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Roche CEO: Novel Gene Therapies Justify New Payment Models 26 April 2019 No. 3952 Scripscrip.pharmaintelligence.informa.com Pharma intelligence | informa “Gene therapies have the potential to actually cure disease, and consequently the value of that to the healthcare system can be huge, not only for the patients who suffer from that disease but also from a cost perspective because you save a lot of follow-on costs and I would add, go beyond that from a societal perspective, if those patients are really cured, as they can go back to work and make their contribu- tions paying taxes, social contributions, etc.,” Schwan said. “Having said that, what is special with gene therapies is that you get this up-front treatment and that can in- deed be a one-off burden for a health- care system and I believe we will need to find innovative approaches and new pricing models.” The issue will become more relevant once Roche takes control of Philadelphia- Roche CEO: Novel Gene Therapies based Spark Therapeutics, which it has offered to buy for $4.8bn and which, after Justify New Payment Models a regulatory delay, is expected to close in the first-half of the year. STEN STOVALL [email protected] Roche views Spark as a valuable prize, largely due to its gene therapy for he up-front, one-off payment mod- systems and society as a whole. He also a rare type of blindness which the US el for patients being treated with said the advent of gene therapy, which FDA approved in 2017, known as Lux- Trevolutionary gene therapies isn’t introduces new genetic material into a turna (voretigene neparvovec). tenable given the huge burden their high person’s DNA, also promises to reduce The Swiss major’s proposed acquisi- prices would place on healthcare systems, the burden of disease on society in gen- tion of Spark Therapeutics gives it a but any solution must adequately com- eral by providing cures, and that a bal- leading seat at the table in the emerg- pensate the biopharmaceutical groups ance therefore needs to be found that ing field of gene therapy, and thus fu- that develop and commercialize them, might involve spreading the cost of the ture conversations with patient groups, says the CEO of Roche. medicines out over time. payers and HTAs. Speaking to journalists during the “I could well imagine that, rather than Swiss group’s first-quarter update – in GENE THERAPY NEEDS NEW having one-off payment at the beginning which he said Roche’s delayed takeover COMMERCIAL MODEL of the treatment, to actually spread out of US-based gene therapy company “The values of gene therapies can be tre- the payment over several years and link it Spark Therapeutics Inc. remained “on mendous for the system, but we need to to the performance of the medicines,” he track” – Severin Schwan acknowledged find new, innovative approaches to make told reporters. “That approach offers risk that expensive gene therapies could put it sustainable for our partners in the sys- sharing between the providers of such unmanageable stresses on healthcare tem,” the Austrian CEO said. CONTINUED ON PAGE 4 BROUGHT TO YOU BY THE EDITORS OF PHARMASIA NEWS, START-UP AND SCRIP INTELLIGENCE Bit By Bit Sky High R&D Updated NASH Notebook Small biotechs at risk if NAS launches reach Developments and diagnoses piecemeal pricing takes hold (p4) record levels in 2018 (p7) from EASL 2019 (p18-20) IN THIS ISSUE from the executive editor [email protected] As the first-quarter results reporting season kicks off, pharma or stop developing these products altogether. the tricky issue of pricing models for expensive one- See pages 1 and 4 for more details. time treatments is again to the fore. In light of its In R&D news, the European Association for the Study upcoming purchase of gene therapy pioneer Spark of Liver Disease meeting in Vienna, Austria, saw research Therapeutics, Roche CEO Severin Schwan has joined on efforts to diagnose non-alcoholic steatohepatitis and other companies developing gene therapies, like Swiss its precursor non-alcoholic fatty liver disease better. The rival Novartis, in highlighting the need to develop issue has became more urgent after the US Food and Drug novel systems to spread their cost if long-term benefit Administration issued draft guidance recommending that can be proven. But where would such systems leave drug sponsors work on such diagnostic tools because smaller companies which are less able to absorb the fi- of the burden and expense of liver biopsies, the current nancial impact of annuity payments? Some experts say standard, and will help when the new wave of therapies for biotechs – which in theory should be able to market this disease come to market. Read more on p18. such specialist products themselves without the need Finally, the industry can congratulate itself on its best for large marketing muscle – could be so fearful of the year of the century in terms of new active substance potential impact that they off-load their assets to big launches in 2018. All the details are on p7. LEADERSHIP ADVERTISING DESIGN Phil Jarvis, Mike Ward, Christopher Keeling Paul Wilkinson Karen Coleman DESIGN SUPERVISOR SUBSCRIPTIONS Gayle Rembold Furbert Scrip Dan Simmons, Shinbo Hidenaga EDITORS IN CHIEF Andrea Charles EDITORIAL OFFICE Ian Haydock (Asia) John Davis Christchurch Court Eleanor Malone (Europe) Kevin Grogan 10-15 Newgate Street Denise Peterson (US) Ian Schofield London, EC1A 7AZ Vibha Sharma CUSTOMER SERVICES Joanne Shorthouse EXECUTIVE EDITORS US Toll-Free: +1 888 670 8900 COMMERCIAL Sten Stovall US Toll: +1 908 547 2200 Alexandra Shimmings (Europe) UK & Europe: +44 (20) 337 73737 Mary Jo Laffler (US) US Australia: +61 2 8705 6907 Michael Cipriano POLICY AND REGULATORY Japan: +81 3 6273 4260 Derrick Gingery Maureen Kenny (Europe) Email: clientservices@ Joseph Haas Nielsen Hobbs (US) pharma.informa.com Mandy Jackson ASIA Cathy Kelly Jessica Merrill TO SUBSCRIBE, VISIT Anju Ghangurde scrip.pharmaintelligence.informa.com Jung Won Shin Brenda Sandburg TO ADVERTISE, CONTACT Brian Yang Bridget Silverman Sue Sutter [email protected] EUROPE All stock images in this publication Neena Brizmohun courtesy of www.shutterstock.com Francesca Bruce unless otherwise stated Scrip is published by Informa UK Limited. ©Informa UK Ltd 2019: All rights reserved. ISSN 0143 7690. 2 | Scrip | 26 April 2019 © Informa UK Ltd 2019 Boehringer’s Roche’s Asian Impact Janssen’s MD Exits Diabetes Success 20 11 14 21 exclusive online content inside: COVER / Roche CEO: Novel Gene Therapies Justify M&A A Major Pillar Of Sumitomo New Payment Models Dainippon’s New Mid-Term Plan 4 Annuity-Based Pricing Models Could Mean Problems IAN HAYDOCK [email protected] For Small Biotechs 6 Lilly/Pfizer’s Tanezumab Safety Takes A Hit With Latest Phase III Results 7 Purple Patch For Pharma/Biotech R&D As NAS Launches Reach Record High 10 Cassiopea Hails Breezula’s ‘Good Hair Day’ And Plans FDA Talks On Phase III 11 BI Bets On Expanding Jardiance As Diabetes Drug Sales Soar Sumitomo Dainippon Pharma Co. Ltd. is to set aside a total campaign chest of between JPY300-600bn ($2.68- 12 J&J’s Spravato’s Star Power Rises While Zytiga’s Sets 5.36bn) over the next five years to pursue merger and ac- quisition opportunities, with the immediate focus to be on 13 Novartis Secures FDA Priority Review For Brolucizumab psychiatry and neurology to fill a mid-term pipeline gap. Thanks To PRV Strategically, the company is looking to ensure sustained growth and develop into what it describes as a “global spe- 14 Asia Begins To See Impact From Roche ‘De-Siloing’ cialized player” by 2033, amid the looming genericization of its top product within this period. 15 Amgen Launches Evenity For High-Risk Osteoporosis As part of a newly unveiled five-year plan covering the At $21,900 List Price fiscal 2018-2022 period, the mid-sized Japanese firm said it would also pursue external partnerships and in-licens- 18 NASH News & Notes From The European Liver Meeting ing across its core areas of therapeutic focus – psychiatry and neurology, oncology and cell therapies/regenerative 19 Pfizer Thinks KHK Mechanism Could Work For NASH, Diabetes medicines. More broadly, the Osaka-based company said it is targeting group revenues of JPY600bn by the end of 20 Gilead Increasingly Focused On Combo Therapy In NASH fiscal 2022 (in April 2023), versus a forecast for net sales this fiscal year of JPY467bn; half of the target revenue is 21 Janssen India MD To Depart seen coming from the core psychiatry and neurology area. The new plan has been drawn up against the back- 22 Pipeline Watch ground of a need to better adapt to changing global eco- nomic and pharma industry pressures, and ahead of what 23 Appointments SDP expects will be “a significant decline” in both revenue and profit in fiscal 2023, following the loss of US exclusiv- ity in February 2023 for the firm’s global top seller Latuda (lurasidone), an atypical antipsychotic. Published online 15 April 2019 @PharmaScrip /scripintelligence To read the rest of this story go to: https://bit.ly/2KWUqPN /scripintelligence /scripintelligence scrip.pharmaintelligence.informa.com 26 April 2019 | Scrip | 3 HEADLINE NEWS/PRICING let’s open our eyes CONTINUED FROM PAGE 1 therapies and payers and, importantly, Annuity-Based Pricing Models Could you avoid these payment peaks, mak- ing it much more sustainable from a fi- Mean Problems For Small Biotechs nancing point of view.” FRANCESCA BRUCE [email protected] “The values of gene ompanies and payers are increas- therapies can be ingly exploring the idea of paying tremendous for the system, Cfor expensive, game-changing pharmaceuticals in instalments over but we need to find new, time rather than in one big initial lump sum.
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