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HUMIRA BIOSIMILARS: Battle Lines Shift from Education to Sustainability by MELANIE SENIOR

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HUMIRA BIOSIMILARS: Battle Lines Shift from Education to Sustainability by MELANIE SENIOR invivo.pharmaintelligence.informa.com OCTOBER 2018 Invol. 36 ❚ no. 09 Vivopharma intelligence ❚ informa HUMIRA BIOSIMILARS: Battle Lines Shift From Education To Sustainability BY MELANIE SENIOR A Phoenix Turn For Tonix: Immuno-Oncology: Unicorns, Aetion: Sealing The Deal With Rising From Phase III Ashes China And The Perfect Storm Payers On Real-World Research PAGE LEFT BLANK INTENTIONALLY invivo.pharmaintelligence.informa.com STRATEGIC INSIGHTS FOR LIFE SCIENCES DECISION-MAKERS CONTENTS ❚ In Vivo Pharma intelligence | October 2018 8 COVER ❚ HUMIRA BIOSIMILARS: Battle Lines Shift From Education To Sustainability Melanie Senior In October 2018 a handful of biosimilars of the world’s top-selling drug, Humira (adalimumab), were due to launch in Europe. They will not topple the $18 billion behemoth. But they will do some damage, as Europe’s cash-strapped payers ready themselves to embrace these cheaper lookalikes. 16 20 24 A Phoenix Turn For Tonix: Twist Bioscience: Aetion: Sealing The Deal With Rising From Phase III Ashes DNA Research Tools Put Fresh Payers On Real-World Research With New PTSD Approach Spin On Drug Discovery WILLIAM LOONEY LUCIE ELLIS WILLIAM LOONEY As biopharma’s embrace of real-world In an exclusive interview, Seth Lederman, Speed and efficiency are fundamental to evidence (RWE) gathers speed, In Vivo CEO of New York-based Tonix the success of today’s biopharmaceutical looks at one company that is using a mix Pharmaceuticals, talks about the enterprise, but the hunt is still on for of prestigious academic, government and company’s R&D rollercoaster ride and transformative technologies to boost non-profit partners to build a credible how it plans to keep its lead asset on pipeline productivity and growth. One foundation for acceptance of this research track for approval as a treatment for answer may lie in the arrival of replicable, tool in the wider commercial space. post-traumatic stress disorder. synthetic versions of DNA. 28 34 Immuno-Oncology: Unicorns, STEM CELL RESEARCH PROGRESS China And The Perfect Storm IN THE US: WHERE ARE WE NOW? SWARNA MEHROTRA, SPONSORED BY: SYNEOS HEALTH ODED BEN-JOSEPH AND The history of stem cell research has ELLEN BARON been marked by a combination of great There is a unique phenomenon being promise, disappointment and realized in immuno-oncology deal- controversy. But progress is being making compared with other segments in made, with a number of stem cell the life sciences sector – an apparent therapies approved and many more in uncoupling between risk and return on the late-stage pipeline. invested capital, as early assets provide similar liquidity to more mature assets. ©2016 Informa Business Information, Inc., an Informa company October 2018 | In Vivo | 1 ❚ CONTENTS In Vivo Pharma intelligence | October 2018 DEPARTMENTS ❚ From The Editor AROUND THE INDUSTRY This month, In Vivo’s lead story from Melanie 4 Japan’s Healios Eyes First Senior looks at the huge market shift for biosimilars Approvals As It Progresses now that patents protecting the world’s best-selling Regenerative Therapies drug have expired in Europe. In October 2018, over a IAN HAYDOCK decade since the first biological copycat product was approved in Europe, a handful of biosimilars of 6 A Chance To Own The Venous AbbVie’s Humira (adalimumab) were able to launch Space: BTG Acquires Novate in the region. ASHLEY YEO This article explores the changing attitudes to- 38 ON THE MOVE ward biosimilars in Europe and further afield, and sheds light on how different countries are Recent executive appointments preparing for switching once multiple biosimilar LUCIE ELLIS in the life sciences industry versions of Humira become available. Biosimilars REGINA PALESKI are here to stay, but when it comes to pricing, the key question is: how low is too low? Melanie explores the issue of sustainability in this emerging and 42 DEAL-MAKING changing market. Deals Shaping The Medical Industry, September 2018 Meanwhile, we have been busy at In Vivo headquarters and have recently made THE STRATEGIC TRANSACTIONS TEAM changes to some of our regular features. You may have spotted in September that we published for the first time our redesigned On The Move column. This is orga- nized in a new, easy-to-view table and includes more entries than the previous format. An even more comprehensive monthly roundup of executive changes across the biopharma and medtech sectors is published on our website in a EXCLUSIVE ONLINE CONTENT searchable, interactive table. invivo.pharmaintelligence.informa.com We have also updated the Up-front page; this section allows our print readers to quickly assess some key points from that month’s content. The In Vivo team ❚ Partnering In Cell And Gene would appreciate any feedback on these changes and looks forward to hearing Therapy Is A Unique Endeavor from our readers. AMANDA MICKLUS In other news, Barbara Freischem has joined the In Vivo Editorial Advisory Board. Ms. Freischem is the executive director of European Biopharmaceutical ❚ Device/Diagnostics Quarterly Enterprises (EBE), a specialized group of EFPIA, the European association for Dealmaking Statistics, Q2 2018 the pharmaceutical industry. She is a qualified veterinarian and has significant AMANDA MICKLUS & experience both on the side of regulatory authorities as well as the regulated industry in a variety of technical and leadership roles. MAUREEN RIORDAN ❚ VistaGen Stocks Neuro- psychiatry Pipeline And Takes In Vivo: Always Online First Aim At Depression Market Relevant and exclusive online-only Don’t have an online user account? LUCIE ELLIS content at your fingertips 24/7. Quickly and easily create one by clicking on the “Create your Full access to our 35-year archive. ❚ Deals In Depth, August 2018 account” link at the top of the page. AMANDA MICKLUS Access your subscription by visiting: Contact: invivo.pharmaintelligence.informa. [email protected] com and log in. or call: (888) 670-8900 or +1 (908) 748-1221 for additional information. All stock images in this publication courtesy of www.shutterstock.com unless otherwise stated. /invivo @invivo /invivo 2 | | October 2018 invivo.pharmamedtechbi.com In Vivo invivo.pharmaintelligence.informa.com invivo.pharmaintelligence.informa.com CONTENTS ❚ ❚ Up-Front SNAPSHOTS FROM OCTOBER'S CONTENT “ I have never seen such a coordinated push for speed, depth and breadth of uptake.” OMAR ALI, FORMULARY ADVISOR SURREY & SUSSEX HEALTHCARE NHS TRUST AS TOLD TO IN VIVO WHEN DISCUSSING THE INFLUX OF HUMIRA BIOSIMILARS. PAGE 8 1H/2018 saw larger venture investments with a VC investors like synthetic There is a growing consensus DNA because it is “platform in the research community agnostic.” More than two that a more inclusive stance 27% dozen US companies and involving both clinical trial INCREASE start-ups are presently data and real-world evidence in average investment active in the field, which will spur efficiencies in drug is on track to surpass $1 development, raise industry size compared with billion in investor funding returns on its massive the prior year and a commitments from the VC investments in R&D and robust VC appetite and public markets this year. possibly ease pressures on PAGE 20 drug pricing. PAGE 24 for early-stage companies, investing heavily “ Psychiatry drug development8 080 in Series A and B. is a journey, and the path7 070 PAGE 28 6060 certainly does not follow 5050 a straight line.”4040 SETH LEDERMAN, CEO 3030 TONIX PHARMACEUTICALS 2020 He talks to In Vivo about 1010 getting the company back onAverage Investment Capital ($M) Average Investment Capital ($M) track after a Phase III setback 0 0 SeriesSeries A A SeriesSeries B B SeriesSeries C C for its lead compound in PTSD. 20152015 20162016 20172017 1H/20181H/2018 Barryfc101_Wikimedia Commons Barryfc101_Wikimedia PAGE 16 CREDIT: CREDIT: ©2016 Informa Business Information, Inc., an Informa company October 2018 | In Vivo | 3 ❚ Around The Industry Japan’s Healios Eyes First Approvals As It Progresses Regenerative Therapies Following the modification and introduction of legislation governing the safety, devel- The firm’s lead project is HLCM051, a opment and use of regenerative and cell therapies in Japan in late 2014, companies somatic stem cell regenerative medicine in the space have been generally positive on the shape and impact of the supportive that is being tested in a Phase II/III trial regulatory environment in the country – which has already led to the reimbursement in Japan for ischemic stroke. HLCM051 is and launch of several therapies. also set to move into the clinic for acute respiratory distress syndrome (ARDS); Tokyo-based Healios K.K. is one such have already received high prices. For Dr. Kagimoto disclosed that discussions company. Formed in 2011 as Retina Institute example, JCR’s mesenchymal stem cell with Japan’s regulatory agency, the PMDA, Japan, a Fukuoka-based venture under Rik- therapy Temcell (licensed from Meso- were already underway for exploration of en (Japan’s largest research organization blast), conditionally approved for acute the treatment in this area. for basic and applied science), the company graft-versus-host disease after allogeneic Behind this are various iPSC-based listed on the Mothers high-tech market of bone marrow transplants in September therapies including HLCR011 for wet age- the Tokyo Stock Exchange in 2015. It now 2015, was given an initial price equivalent related macular degeneration (AMD), also has around 110 employees (up from around to around $125,000 per treatment course. set to move into Phase I soon. Also, an in- 40 at the time of the initial public offering) “The regulatory framework in Japan ternational clinical program for HLCR012, an and affiliated research and company opera- is very clear,” Dr. Kagimoto continues. allogeneic iPSC-derived retinal pigment epi- tions in both Japan and the US. “Although there is a strong emphasis on thelium cell therapy for dry AMD, based on a “The deregulation of the laws for re- safety, a major aim is to accelerate in- US Phase III trial, is being considered.
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