With Medivation, Pfizer Sees GSK, J&J And Roche Speak Up Stockwatch A Chance For More Combinations On Women’s Equality Day Last week the increasing volume of Pfizer is relying on future growth of Scrip spoke to big pharma about press backlash against Mylan’s Turing the prostate cancer therapy Xtandi to gender equality issues that need Pharmaceuticals-like pricing policy on justify the $14bn price it will pay to highlighting across the life science EpiPen resulted in another social media buy Medivation (p3) industry (p14) condemnation (p19) 2 September 2016 No. 3818 Scripscrip.pharmamedtechbi.com Pharma intelligence | informa maceutical Inc. as well as a trio of firms that could offer significant cancer assets – Re- generon Pharmaceuticals Inc., Incyte Corp. and Ariad Pharmaceuticals Inc. While BioMarin – an oft-cited takeout target of late – could add heft to the rare disease franchise within Sanofi’s Genzyme Corp. unit and Vertex would bring along a potential blockbuster cystic fibrosis fran- chise, a deal that could spark the established but dwindling cancer business at Sanofi might be the most desirable way to go. A further consideration against pursuing Bio- Marin is the reality that potential interest by rare disease specialist Shire PLC could pro- duce another bidding war like the one that rose up around Medivation. In an Aug. 23 note, Bryan Garnier & Co. ana- Shutterstock: Mmaxer Shutterstock: lyst Eric LeBerrigaud called Pfizer’s acquisition of Medivation “not great news” for Sanofi de- spite the premium price, saying it could have Sanofi Could Pursue Other Oncology “dramatically boosted” the pharma’s cancer franchise and been immediately accretive. “Obviously, the company won’t call it a day M&A Targets After Medivation Loss and will continue to look for other potential JOSEPH HAAS [email protected] targets in the field (and preferably profitable ones, with a promising development pipe- Losing Medivation could end up being a apply that capital now toward another can- line),” he wrote. “And we believe Regeneron, winning proposition for the French phar- cer-focused biotech purchase to bolster its Incyte or Ariad might attract Sanofi’s interest.” ma if it can boost its cancer franchise an- oncology portfolio at a more reasonable cost. Meanwhile, Jefferies Equity Research ana- other way, like by acquiring its partner In the days immediately following Pfizer’s lyst Brian Abrahams named Incyte as one of in multiple collaborations Regeneron or purchase of Medivation – at $81.50 per the most desirable biotech takeout candi- making a less expensive takeout, such as share, an estimated 21% premium over a dates industry-wide in an Aug. 22 note due Incyte or Ariad. share price that already had ballooned since both to its portfolio and pipeline, as well as Sanofi’s buyout interest first became public its “digestible” size. anofi opened the bidding and knowledge in May – analysts speculated drummed up interest in Medivation that Sanofi might be able to get the pipeline A MATURE CANCER SInc., but another suitor – Pfizer Inc. – boost it seeks at a lower price. FRANCHISE AT SANOFI walked off with the prize. While the French Suggested buyout targets for Sanofi or Though Sanofi has a long legacy in cancer pharma may have found the $14bn price tag other big pharmas also competing in the drug development, built around mature, and the share price premium paid by its US Medivation auction include Vertex Pharma- generic-challenged chemotherapy drugs rival too rich for its tastes, it may be able to ceuticals Inc., Biogen Inc. and BioMarin Phar- CONTINUED ON PAGE 7 BROUGHT TO YOU BY THE EDITORS OF PHARMASIA NEWS, START-UP AND SCRIP INTELLIGENCE IN THIS ISSUE More and larger M&A deals could boost public Meulien biopharma companies talks about successes & challenges Phase III Endpoint Hit For of leading IMI Novartis’s Gilenya Follow- 4 On In Progressive MS 13 20 COVER / Sanofi Could Pursue Other Oncology from the US editor M&A Targets After Medivation Loss [email protected] 3 With Medivation, Pfizer Sees A Chance For More Combinations Pfizer’s Aug. 22 acquisition of Medivation put an 4 Pfizer’s Medivation Buyout: end to a long bidding war, but it wasn’t the end of One-Off Deal Or Start Of A Biopharma Spending Spree? the story. Will $81.50 per share – more than dou- 6 Mylan Could Get Out Of EpiPen Price Backlash With ble the trading price before M&A rumors started A Little Contrition, Analyst Says swirling – turn out to be a reasonable price for an established prostate cancer drug and the promise 8 Lundbeck’s Alzheimer’s Strategy Targets of new immuno-oncology combinations? Pfizer Symptoms And Disease Modification will need to push Xtandi to new practitioners and 10 R&D Bites new patients. Medivation has played up its PARP 11 AstraZeneca Sells Small-Molecule Antibiotics inhibitor talazoparib, but there’s little evidence yet. To Pfizer But Still Investing In R&D Pidilizumab has promise too, but Pfizer will have to 12 Pfizer/Celltrion Prep For October Inflectra Launch figure out what it is and how it will help its existing IO plans. What’s next for Sanofi, which started off 13 Phase III Endpoint Hit For Novartis’s Gilenya the frenzy? It could build up its base in oncology, or Follow-On In Progressive MS it could go another direction and double down on 14 GSK, J&J And Roche Speak Up On Women’s Equality Day rare diseases. The question of what’s next for Pfizer 16 Business Bulletin is also still on the table. The $14bn deal was small scale for the pharma giant, so it doesn’t preclude 17 Pharmaceutical R&D In Turkey: the possibilities of a split. Pfizer has promised an Important Steps Forward But A Long Way To Go answer on that by the end of the year. It will take 18 Policy & Regulation Briefs longer than that to see the effect of the Medivation 19 Stockwatch: Teva And Mylan Hit Terminal Velocity deal on the biotech M&A market. 20 Interview: View From The Top Of IMI: Heading Up Life Sciences’ Biggest Public-Private Partnership 22 Pipeline Watch 23 Appointments exclusive online content INTERVIEW: GSK India’s Playbook For Vaccines Dominance Deft pricing and effective physician engagement appear to have helped shape GSK’s sustained dominance in the Indian self-pay vaccines market. GSK Pharmaceuticals India managing director, Annaswamy Vaidheesh, takes Scrip through some of the strategies at play. http://bit.ly/2bSMX03 INTERVIEW: Oscotec Lays Out Global Ambitions For RA, Cancer Drugs Executives from the South Korean bioventure firm Oscotec talk to Scrip about the significance of the recent license agreement for a third-generation EGFR inhibitor by partner Yuhan, and extolled the company’s other core pipeline products, which @scripnews /scripintelligence include novel candidates for rheumatoid arthritis and cancer. http://bit.ly/2bBNTn0 /scripintelligence /scripintelligence 2 | Scrip intelligence | 2 September 2016 © Informa UK Ltd 2016 HEADLINE NEWS With Medivation, Pfizer Sees A Chance For More Combinations Most of the $14bn value Pfizer agreed to pay to buy Medivation is tied to future growth of Xtandi, according to the company, but two pipeline assets and the potential to combine drugs could offer upside. JESSICA MERRILL [email protected] fizer Inc. is relying on future growth of the prostate cancer ther- adding to Lupron or other androgen deprivation therapy, particu- apy Xtandi (enzalutamide) to justify the $14bn price it will pay larly in the urologist’s office, will be a key to growth.” Pto buy Medivation Inc., but two pipeline products and the po- Xtandi generated sales of $1.9bn worldwide in 2015, which Me- tential for developing drugs in combination across pipelines could divation shares with its marketing partner Astellas Pharma Inc., but be longer term growth drivers. it is expected to grow substantially by 2021. Bourla said Pfizer be- “Medivation’s pipeline and innovative assets, including a PARP in- lieves it will own two of the top 10 oncology drugs in the world by hibitor and an immuno-oncology agent, play in the most attractive 2021 with Ibrance and Xtandi. areas in oncology,” CEO Ian Read said during a conference call Aug. Medivation, meanwhile, in the run up to the auction, has been 22, announcing the acquisition. “By combining with Medivation, talking up the potential of talazoparib, which is being studied in we’ll be creating one of the industry’s leading oncology franchises,” a Phase III test in BRCA-mutated breast cancer that is expected to building on the momentum the firm has had with its breast cancer read out in 2017. therapy Ibrance (palbociclib). Medivation believes talazoparib has the potential to be a best- in-class PARP inhibitor. The only approved PARP inhibitor on the Pfizer believes it will own two of the market is AstraZeneca PLC’s Lynparza (olaparib), approved to treat BRCA-mutated ovarian cancer. Clovis Oncology Inc.’s rucaparib is top 10 oncology drugs in the world pending at FDA for ovarian cancer, with action expected in the sec- ond quarter of 2017. by 2021 with Ibrance and Xtandi. Ironically, Pfizer previously owned rucaparib and out-licensed it to Clovis in 2011 for $7m upfront plus $255m in milestones. Man- Pfizer showed just how serious it is about competing in oncology agement said it is confident talazoparib will be best in class when with the pricey buyout. The companies announced Aug. 22 that asked by analysts how the drug might compare to rucaparib. Pfizer was the winner of a competitive bidding process for the San Pidilizumab is an immuno-oncology agent that is being studied Francisco-based biotech. in several Phase I/II studies, including a 150-patient Phase II trial in The crown jewel in Medivation’s portfolio is the hormone thera- patients with diffuse large B-cell lymphoma.