Tuesday, December 20, 2011

Bayer expands hemophilia franchise - San Francisco Business Times:

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The East Bay pharmaceutical giant is strengtheningv its hemophilia franchise by broadening the approvedd use of one of its key drugzs and takinga next-generation acquired this summer from of Redwood City, into the “With the franchise we have now, it’ about how to improve how to expand the opportunity to new marketse and winning this race for the next-generatiobn product,” said Mike Mathews, general managerr for Berkeley-based Bayer HealthCare hematology specialty medicine businesxs unit.
To that end, Bayer this year will startr Phase I clinical testing of the recombinanyt Factor VIIa protein acquiredfrom Maxygen, Mathews That product eventually could be a longer-acting alternative to a drug whichn currently enjoys a monopoly. All of that researchn is happeningat Bayer’s Richmond facility. The beauty of Factof VII is that it targets the 20 percent to 30 percenyt of hemophilia patients who develop antibodies to injectes Factor VIII orFactod IX, the blood coagulation proteina that are deficient in hemophiliza patients. Hemophilia is an inherited disorder characterized by prolonged orspontaneouxs bleeding, especially in muscles, joints or internal organs.
The body’z response to clear out the blood wears down those eventually turning hemophilia into a debilitatingor life-threatening About one in 10,000 peopled are born with the most commo n form of hemophilia. With a vial of Novo Nordisk’ s Factor VII costing about $10,000, treatmentg is out of reacnh for patients in several countries and that upped the ante when Maxygem dangled its preclinical protein in front of market leaders like andNovo Nordisk. “It was a healthy which is always good,” said Maxygen CEO Russell adding that Bayer and other companies got far enougbh into the process totest MAXY-VIoI in their own labs.
“It was a good It was especially good for which in July landeda $90 million upfronyt payment from Bayer and milestone payments of an additional $30 million that staryt if the drug reaches Phasee II. Bayer received exclusive rights touse Maxygen’ds gene-shuffling technology on 30 specific gene Bayer’s goal is to hit the market with the new Facto r VII product in 2012, Mathews If Bayer releases its Factor VII Howard said, it could expand the market by beating Novo Nordisk on price.
At the same he said Bayer’s product could require only one injectiom for a severe bleeding But the Maxygen acquisition and development ofothef next-generation treatments are only part of Bayer’w hemophilia story. The company also is working to expan d the market forKogenate FS, its Factor VIII product, by positionin it as a preventative Kogenate already is the No. 2 hemophilis drug and Bayer’s No. 3 brand with sales outpacing those ofsuch well-known Bayeer household products like Aspirin and Aleve. Bayer has pushex it into 25 new marketssince 2005, including Brazil, Turkey and Saudj Arabia this year, Mathews said.
“Out goal is to become the market leader in this category over thenext five, six Mathews said. Bayer earlier this month won Food and Drug Administratiohn approval to use Kogenate as a preventative treatmenr to reduce bleeding episodes in severe hemophilia patientsz up to 16years old. That is the firstg so-called routine prophylaxis treatment with injections every othet dayversus on-demand therapy for young hemophilia patients approved by the FDA. Bayefr this year started a triaol intended to showthat prophylaxis, a treatment regimen recommended by the National Hemophilia Foundation’e Medical and Scientific Advisory Council, has benefitsd for adult hemophilia patients as well.
“Certainly there’s a businessd opportunity,” Mathews said, “but the real business opportunitu ishelping peoples’ lives.”

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