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Roche's Pred Leaders on Its Next Generation of Drugs

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Roche's Pred Leaders on Its Next Generation of Drugs No. 3982 November 22, 2019 infectious disease, ophthalmology, neu- roscience, rare disease and oncology. ADVANCEMENTS IN PARKINSON’S DISEASE In neuroscience, head of pRED neurosci- ence and rare diseases Azad Bonni said the company is prioritizing Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, autism spectrum disorders and schizophrenia. “pRED actually has had a large impact on the Roche neuroscience and rare dis- ease portfolio,” he said. The early develop- ment group has five molecules in Phase I and Phase II development, and there are six molecules in late-stage development at the Swiss pharma that either came from pRED or that pRED had substantial involvement with, he said. In Parkinson’s disease, a potential disease Roche’s pRED Leaders On Its Next modifying monoclonal antibody prasin- ezumab is advancing in Phase II. Prasin- Generation Of Drugs ezumab, developed in partnership with Prothena Corp. PLC, could be the first dis- JESSICA MERRILL [email protected] ease modifying treatment for Parkinson’s disease. It targets soluble and insoluble he Roche Pharma Research and to invest in technologies in order to push neurotoxic forms of alpha-synuclein. The Early Development (pRED) unit has the boundaries of what’s possible in terms aim is to prevent the cell-to-cell spreading T helped to shape the development of making drugs.” of pathogenic alpha-synuclein aggregates of drugs like Ocrevus and Hemlibra, fast- Among the newest drugs pRED sci- and prevent the loss of neurons. growing blockbusters that are getting the entists contributed to are satralizumab, Roche is studying prasinezumab in a Swiss pharma through a challenging peri- pending at the US Food and Drug Admin- two-part Phase II study, each portion of od as its older cancer pillars weaken. Now istration for the rare central nervous system which is running 52 weeks, with the first the pharma research group is working disease neuromyelitis optica spectrum dis- data read out expected in 2020. The study to develop the next generation of drugs order, and risdiplam, an oral drug for spinal is enrolling patients with early Parkinson’s that will maintain that momentum for the muscular atrophy that Roche expects to disease who are either treated or untreat- long term. file with the FDA by the end of the year. The ed with monoamine oxidase-B (MAO-B) During an investor event on 11 Novem- pRED group, which employs 2,400 people inhibitors, used to treat symptoms of Par- ber, the group’s leaders, including pRED across seven research sites, is one of three kinson’s disease but not the underlying head William Pao, highlighted some of the independent R&D units within Roche, the cause. The primary endpoint of the ongo- drugs in the early pipeline that they hope, other two being Genentech Early Research ing trial is change in baseline in the Move- years from now, will also be big winners. and Development (gRED) and Chugai. ment Disorders Society Unified Parkin- “We’re not resting on our laurels,” Pao PRED works in several focused thera- son’s Disease Rating Scale (MDS-UPDRS). said. “We realize that we need to continue peutic areas, including immunology, CONTINUED ON PAGE 4 FOR THE LATEST BUSINESS INSIGHT ON THE BIOPHARMA INDUSTRY VISIT: SCRIP.PHARMAINTELLIGENCE.INFORMA.COM Vascepa’s Next Steps Buying And Selling NASH Ambitions Amarin set for label wrangling Roche and Merck & Co acquire, AASLD meeting sees Novartis after FDA panel meeting (p15) Lupin and Almirall divest (p5-9) and Pfizer set out their stalls (p20) IN THIS ISSUE from the editor [email protected] This week is the World Health Organization’s Antibiotic plicated urinary tract infections in the US in 2018 but Awareness Week. Unfortunately, after many years of sales were so low that the company filed for bankruptcy awareness raising about the issue of antimicrobial less than a year later. resistance, serious structural problems with the Also this year, Tetraphase has had to shut down its market for antibiotics continue to jeopardize R&D. R&D to focus on commercializing its product for se- Awareness is one thing, action is another. rious infections, Xerava (eravacycline), which was Big pharma has mostly withdrawn from antibiotic launched in the US in 2018. R&D. Discovering novel alternatives to existing drugs And just this week, Melinta Therapeutics, which to stay ahead of drug resistance is now left to small launched its MRSA antibiotic Baxdela (delafloxacin) companies. Initiatives like CARB-X, GARD and ND4BB in 2018 and sells other antibiotics acquired from The have helped such firms proliferate in recent years, but Medicines Co, warned investors that it looked likely to their future is under threat. be heading for a Chapter 11 bankruptcy filing. As the BEAM Alliance of European SMEs in the anti- The UK is planning a limited pilot subscription mod- infective field points out, companies that manage to dis- el for access to new antibiotics. Much more like this is cover and develop novel therapies through to approval urgently needed around the world to avoid innovators still risk “failure in the face of success”. Achaogen is a going to the wall and investors vacating the space. case in point: it launched Zemdri (plazomicin) for com- LEADERSHIP ADVERTISING DESIGN Phil Jarvis, Mike Ward, Christopher Keeling Paul Wilkinson Karen Coleman HEAD OF SUBSCRIPTIONS PUBLICATION DESIGN Dan Simmons, Gayle Rembold Furbert Shinbo Hidenaga EDITORS IN CHIEF Andrea Charles EDITORIAL OFFICE Ian Haydock (Asia) John Davis Blue Fin Building Eleanor Malone (Europe) Kevin Grogan 3rd Floor, 110 Southwark St Denise Peterson (US) Andrew McConaghie London, SE1 0TA Ian Schofield CUSTOMER SERVICES EXECUTIVE EDITORS Vibha Sharma US Toll-Free: +1 888 670 8900 COMMERCIAL Sten Stovall Alexandra Shimmings (Europe) US Toll: +1 908 547 2200 UK & Europe: +44 (20) 337 73737 Mary Jo Laffler (US) US Australia: +61 2 8705 6907 POLICY AND REGULATORY Michael Cipriano Japan: +81 3 6273 4260 Maureen Kenny (Europe) Derrick Gingery Email: clientservices@ Nielsen Hobbs (US) Joseph Haas pharma.informa.com Mandy Jackson ASIA Cathy Kelly Anju Ghangurde Jessica Merrill TO SUBSCRIBE, VISIT scrip.pharmaintelligence.informa.com Vibha Ravi Leah Samuel Jung Won Shin Brenda Sandburg TO ADVERTISE, CONTACT Brian Yang Bridget Silverman [email protected] Sue Sutter 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 | November 22, 2019 © Informa UK Ltd 2019 Roche Buys Promedior Sanofi Pasteur Looks 10 To Future Bayer’s 20 5 Digital Plans 12 exclusive online content inside: COVER / Roche’s pRED Leaders On Its Next Generation Of Drugs Orphan Drug Access: One-Third Of US 5 Roche Paying $390m Up Front For Coverage Decisions Involve Restrictions, Fibrosis-Fighting Promedior Study Finds CATHY KELLY [email protected] 6 Merck Acquires Novel Neurodegenerative Disease Target With Calporta Buy 7 Lupin Offloads Kyowa Pharma For $525m But Not Exiting Japan 9 No Alarm At Almirall Despite Stake Sale 10 Sanofi Pasteur Head Loew On The Vaccine Unit’s Future Growth Drivers 12 Staying Diversified, Bayer Sees Opportunities In Digital Innovation 15 Amarin Heads Into Vascepa Expansion Labeling Talks The largest US private health plans restrict access to or- After Positive US FDA Panel Review phan drugs in 29% of commercial coverage decisions, ac- cording to a study by James Chambers, et al. from the Cen- 17 Double Delight For Novartis At The CHMP ter for the Evaluation of Value and Risk in Health at Tufts Medical Center. 18 European Biotechs Enter The IPO Big League Health plans still cover orphan drugs more generously than non-orphans; the study found plans apply coverage 19 ‘Watch China’ As Its Pharma Butterfly Flaps Its Wings restrictions to non-orphan drugs an average of 41% of the time. However, “the roughly one-third of orphan drug cov- erage decisions with restrictions are notable and have not 20 Novartis, Pfizer Advance Their NASH Ambitions Separately, As Partners been previously reported,” the authors pointed out. Published in the October issue of the American Jour- nal of Managed Care, the study evaluated 2,268 orphan 22 Pipeline Watch drug coverage decisions by commercial plans operated by 17 of the largest US insurers. The decisions were cur- 23 Clear Path For AstraZeneca’s Roxadustat rent as of March 2018. The data was drawn from the Tufts Medical Center Specialty Drug Evidence and Cov- 23 Appointments erage database, which includes publicly available spe- cialty drug coverage policies. Published online 11 November 2019 To read the rest of this story go to: https://bit.ly/2QwlE0z @PharmaScrip /scripintelligence /scripintelligence /scripintelligence scrip.pharmaintelligence.informa.com November 22, 2019 | Scrip | 3 HEADLINE NEWS CONTINUED FROM PAGE 1 logical malignancies. Roche decided in as a potentially fundamental therapy in Roche is also pioneering new biomark- May to move the drug forward into late- particular for solid tumors?” he said. ers for Parkinson’s disease, including the stage testing. It’s currently in Phase I test- development of a skin biopsy immuno- ing as a monotherapy, as well as in Phase EYEING IMPROVEMENTS IN histochemistry assay that could diag- Ib in combinations with chemotherapy, OPHTHALMOLOGY nose synucleinopathy in patients, which Roche’s PD-L1 inhibitor Tecentriq (atezoli- In ophthalmology, Roche has had a could establish a new method of diagno- zumab) and the CD20 antibody Gazyva strong commercial presence with Lu- sis for patients. (obinutuzumab). centis (ranibizumab), a VEGF inhibitor for “We’re developing this in the trial, but In heavily pretreated patients with ag- wet age-related macular degeneration. we’re also excited for its use in future trials, gressive non-Hodgkin’s lymphoma who Global Head of pRED ophthalmology Sas- because it should allow us to characterize have exhausted their treatment options, cha Fauser said the company is looking to different groups of patients, as well as in Roche has seen encouraging responses to build on that success in eye disease.
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