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In Lung Cancer 4 August 2017 No. 3865 Scripscrip.pharmamedtechbi.com Pharma intelligence | informa • a Phase I asset also in development for SCLC, though trials for this compound, known as 2879552, will continue in acute myelogenous leukemia (AML) and myelo- dysplastic syndrome (MDS); • retosiban, which is in Phase III for sponta- neous pre-term labor; • three Phase II assets that had been target- ing heart failure, cholestatic pruritus and psoriasis. RARE DISEASE REVIEW The UK big pharma has also undertaken a strategic review of its rare diseases unit and is now considering options for future own- ership of these assets. GSK’s rare disease portfolio currently generates sales of around £425m annually. Bernstein analysts said in a Shutterstock: Gajus Shutterstock: July 26 note that the business could fetch between £2bn and £3bn. The corporate changes presented by Walmsley Shakes Up GSK; Walmsley during a three-hour company update in London on July 26 are based on three long-term priorities: innovation, per- Cuts 30 Drug Programs formance and trust. LUCIE ELLIS [email protected] R&D REFURBISHMENT uring the company’s second In a move to “strengthen” its pharma Under its “innovation” priority, in paral- quarter earnings report, GlaxoS- unit, GSK is doing away with more than 30 lel with pipeline divestures, GSK has de- DmithKline PLC’s new CEO Emma development programs that are “unlikely veloped a list of pipeline assets to pour Walmsley outlined key issues for the busi- to generate sufficient returns,” the com- more investment into. This list will evolve ness over the next three years and set out a pany noted in its July 26 2Q report. as data read out, the group noted, but series of new priorities, putting the group’s “GSK has so far made decisions to termi- items currently focus on respiratory and pharmaceutical unit at the top of her to- nate, partner or divest more than 30 pre- infectious disease pipeline programs. GSK fix list ahead of the consumer health and clinical and clinical programs,” the company will pour 80% of its pharmaceutical R&D vaccine units. said, suggesting that other assets may also capital into these two current therapy ar- The new CEO’s corporate overhaul get the cut. eas as well as two more R&D areas seen contains many more fireworks than ana- Programs already confirmed to be termi- as potential growth drivers: oncology and immuno-inflammation. lysts and investors had anticipated. GSK’s nated or divested include: Walmsley said: “We need a significant stock price (London Stock Exchange) was • a Phase II hepatitis C drug; overhaul to how we develop our clinical trending down by around 1.5% in the af- • danirixin, which is in Phase II trials for assets.” GSK’s chief highlighted that the ternoon of July 26 after the company’s influenza; big pharma has fallen behind its rivals long list of corporate changes and cut- • tarexumab, which is in Phase II for small backs were announced. cell lung cancer (SCLC); CONTINUED ON PAGE 7 BROUGHT TO YOU BY THE EDITORS OF PHARMASIA NEWS, START-UP AND SCRIP INTELLIGENCE MYSTIC Misses A Whopper Of A Deal Quarterly Results Devastation for AZ as Imfinzi fails AZ hands half of Lynparza to Roche, AZ, Eli Lilly, Celgene, Amgen PFS endpoint (p5) Merck & Co (p8) and BMS (p6, 11, 18-21) IN THIS ISSUE from the editor [email protected] Announcements from twin engines of UK pharma, survival endpoint (page 5), while the deal the company GlaxoSmithKline and AstraZeneca were the hottest signed with Merck & Co for Lynparza and selumetinib is news affecting the industry last week. to be viewed with caution. It brings in a healthy chunk GSK saw its share price dip by 4.6% by the end of the of up-front money and the potential for sizeable mile- week after new CEO Emma Walmsley put her stamp on stones, but dilutes the company’s future profits and was the company by announcing a major shake-up of the seen by some as an indication that AZ was losing confi- pharma business on Wednesday (see cover story). With dence in its immuno-oncology assets (p8). multiple cuts and a strategic review of the rare diseases AstraZeneca’s stock plummeted by almost 17% in portfolio envisaged, the aftershocks will resound for reaction to Thursday’s MYSTIC revelation. Still, inves- some time. Still, there could be opportunities for others tors came out in support of CEO Pascal Soriot. Con- as assets go looking for new homes. trary to recent rumors, he appears to be staying put For AstraZeneca, any positives – healthy second-quar- and is standing by his long-term expectations for the ter figures (p6), encouraging data on Tagrisso in first- company, Imfinzi disappointment notwithstanding line EGFR mutant non-small cell lung cancer – were (p4). The stock bounced back to end the week 12.4% effectively obliterated by the news that the much-antic- lower than it had been before AZ dropped its cluster ipated MYSTIC trial had missed on its progression-free bomb of news. LEADERSHIP ADVERTISING DESIGN Phil Jarvis, Mike Ward Christopher Keeling Paul Wilkinson SUBSCRIPTIONS DESIGN SUPERVISOR Scrip Daniel Frere Gayle Rembold Furbert EDITORS IN CHIEF Ian Schofield EDITORIAL OFFICE Eleanor Malone (Europe) Vibha Sharma Christchurch Court Denise Peterson (US) Joanne Shorthouse 10-15 Newgate Street London, EC1A 7AZ Ian Haydock (Asia) Sten Stovall US CUSTOMER SERVICES EXECUTIVE EDITORS Michael Cipriano Tel: +44 (0)20 7017 5540 COMMERCIAL Derrick Gingery or (US) Toll Free: 1 800 997 3892 Alexandra Shimmings (Europe) Joseph Haas Email: clientservices@ Mary Jo Laffler (US) pharmamedtechbi.com Emily Hayes Mandy Jackson POLICY AND REGULATORY TO SUBSCRIBE, VISIT Cathy Kelly Maureen Kenny (Europe) scrip.pharmamedtechbi.com Nielsen Hobbs (US) Jessica Merrill Brenda Sandburg TO ADVERTISE, CONTACT [email protected] Bridget Silverman EUROPE Sue Sutter Lubna Ahmed Neena Brizmohun Francesca Bruce ASIA John Davis Ying Huang Lucie Ellis Anju Ghangurde All stock images in this publication Kevin Grogan Jung Won Shin courtesy of www.shutterstock.com John Hodgson Brian Yang unless otherwise stated Scrip is published by Informa UK Limited. ©Informa UK Ltd 2017: All rights reserved. ISSN 0143 7690. 2 | Scrip intelligence | 4 August 2017 © Informa UK Ltd 2017 Second Remicade 9 Biosimilar Keytruda Gets PD-1 Possibilities In 20 Benefit Of Doubt 10 Cervical Cancer 16 exclusive online content inside: COVER / Walmsley Shakes Up GSK; Cuts 30 Drug Programs Gilead Raises HCV Guidance Slightly, 4 Soriot Stands By His Post-Pfizer Sales Pledge For AZ Still Mum On M&A http://bit.ly/2vYdAZZ 5 MYSTIC Misses: Devastation For AstraZeneca As Imfinzi Fails Gilead Sciences Inc. still didn’t have anything concrete to PFS Endpoint In NSCLC say about M&A strategy during its second quarter earnings 6 AstraZeneca 2Q: Soriot’s In It For The Long Haul call on July 26, but it surprised market analysts anyway by increasing 2017 sales guidance for its hepatitis C virus (HCV) 8 A Whopper Of A Deal: AZ Hands Half Of Lynparza To Merck drugs just a few months after slashing expectations for its sofosbuvir-driven portfolio. 9 Merck’s Second-To-Market Renflexis Biosimilar Priced Below The First Almirall’s “Perfect Storm”: How Will It Recover? 10 Merck’s Keytruda Gets Benefit Of Doubt, Despite Failing in Head & Neck http://bit.ly/2wejfu9 Spain’s Almirall SA revealed on July 24 that a further part of its 11 Lilly Hopes To Revitalize Its Cancer Brand With ‘Foundational’ business, the aesthetic company ThermiGen, has had a “slow Agents start to the year,” adding to what CEO Eduardo Sanchiz has already called a “perfect storm” of adverse business issues during 12 Celgene Eases Angst Over Otezla the first half of this year. 13 Lilly/Nektar’s ‘Stimulating’ IL-2 Drug 14 Biogen’s Neuroscience Strategy Includes De-Risking The Are Theravance And Mylan’s US COPD Chances Bigger Pipeline Than First Thought? http://bit.ly/2uQPoZx 15 J&J Prepares For US Sirukumab Launch After Regaining Partners Mylan NV and Theravance Biopharma Inc. say they Rights From GSK will submit their nebulized once-daily LAMA respiratory drug 16 PD-1 Data Emerge In Cervical Cancer revefenacin for regulatory approval after receiving good Phase III safety and tolerability data for the long-acting muscarinic 17 Roche Lifts Outlook, Spotlights Perjeta To Drive Growth antagonist (LAMA) in treating chronic obstructive pulmonary 18 Amgen Beats Consensus, Raises Earnings Guidance, But Is It disease (COPD). Sustainable? 19 Bayer And Morphosys Brush Off ADC Mesothelioma Failure Dong-A Faces Price Hit As Korea Ups Fight Against Illegal Rebates 20 Post-MYSTIC, Bristol Renews CTLA-4 Vows, But Is http://bit.ly/2vj4jy2 “Not Wedded” In Lung Cancer In its ongoing clamp down against illegal rebate activities in 21 J&J’s Symtuza Will Debut In Europe On Cramped HIV Market the domestic pharmaceutical industry, South Korea cuts prices of Dong-A ST’s drugs. This follows recent punitive measures 22 Pipeline Watch against Novartis’ Korean subsidiary. 23 Will Mitsubishi’s High Offer Price For CNS Target NeuroDerm Deter Others? Policy Prescriptions: User Fees, Biosimilars, Brexit 23 Appointments http://bit.ly/2tR3M2n A round up of recent regulatory news and trends reported by sister publication, the Pink Sheet, including the struggle to clear the FDA user fee reauthorization bill, the regulatory pathway for Mylan’s biosimilar trastuzumab and Amgen’s biosimilar bevacizumab, and Brexit planning by the European @PharmaScrip /scripintelligence Medicines Agency. /scripintelligence /scripintelligence scrip.pharmamedtechbi.com 4 August 2017 | Scrip intelligence | 3 EXECUTIVE INTERVIEW Soriot Stands By His Post-Pfizer Sales Pledge For AZ ELEANOR MALONE [email protected] ust one day after the revelation that AstraZeneca PLC’s PD-L1 In the words of Bohen, “if you don’t have failures, you’re not taking inhibitor Imfinzi (durvalumab) as monotherapy and combined enough risks.” Both executives underlined that for MYSTIC the end Jwith its CTLA-4 inhibitor tremelimumab had failed to meet the game has always been overall survival as opposed to progression- progression-free survival endpoints in the much-anticipated MYSTIC free survival.
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