Sandoz’s Biosimilar Rejection Ups Key Clinical Data And Drug Expert View Risks, But Won’t Kill Market Approvals Expected New data on growth in China’s FDA’s rejection of Sandoz’s version of In 2H 2016 Scrip takes a look at some turbulent pharma sector paint a Amgen’s Neulasta has revealed the truth clinical trial read-outs and drug approvals mixed and complex picture, indicating that chasing the biosimilar market may expected, clinical trials due to report in both challenges and opportunities be riskier & more costly (p3) the second half of the year (p18) ahead (p20) 29 July 2016 No. 3813 Scripscripintelligence.com Pharma intelligence | informa space given what’s coming.” The company has previously stressed that its leadership position in chimeric antigen receptor T-cell therapy (CAR-Ts) will get it back in the thick of it. “I believe that we have a very strong self-generated, through in-licensing and through acquisition, early-stage immuno- oncology pipeline,” he said. And, he reiterat- ed the common refrain in the industry that success in the field will be determined over the long-term through the development of combinations. In May, Novartis announced a restructur- ing to break Novartis Oncology out into a separate business unit led by its own CEO, Bruno Strigini, who will report directly to Joseph Jimenez Jimenez. Merck & Co. Inc., Bristol and Roche have already launched the first immune check- point inhibitors, the PD-1/L1 inhibitors Key- Does Novartis Need A Big Immuno- truda (pembrolizumab), Opdivo (nivolumab) and Tecentriq (atezolizumab), respectively, while many others are in mid- to late-stage Oncology Deal? Jimenez Says No clinical development by drug makers like JESSICA MERRILL [email protected] AstraZeneca and Pfizer Inc. Novartis, which has been the number The oncology player missed out on the first The chief executive was pressed by ana- two oncology player in the world behind round of immune checkpoint inhibition lysts on two occasions during the compa- Roche, largely riding on the success of the and now some investors are wondering if ny’s second quarter sales and earnings call blood cancer blockbuster Gleevec (ima- the pharma needs to buy a rival to catch July 19 about whether or not Novartis needs tinib), is now trying to catch up in immuno- to complete an expensive acquisition, or up. During the company’s second quarter oncology at the same time Gleevec is fac- even consider buying an immuno-oncol- ing generic competition for the first time. sales call CEO Jimenez insisted Novartis ogy leader like Bristol-Myers Squibb Co. or The company’s other big cancer drug is the has the internal expertise to execute. AstraZeneca PLC to remain competitive in Gleevec follow-on Tasigna, which gener- oncology. ated $458m in sales in the second quarter, ovartis AG CEO Joseph Jimenez is Jimenez largely side-stepped the mega- up 15% despite the availability of generic maintaining that the Swiss pharma merger question by responding that he imatinib beginning in February. Nhas the internal expertise to execute wouldn’t speculate on what the company With its expertise in blood cancer, No- on its oncology strategy, despite having might do next in immuno-oncology. How- vartis bought quickly into CAR-T immuno- fallen behind rivals in the competitive field ever, he added, “I don’t feel like we have to therapy technology through a 2012 deal of immuno-oncology. do something in the immuno-oncology CONTINUED ON PAGE 8 BROUGHT TO YOU BY THE EDITORS OF PHARMASIA NEWS, START-UP AND SCRIP INTELLIGENCE IN THIS ISSUE J&J reports strong 2Q earnings and executives talk about While FDA supported approval strategy for defending against biosimilar competition in the US of brodalumab, several recommended a black box warning FDA approval of Valeant’s Relistor will pit the franchise against Movantik 9 11 13 COVER / Does Novartis Need A Big Immuno-Oncology Deal? from the editor Jimenez Says No [email protected] 3 Sandoz’s Biosimilar Rejection Ups Risks, But Won’t Kill Market The fully diversified big pharma corporation is a 4 Novo’s CSO Has A Lifetime Product Plan For business model that has been falling out of favor Diabetes Patients for years now. Lucie Ellis’s interview with Novo Nor- disk CSO Mads Krogsgaard Thomsen on page 4 7 Roche Sees Cancer Combos Start To Deliver highlights the risks of going too far the other way, though: specializing in one area has its own chal- 9 Valeant’s Oral Relistor Poised To Face-Off Against lenges, and not just because all your eggs are at risk AstraZeneca’s Movantik if something bumps your basket. You also have to 10 Emerging Diseases: Disruptive, Commercially Risky, worry about being your own worst enemy when it But GSK Has A Solution comes to competing on the market. Meanwhile, it’s results season, which is a tempt- 11 J&J Thinks It Can Win Over Biosimilar Competition ing time to bury bad news. Novartis was first to re- 12 Policy & Regulation Briefs port its financials (see cover story), and sure enough it had a couple of awkward revelations tucked un- 13 Suicide Warnings For Valeant’s Siliq Could Hinder Access To Psoriasis Treatment obtrusively into its 12-page announcement. It is understandable that a firm might be reticent about 14 Business Bulletin the fact that one of its US biosimilars had received 15 Changes Brewing At Bayer, But Pharma Strategy an FDA knockback (p3), or that it had flunked an Remains On Point inspection by the UK medicines regulator. Less obvi- ous is why it wouldn’t want to crow about its much- 16 Merck Singapore R&D Collab Looks To Get Peptides vaunted CAR-T program, which failed to make the Into Cells cut in a list of future blockbusters. 17 R&D Bites 18 Key Clinical Data And Drug Approvals Expected In 2H 2016 20 Expert View: Bounce Or More Bumps? New China Market exclusive online content Data Offer Bit Of Both 21 Stockwatch: Earnings Season Appears Not At Home Deal Watch: Galenica Offers For Relypsa, But Other To Brexit Suitors May Emerge 22 Pipeline Watch Allergan backs out of deal with Adamis for an EpiPen competitor just two months after signing the licensing deal, but before an up-front 23 Appointments payment due date kicks in. AbCellera to team with MassBiologics to discover antibodies against drug-resistant Klebsiella infections. http://bit.ly/2a5GzVI Where Is The Patient Voice In Alzheimer’s Disease Drug Development? Companies developing treatments for Alzheimer’s disease and other types of dementia are failing to incorporate the patient voice in their drug development plans, said Marc Wortmann, Executive Director, Alzheimer’s Disease International, in an interview with Scrip. @scripnews /scripintelligence http://bit.ly/2a942QT /scripintelligence /scripintelligence 2 | Scrip intelligence | 29 July 2016 © Informa UK Ltd 2016 HEADLINE NEWS Sandoz’s Biosimilar Rejection Ups Risks, But Won’t Kill Market DONNA YOUNG [email protected] The FDA’s rejection of Sandoz Inc.’s version of Amgen’s Neulasta Apotex’s application for its filgrastim biosimilar, which the com- (pegfilgrastim) has revealed the hard truth that chasing the bio- pany said in February 2015 was officially under review by the FDA, similar market may be a riskier and more costly endeavor than also likely has been turned away. The firm, however, has remained companies anticipated. mum on the matter and as a private company, doesn’t have to dis- close that information. andoz Inc. has appeared to be on easy street with its US biosim- ilars – being the first company to enter the US market last year, GREATER RISK Swhile another of its applications last week breezed through an But with Novartis confirming Sandoz’s US pegfilgrastim application FDA advisory committee meeting. had been declined, the risk for all biosimilar companies has just gone But stark reality came knocking: Sandoz was hit with a complete up – a concern that may have some firms contemplating backing response letter (CRL) for its version of Amgen Inc.’s long-acting away over worries they may have to work harder and expend more granulocyte colony-stimulating factor (G-CSF) Neulasta (pegfilgras- resources to bring a product to the US market, Fuhr said. tim) – reminding the biosimilar community that as much as some After all, he said, if the economics don’t add up and it looks like US regulators have appeared to be cheerleaders in recent months, biosimilar manufacturers may not get a good return on their invest- the agency won’t pull its punches if it decides a product isn’t ready ment, why go down that road, especially where there’s now even for prime time. more uncertainty –drug makers’ greatest fear. But, said Joseph Fuhr, professor of economics at Widener University, “These companies are going to look at this as another barrier to it’s also a reminder biosimilars is an emerging market in the US and market entry,” Fuhr said. “things like that happen along the way when you have a new industry.” He noted biosimilar makers already are contending with the 180- Nonetheless, Fuhr said the FDA’s rejection of Sandoz’s biosimilar day notice of commercial marketing a panel at the US Court of Ap- application brings home the hard truth it may be a riskier and more peals recently ruled was mandatory for all applicants, meaning it costly endeavor than companies anticipated. will be at least six months after approval before those firms can start bringing in cash from their products. BURYING BAD NEWS Sandoz’s parent company Novartis AG disclosed the news it had re- MARKET SURVIVAL ceived the CRL from the FDA for the pegfilgrastim biosimilar candi- But Fuhr said he wasn’t completely discouraged on the news over date by embedding a brief statement in its July 19 second-quarter Sandoz’s pegfilgrastim application being refused by the FDA.