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Multiple Myeloma Would Make Good Guinea Pig for Oncology Cost Control

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Multiple Myeloma Would Make Good Guinea Pig for Oncology Cost Control Pfizer Decides Against A Split GSK’s Mature Products Head: What’s A Fair Price For A Biosimilar Pfizer’s decision not to break up into Innovation Still Possible In Europe? two companies reflects an improved Richard Saynor talks about the What kind of discounts are considered growth outlook. Now it can get on generics business, challenges and reasonable & what returns should with business (p3) how GSK is different (p4) companies expect? (p20) 7 October 2016 No. 3823 Scripscrip.pharmamedtechbi.com Pharma intelligence | informa four other new drugs have recently launched – Johnson & Johnson/Genmab AS’ Darzalex (daratumumab), Bristol-Myers Squibb Co.’s Empliciti (elotuzumab), Takeda’s Ninlaro (ixa- zomib), an oral follow-on to Velcade, and No- vartis AG’s Farydak (panobinostat). In the US and major European markets, payers are cognizant of the costs associated with treating multiple myeloma and the availability of a number of good options is giving them more leverage, reimbursement experts said in a Sept. 21 webinar on payer perspectives in the space. US MARKET SET TO ROCKET The multiple myeloma market in the US overshadows the other key world markets and has been growing at a healthy pace. Shutterstock: Shutterstock: Vatel Elya Datamonitor Healthcare estimates that be- tween 2015 and 2021, US sales will grow by over 50% from $5.5bn to $7.9bn. The patent Multiple Myeloma Would Make expirations of Velcade in 2017 and Revlimid after 2020 will allow for tough competition that will balance rising costs overall. Includ- Good Guinea Pig For Oncology ing the US, the five major European markets and Japan, the market for multiple myeloma Cost Control is expected to grow from $8.7bn in 2015 to $12bn in 2020, according to Datamonitor’s EMILY HAYES [email protected] April 2016 multiple myeloma market fore- cast report. With an array of high quality drugs and Takeda Pharmaceutical Co. Ltd.’s Velcade Guidelines from the National Compre- preference for stacked combo therapy in (bortezomib) and Celgene Corp.’s immuno- hensive Cancer Network advise regimens multiple myeloma, the disease is poised modulatory agents Thalomid (thalidomide) including Velcade, Revlimid or its predeces- to become a testing ground for cost con- and Revlimid (lenalidomide) have tradition- sor Thalomid for first-line therapy, though tainment in oncology. ally dominated the market for multiple my- other brands are trying to break in to that eloma. But despite a relatively small patient line of treatment. Newer drugs are included ith multiple new drugs ap- population, development has been very ac- for use in the second-line or greater, as pa- proved and rising costs, multiple tive for this disease. tients relapse repeatedly (see graphic). W myeloma has emerged as a tar- In addition to newer contenders like Head-to-head trials represent one way of get for cost control and may become an Amgen Inc.’s proteasome inhibitor Kyprolis influencing payers from removing agents area to test out models for oncology gener- (carfilzomib) and Celgene’s immunomodu- from coverage, said Beth Nash, chief medi- ally, reimbursement experts say. latory follow-on Pomalyst (pomalidomide), CONTINUED ON PAGE 8 BROUGHT TO YOU BY THE EDITORS OF PHARMASIA NEWS, START-UP AND SCRIP INTELLIGENCE IN THIS ISSUE Saynor went Amgen and Novartis revealed from poacher Phase III data for a CGRP inhibitor treating episodic to game keeper GSK is working to migraine when he became establish an immuno- head of GSK’s inflammation portfolio & products extend learnings to other portfolio therapy areas 4 6 12 COVER / Multiple Myeloma Would Make Good Guinea Pig from the editor For Oncology Cost Control [email protected] 3 Stronger Together: Pfizer Decides Against A Split After a seemingly interminable drum-roll, Pfizer has 4 Profile: GSK’s Mature Products Head Says Innovation finally announced what will happen to its estab- Still Possible In Established Drugs Business lished products business. Nothing. It will stay with the group. 6 Speed Is Everything In CGRP Race As Amgen/Novartis Reveal Phase III Data A couple of years ago speculation over big pharma groups’ plans to sell large portfolios of mature products 7 New Crohn’s Indication Puts Janssen’s Stelara On was rife. It wasn’t just Pfizer: Merck & Co apparently Equal Ground With Anti-TNFs hoped to secure $15bn by selling its portfolio to a gener- ics firm, while Sanofi’s former CEO Chris Viehbacher 10 Business Bulletin formed a plan to secure $8bn for the French group’s 11 1,000 Layoffs Expected At Novo Nordisk As US Pricing older products and GSK was open about its intention Pressures Bite to divest established products in developed markets. Back then, big pharma seemed to expect that pri- 11 Novartis Sees Disruptive Potential For Novel vate equity or generics companies would pay decent Malaria Drug money to buy a whole established products division. 12 GSK’s Immunology Strategy Edges Closer To Delivering But these are not easy businesses to acquire and optimize. They are complicated and varied, operat- 13 Allergan’s Oral CGRP Inhibitor Overlooked ing across diverse geographies and therapeutic areas 14 New Interim CAR-T Data Support Kite’s BLA with disparate facilities, supply chains and sales in- Submission Plans frastructures. And they are low-margin businesses, as well as being hard to grow in developed markets. 15 R&D Bites Abbott Labs and Baxter International showed that 16 Boehringer Gets Option To Buy ViraTherapeutics it’s easier to hang on to them and set innovation free And Cancer Virus Therapy than the other way round. 17 Amgen’s Kyprolis Miss In First-Line Myeloma Surprising, But Clinically Irrelevant 18 Policy & Regulation Briefs exclusive online content 19 Stockwatch: Regeneron Failure Could Hurt Rivals More 20 Expert View: What’s A Fair Price For A Biosimilar DMD Pipeline: After Sarepta’s First-Ever Approval, Are In Europe? Combinations Next? Several companies have DMD drug candidates waiting in the 21 Surprise Failure for Intra-Cellular’s Schizophrenia Drug wings to follow Sarepta’s Exondys 51 into the commercial market after FDA approval of the exon-skipping therapy, which could be 22 Pipeline Watch the backbone for future combination treatment regimens. 23 Appointments http://bit.ly/2cM86LO Cystic Fibrosis Drug Sales Should Soar; VX-661/ Ivacaftor To Lead Way Sales of key cystic fibrosis drugs will jump in western economies over the next decade, driven by strong uptake of high-cost CFTR modulator therapies and longer use as life expectancies improve, according to a new report by Datamonitor Healthcare. @scripnews /scripintelligence http://bit.ly/2cMb0jW /scripintelligence /scripintelligence 2 | Scrip intelligence | 7 October 2016 © Informa UK Ltd 2016 HEADLINE NEWS Stronger Together: Pfizer Decides Against A Split The pharma giant’s decision not to break up into two separate publicly traded companies as it has been contemplating for several years reflects an improved growth outlook and the inability to unlock trapped value. Now Pfizer can finally get on with business. JESSICA MERRILL [email protected] fizer Inc. will remain one company with two separate busi- ing that some of the blow from the news was already absorbed. In a ness units – Innovative Health and Essential Health – after statement Read said, “We believe that by operating two separate Pthe pharma giant’s board of directors and executive leader- and autonomous units within Pfizer we are already accessing many ship team determined that a split into two separate publicly trad- of the potential benefits of a split – sharper focus, increased ac- ed companies wouldn’t unlock trapped value and would result in countability and a greater sense of urgency – while also retaining less financial flexibility. the operational strength, efficiency and financial flexibility of op- The announcement Sept. 26 removes a long-standing overhang erating as a single company as compared with operating as two, for Pfizer, so that after years of indecision, the company can finally separate publicly traded companies.” move beyond the breakup story. The financial flexibility to dedicate toward business development has been one of the pros in favor of the single company approach Pfizer will generate the appropriate previously highlighted by Read. Pfizer will continue to generate the appropriate financial infor- financial information to preserve the mation to preserve the option for a split at a point in the future if business factors should change. One of the reasons Pfizer took so option for a split in the future long to come to a decision about the future structure of the com- pany was because it needed to collect the appropriate financial information for both sides of the businesses as separate entities. The outcome of the lengthy review highlights how much Pfizer Analysts largely agreed with Pfizer’s final determination. “While a has changed in the five years since investors began pushing for a no split decision may be disappointing to some investors, we agree breakup in 2011. Then, the company was hurtling over the Lipitor with the rationale,” said BMO Capital Markets analyst Alex Arfaei. “In patent cliff and reeling from the consequences. Now, Pfizer’s stock our view, there were too many uncertainties, including the inability to is trading at nearly double the value of where it was trading then extract operational and tax efficiencies, the growth prospects of the ($33.64 compared to $17.70 at the start of 2011) and its growth two separate entities and the market valuation of comparable assets.” prospects are much brighter, powered by the launch of the up and Barclay’s analyst Geoffrey Meacham said, “Pfizer had previously comer breast cancer therapy Ibrance (palbociclib) and a potential estimated that a potential separation would cost in excess of $1bn pipeline of immuno-oncology drugs. along with subsequent transactional support costs, which was not Both business units have been generating strong growth, with likely to result in significantly improved cash flows and tax efficien- Innovative Health revenues up 18% for the first six months of 2016 cies, or, more important, meaningful value creation.” versus the prior-year period and Essential Health revenues up 22%.
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