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Bayer's 2018 Financial Forecast Hit by Manufacturing Woes 9 March 2018 No. 3895 Scripscrip.pharmaintelligence.informa.com Pharma intelligence | informa its specifications, whether or not the batch has already been distributed.” Among the other charges is that Bayer’s quality control unit did not sufficiently oversee adequacy of procedures at the facility to assure drug product quality. During the company’s 2017 full year financial results presentation on Feb. 28, the company highlighted that it was expect- ing temporary supply interruptions due to remediation measures in production. Bayer expects the impact on adjusted EBITDA to be about €300m. The largest proportion of this amount is related to the pharmaceuti- cals division and a minor part to the con- sumer health business unit. Weinand, who is also a member of Bay- Dieter Weinand er’s management board, told Scrip after the company’s earnings presentation in Leverkusen, “Our biggest challenge is to get the supply chain running… bringing the Bayer’s 2018 Financial Forecast warning letter to a conclusion as quickly as possible because that is a limitation.” Weinand added that while in-market per- Hit By Manufacturing Woes formance was good the company needed LUCIE ELLIS [email protected] to quickly make adjustments at its Leverku- sen plant to answer the FDA’s qualms. “We etting its German manufacturing is- Bayer received a lengthy warning letter are working diligently with the FDA to re- sues sorted as quickly as possible will from the US FDA in November last year, solve the warning letter as fast as possible,” Gbe the biggest challenge for Bayer which was published in February 2018, he said. “We hope to do this by the end of AG in 2018, according to the company’s about significant manufacturing violations the year… We have hired external support.” head of pharmaceuticals Dieter Weinand. at the German group’s Leverkusen facility. The FDA’s warning letter relates to an in- Until good manufacturing practice (GMP) The warning letter stated that Bayer’s “meth- spection of the Leverkusen plant in January violations at one of its sites in Germany are ods, facilities, or controls for manufactur- 2017. Products affected include some big- corrected, Bayer will only be able to run lim- ing, processing, packing, or holding do not earners, such as the blood pressure treat- ited services. This situation is expected to set conform to current good manufacturing ment Adalat (nifedipine) and the erectile Bayer back by around €300m in 2018. practice (CGMP).” And the list of violations is dysfunction drug Levitra (vardenafil). a long one. Bayer has forecast sales of €16.5bn for 2017 FULL YEAR RESULTS Bayer stands accused of failing to establish the pharma unit in 2018, falling short of the AT A GLANCE and follow adequate written procedures for €17.6bn previously predicted by analysts. • Group sales for FY 2017: €35bn cleaning and maintenance of equipment, This corresponds to a low-single-digit per- • EBITDA before special items: €9.3bn and not thoroughly investigating “any un- centage increase on a currency- and portfo- • Net income: €7.3bn explained discrepancy or failure of a batch lio-adjusted basis. • Core EPS: €6.74 or any of its components to meet any of Published online 1 March 2018 BROUGHT TO YOU BY THE EDITORS OF PHARMASIA NEWS, START-UP AND SCRIP INTELLIGENCE Celgene MS Setback Amgen’s Investment Strategy Artificial Intelligence FDA delay for ozanimod R&D Head Harper plays the Who’s doing what with whom? (p4) long game (p6) (p10-11) IN THIS ISSUE from the editor [email protected] This week’s edition of Scrip paints a rather gloomy pic- That attention to how one seeks the needle in the ture of the industry. While Bayer faces a €300m earn- haystack is also in evidence in Mandy’s report from ings hit this year because of manufacturing compliance Biocom’s Global Life Science Partnering Conference violations in Germany, Celgene suffered yet another (p10), where big pharma business development heads setback when the FDA sent back for more work its highlighted their growing interest in partnering with new drug application for the multiple sclerosis candi- those who can help them crunch data better, or who of- date ozanimod, which has been earmarked as a multi- fer new approaches to drugging difficult targets. Lucie billion dollar revenue generator (see p4). At Daiichi Ellis delves further into how artificial intelligence com- Sankyo there are job cuts (p5) and Biogen and AbbVie panies are expanding into drug discovery and develop- have pulled their MS drug Zinbryta from the market on ment on p11. safety grounds less than two years after its launch (p8). Elsewhere in the issue we have interviews with exec- It’s not all doom and gloom. Mandy Jackson’s inter- utives from Merck KGaA (p18), Sanofi (p19) and the view with Amgen’s R&D chief Sean Harper reveals how new AstraZeneca spinout Viela Bio (p20). Their focus looking for a needle in a haystack need not be a thank- on exciting areas of R&D innovation reminds us of less task when you commit to refining your methods the huge opportunities this industry enjoys – despite and pick your needle carefully (p6). its setbacks. 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 Ian Haydock (Asia) Sten Stovall London, EC1A 7AZ 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) Emily Hayes pharma.informa.com Mandy Jackson POLICY AND REGULATORY Cathy Kelly TO SUBSCRIBE, VISIT Maureen Kenny (Europe) Jessica Merrill scrip.pharmaintelligence.informa.com Nielsen Hobbs (US) Brenda Sandburg TO ADVERTISE, CONTACT Bridget Silverman [email protected] EUROPE Sue Sutter Neena Brizmohun Francesca Bruce ASIA John Davis Anju Ghangurde Lucie Ellis Ying Huang 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 2018: All rights reserved. ISSN 0143 7690. 2 | Scrip | 9 March 2018 © Informa UK Ltd 2018 Oncology Lift Off Digital Health Pact AstraZeneca Spin Out 20 14 16 20 exclusive online content inside: Pfizer Japan Cautious Over New Policies As Sales Slip COVER / Bayer’s 2018 Financial Forecast Hit By Manufacturing Woes http://bit.ly/2D5oTBS Despite a fall in local revenues, Pfizer remains bullish on its 4 Celgene Reveals Refuse-To-File Letter For Ozanimod newer products and pipeline in Japan but is cautious about this year’s planned price reforms in the country. 5 More US Positions Go As Daiichi Sankyo Refocuses 6 R&D Head Sean Harper On Amgen’s Long-Term Turkish Pharma Outlook 2018: Growth Tempered By Lira Devaluation And Pricing Policies Investment View http://bit.ly/2oMK5bG 8 Biogen, AbbVie Withdraw Struggling MS Drug Zinbryta Turkey’s pharmaceutical market is likely to grow by around 12- Due To Safety Issues 15% this year, but tight pricing policies and a low fixed exchange rate for the euro at a time when the Turkish lira is volatile and weak 9 Valeant Claims Progress, Asks Investors For Patience against both the euro and US dollar spell trouble for the industry. 10 Biopharma Investing In Better Success Rates Via AI, Dermira Ends Acne Program After Phase III Failure, Data And New Modalities Tries To Keep Focus On Hyperhidrosis Drug 11 Who’s Who In Artificial Intelligence Drug Development http://bit.ly/2I7cLny FDA approval for DRM04 in hyperhidrosis is expected at the 14 The Most Successful Oncology Launches Of A Decade end of June, but Phase III data for DRM01 in acne was the main event for investors. CEO Tom Wiggans said Dermira will try to 15 Mylan Plans To Compete In US HIV Market understand what went wrong, while staying focused on DRM04 16 Novartis Teams With Pear Therapeutics In Neurological commercialization and lebrikizumab in Phase IIb. Digital Health Pact Venture Funding Deals: Celularity Launches With 17 Nektar’s IO Deal With Bristol Looks Even Sweeter $250m; Generation Bio Grabs $100m Series B http://bit.ly/2FYaN8w 18 How Merck KgaA Is Riding The Gene Therapy Wave Celularity launched with $250m to develop cell therapies with 19 How Sanofi Is Stepping Up Blue Sky Research technology licensed from Celgene and others, while mRNA specialist Moderna brought in another $500m mega round and 20 AstraZeneca Keeps R&D Focus, Spins Out Phase II Generation Bio closed a $100m Series B to fund ongoing gene Neuromyelitis Optica MAb Into New Biotech therapy programs. 21 Dupixent FDA Asthma Review Bolsters Sanofi Sun’s Key Halol Plant Flunks FDA Inspection Again And Regeneron http://bit.ly/2G0b8Yj 22 Pipeline Watch The US FDA has flagged more issues at Indian firm Sun Pharma’s largest manufacturing plant in Halol but analysts are hoping 23 Late-Stage CNS Drugs Key For Alkermes, But Early-Stage the infractions are minor and that the Indian facility will get the IL-2 Agonist Fascinates regulatory green light soon, ending a blacklist on the factory supplying new products to the US. 23 Appointments Deal Watch: Fresenius Buyout Of Akorn Potentially Threatened By Data Integrity Issues http://bit.ly/2FYXCnV AstraZeneca takes second license of antisense candidate under 2012 pact with Ionis, this time for kidney disease. Aldeyra is working with J&J on novel immune-modulating drugs for systemic inflammatory conditions. @PharmaScrip /scripintelligence /scripintelligence /scripintelligence scrip.pharmaintelligence.informa.com 9 March 2018 | Scrip | 3 HEADLINE NEWS Celgene Reveals Refuse-To-File Letter For Ozanimod MANDY JACKSON [email protected] elgene Corp.
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