it is also chang- ment in your career? positions in academic institutes. I was ing the way patients can live their lives. lucky because one of these was at The KB: After Prolifaron was acquired I tried These are all very exciting developments. Scripps Research Institute, which was a to spin out a few programs to develop very entrepreneurial environment. At the IO projects but investors at the time LE: What do you look forward to seeing the time, I also chose to spend time in a were not convinced and I had to put the from the biotech sector in 2017? corporate or more applied scientific set- research on the shelf. For a variety of rea- KB: I want to see more from combination ting. I went to graduate school and then sons, I had to delay the pursuit of this sci- therapies that are raising the bar higher did a post-doc, after which I decided ence for nearly a decade. It was painful to for cancer patients. We are finally realizing to launch a company, Prolifaron, that do at the time, but I guess I have solved it the immune system can play a vital role in combined much of my earlier research. by joining the investing side and I get to treating cancer. The pharma and biotech I stayed with that company for 10 years readdress it a decade later. sectors are working hard to find out which through partnerships, an acquisition and are the best combinations to treat various LE: When was the last time you changed beyond. But I still had the biotech bug cancers. in my system and I went on to lead two your mind in a business decision? other early-stage companies: Anaphore KB: I have changed my mind a few times LE: Tell us one myth about the industry (now Birdrock Bio); and Permeon Biolog- about pushing an opportunity forward in that you’d like to set straight. ics, a company developing a novel ap- Sunrise, that is deciding not to go forth KB: I have heard people outside of the in- proach to intracellular delivery of bio- with a specific investment. With inno- dustry say pharma does not want to come logical therapies. During all this time vative science, sometimes the science up with cures because it will reduce its abil- in my career I actively said no to mov- might not be ready for us or in other cas- ity to make money in the long term. This ing into large pharma until I received es we might not be ready for the science. just isn’t true, it’s amazing how many hard- a called from Sanofi. This role leading In this case, we were not quite ready working scientists there are trying to come Sunrise felt different: I was brought in to for the science, this was broadly in cell- up with the best treatments for patients. launch a unit to invest and simultane- based therapies. We decided as a group ously partner with leading scientists. The we weren’t ready to go down that path LE: Finally, whom do you admire in the in- goal was to bridge gaps and accelerate just yet. dustry, and why? the science. KB: Elias Zerhouni, Sanofi’s global presi- LE: Where would you like to be in five dent of R&D, comes to mind for me. He is LE: What has been the proudest moment years’ time? very smart and thinks very broadly – but of your career? KB: That is a tough one. I enjoy what I do can also drill down to the detail when it KB: One of my proudest moments was and I believe that Sunrise is the right way is required. I admire that when everyone when I was leading Prolifaron in the early to impact, partner and nurture early-stage else is looking under the lamppost, Elias 90s. We stumbled into immuno-oncology science. I still feel that I can be helpful in can step back and see the bigger picture. from a discovery in a scientific fishing -ex the efforts Sunrise and others are taking He is very insightful in his role. pedition. I had experts on my team that to nurture early-stage scientific research. Published online 23 January 2017 scrip.pharmamedtechbi.com 3 February 2017 | Scrip intelligence | 17 BUSINESS BULLETIN

AbbVie’s Cancer Expansion Is Paying Off Billions On The Line With Celgene’s With sales declining for hepatitis C fixed- Partnered Pipeline dose combo Viekira Pak, AbbVie Inc. wants to convince investors that its can- Celgene Corp. had another double-digit growth year and expects sales cer portfolio and pipeline – led by hema- spikes to continue for the next several years. Driving that view is exist- tology drugs Imbruvica and Venclexta – ing blockbusters as well as mid- to late-stage research and development offer a pathway to sales growth that will programs, many of which the company highlighted in its Jan. 26 earnings enable the pharma to keep diversifying report. Celgene is one of the most transparent public biopharmaceutical from top-seller Humira. AbbVie has been companies in terms of financial projections for the near, mid- and long- criticized as a one-product shop since it term, so the big biotech firm spent much of its fourth quarter earnings was spun out of parent Abbott in 2013, conference call providing more clarity in regard to research and develop- and much of the company’s efforts since ment milestones for the next few years and how they may impact revenue then have been put into diversifying its growth. Many of those R&D programs are drug candidates that Celgene portfolio before encountering competi- bought or is developing with partners, such as the closely-watched oza- tion from biosimilars and new classes. nimod, which the company acquired in 2015 via its $7.2bn acquisition of HCV and cancer franchises are core pil- Receptos Inc. Celgene reported $2.98bn in net product sales for the fourth lars of that strategy. AbbVie reported quarter and $11.19bn for the year, representing year-over-year increases of during its fourth quarter and full-year 17% and 22%, respectively, largely in line with analyst consensus expecta- 2016 earnings call Jan. 27 that Humira tions. The gains were driven by the company’s keystone product Revlimid (adalimumab) posted full-year sales of (lenalidomide) for multiple myeloma, which generated $1.8bn in world- $16.1bn ($10.43bn US/$5.65bn interna- wide sales for the quarter and $6.97bn for the year, rising 15.9% and 20.2%, tionally), good for 14.7% year-over-year respectively. Guidance for $13bn to $13.4bn in full-year 2017 revenue growth overall. Most of that growth across all of Celgene’s products – an 18% increase from 2016 at the mid- came domestically: sales of the TNF in- point of the range – was unchanged from what the company presented hibitor rose 24.1% for the year in the US during the J.P. Morgan Healthcare Conference in San Francisco earlier this and 4.3% in the rest of the world. Humira month. Celgene also maintained its goal of more than $21bn in annual brought in $4.3bn in the fourth quarter, revenue by 2020, but noted that most of its later-stage R&D programs are up 15% from the same period in 2015. not included in that forecast. The nearly $2.9bn in US sales represent- [email protected], 26 Jan 2017 ed 23.5% growth, but the international total of $1.4bn was only a 4.1% increase. It still garners well over half of the firm’s hemophilia drugs, a broad lifecycle 6 analyst meeting, the spin-out’s man- total revenue; Humira brought in 63% of management strategy and business agement released 2017 guidance call- AbbVie’s fourth quarter sales of nearly development ambitions. The company ing for revenue growth of 17% to 19%. $6.8bn. Meanwhile, Viekira Pak (ombi- is scheduled to spinout from Biogen The company will employ roughly tasvir, paritaprevir, ritonavir/dasabuvir) Inc. as an independent company Feb. 400 people. Growth in the near-term fell 44% on the quarter to $311m due 1, with full trading to resume on NAS- will be driven by expansion of the two to discounting, declining patient starts DAQ under the symbol BVV the next young brands, which both launched in and competition from a third fixed-dose day. CEO John Cox talked about the 2014. The products have only recently combination product, sector leader Gile- company’s independent growth strat- launched in Japan and Canada and are ad Sciences Inc.’s Epclusa (sofosbuvir/ egy during an interview Jan. 11 at the launching now in Europe through a velpatasvir). The fourth quarter total J.P. Morgan Healthcare conference. partnership with Swedish Orphan Bio- came in 16% below consensus estimates “The goal is to build a really extraor- vitrum AB, under which Bioverativ will of $370m. For the full year, Viekira sales dinary rare disease company focused receive a royalty. Real-world experience totaled $1.5bn, down 6.4% from 2015. on blood disorders starting with he- with the products is driving growth in [email protected], 27 Jan 2017 mophilia,” he said. Biogen announced the US, Cox said. “It started off – be- plans to spin off its hemophilia fran- cause of the long-acting nature – peo- chise in May; the business includes ple have the benefit of not having to Bioverativ Hits The Street two long-acting products, Eloctate dose so often,” he said. “What is really Bioverativ Inc. – a new biotech focused for hemophilia A and Alprolix for he- happening is people are realizing what on rare blood disorders – expects to mophilia B. The two drugs generated it means is extended protection for deliver long-term growth by expand- $846.9m in 2016, growth of 52%, Bio- your lifestyle.” ing the use of its two long-acting gen announced Jan. 26. During a Jan. [email protected], 26 Jan 2017

18 | Scrip intelligence | 3 February 2017 © Informa UK Ltd 2017 HEADLINE NEWS

Lenvatinib Measures Up In HCC But Prospects Limited? IAN HAYDOCK [email protected]

Eisai’s lenvatinib has hit its primary end- cluding China.” Whether lenvatinib will be hypertension, diarrhea and weight loss, and point in a large Phase III trial comparing able to carve a significant position away were consistent with the drug’s known safe- it with sorafenib in first-line hepatocel- from entrenched first-line competitor ty and toxicity profile. lular carcinoma, paving the way for regu- sorafenib (Bayer AG’s Nexavar) remains an HCC accounts for 85-90% of primary liver latory filings in the important indication open question, however. cancer, which in turn causes an estimated and strengthening the firm’s expansion The trial, Study 304, randomized 954 700,000 deaths globally every year, with strategy in oncology. patients with advanced HCC to either len- China and Asia major areas of incidence. vatinib 8mg or 12mg once a day depend- Informa’s Datamonitor Healthcare forecasts n open-label international Phase III ing on baseline body weight, or sorafenib that the total HCC market in the US, Japan trial comparing Eisai Co. Ltd.’s lenva- 400mg twice a day, until disease progres- and five major European markets will peak Atinib mesylate with the current stan- sion or unacceptable toxicity. at $954m in 2018, led by the US. dard of care in the first-line treatment of un- While Eisai did not release detailed results However, while lenvatinib will provide resectable hepatocellular carcinoma (HCC) (which will be presented at an upcoming an important new therapy, it sees the has met its primary overall survival endpoint. (unspecified) academic conference), it said drug capturing only a small proportion of The top-line results set the stage for the the study met the statistical criteria for non- Nexavar’s already dominant market share submission of approval filings for the oral inferiority in overall survival compared to in the first-line setting; sales are expected multi-kinase inhibitor in the new indication in sorafenib, the primary endpoint. to peak at a modest $163m in these same major markets, probably this year, and provide A range of secondary endpoints includ- markets in 2019. another boost to the Japanese firm’s strategic ing progression-free survival, time to pro- Published online 25 January 2017 push into oncology, which is marked by use gression, and objective response rate were expansion for its two main products. also met, with lenvatinib showing “statisti- CLICK Eisai stated that it plans “to hold discus- cally significant and clinically meaningful Read full story at: sions with regulatory authorities for submis- improvement” against these. The most com- http://bit.ly/2kLeAue sion in Japan, the US, Europe, and Asia, in- mon adverse events in the study included

Scrip Awards Sponsored by Winner 2016 WuXi AppTec’s Biotech Company of the Year Award

Genmab’s business achievements over the period led to a third year of profitability and a significant increase in its valuation. The company received EU and US approval for Darzalex, plus expanded US approval for Arzerra, and entered into a new collaboration with Novo Nordisk for its DuoBody bispecific antibody technology. Winner: Genmab

‘I am proud and humbled to accept this honor on behalf of a highly talented team at Genmab. We will continue to strive creating and developing products that transform the treatment of cancer.’ Scrip Awards Pharma intelligence | informa Genmab’s President and CEO, Jan van de Winkel

scrip.pharmamedtechbi.com 3 February 2017 | Scrip intelligence | 19 EXPERT VIEW

How To Get Ahead In The Trendy World Of IO With basic research in immuno-oncology still very limited, there are still a lot of opportunities to develop new breakthrough therapies beyond checkpoint inhibitors, companies active in the space said during a panel at the recent Biotech Showcase. EMILY HAYES [email protected]

ewcomers to immuno-oncology need to take smart risks “How? I don’t know. Nobody knows. It is a terrifically exciting and make courageous decisions to explore completely new field. I don’t know how to study it but it’s starting to become a little Nareas of inquiry, rather than follow the now well-worn devel- bit clear and I certainly don’t know what to do about it. This is going opment paths of checkpoint inhibitors, industry execs advised dur- to be important in the future,” Mellman said. ing a panel at the recent Biotech Showcase, held in parallel with the The genetic makeup of each individual patient is also important. J.P. Morgan Healthcare Conference in San Francisco. In inflammatory conditions, researchers have known for years that Checkpoint inhibitors targeted at PD-1 and CTLA-4 have trans- certain genes predispose patients to illness and that the combi- formed cancer treatment in recent years. During a Jan. 11 panel on nation of the microbiota, genetics and environment influence re- the “overflowing IO buffet,” Tito Serafini, CEO of immune profiling sponse. This is likely to be the case in cancer as well but the area company Atreca Inc., noted that hundreds of companies are doing is poorly understood and studied and likely to be where the next trials with existing therapeutic modalities, however. major breakthroughs are going to occur, Mellman said. Serafini advised companies looking to get off the ground in -im “What to do about it I don’t know. That is where the innovation, muno-oncology that they would be better off developing a new that’s where the risk and scientific courage come in to try and sort mechanism of action and must always be looking years ahead to that stuff out,” Mellman said. anticipate where the field will be at that time. Take calculated risks, Serafini noted that Roche’s cancer drug Rituxan (rituximab) works Serafini said. “Take a chance. You are going to have to take a chance.” by acting on B-cells, which in turn instruct T-cells. “There are mul- tiple other major levers that can be pulled given the complexity of BASIC RESEARCH LACKING the system and it’s important to look at the biology for unexploited Ira Mellman, VP of immunology at Genentech Inc. commented that levers,” Serafini said. historically, immunologists didn’t pay much attention to cancer while Mellman said that he is optimistic that progress will continue and cancer research was largely focused elsewhere, so consequently, ba- that that his company is always on the lookout for novel, scientifi- sic research is lacking. Whereas traditionally, ideas are explored in the cally exciting technologies externally. lab and then taken into the clinic, the reverse is true when it comes In September 2016 Genentech established a collaboration to cancer immunology – scientists see what works in the clinic and with BioNTech AG, which developed a platform for messenger then figure out why it works in the lab. RNA-based personalized cancer vaccines, for $310m. Genentech “There is an enormous backlog of basic fundamental scientific realized that if it were to develop a platform it would be exactly understanding regarding the field that is just open for grabs,” the like what BioNTech had already developed. At the time BioNTech exec said. started, cancer vaccines were not in favor – the idea of a personal- Atreca’s Serafini agreed that a lot of basic research is yet to be ized cancer vaccine, where a new drug is made for every patient done. “This is at least a 20-year program to really understand how with a turnaround time of 2-4 weeks seemed “completely nuts,” the immune system can be used to combat cancer,” he said. Mellman said. Most of the development in the field has been focused on tar- Robert Coffin, CEO of Replimune Ltd., commented that at the geting T-cells to improve response to cancer. Intracellular small time talimogene laherparepvec started in in development at Bio- molecule targets haven’t received much attention but given the Vex Inc. in the late 1990s there was “huge skepticism” about onco- toxicities of checkpoint inhibitors like Bristol-Myers Squibb Co.’s lytic viruses. BioVex was acquired in early 2011 by Amgen Inc. in anti-CTLA-4 Yervoy (ipilimumab), having a small molecule ap- a deal worth about $1bn and the drug was approved in 2015 for proach with stimulatory activity will turn out to be important, melanoma. Mellman said. Timing is everything, but even with timing you need strong logic There is more to getting T-cells to work better than targeting and strong data – the right combination of the two to achieve max- them directly, he said. Immune response involves cyclical series imum traction, said Coffin, who was a founder of BioVex. of events that starts with antigen processing and getting T-cells Coffin said that he believes oncolytic viruses, which stimulate into the tumor so that they may respond to checkpoint inhibitors. the immune system, may well turn out to be the natural partner Genentech is looking to partner with companies that are for other approaches, including checkpoint inhibitors. The check- where it needs to be as the understanding of cancer immunity point inhibitors release the brakes on the immune system, but “un- and biology develops. In immunology broadly, there has been less there is an ongoing immune response in the first place there’s an understanding that every patient has an immune set point nothing for checkpoint blockade to get hold of,” he said. Co-stimu- that influences response to diseases. Emerging data suggest latory approaches are a popular field of research in immunotherapy that two or three key things control the set point, including the combinations. microbiota. Published online 23 January 2017

20 | Scrip intelligence | 3 February 2017 © Informa UK Ltd 2017 STOCKWATCH

Mistaken Acquisitions Dim Earnings Season Fourth-quarter earnings reports from J&J, Novartis, AbbVie and Biogen all missed on sales but more worryingly, lower sales from some recent acquisitions contributed to the missed expectations. The time from child star to problem child seems to be shorter than I remember. ANDY SMITH

ast week I had the honor of review- side a strong US dollar and biosimilar Remi- (adalimumab) (although, like J&J, it beat ing the work of this year’s cohort of cade (infliximab) were factored in, while the earnings expectations). The stock price of LUniversity of Cambridge Masters of divestment of the problematic diabetes AbbVie closed the day of its announce- Bioscience Enterprise students. A common business – acquired for $1.3bn from In- ment and the week down about 2%. The theme in many of the companies analyzed verness Medical Technology Inc. – and any fading of the acquisition of Pharmacyclics was that some of last year’s biggest acquisi- tax rate changes by the new Republican may however not be disappointing Ab- tions are now looking like mistakes. I specu- administration weren’t. J&J weren’t the only bVie’s investors as much as their concern lated that had you asked the CEOs of Mylan ones taking the opportunity to view its past about the potential near-term intellectual NV, Lannett Co. Inc. and Teva Pharmaceu- acquisitions as problem children with No- property challenges to Humira. tical Industries Ltd. if they had the choice vartis AG floating the idea that its troubled Biogen Inc.’s fourth-quarter results fol- of turning the clock back and avoiding Inc. eye care business could now be lowed the same script set by J&J and Ab- the acquisitions of Meda AB, Kremers Ur- a disposal. bVie by missing analysts’ consensus esti- ban Pharmaceuticals Inc. and the generics Before the week was out J&J had increased mates of sales, but modestly beating on business of Allergan PLC, respectively, they its 2017 sales beyond its guidance when it earnings. Biogen’s sales were also affected would probably now jump at the chance announced the $30bn acquisition of Actelion by the stronger dollar but there appeared of not swelling their debt burdens in ex- Pharmaceuticals Ltd. to be more than a crumb of comfort in change for assets that have since started to Much of the commentary I read settled on the results as its share price finished the sour. In the same way, the CEO of Shire PLC J&J paying a very rich price for the commer- week up just under 4%. The completion may soon be ruing its acquisition of Baxalta cial assets of Actelion and left me wondering of the spin-off of Biogen’s hemophilia Inc. As the opening week of fourth-quarter if the transaction would come back to haunt franchise into Bioverativ Inc. was probably earnings season progressed, it brought a J&J. Even without the impending generici- the source of the support. The competi- similar perspective on companies and their zation of Tracleer (bosentan), Actelion’s first tive dynamics of the hemophilia market acquisitive mistakes. drug for the treatment of pulmonary hyper- are about to change significantly with the Johnson & Johnson (J&J) might have set tension (PAH), the recent clinical failure of its emergence of gene therapies and Roche’s the scene for fourth-quarter earnings sea- successor Opsumit (macitentan) in a label- emicizumab so while Biogen’s sharehold- son by reporting sales that were $156m expansion trial before J&J’s acquisition an- ers can breathe a sigh of relief, Shire’s below analysts’ consensus estimates. The nouncement and the European approval of a $32bn of the hemophilia specialist Baxalta sales miss was not just for the company as generic version of another of Actelion’s drugs now looks likely to be a mistake and an a whole but also in its pharmaceutical divi- for PAH – Zavesca (miglustat) – announced eventual problem child. sion which usually picks up the slack in the after the acquisition, must have given J&J at The opening salvo of fourth-quarter healthcare conglomerate. It was J&J’s lower least a few concerns. earnings season was an inauspicious start profitability divisions that helped out with At least part of the weakness in J&J’s with sales shortfalls across the board. This the $236m pharmaceutical shortfall com- pharmaceutical division was due to a bad situation would be made much worse pared to analysts’ estimates with its medical $29m quarterly sales shortfall compared and possibly lead to a re-rating of the whole diagnostic and device sales meeting ana- to analysts’ consensus estimates of Imbru- sector if the underperformance of recent lysts’ expectations and its consumer divi- vica (ibrutinib) for hematological cancers. acquisitions is seen as the culprit. Investors sion sales beating expectations by $67m. Imbruvica was a 50:50 co-development who believed the rosy sales promises of Although J&J’s earnings modestly beat by J&J and partner Pharmacyclics Inc. acquiring CEOs are likely to end up regard- analysts’ expectations – leading the ana- before Pharmacyclics was acquired for ing those problem child acquisitions in the lysts from JP Morgan to describe the results $21bn by AbbVie Inc. When AbbVie re- same was as Mexican avocado farmers view as “mixed” – it was J&J’s below-consensus ported its fourth-quarter results at the the border tax. sales and earnings guidance for 2017 that end of the week, those weak Imbruvica stole the show and probably resulted in sales that were an irritation at J&J were Andy Smith gives an investor’s view on life the 2% share price drop on the day of its magnified in the smaller AbbVie and com- science companies. He has been lead fund announcement and a 0.5% underperfor- pounded by the strength of both the US manager for four life science–specific funds, mance against the NYSE ARCA Pharma- dollar and weakness in its HCV franchise. including 3i Bioscience, International Bio- ceutical Index which finished the week In consequence, AbbVie missed analysts’ technology and the AXA Framlington Biotech down 0.13%. J&J’s 2017 guidance included expectations of sales despite a good per- Fund, and was awarded the techMark Tech- a number of moving parts. On the negative formance by its biggest product Humira nology Fund Manager of the year for 2007.

scrip.pharmamedtechbi.com 3 February 2017 | Scrip intelligence | 21 PIPELINE WATCH

Scrip’s weekly Pipeline Watch tabulates the most recently reported late-stage, Phase III clinical trial developments for the more than 10,000 CLICK drug candidates under active research worldwide. To see changes to the Visit the Pipeline Watch webpage at progress of product candidates further back in the development pipeline, scrip.pharmamedtechbi.com for all and a table of the week’s product approvals, please visit our Pipeline the week’s changes to the industry’s R&D pipeline Watch webpage at scrip.pharmamedtechbi.com.

Selected clinical trial developments for the week 20–26 January 2017

LEAD COMPANY/PARTNER COMPOUND INDICATION COMMENTS Phase III Results Published Novartis AG Zykadia (ceritinib) non-small cell lung cancer ASCEND-4; in The Lancet online, Jan. 23, 2017.

Clostridium difficile Merck & Co. Inc. Zinplava (bezlotoxumab) Modify I, II; NEJM, Jan. 26, 2017. infection recurrence

Phase III Interim/Top-line Results

Study 304; non inferior on overall survival, first-line unresectable Eisai Co. Ltd. Lenvima (lenvatinib) better than sorafenib on PFS and objective liver cancer response rate.

Actelion Pharmaceuticals Ltd./ MAESTRO; missed primary endpoint of change in Opsumit (macitentan) Eisenmenger syndrome Nippon Shinyaku Co. Ltd. exercise capacity on 6-minute walk test.

Phase III Initiated

Waldenstrom Versus ibrutinib, two Bruton tyrosine BeiGene (Beijing) Co. Ltd. BGB-3111 macroglobulinemia kinase inhibitors.

fremanezumab chronic cluster headache Monthly average number of attacks Teva Pharmaceutical Industries Ltd. (TEV-48125) (migraine) to be assessed.

primary immune Biotest AG IgG next generation Study 992; in 40 patients in Europe. thrombocytopenia

mirvetuximab soravtansine ImmunoGen Inc. (an antibody drug ovarian cancer FORWARD I; in platinum resistant disease. conjugate)

Phase III Announced

daprodustat (a hypoxia anemia associated with GlaxoSmithKline PLC inducible factor-prolyl To be compared with erythropoietin. chronic renal disease hydroxylase inhibitor)

rovalpituzumab tesirine (an AbbVie Inc. small cell lung cancer MERU; as maintenance therapy. antibody drug conjugate)

Jazz Pharmaceuticals PLC JZP-258 narcolepsy Around 130 patients will be enrolled.

Novartis AG Cosentyx (secukinumab) psoriatic arthritis In juvenile disease subtype.

prevention of BeyondSpring Inc. plinabulin chemotherapy induced In docetaxel treated patients. neutropenia Source: Biomedtracker

22 | Scrip intelligence | 3 February 2017 © Informa UK Ltd 2017 APPOINTMENTS

Sanofi has appointed Kathleen Tregoning to this, he held medical leadership posi- focused biopharma company, which was a member of its executive committee and tions at Pfizer Inc, Boehringer-Ingelheim, acquired by Amgen in 2012. Before this, executive vice president, external affairs – Linde and the University of Surrey’s Clini- he was president, CEO and on the board of effective Feb. 27, 2017. Tregoning joins Sa- cal Research Centre. NPS Pharmaceuticals. Coles has also held nofi from Biogen where she was senior vice leadership positions in the biopharmaceu- president of corporate affairs. She carries Cambridge Innovation Capital (CIC) tical and pharmaceutical industries includ- over 20 years of professional experience in has appointed Michael Anstey invest- ing Merck & Co. Inc., Bristol-Myers Squibb policy, advocacy, stakeholder outreach and ment director specialising in healthcare Company and . external engagement. She began her career investments. Anstey joins CIC from The with Andersen Consulting in San Francisco Boston Consulting Group’s (BCG) office Antibody company, Abpro, has appointed and later served as assistant deputy mayor, in Toronto, Canada, where he was princi- Adam Mostafa chief financial officer (CFO). office of the mayor for the city of Los Ange- pal in the healthcare practice area. He is Mostafa has worked as managing director in les. Tregoning joined Biogen in 2006 as vice a co-founder of a Canadian biotechnol- the healthcare investment banking group president, public policy and government af- ogy company, Proteorex Therapeutics Inc. at Cantor Fitzgerald and before this, he was fairs and in 2015 was appointed senior vice Before BCG, he worked in venture capital, with Needham & Company, CRT Capital president, corporate affairs. investing predominantly in healthcare and Group and Citigroup as a member of their life science businesses. healthcare investment banking groups. In other Sanofi news, the company has also appointed Hugo Fry general manag- Mark W. Schwartz has resigned from Ga- MyoKardia Inc. has appointed June Lee er for the UK and general manager Sanofi lena Biopharma and its affiliates as the chief operating officer and Radhika Tripu- Pasteur for the UK and Ireland. In addition president, CEO and member of the board raneni vice president, medical affairs. Previ- to this, Hubert Bland has been appointed of directors. The company’s board of direc- ously, Lee was on the faculty of the Univer- UK medical chair and medical head of dia- tors expects to appoint an interim CEO in sity of California, San Francisco, where she betes and cardiovascular for the UK and the coming weeks. was director of the Catalyst program at the Ireland. Fry has more than 20 years of ex- Clinical Translational Science Institute and perience in the pharmaceutical industry Regeneron Pharmaceuticals Inc. has professor at the School of Medicine. Tripu- and has held various global and regional appointed Tony Coles to its board of direc- raneni brings more than 10 years of experi- management, commercial strategic roles. tors. Coles is chair and CEO of the neuro- ence to MyoKardia and most recently, she Before Sanofi, Fry was chief marketing of- degenerative disease-focused company, was vice president, medical affairs at Syna- ficer for Sanofi Pasteur MSD. Bland joins Yumanity Therapeutics. Previously, he was geva BioPharma (later Alexion Pharmaceu- Sanofi from TMC Pharma, where he was president, CEO and chair of the board ticals). Previously, she was cardiovascular vice president of medical since 2013. Prior for Onyx Pharmaceuticals, an oncology- medical director at Gilead Sciences Inc. Scrip ELEANOR MALONE @SCRIPELEANOR LUCIE ELLIS @SCRIPLUCIE YING HUANG [email protected] [email protected] [email protected] ALEXANDRA SHIMMINGS @SCRIPALEXS LUBNA AHMED @SCRIPLUBNA JUNG-WON SHIN [email protected] [email protected] [email protected] SUKAINA.VIRJI @SCRIPSUKI PAUL WILKINSON @PAUL__WILKINSON BRIAN YANG [email protected] [email protected] [email protected] ANJU.GHANGURDE @SCRIPANJUG JOHN HODGSON @SCRIPJOHN [email protected] [email protected] All stock images in this publication MANDY JACKSON @SCRIPMANDY MIKE WARD @SCRIPMIKEWARD courtesy of www.shutterstock.com [email protected] [email protected] unless otherwise stated. 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scrip.pharmamedtechbi.com 3 February 2017 | Scrip intelligence | 23 BIO-EUROPE S PRING® BARCELONA, MARCH 20–22 SPAIN // 2017

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