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The Birth of an Orphan Biosimilar Market Orphans Should Live Alone

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www.PharmaMedtechBI.com FEBRUARY 2016 VOL. 34 / NO. 2 INSIDE ORPHAN DRUGS OPHTHALMOLOGY Glaukos Holds Lead In Microinvasive Glaucoma Surgery BY TOM SALEMI MEDTECH STRATEGIES Medtechs Bet On Transcatheter Mitral Valve Repair BY JENNY BLAIR Orphans Should IN VITRO DIAGNOSTICS Live Alone European IVD Companies BY ALAIN J. GILBERT See Worrying Trend In Market BIONEST PARTNERS Access Barriers BY ASHLEY YEO CARDIOVASCULAR DEVICES Boston Scientific Thinks Big In HF Provider Risk-Share Plan BY ASHLEY YEO The Birth Of An ▼ ONLINE EXCLUSIVE Orphan Biosimilar IO Combos By The Numbers BY JIM KLING AND AMANDA MICKLUS Market BY PAUL ZHANG NAVIGANT CONSULTING FEBRUARY 2016 COVER STORY Orphans Should Live Alone 10 Alain J. Gilbert, Anne-Sophie Demange and Mark Ratner For larger organizations with interests in rare diseases, Bionest Partners believes it is necessary to maintain a separation from the rest of the company in order to keep the culture needed for successful product commercialization. Easier said than done. COVER STORY The Birth Of An Orphan 18 Biosimilar Market COVER STORIES: Paul Zhang, Triona Bolger, Varun Renjen, Brian Sattin, Anny ORPHAN DRUGS Lin and Aditya Venugopal Hard-won experience from the first wave of broad-market biosimilars will inform development of “orphan biosimilars.” Navigant Consulting says that biopharmas entering this 18 Projected 2020 Protein orphan market will face a unique set of challenges. Revenue ($m) Enzyme mAb 25000 Glaukos Holds Lead In Microinvasive 20000 $33bn 15000 26 Glaucoma Surgery Total Revenue 10000 Tom Salemi From Orphan 5000 Biologics Glaukos has emerged as the leader in microinvasive 0 glaucoma surgery, a new treatment for the multibillion- Patent Expiry Year <2020 2021-2025 dollar market. CEO Tom Burns lays out his vision for his company and for the future of MIGS. Orphan Biologics Market Size Medtechs Bet On Transcatheter 26 32 Mitral Valve Repair Jenny Blair The success of TAVR has generated optimism that the much larger pool of mitral regurgitation patients can be similarly served. While big strategics bet on replacement, other companies bet on repair, developing less invasive devices inspired by an array of established mitral valve surgical repair techniques. EXCLUSIVE ONLINE-ONLY Tom Burns, Glaukos Corp. IO Combos By The Numbers Jim Kling and Amanda Micklus ©2016 Informa Business Information, Inc., an Informa company | IN VIVO: THE BUSINESS & MEDICINE REPOrt | February 2016 | 1 FEBRUARY 2016 $500m Roche signs autologous cell therapy deal with SQZ 4 Around The Industry 4 Boston Scientific Thinks Big In HF Provider $825m Lilly is Halozyme's latest Enhanze partner Risk-Share Plan Ashley Yeo $1000m BioAtla, Pfizer partner in cancer antibody therapies 6 European IVD Companies See Worrying Trend Gilead gets filgotinib rights from Galapagos; In Market Access Barriers $2075m deal value could top $2bn Ashley Yeo Viiv acquires Bristol's early- and late-stage HIV candidates 8 IN VIVO’s Deals Of The Month: January 2016 $2905m ONLINE ONLY: Top Alliances In December 2015 40 On The Move Significant recent job changes in pharma, medtech and diagnostics 14,000 1 3 5 1 Dealmaking 12,000 44 9 10,000 3 Deals Shaping The Medical Industry, January 2016 9 2 7 8 9 5 1 8,000 4 0 m 2 $ 6 8 3 6,000 1 Executive Summaries 4 5 56 8 1 4,000 2,000 1 7 3 5 7 2 7 3 EXCLUSIVE ONLINE-ONLY 7 1 5 2 0 9 6 4 8 Q1 Q2 Q3 Q4 ■ Deals In Depth FOPO Early-stage VC DeONLINEbt IPO ONLY:L ate-stage VC PIPE Other An overview of biopharma, device and diagnostics Total Money InvestedSpin -InOf fBiopharma In 2015 dealmaking in December 2015 53.4bn Amanda Micklus TOTAL 2015 BIOPHARMA FINANCING ■ Biopharma Quarterly Dealmaking Statistics, Q4 2015 You Asked...We Delivered! Amanda Micklus and Maureen Riordan Relevant and exclusive online-only content at your fingertips 24/7 ■ Emergings Access your subscription by visiting: START-UP Previews PharmaMedtechBI.com/publications/in-vivo and log in. Start-Ups Across Health Care: Profiles of Biolectrics, DigiSight Technologies, Don’t have an online user account? Quickly and easily Redx Pharma and Woven Orthopedic Technologies create one by clicking on the “Create your account” link at the top of the page. Contact [email protected] or call: (888) 670-8900 or +1 (908) 748-1221 for additonal information. 2 | February 2016 | IN VIVO: THE BUSINESS & MEDICINE REPOrt | www.PharmaMedtechBI.com The most trusted source of health care deal intelligence Looking for the right partner? Tracking investor activity? Structuring your own deals to maximum benefit? You can rely on the insight and information in Strategic Transactions to carry out these and many more critical business development activities. The top pharmaceutical firms and leaders in medical devices, diagnostics, finance and consulting already do. Private & Public Financings in Biopharma & Device Sept 2012 – Feb 2013 2,000 SEE WHAT YOU’VE 1,803 1,800 Public BEEN MISSING! Private 1,600 1,400 1,346 1,200 Available via annual subscription. 1,000 962 $M 846 816 For more information and 800 598 to request a complimentary 600 529 539 449 411 demonstration, visit: 400 288 310 193 209 200 159 151 164 93 118 105 www.PharmaMedtechBI.com/STLP 6 12 0 Rx Device Rx Device Rx Device Rx Device Rx Device Rx Device September October November December January February AROUNDTHEINDUSTRY Digital Health BOSTON SCIENTIFIC THINKS BIG IN HF Another important element is the differ- ing national health care data regulations and PRoviDER RIsk-SHARE PLAN laws on patient confidentiality. For instance, many European countries do not let the Boston Scientific Corp. is not one of the large caps that risks being left behind as the health data leave the country. “That’s the benefit care sector transitions increasingly to a value-based model. That much is clear from the recent of a having a worldwide partner like Accen- expansion of its involvement in health care delivery solutions engagement. ture, which has the ability to keep the data In late January, the Marlborough, MA, group the value equation is defined by longer-term in-country,” says Toland. He feels that some announced a new joint project with Accen- outcomes other than just by acute care pro- companies in this space or aspiring to be in it ture PLC in the care pathway management cedural events.” may have underestimated issues surrounding of post-discharge heart failure (HF) patients. Bundled payments are already a fact in US the local laws and regulations in this respect. The project, which has global potential, tar- orthopedics, and the likelihood is that bun- The Care Pathway Transformation solution gets the total cost-of-care management of a dling of CV procedures will become a reality is not predicated on any particular Boston patient group that accounts for an average in the coming two to five years. That means Scientific technology, but is rather is a move of 2% of health care spending and currently that companies will be taking some responsi- toward developing service-based solutions requires an 11-day inpatient stay (European bility – sharing the risk – for the patients after surrounding disease states and segments. average figures). the patient leaves the hospital. Toland says, Boston explains that its devices go into a Boston and long-term collaborator Accen- “That’s the direction we are heading in – go- relatively small percentage of HF patients, ture jointly designed the plan which started ing beyond just the event in the hospital. At who it says actually may not be that sick but in a pilot phase at Sweden’s Karolinska Boston, we think we can play a role in ensur- are likely costing the health care system a University Hospital (one of two customers ing that the outcomes are maximized and lot of money. “For us, having Accenture as a to develop the program) some 18 months optimized in that value-based world.” partner would allow us to capture the entire ago. The two companies describe it as cloud- The Care Pathway Transformation solution HF population,” says Toland. based, data-driven digital health solution will first involve pathway analytics on how Accenture Life Sciences senior managing for hospitals that will both improve patient efficiently HF patients move through the director Anne O’Riordan sees the new project outcomes and reduce the costs of caring for hospital system. It will also cover elements as combining Boston’s “great capabilities that chronic cardiovascular (CV) disease patients. of their care management, and their en- reach into the hospital networks” with Accen- Heart failure, the biggest CV burden for most gagement, education and monitoring, both ture’s “pivot to the patient” concept that seeks health care systems, was chosen as the natu- during hospitalization and after discharge. to drive forward patient outcomes. ral place to start, but other CV diseases could For Toland, the educational aspects in the She says, “We talked to Boston about how be added later. discharge program are the biggest contribu- we could make this count, and then set up The system combines Boston’s custom- tor to successful system change. “Boston is the pilot studies to see how we could really tailored ADVANTICS solutions brand and building in a really strong educational ele- add value to patients.” The two Scandinavian Accenture’s analytics-based Intelligent Patient ment – for both patients and health care pro- pilots, done in late 2014-early 2015 at the Platform together in the Care Pathway Trans- viders. Ensuring that the education transfers Tampere Heart Hospital in Finland as well formation solution. This service will flag up to the patient in the 30-60-90 day window as at Karolinska, used analytics to assess HF patient population health patterns and iden- after they leave the hospital is the crux of patients who had been treated and had left tify opportunities to improve the treatment making things work well,” he says.
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