Bayer expands hemophilia franchise - San Francisco Business Times:

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The East Bay pharmaceutical giant is strengthening its hemophilia franchise by broadening the approved use of one of its key drugzs and takinga next-generation product, acquired this summer from of Redwood City, into the clinic. “With the franchise we have now, it’s about how to improve outcomes, how to expan the opportunity to new markets and winninv this race forthe next-generation said Mike Mathews, general manager for Berkeley-based Bayere HealthCare Pharmaceuticals’ hematology specialty medicine business unit. To that end, Bayeer this year will start Phase I clinical testin g of the recombinant Factor VIIa protein acquired from Mathews said.
That product eventually could bea longer-acting alternative to a drug whicn currently enjoys a monopoly. All of that research is happeningyat Bayer’s Richmond facility. The beauty of Factoe VII is that it targets the 20 percenyt to 30 percent of hemophilia patients who developp antibodies to injected Factor VIII orFactor IX, the bloofd coagulation proteins that are deficient in hemophiliaq patients. Hemophilia is an inherited disorder characterize d by prolonged orspontaneous bleeding, especially in joints or internal organs.
The body’s responsee to clear out the blooe wears downthose regions, eventually turningg hemophilia into a debilitating or life-threatening About one in 10,000 people are born with the most commoh form of hemophilia. With a vial of Novo Nordisk’sa Factor VII costing about $10,000, treatmen is out of reach for patients in severaklcountries — and that uppedc the ante when Maxygen dangler its preclinical protein in front of marke leaders like Bayer, and Novo “It was a healthy competition, whicy is always good,” said Maxygen CEO Russell adding that Bayer and other companies got far enougn into the process to test MAXY-VII in their own “It was a good race.
” It was especiall good for Maxygen, which in July landed a $90 millionj upfront payment from Baye r and milestone payments of an additional $30 million that star if the drug reaches Phaswe II. Bayer received exclusive rights touse Maxygen’s gene-shuffling technology on 30 specific gene Bayer’s goal is to hit the markett with the new Factor VII productt in 2012, Mathews said. If Bayer releasees its Factor VII commercially, Howard said, it could expand the marketg by beating Novo Nordiskon price.
At the same he said Bayer’s product could requirre only one injection for a severe bleeding But the Maxygen acquisition and development ofothee next-generation treatments are only part of Bayer’s hemophilia story. The company also is working to expand the market forKogenate FS, its Factof VIII product, by positioning it as a preventative Kogenate already is the No. 2 hemophilia drug and Bayer’se No. 3 brand with sales outpacing those ofsuch well-known Bayef household products like Aspirin and Aleve. Bayer has pushed it into 25 new markets since including Brazil, Turkey and Saudi Arabiwa this year, Mathews said.
“Our goal is to become the market leader in this category over thenext five, six years,” Mathewzs said. Bayer earlier this month won Food and Drug Administrationn approval to use Kogenate as a preventative treatment to reduce bleedinfg episodes in severe hemophilia patients up to 16years old. That is the first so-called routine prophylaxis treatment — with injections everh other dayversus on-demand therapy — for yount hemophilia patients approved by the FDA.
Bayer this year started a trial intendec to showthat prophylaxis, a treatment regimehn recommended by the National Hemophilia Foundation’a Medical and Scientific Advisory Council, has benefits for adult hemophili a patients as well. “Certainly there’s a businessd opportunity,” Mathews said, “but the real businesz opportunity ishelping peoples’ lives.”