4 May 2018 No. 3903 Scripscrip.pharmaintelligence.informa.com Pharma intelligence | informa VP and Global Head of CV Franchise Shel- don Koenig said in an interview, repeating a complaint the manufacturers have raised since the launch of the injectable high- cholesterol therapies. “This really simplifies the documentation necessary.” Express Scripts Chief Medical Officer Steve Miller said the negotiated price would be at the low end of the range rec- ommended by the third-party Institute for Clinical and Economic Review (ICER) as being cost-effective. After reviewing positive outcomes data on Praluent ear- lier this year, ICER concluded the net price for Praluent for high-risk patients with cholesterol of at least 100 mg/dL despite intensive statin therapy should be $4,500 to $8,000 per year, depending on the risk Shutterstock: LittlePerfectStock Shutterstock: to the patient. “We are really excited because it puts this drug now within the affordable range of Sanofi/Regeneron Extend A Hand more patients,” Miller said. The WAC of Pralulent is $14,600 a year, though the companies have been offer- On Praluent, Express Scripts Takes It ing rebates that some analysts estimate JESSICA MERRILL [email protected] have reduced the costs to about $8,000 per year. After releasing the FOURIER car- anofi and Regeneron Pharmaceuti- Scripts’ national formulary only through a diovascular outcomes trial for Repatha in cals Inc. said in March they were will- medical exception pathway. 2017, Amgen concluded the benefit sup- Sing to make a deal on the cost of the Reducing the access restrictions for ported a net price in the range of $7,700 PCSK9 inhibitor Praluent (alirocumab) in ex- Praluent is an important win for Sanofi/ to $11,200 per year. (Also see “Amgen Says change for improved access. Now, Express Regeneron. Prescription rejection rates Repatha Outcomes Trial Backs Up Its Pricing Scripts Holding Co. has taken them up on have been as high as 75% for PCSK9 Math” - Pink Sheet, 19 Mar, 2017.) the offer. drugs, according to Sanofi. Amgen has Sanofi/Regeneron announced they The companies announced on May 1 presented data showing as many as 80% were willing to lower the price of Praluent that Express Scripts will grant Praluent pre- of PSCK9 prescriptions initially are reject- in line with ICER’s recommendations for ferred access on its national formulary over ed. (Also see “Will Physician Demand For Re- insurers that removed access restrictions Amgen Inc.’s Repatha (evolocumab) and patha Put Pressure On Payer Restrictions?” - in March, at the same time the partners remove some of the burdensome access Pink Sheet, 19 Mar, 2017.) released positive outcomes data from the restrictions in exchange for a higher rebate “It takes [physicians] days and some- long-term ODYSSEY trial, showing a sig- on the wholesale acquisition cost (WAC) of times weeks to get approvals, and there- nificant reduction in cardiac events and a benefit on mortality for patients taking Praluent. Express Scripts national formulary fore, in the end, it is the patient that re- Praluent. Sanofi/Regeneron’s decision to includes 20 million individuals. Repatha will ally suffers, waiting a month, or sometimes now be available to patients on Express more, to get a prescription,” Sanofi Senior CONTINUED ON PAGE 7 BROUGHT TO YOU BY THE EDITORS OF PHARMASIA NEWS, START-UP AND SCRIP INTELLIGENCE Chinese Biogenerics Return Of The Mega-Merger? Q1 Results Limited uptake perplexes (p16) One big deal could do it, Sanofi, Roche, Amgen, Shire, says PwC (p18) Boehringer and Sun report (p4-6, 8-11) IN THIS ISSUE from the editor [email protected] Many of our readers will be aware of the annual Scrip don Hilton on Park Lane, Mayfair, on November 28. Awards, which recognize outstanding achievements in Check out those entry criteria and good luck with your the pharmaceutical, biotech and allied industries. It’s submissions. The entry deadline is June 1. my great pleasure to inform you that the 2018 Scrip Back to the here and now, this issue’s coverage Awards are now open for entries. I know from our daily is heavy on details gleaned from first-quarter big reporting how much there is to celebrate in this indus- pharma financial reporting, from Roche’s executives try, and I encourage all of you to get nominating. talking about their vision for their electronic health With a new award for best use of real-world evidence record specialist acquisition Flatiron Health (p8) to having been added this year, there are now 16 trophies Boehringer Ingelheim’s expectations for the impact up for grabs, to be judged by our independent panel of of impending patent US patent expiries on its big- 17 senior industry experts. For details of the individual gest revenue generator, Spiriva (p11). Sanofi, Amgen, award categories and how to enter, visit scripawards. Shire and GlaxoSmithKline are among the other ma- com. Every year our prestigious ceremony gets bigger jor firms whose results we cover in the issue; go to our and better, and I look forward to welcoming even more website for additional reporting on companies includ- of you when we gather to bestow the awards in the Lon- ing Biogen and Gilead. LEADERSHIP ADVERTISING DESIGN Phil Jarvis, Mike Ward Christopher Keeling Paul Wilkinson SUBSCRIPTIONS DESIGN SUPERVISOR Scrip Daniel Frere Gayle Rembold Furbert EDITORS IN CHIEF John Hodgson EDITORIAL OFFICE Eleanor Malone (Europe) Ian Schofield Christchurch Court Denise Peterson (US) Vibha Sharma 10-15 Newgate Street Ian Haydock (Asia) Joanne Shorthouse London, EC1A 7AZ Sten Stovall CUSTOMER SERVICES EXECUTIVE EDITORS US Tel: +44 (0)20 7017 5540 COMMERCIAL Michael Cipriano or (US) Toll Free: 1 800 997 3892 Alexandra Shimmings (Europe) Derrick Gingery Email: clientservices@ Mary Jo Laffler (US) Joseph Haas pharma.informa.com Emily Hayes POLICY AND REGULATORY Mandy Jackson TO SUBSCRIBE, VISIT Maureen Kenny (Europe) Cathy Kelly scrip.pharmaintelligence.informa.com Nielsen Hobbs (US) Jessica Merrill TO ADVERTISE, CONTACT Brenda Sandburg [email protected] Bridget Silverman EUROPE Sue Sutter Neena Brizmohun Francesca Bruce ASIA John Davis Anju Ghangurde All stock images in this publication Lucie Ellis Jung Won Shin courtesy of www.shutterstock.com Kevin Grogan Brian Yang unless otherwise stated Scrip is published by Informa UK Limited. ©Informa UK Ltd 2018: All rights reserved. ISSN 0143 7690. 2 | Scrip | 4 May 2018 © Informa UK Ltd 2018 Lilly’s Baricitinib Limited Exit Zerhouni, Enter Reed GSK In Artifical Intelligence 20 6 12 21 exclusive online content inside: Alnylam Set For Transformation As Patisiran Nears COVER / Sanofi/Regeneron Extend A Hand On Praluent, Market With Data Upgrade Express Scripts Takes It https://bit.ly/2I3evRD 4 Dupixent Dip Dogs Sanofi Efforts To Deal With Alnylam has outlined further data and analyses from the Phase Diabetes Decline III APOLLO study supporting the use of its selective interfering RNA agent, patisiran, as it nears the market for the treatment of 5 As Amgen Looks To Aimovig’s Launch, It May Learn hATTR amyloidosis. From Repatha’s Past Brakes On Sanofi’s Dengvaxia Prospects Amid WHO- 6 Zerhouni Retires, Sanofi Hires John Reed SAGE Screening Advice? https://bit.ly/2HJieQS 8 ‘Watch This Space’ Roche Execs Say, Outlining RWE Rationale For Flatiron Buy WHO’s recommendation around a pre-vaccination screening strategy for Sanofi’s Dengvaxia could potentially dull the 9 Keeping Mum On Takeda, Shire Outlines Two-Division prospects of the product further, especially in emerging markets Performance with stretched healthcare resources. One industry expert suggests that governments should probably consider introducing the 10 Sun Rises For GSK’s Trelegy And Shingrix, Sets For Advair vaccine only after “better tests and tools” become available. 11 Boehringer Breathes Easy Over Spiriva Patent Expiry In US Biogen’s Spinraza Sales Plateau; The Challenge Is Keeping Up With The Successful Launch 12 Lilly May Need To Reassess Baricitinib Market After https://bit.ly/2HGqC7Z FDA Advisory Committee Sales of Biogen’s blockbuster rare disease drug moderated in the 13 Bayer Exercises Option To Up Stake In JV With Zydus first quarter as the company worked through the bolus of urgent infant and pediatric patients awaiting treatment in the US. 14 Glenmark Eyes First In-House Biologic Blockbuster HCV Sales Drive AbbVie’s Great Quarter, But Gains 15 Toujeo, Perjeta Biosimilars On Biocon-Mylan Menu Won’t Last But Humira Version Iffy https://bit.ly/2Ks8MTO Q1 earnings far outpaced expectations due to the successful 16 Biologics Kill Biosimilars? Limited Originator Uptake launch for new hepatitis C drug Mavyret, but with the HCV Perplexes China Biogenerics Market market overall in decline those gains won’t last and won’t make 18 Q1 Was Slow For Deals, But That Could Change With up for the looming loss of Humira revenue. One Big Transaction – PwC GW CEO: Cannabinoid Platform Is Growth Engine 19 Mereo Halts Plans For US Listing Beyond Epidiolex https://bit.ly/2raBJM6 20 Crescendo In Largest European Biotech Series B Of Year Aside from epilepsy in children, GW Pharma also looking to other therapeutic spaces for testing its cannabinoid product 21 GSK’s Head Of Artificial Intelligence Unveils R&D Goals candidates, including autism and brain cancer. 22 Pipeline Watch Finance Watch: Former Alexion Execs Raise $37m To 23 Appointments Launch Rare-Disease Focused RallyBio https://bit.ly/2FwJqAs Private Company Edition: Martin Mackay and two other former Alexion executives co-founded the rare disease start-up in January with a $37m Series A to kick things off. Also, Innovent @PharmaScrip /scripintelligence raises $150m in venture cash, Tmunity adds $35m and Third Rock launches Cedilla. /scripintelligence /scripintelligence scrip.pharmaintelligence.informa.com 4 May 2018 | Scrip | 3 Q1 RESULTS Dupixent Dip Dogs Sanofi Efforts To Deal With Diabetes Decline KEVIN GROGAN [email protected] anofi is hoping for a stronger second therapy” both in atopic dermatitis and mod- Factor IX) for hemophilia B contributed half of 2018 after posting a first-quar- erate-to-severe asthma.