Friday, October 14, 2011

Deals of the Week Considers Another Blockbuster

"If you guys were the inventors of regorafenib, you'd have invented regorafenib." It may not have much of a ring to it, but that's the line a Bayer executive might have spoken if screenwriter Aaron Sorkin had scripted the company's tiff with longtime partner Onyx Pharmaceuticals. And like the spats Sorkin brought to the silver screen in The Social Network last fall, the Bayer-Onyx quarrel resulted in a settlement.

What could have shaped up as a cinematic tale of betrayal ended with a handshake this week, as Onyx agreed to drop its lawsuit against Bayer, several days into a trial in U.S. Federal District Court in San Francisco. The agreement resolves litigation that has persisted since May 2009 and restores peace to a partnership that dates back to 1994.

At stake were the rights to Phase III candidate regorafenib, a cancer-fighting compound that bears a strong resemblance to Nexavar (sorafenib), the nearly-$1-billion-a-year oncology drug on which Bayer and Onyx have collaborated since the mid-90s. ("You know what's cool? A billion-dollar drug.") Onyx had charged that Bayer developed the newer molecule in secret, violating the companies' agreement to disclose research of other compounds related to Nexavar. Regorafenib's chemical structure is almost identical to Nexavar's, substituting one fluorine atom for a hydrogen atom.

Rather than simply cutting a check or handing over equity, as Zuck did for both the adversarial Winklevii and his former friend Eduardo Saverin, Bayer has resolved to move forward with its partnership with Onyx, while restructuring some elements. Onyx gets 20% of worldwide sales of regorafenib in oncology, and it won't shoulder any costs for its late-stage development; Bayer will handle that. Bayer will also pay Onyx fees if they agree to co-promote the drug inside the U.S., where it has been tested in metastatic colorectal cancer and gastrointestinal stromal tumors.
Cash changes hands right away, too: Bayer is buying out Onyx's rights to Nexavar royalties in Japan for $160 million, giving Onyx additional funds as it readies another Phase III cancer drug, carfilzomib, for regulatory approval. Moreover, Bayer agreed to waive the change-of-control provisions that would have required Onyx to give up Nexavar profits in the event Onyx is sold, thereby freeing up its merger-and-acquisition options.

It's a good deal for Onyx, which gets timely cash and potential downstream money from a drug it won't have to develop itself. And although the companies have insisted that it's been business as usual between them all along, they appear to have patched things up without much damage to anyone's reputation; Bayer admitted no wrongdoing in the process.

If they never make a movie about regorafenib after all, well, we've got Contagion, haven't we? And also...

Pfizer/Humana: As fans of both the Philadelphia Phillies and the New York Yankees well know, the only post-season outcome that matters is a World Series victory. In the less glitzy world of pharma, outcomes -- particularly data that track real-world outcomes and measure a drug's effectiveness relative to competitors -- could mean the difference between drug launches that sparkle and others that fall flat. With payors now wielding greater control, pharmas need access to the breadth of data required for more informed drug development or post-marketing product plans. Hence, the rise of a new kind of partnership in 2011: the pharma-payor collaboration. AstraZeneca and Sanofi were the first to jump on the bandwagon, inking deals with Wellpoint's HealthCore and Medco's United BioSource respectively. This week it's Pfizer's turn: In a five-year partnership, the world's biggest pharma is teaming up with insurer Humana and its research affiliate Competitive Health Analytics to use real-world outcomes data and comparative effectiveness. The partnership addresses three chronic disease areas affecting the elderly: pain, cardiovascular disease, and Alzheimer's disease. The companies didn't disclose financials and whether or not the relationship is exclusive. Presumably Pfizer is providing some kind of upfront money to support research by the two groups over the length of the agreement. What kind of "skin" Humana has in this particular game remains unknown. For instance, if Pfizer worked with Competitive Health Analytics to show a particular Alzheimer's drug were better than a rival's, could such data spark a reimbursement commitment from the parent company? We're guessing not. But that raises the question: is this multi-year collaboration a true partnership or a fee-for-service arrangement that gives Pfizer data access? What's clear is that, as in the AZ/HealthCore and Sanofi/Medco deals, Pfizer anticipates using the data to improve uptake of already launched products and to help the R&D crew make better decisions about the kinds of studies to conduct with pipeline products to win a stamp of approval not just from regulators but payors as well. -- Ellen Licking

Teva/Par: Generic drug seller Par Pharmaceuticals is shaping up to be the beneficiary of a Federal Trade Commission consent order requiring Teva Pharmaceuticals Industries to divest itself of two products totaling $200 million in annual sales, as a condition for Teva to acquire Cephalon. If the consent order is approved, Par would acquire the generic versions of transmucosal cancer pain lozenge Actiq (fentanyl citrate) and muscle relaxant Amrix (cyclobenzaprine) from the combined company for an amount to be determined. Teva will also supply a year's worth of generic Provigil (modafinil) to Par after its patent expires in 2012. Teva held 43% market share of generic Actiq, while Cephalon and Watson Pharmaceuticals jointly held 40% of an overall generic Actiq market worth $173 million. Amrix is not marketed in the U.S. as a generic, but the FTC determined that both Teva and Cephalon were on a short list of suppliers who could launch a generic version quickly. The consent order is subject to public comment until Nov. 7, after which time the Commission will decide whether to make it final, potentially greenlighting the $6.8 billion all-cash deal announced in May. -- Brenda Sandburg & P.B.

Pfizer/GlycoMimetics: Pfizer deepened its foray into rare diseases by taking worldwide exclusive rights to a sickle cell disease treatment currently in Phase II. In a deal announced October 11, Pfizer will pay up to $340 million to GlycoMimetics of Gaithersburg, Md., for GMI-1070, which has received orphan drug and fast-track status from the FDA. The drug aims to treat painful episodes of vaso-occlusive crisis, a complication of sickle cell anemia that causes obstruction of blood flow and can lead to organ damage. It is the major cause of morbidity and mortality for patients with the rare genetic disease, which occurs more commonly in people or descendants of people exposed to malaria. In the US, 1 of roughly 500 African-Americans are born with sickle-cell anemia, according to the Centers for Disease Control. To date, veno-occlusive crisis episodes have been treated with hydration, pain medication, and blood transfusion, usually requiring up to a week of hospitalization -- over 75,000 a year, according to GlycoMimetics. The firm says that GMI-1070 is thought to inhibit an early step in the inflammatory process that leads to leukocyte adhesion and recruitment to inflamed tissue. GlycoMimetics will be responsible for continued Phase II development, after which Pfizer will take the reins. Beyond the $340 million potential total, the details of the deal were not disclosed. The total does not include sales royalties if Pfizer brings the drug to market. The deal should provide further motivation to venture backers who see rare diseases as a fruitful investment area. Pfizer isn't the only active acquirer or in-licensor; GlaxoSmithKline, Shire, and Sanofi have all made significant investments in the area, and startups such as Ultragenyx Pharmaceutical and Orphazyme have benefited by attracting lavish venture dollars. -- Alex Lash 

Bayer/Yunona Holdings: Bayer has signed a preliminary agreement with Russian pharmaceutical maker Yunona Holdings to set up manufacturing, distribution and sales of drugs in Russia. Under its two-year-old Pharma2020 program, the Russian government has put in place incentives to increase the percentage of drugs sold in Russia to be made in that country, from 23% currently to 50%. A key driver is giving locally-made drugs more favorable reimbursement. As a result, foreign firms such as AstraZeneca, Novartis AG and Novo Nordisk are rapidly committing to build plants in the country, mostly in collaboration with local companies. It’s not clear what drugs Bayer plans to make in Russia, but Yunona is involved in diverse businesses, including oncology drugs and insulin. Analysts consider the country to be one of the major emerging markets for pharmaceuticals. Yunona, which is based in Yekaterinburg in the Sverdlovsk region, represents the Ural Pharmaceutical Cluster, which the Russian government has described as a high-tech complex of production and infrastructure capabilities. The cluster is earmarked for $860 million in government funding between 2010 and 2015. In addition to Yunona, the cluster includes the Ural division of the Russian Academy of Sciences and the Ural Federal University.  -- Wendy Diller

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