Corporate Affairs: Biopharma’S First Line of Defense Against Scrutiny by WILLIAM LOONEY

VOLUME 37 NUMBER 09

OCTOBER 2019

Corporate Affairs: Biopharma’s First Line Of Defense Against Scrutiny BY WILLIAM LOONEY

Coordinated Open Data Will Drive MorphoSys: A European Champion The Case for Agile Innovation Next-Level Research Crossing The Biopharma Rubicon In Health Care PAGE INTENTIONALLY LEFT BLANK invivo.pharmaintelligence.informa.com STRATEGIC INSIGHTS FOR LIFE SCIENCES DECISION-MAKERS CONTENTS ❚

October 2019

8 COVER ❚ Corporate Affairs: Biopharma’s First Line Of Defense Against Scrutiny William Looney

Amgen’s Judy Gawlik Brown is using her finance and consumer health background to make the big biotech’s message more authentic and accessible – a refreshing reset against today’s disconnected world of alternative facts.

14 18 22 Coordinated Open Data MorphoSys: A European PureTech’s Problem-Solving Will Drive Next-Level Champion Crossing The Skills Target The BIG Picture Health Research Biopharma Rubicon ASHLEY YEO LUCIE ELLIS ANDREW MCCONAGHIE PureTech Health has amassed niche Experts from a European data sharing The Munich-based company is one expertise and built a unique structure that initiative talk about the importance of of a handful of mature European allows it to develop technologies for coordinated computational biology biotechs poised to enter the big league. unmet needs in the separate but related efforts for the future of life sciences New CEO Jean-Paul Kress talks to In Vivo areas of brain-immune-gut. Senior innovation. about the firm’s next generation executives Eric Elenko and Joep Muijrers antibody platform and why US reveal more about the focus and aims of expansion is crucial to its future. the Boston, US group. 26 Digital Labels: Reimagining ERIC ELENKO Product Information In The Digital 30 Age To Improve Patient Outcomes The Case For Agile Innovation AMY CHEUNG, OLIVER STECK, MUKESH SINGHAL, SHIMON YOSHIDA In Health Care AND SHARON GORMAN KALYAN JONNALAGADDA, The rules behind product labeling have DAVE FLEISCH AND PETE HULTMAN JOEP MUIJRERS not undergone any significant revisions In a recent Bain & Company survey, nearly in the major markets of the US and 80% of health care executives said they Europe for many years, but is this about needed to be more agile. Yet more than to change? In the last decade two seminal half said they were not familiar with formal shifts have occurred which suggest this agile methodologies and tools, and were may be the case. not using them in their companies.

October 2019

DEPARTMENTS ❚ From The Editor AROUND THE INDUSTRY This month In Vivo is exploring different issues of 4 Can Novartis Reclaim Pioneering prominence for the biopharma industry – with Role In Transplantation? reputation leading the discussion. JOHN DAVIS Our cover story is focused on the evolving role of a critical but often overlooked function within the 5 International IP Arbitration – pharma model: corporate affairs. In an exclusive A Blessing Or A Bad Idea? interview, Amgen’s Judy Gawlik Brown gives an DOROTHEE SCHRAMM open account of what it takes to lead corporate affairs within a large drug company. Brown took on 34 ON THE MOVE the role of senior vice president for corporate affairs at Amgen in Spring this year, replacing Ray Recent executive appointments Jordan, who had held the title since 2012. She is in the life sciences industry LUCIE ELLIS responsible for strategic communications across REGINA PALESKI Amgen, including internal and external comms, issues management and philanthropy. Previously, Brown worked at Perrigo Company as EVP of business operations and CFO. She makes use of this in her 38 DEAL-MAKING mission to reposition Amgen as a “truly global player.” Deals Shaping The Medical Industry, Brown also discusses the ever-important topic of reputation. “There is no September 2019 doubt that it is tough to maintain a strong reputation in the context of chang- THE STRATEGIC TRANSACTIONS TEAM ing societal expectations,” she tells In Vivo’s William Looney. “There are companies in other areas who have maintained their reputation when the broader industry reputation suffered.” One example, Microsoft. Which has “had some success with this by building trust through best-in-class performance in digital security.” EXCLUSIVE ONLINE CONTENT Also included this month is a feature interview with MorphoSys’ new CEO Jean- invivo.pharmaintelligence.informa.com Paul Kress. He discusses the European biotech sector and how it is expected to evolve over the coming few years, as key biotech players continue to mature and ❚ GSK's Hal Barron On R&D reach key milestones. “The US market tends to reward innovation … It's a virtu- Progress At Two-Year Mark ous circle which works really well. But it is a mentality as much as anything,” ANDREW MCCONAGHIE Kress says, when assessing the European biotech market in comparison. Elsewhere, Ashley Yeo speaks with executives at PureTech Health, a company which has had its own issues with reputation recently. Senior executives Eric ❚ Device/Diagnostics Quarterly Elenko and Joep Muijrers reveal more about the focus and aims of the Boston- Dealmaking Statistics, Q2 2019 based group for its biopharma and technology portfolios. AMANDA MICKLUS AND Finally, an editorial note: eagled-eyed readers may have spotted an error in last MAUREEN RIORDAN month’s Personalized Medicine Infographic. The product Tegsedi (inotersen) was mislabeled. The company listed for this product should have been Akcea Therapeutics. ❚ Roche: We’ve Abandoned Budgets And It’s Liberated Employees ANDREW MCCONAGHIE In Vivo: Always Online First Don’t have an online user account? Quickly and easily create one Relevant and exclusive online-only ❚ Deals In Depth, September 2019 by clicking on the “Create your content at your fingertips 24/7. AMANDA MICKLUS account” link at the top of the page. Full access to our 36-year archive. Contact: Access your subscription by visiting: [email protected] invivo.pharmaintelligence.informa. or call: (888) 670-8900 or +1 (908) com and log in. 748-1221 for additional information.

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❚ Up-Front SNAPSHOTS FROM OCTOBER’S CONTENT

Akili leads the way in “Today’s corporate affairs professional role is harder digital medicine and than ever before. Deciding what kinds of content solving cognition will be most impactful to various problems. Depression, audiences and how it should be cognitive issues and MS, deployed are important strategic are potential applications, decisions. There are so many after ADHD. PureTech, options for people. Content of all which owns 34.9% of the kinds – from around the world – company, sees this as a is literally at their fingertips.” huge unmet need where PAGE 8 there are not many – Judy Gawlik Brown, pharmacological options. Amgen’s SVP For Corporate Affairs PAGE 22

One of the most remarkable things about MorphoSys, when considering a biotech of its size, is the breadth and depth of its pipeline. It has more than 100 distinct molecules in its pipeline, giving it what it calls “one of the broadest pipelines in the biotechnology industry.” PAGE 18

“ELIXIR is the only life Most Companies Struggle With Four Main Obstacles: PAGE 30 science data infrastructure at this scale offering 77% 71% openly available platforms, tools and services for scientists. Misaligned funding Lack of an enterprise-wide model for agile strategy for agile So, no matter where you are on the planet, you can access many of those 66% 57% resources and innovate.” PAGE 14

Company culture that Missing key IT enablers for – Katharina Lauer, does not support agile agile soware teams ELIXIR's Industry Officer

Can Novartis Reclaim Pioneering Role In Transplantation?

Novartis is developing a new type of immunosuppressive agent, an anti-CD40 mono- attack by the patient’s immune system, clonal antibody, which might allow organ transplants to last longer in recipients, leading to inflammation, the develop- reducing the pressure on transplant waiting lists and improving the long-term outlook ment of scar tissue and, eventually, fail- for patients. ure of the transplant. Standard therapies for immunosup- Novartis AG might soon be able to donated kidney fails, patients are placed pression like calcineurin inhibitors reclaim some of the kudos it once re- on hemodialysis and/or are added to (tacrolimus, ciclosporin), are associated ceived for developing groundbreaking transplant waiting lists, which for kid- with a range of side effects, so low doses transplant-enabling therapies like ciclo- neys in the US has more than 100,000 are administered that appear to allow sporin, through its pioneering of a new people on it. “Novartis did a great job, a patient’s immune system to continue class of potential products now in early 35 years ago, making organ transplants to attack organ transplants: “We need clinical development. The Basel, Switzerland-based multi- national has an impressive heritage in “Everyone is excited about iscalimab. the organ transplant sector going back more than 30 years, but the company We want to help. Novartis is happy has been rather quiet in this therapeu- to be contributing to a field we have tic arena in recent years. However, it is now developing a fully human anti- been involved in for so long,” CD40 targeting monoclonal antibody, Eric Hughes iscalimab (CFZ533), which acts to inhibit the CD40 signaling pathway and inhibit activation of CD40-expressing cells such as dendritic cells, monocytes and B-cells. Only a handful of companies have expressed an interest in this immunosuppressive process – in contrast to what appears to be a greater push to exploit the possible. But we need to do better now to find new drugs that prevent the slow opposite effect, CD40 activation, for the because the demand for kidneys is so inflammatory processes that damage development of new anticancer agents. high and the life of a person on hemodi- donor kidneys, without the harmful ef- That said, Novartis’s iscalimab has alysis is so miserable,” Hughes pointed fects of current treatments,” urged the achieved remarkable results in early- out in a recent interview with In Vivo. Novartis executive. stage clinical studies that have research- “The general public fails to realize Researchers are therefore hopeful ers in the field talking excitedly about the importance of keeping patients off that anti-CD40 monoclonal antibodies the drug's potential role in patients, hemodialysis. The procedure has a huge could be those sought-for well-tolerated particularly for prolonging the life of impact on the life of patients, who have immunosuppressive agents, with Hughes transplanted organs. to attend a clinic three times a week for pointing out that in early studies, “is- Prolonging the durability of organ three to four hours, and afterwards the calimab is showing great potential.” transplants could be key to reducing the patients don’t feel great,” Hughes said. Novartis is not alone in this endeavor – growing demand for donated organs. But why are kidney transplants not a small number of pharmaceutical compa- “Less than 50% of patients who receive lasting for longer with the benefit of im- nies are involved in developing anti-CD40 a kidney from a deceased donor have munosuppressant therapy? It all comes antibodies for improving the durability of that kidney survive more than 10 years,” down to achieving a balance between transplants. For example, Gaithersburg, explained Eric Hughes, Novartis’s global suppressing the immune system and not MD-based Viela Bio Inc. has VIB4920, development unit head for immunology, causing too many side effects; achieving an anti-CD40L-Tn3 fusion protein, at the hepatology and dermatology. After the this balance can leave kidneys still under Phase II-ready stage. And Astellas Pharma

4 | In Vivo | October 2019 invivo.pharmamedtechbi.com invivo.pharmaintelligence.informa.com invivo.pharmaintelligence.informa.com AROUND THE INDUSTRY ❚

Inc. has bleselumab (ASKP1240), an anti- mus, each combined with a treatment increase the rate of Epstein–Barr virus in- CD40 Mab, in Phase II for the recurrence of backbone of steroids plus mycofenolate. fection, and was well tolerated. focal segmental glomerulosclerosis in de Pathologists found that three of five Phase IIb studies have already started novo kidney transplant recipients, which patients treated with iscalimab had a with iscalimab, and are enrolling faster it is developing in partnership with Kyowa normal renal histology in their donated than scheduled. The company is hoping Hakko Kirin Co. Ltd. (Also see "Antibodies kidney, while none of the seven patients that it can accelerate development of the emerge as key focus for Kyowa Kirin" - treated with tacrolimus had such pristine drug in discussions with health authorities. Scrip, 5 Jun, 2009.) donated kidneys. Iscalimab also has promise in other But Novartis appears to be leading The findings were “very surprising, auto-immune conditions. “Top of our list the anti-CD40 effort, and Hughes said you wouldn’t expect that after a kidney right now is Sjögren’s disease, another iscalimab had been engineered to poten- transplant, you always have some level condition that has no good treatments, tially be the best-in-class. Any progress of smoldering inflammation,” Hughes and where patients are fatigued to would be a nice boost for a company said. And other preliminary data sug- such an extent that it affects their daily which no longer receives blockbuster gested that iscalimab was as effective lives," Hughes said. The company is also sales for its marketed immunosuppres- as tacrolimus in protecting transplanted evaluating the product in liver transplant sive agents: Neoral/Sandimmune (ci- organs from rejection during the first year patients, and one day hopes to extend closporin), had sales of $110m in the of therapy. The findings “suggested to us those activities to include cardiac trans- first half of 2019, and Zortress/Certican that the drug has the potential to extend plant patients. (everolimus) had sales of $250m (up by the life of transplanted kidneys, perhaps As well as improving the lot for pa- 7%) in the same period. for longer than 10 years," Hughes noted. tients, the development of iscalimab is “We weren’t expecting the strength of having a beneficial effect on the mood CLINICAL DATA the response or the type of response,” in Novartis. “Everyone is excited about In presentations at US and EU scientific he added. iscalimab. We want to help. Novartis meetings over this summer, clinical re- With all immunosuppressive drugs is happy to be contributing to a field searchers and Novartis researchers re- you run the risk of infections, but the data we have been involved in for so long,” ported biopsy data from a small subset of right now on the side effects of iscalimab Hughes concluded. patients from a clinical study of iscalimab were encouraging, Hughes continued. IV124338 versus the calcineurin inhibitor tacroli- In preclinical studies, iscalimab did not JOHN DAVIS

International IP Arbitration – A Blessing Or A Bad Idea?

Medtech companies traditionally resolved disputes over IP rights before national the joint R&D project, that project results courts, but more and more of them are now turning to international arbitration to make their way into patent applications protect their IP rights. Dorothee Schramm, a partner at Sidley Austin specializing in of some partners and into the products international commercial disputes, explains the benefits of this growing trend and of other partners. the pitfalls to avoid. If the partner seeking the patents then sues another partner for patent Intellectual property (IP) has an enor- ternational Contract Will Be Enforced" - In infringement, the infringement suits can mous value in today’s global innovation- Vivo, 4 Feb, 2019.) be brought in several jurisdictions, de- driven economy. It is also relevant to pending on where the products are sold common medtech contracts, such as PATENT DISPUTES IN A JOINT and manufactured. In such a scenario, an collaboration agreements for R&D, R&D PROJECT arbitration clause in the joint R&D agree- production and marketing, licensing Arbitration clauses can have an important ment may allow the partner who is sued for and distribution agreements, as well as impact on IP rights. Many companies patent infringement to initiate arbitration technology transfer agreements. collaborate and contribute to joint R&D in a neutral forum to claim co-ownership Such contracts with foreign partners projects. Agreements for such projects and access rights to the asserted patents, typically contain arbitration clauses to typically provide for joint patent owner- withdrawal of the infringement suits and resolve disputes that may arise and that ship if several partners contribute to a the cost of legal fees incurred in defending cannot be resolved through negotiations joint invention, and/or for perpetual, those suits as damages. and/or mediation. (Also see "Conflict royalty-free access rights to all knowledge In this exemplary scenario, interna- Management Strategies And Dispute resulting from the project. There is always tional arbitration can help a company en- Resolution Clauses – Ensuring Your In- the possibility following the completion of force its IP rights and avoid legal battles

that may take years, involve significant Moreover, many commercial disputes legal costs and risk conflicting decisions concern a variety of issues, some of which by different national courts in different may be IP related while others may not. countries. This scenario is typical in that In such cases, a carve-out clause may not most arbitrations over IP are about dis- only split a commercial dispute between putes over patents. Such disputes often different jurisdictions, but may also relate to: result in disagreements about whether • Patent ownership, including transfer certain aspects of the dispute must be of patents: examples are joint R&D cases, submitted to arbitration or state court liti- and cases of improvements patents con- gation. Carve-out clauses therefore often ceived during a contractual cooperation; lead to costly disputes over jurisdiction in addition to multiple parallel proceedings, • Utilization rights to patents versus which are costly, difficult to coordinate, patent infringement: examples are joint often involve several legal teams and may R&D cases, and licensing agreements lead to contradictory outcomes. where the licensee (allegedly) uses the These downsides have contributed licensed patent in new or modified prod- to the rise of IP arbitration, which can ucts beyond the limits of a license or after If a dispute concerns patent invalid- offer advantages in the form of six Cs: termination of a license; and ity, obtaining an award that affects only consolidation, confidentiality, choice, the rights between the parties is almost capability, clock and cost. • Patent invalidity: examples are always sufficient to satisfy the claim- As the joint R&D example described cases where the licensor argues that it ant’s main interest, such as a licensee’s above illustrates, international arbitra- owes no licensing fees because the pat- interest in having the licensor’s claim for tion offers the possibility to consolidate ent is invalid, and cases where patent royalty payments or patent infringement the overall dispute in one arbitration. An- inva