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Sanofi R&D Chief Zerhouni Scrip Asks... IO Roundtable Expert View Do experts see orphan drug pricing Five companies talk about their place New products are set to shake the coming under pressure over the next in immuno-oncology (p10) hemophilia market – but convincing five years? (p4) payers will be a challenge (p14) 10 March 2017 No. 3844 Scripscrip.pharmamedtechbi.com Pharma intelligence | informa consultant to Sanofi; it gained steam when he joined Sanofi in his present position. “I structured the strategy for Sanofi in two phases. The first phase was how do we build a pipeline to be delivered in 2015, 2016, 2017 when we had loss of exclusiv- ity on key products, with Lantus being the last major drug after Plavix and others that lost their patents. The goal was how to do it without breaking the bank,” Zerhouni told Scrip in a recent interview. That initial revamp involved overhauling the pipeline and trimming 19 Phase II and Phase III programs from Sanofi’s R&D pipe- line between 2009 and 2012. Some of the programs missed Phase II endpoints. Oth- ers were discontinued because the value Elias Zerhouni proposition wasn’t there from either the patient or payer perspective. “I modified the strategy in a big way, by putting development first: we have to Sanofi R&D Chief Zerhouni: take care of development and underneath all that, start to fix research, not the other way around. Most heads of R&D, are heads How I’m Doing More With Less of R&D; I said, ‘No, I want to be a head of Elias Zerhouni says Sanofi’s ongoing R&D revamp has produced improved D&R,’ rather than R&D at Sanofi,” Zerhouni innovative results with controlled spending, in part by emphasizing cutting- explained. edge product development ahead of research. IMPROVED PRODUCTIVITY STEN STOVALL [email protected] The second phase of the revamp is focused on early research and is ongoing. anofi ‘s head of global research and by former Sanofi CEO Chris Viehbacher. Zerhouni says the pipeline turnaround development Elias Zerhouni feels the Remaining in that role under current CEO can already be seen in new drug launches. outside world – meaning analysts and S Olivier Brandicourt, Zerhouni has been “Between 2008 and 2012, Sanofi investors – have yet to fully appreciate the vigorously remolding the company’s early launched three drugs. Between 2012 and pipeline progress and future promise gener- and mid-stage pipeline so the company 2017 - provided we get FDA approval for ated by his ongoing revamp of the French can replace revenues lost from patent dupilumab at the end of this quarter that group’s R&D process, but he is confident that expiries for blockbusters like platelet anti- we hope for - we will have had 13 launch- will soon happen, helped by further expected aggregant Plavix (clopidogrel) and Lantus es. So, by numbers, it’s doing well,” Zer- success developing multi-specific therapies. (insulin glargine). houni said. He said that in terms of sales A native of Algeria, Zerhouni was ap- The initial R&D strategy revamp began for 2016, new drugs represented €2.7bn pointed to his current position in 2011 even earlier in 2009 when Zerhouni was a CONTINUED ON PAGE 7 BROUGHT TO YOU BY THE EDITORS OF PHARMASIA NEWS, START-UP AND SCRIP INTELLIGENCE IN THIS ISSUE Breathing Room For Teva What Next In Orphan Pricing? 3 4 How To Please Payers? 15 COVER / Sanofi R&D Chief Zerhouni: How I’m Doing More from the editor With Less [email protected] 3 Teva Catches A Break On Copaxone 40mg, But For How Long? In January Scrip reported on the launch of the new Coalition for Epidemic Preparedness Innovations, 4 Scrip Asks: What Will Happen Next In Orphan which aims to drive development of DNA/RNA- Drug Pricing? based vaccines against emerging infectious diseases, and reduce the risk of a new crisis like that of Ebola, 6 Chi-Med Roll Continues With Positive Fruquintinib which had languished in pharma R&D owing to a 8 Spring Break: Novo’s US Head Resigns After Rough Winter lack of commercial incentives. Now, a new index mapping how companies are 9 R&D Bites performing in driving access to vaccines in high-need 10 Roundtable: Immuno-Oncology 2.0 Roundtable: countries has been published by the Dutch non-profit Emerging Players Eye Crowded Field Access to Medicine Foundation, which has been producing the Access to Medicine Index since 2008. 12 UK’s Crackdown On Anti-Competitive Deals Continues The Access to Vaccines Index maps how eight key 13 Policy & Regulation Briefs companies are performing against 13 metrics, and the evidence shows they are doing a lot. The authors 14 Expert View: Hemophilia: How To Please Payers And suggest the index can help identify opportunities Secure Market Share to improve vaccines access, and where new incen- 16 Roche’s APHINITY Trial Boosts Outlook On Its tives are needed. In fact, it identifies the actions Oncology Business and omissions specifically of industry and does not explicitly propose external incentives. Companies 17 Juno Ends JCAR015 Development In ALL are expected to be morally motivated to do more, 18 R&D Strategy: WHO’s List Of Pathogen Threats To aided by the new benchmarking tool. Like it or not, Rouse Developers the gauntlet is thrown down, and the onus is now on major vaccines players to pick it up. 20 Business Bulletin 21 Exclusive Interview: Shire’s Wellhoefer On Genetic Disease R&D And Expanding Access To Medicines exclusive online content 22 Pipeline Watch 23 Appointments Keryx Looks To Label Expansion To Drive Auryxia Keryx plans to expand Aurexia’s label to treat iron deficiency in pre-dialysis patients while searching for additional nephrology assets during 2017. http://bit.ly/2mMvaif Beyond Belviq: Reinventing Arena To Focus On Phase II Candidates Dr. Amit Munshi, new CEO of Arena Pharmaceuticals, has already made several changes in the company’s focus and direction as it reduces its commitment to Belviq. He talked to Mike Ward about progress to date. http://bit.ly/2lwf0cw @scripnews /scripintelligence /scripintelligence /scripintelligence 2 | Scrip intelligence | 10 March 2017 © Informa UK Ltd 2017 HEADLINE NEWS Teva Catches A Break On Copaxone 40mg, But For How Long? An FDA warning letter cites deficiencies at the Pfizer-owned manufacturing facility poised to produce a Momenta/ Sandoz generic competitor. It’s unclear how long Pfizer might take to resolve the violations, which include particulates in finished products. JESSICA MERRILL [email protected] eva Pharmaceutical Industries Ltd. has gotten some breath- It’s not clear how quickly the problems might be rectified, but in a ing room with news that the launch of a generic rival to the same-day email to investors, Evercore ISI analyst Umer Raffat said the T important 40mg version of its blockbuster multiple sclerosis median time to resolve manufacturing issues on finished pharmaceu- drug Copaxone (glatiramer) has been delayed due to a manufactur- ticals is 13 months. He analyzed data over 20 years and found the mini- ing issue. mum time to resolution is five months and the maximum 47 months. An FDA warning letter, made publicly available Feb. 28, cites several He also pointed out that the letter was addressed to Pfizer CEO Ian manufacturing violations at the Pfizer Inc.-owned facility in McPher- Reed rather than a lower-level manager. “When FDA addresses the let- son, Kan., that was poised to produce the 40mg product on behalf ter to the senior most person, it is trying to make a statement,” he said. of sponsors Sandoz Inc. and Momenta Pharmaceuticals Inc. The two drug makers had been planning to launch the generic imminently after a district court invalidated several patents protecting the newer formula, which is administered three times a week, rather than every day like the older 20mg formula. Momenta announced a delay in the launch Feb. 21 because of the manufacturing violations, but didn’t offer many details on the contents of the letter. CEO Craig Wheeler said at the time the company was still hopeful the launch could occur in 2017. For Teva, the delay is a positive turn at a pivotal time, when the Is- raeli drug company is facing backlash from investors over slow generic growth, an expensive merger and the disappointing patent ruling. The ongoing challenges have resulted in two high-profile leadership de- partures at Teva: former CEO Erez Vigodman, who left the company in February, and generics head Sigurdur (Siggi) Olafsson, who stepped down in December. The company has appointed an interim CEO, Yitzhak Peterburg, while it searches for a fulltime replacement and Shutterstock: Alextype Shutterstock: conducts a thorough business review. Teva issued financial guidance in January forecasting a revenue re- Other drug manufacturers also pose a threat to Teva. Aside from duction of $1bn to $1.3bn in 2017 if one or two generic competitors Sandoz/Momenta, several other generic drug manufacturers also to Copaxone 40mg were to hit the market. Sandoz/Momenta already have ANDAs at FDA pending for the 40mg Copaxone dose, including market a generic version of the once-daily version of Copaxone called Amneal Pharmaceuticals LLC, Dr. Reddy’s Laboratories Ltd., Mylan NV Glatopa, which the Pfizer plant has been producing for commercial and Synthon Pharmaceuticals Inc., which is partnered with Pfizer on use since April 2015. Teva’s success transitioning patients to the 40mg the marketing. version ahead of the Glatopa launch has been one of the bright spots Although Teva is the world’s largest generic drug manufacturer, it for the company. also markets a substantial specialty drug portfolio, focused in multiple sclerosis and respiratory disease.
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