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GSK's Big Reveal 3 August 2018 No. 3916 Scripscrip.pharmaintelligence.informa.com Pharma intelligence | informa at Genentech Inc. (Also see “GSK Bags Bar- ron As R&D Boss As Vallance Joins UK Govern- ment” - Scrip, 8 Nov, 2017.) With a budding early immuno-oncology pipeline, Walmsley clearly has her eye on establishing GSK as an important player in the space. The event in London was Barron’s first op- portunity to present his R&D strategy and coincided with the company’s second quar- ter sales and earnings release. “This is an ideal time to be thinking about reinventing R&D, because we are doing well. We are growing,” Barron said. PILLARS FOR INNOVATION Investors have been eager to hear from the R&D legend, but with few near-term catalysts or big changes to the late-stage pipeline, they may be underwhelmed by the update. Barron, meanwhile, is focused on deliver- GSK’s Big Reveal: ing scientific and cultural changes that will yield breakthroughs over the long-term. An R&D Overhaul Poised To Yield He talked about a time horizon of 2021 to 2026, and he talked more high-level, rather than specifics, about incentives needed to Long-Term Cultural Change drive innovation, the technologies that can JESSICA MERRILL [email protected] help improve clinical trial success, and cul- tural changes. He said science, technology laxoSmithKline PLC CEO Emma pharma R&D – is that investors will need to and culture are the three pillars needed to Walmsley may have spelled out the be patient to see GSK deliver on its promise drive innovation, and all three must be in Gbig pharma’s R&D turnaround plan of innovation. GSK does not have a wealth place to be successful. best while introducing the company’s new of late-stage drugs in the pipeline and GSK’s focus will be on developing Chief Scientific Officer and President-R&D despite delivering advancements in core breakthrough medicines, rather than Hal Barron to the stage during an investor areas like respiratory disease and HIV re- incrementally beneficial ones. As he ex- event July 25. cently, the company has fallen well behind plained it, “ones that are going to be very “His job is to transform our pipeline and rivals in important areas like oncology and transformative, ones that don’t stop after reignite GSK’s reputation as an innovator,” immunology, where it’s clear Barron plans the first indication, ones that have a broad she said. “That is going to take some time, to course correct. lifecycle and ones that when they help, but I can assure you he is already having Walmsley recruited Barron to GSK late they help in a fundamental way.” He said an impact.” last year to reinvent the company’s phar- the company would be more agonistic to Indeed, the big takeaway from the meet- maceutical R&D, with an eye toward build- therapy area and go where the science ing – the first in which Barron addressed ing in oncology. It was a big coup given his leads, underpinned by genetics. investors at length about his plans for legacy in cancer as the former head of R&D CONTINUED ON PAGE 7 BROUGHT TO YOU BY THE EDITORS OF PHARMASIA NEWS, START-UP AND SCRIP INTELLIGENCE Abbvie’s Orilissa Approved Leadership Perspective Pricing Debate Pricing strategy aims to enable Silence Therapeutics exec explains why Pfizer’s CEO is notably optimistic access to endometriosis drug this is a key moment for the company about potential US policy changes (p15) and the RNAi space (p17) (p21) IN THIS ISSUE from the editor [email protected] The presentation of 18-month Phase II data for Biogen/ fect); the companies’ adaptive trial design including a new Eisai’s anti-amyloid-beta protofibril antibody BAN2401 Eisai-designed composite scale for measuring clinical out- generated the biggest buzz at the Alzheimer’s Association comes in Alzheimer’s; lack of clarity over the link between International Conference last week (see p9). changing levels of amyloid plaque in the brain and clini- But enthusiasm for the results was more a reflection of cal outcomes; and, more fundamentally, the fact that the the context of repeated confusion and failure in the field trial has yet to be published and peer reviewed. of Alzheimer’s R&D (and indeed the previous lackluster Meanwhile, second-quarter results season has been 12-month data in this very trial), than a ringing endorse- marked by changes at the top, with Gilead announcing ment of this particular drug candidate. And Biogen reeled the impending departure of CEO John Milligan and chair back from pre-presentation hints that the drug might be John Martin (p8), new R&D head Hal Barron dominating headed for a speedy FDA review on the basis of the Phase GSK’s Q2 call (p1), Amgen announcing the retirement of II results as skeptics raised their voices. Various factors cry R&D chief Sean Harper and commercial head Anthony out for caution and further analysis – including the nu- Hooper and Bristol-Myers Squibb revealing that commer- merical imbalance of carriers of the APOE4 genetic risk cial head Murdo Gordon is to replace Hooper at Amgen factor for Alzheimer’s (far higher in the placebo group (see Scrip online for these latter two articles.) than in the highest treatment dose that showed most ef- LEADERSHIP ADVERTISING DESIGN Phil Jarvis, Mike Ward, Christopher Keeling Paul Wilkinson Karen Coleman DESIGN SUPERVISOR SUBSCRIPTIONS Gayle Rembold Furbert Scrip Dan Simmons, Ewan Ritchie, Shinbo Hidenaga EDITORS IN CHIEF John Davis EDITORIAL OFFICE Ian Haydock (Asia) Kevin Grogan Christchurch Court Eleanor Malone (Europe) Ian Schofield 10-15 Newgate Street Denise Peterson (US) Vibha Sharma London, EC1A 7AZ Joanne Shorthouse CUSTOMER SERVICES Sten Stovall EXECUTIVE EDITORS US Toll-Free: +1 888 670 8900 COMMERCIAL US Toll: +1 908 547 2200 Alexandra Shimmings (Europe) US UK & Europe: +44 (20) 337 73737 Mary Jo Laffler (US) Michael Cipriano Australia: +61 2 8705 6907 Derrick Gingery POLICY AND REGULATORY Japan: +81 3 6273 4260 Joseph Haas Maureen Kenny (Europe) Email: clientservices@ Emily Hayes 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 2018: All rights reserved. ISSN 0143 7690. 2 | Scrip | 3 August 2018 © Informa UK Ltd 2018 20 5 9 17 exclusive online content inside: COVER / GSK’s Big Reveal: An R&D Overhaul Poised To Yield Hemlibra Effect Is Muted At Shire - For Now Long-Term Cultural Change https://bit.ly/2v2l13q Hemlibra has taken a bite out of Shire’s FEIBA sales, but 4 AstraZeneca’s Oncology Business Delivers, Edging Toward compensatory boosts in other areas of the business helped CV/Metabolic As Top Contributor CEO Ørnskov keep the business ticking over while awaiting the finalization of Takeda’s takeover. 5 First-Line Chemo Combo Data Help Merck’s Keytruda Power Past Opdivo Buoyant Biotech Funding Environment Directly 8 Milligan’s Retirement Means New CEO For New Gilead Impacts CRO Q2s https://bit.ly/2vn9Lhq 9 Biogen, Eisai Report BAN2401 Seemingly Positive In The contract services industry is reaping the rewards of a Alzheimer’s; Others Skeptical resilient biotech funding environment, re-accelerating growth in the sector. 12 UCB Looks To Its Next Wave Of Innovative Products First-Line Chemo Combo Data Help Merck’s Keytruda 13 Chugai Explores New Tech In Strategic Push For Innovation Power Past Opdivo https://bit.ly/2ApgX2f 14 AbbVie HCV Revenue Surprises Again, But Falloff Is Coming Keytruda sales are soaring on first-line lung cancer use, but with many new filings and approvals, Merck tells its second-quarter 15 AbbVie Prices Oral Endometriosis Drug Orilissa In Value earnings call it’s just the beginning. Range, Focusing On Access Bristol Touts Opdivo’s Stability – And Diversity – 17 Interview: Silence Therapeutics’ Chair On Why Keeping In Strong Q2 Quiet Has Done The Biotech No Favors https://bit.ly/2v6YfXr The recently launched Opdivo/Yervoy combination already has 20 Innovation Critical As Japan Pharma Faces Continued a leading position in first-line kidney cancer in the US – with a Pricing Pressures 30% share of new patients – but has been rejected in Europe. 21 Pfizer’s CEO Is Bullish On Rebate Changes That Could Sanofi Top UK Exec Plans For Hard Brexit, Power New Launches Blasts ‘Poor Access’ To New Drugs https://bit.ly/2KikHCC 22 Pipeline Watch The managing director for Sanofi in the UK says clinical trials there will become less likely in future if access to innovative 23 Lysosomal Storage Disorders: Azafaros Takes Aim drugs doesn’t improve, causing comparative standards of care At Small Molecules to deteriorate. 23 Appointments Harper, Hooper Exit As Amgen Revenues Rise https://bit.ly/2O0qAGM Amgen revealed better-than-expected second quarter earnings July 26 and said its R&D and commercial heads Sean Harper and Anthony Hooper are retiring. Harper, who’s getting involved with start-ups, is being replaced from within by David Reese; Bristol’s Murdo Gordon will take over for Hooper. @PharmaScrip /scripintelligence /scripintelligence /scripintelligence scrip.pharmaintelligence.informa.com 3 August 2018 | Scrip | 3 Q2 UPDATE: ONCOLOGY AstraZeneca’s Oncology Business Delivers, Edging Toward CV/Metabolic As Top Contributor JESSICA MERRILL [email protected] straZeneca PLC may soon be most recognized as an oncology compa- Any. The UK pharma’s oncology port- “ There is not just one product folio is its dominant growth driver and will soon edge out the other two business units driving our growth.
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