Millennium, Looking to Fend Off Onyx, Awaits FDA Word on New Velcade

1/20/12Follow @xconomy

The drug that made Millennium into a biotech power is on the verge of getting a subtle but meaningful upgrade, just in time to help the company fend off a serious new competing therapy from South San Francisco-based Onyx Pharmaceuticals (NASDAQ: ONXX).

Cambridge, MA-based Millennium, the cancer drug unit of Takeda Pharmaceuticals, is awaiting word from the Food and Drug Administration on whether it can start marketing a new version of bortezomib (Velcade) that can be injected just underneath the skin. The U.S. drug regulatory agency has a deadline of Jan. 23 to complete its review of Millennium’s application for the subcutaneous form of the treatment, which would be a new option beyond the current version that’s given intravenously.

Ordinarily, this kind of application would be an incremental advance. But the FDA’s decision could mean a lot to Millennium, because the new subcutaneous form is not only faster and more convenient for hospitals to administer, but clinical trials show it causes less nerve damage in the fingers and toes than the conventional IV product. If the FDA agrees to allow Millennium to market the new version, then Millennium will have a stronger defense against emerging competition from Onyx Pharmaceuticals, which is angling for FDA clearance of a rival drug that has long claimed to have an advantage with its milder side effects.

The Millennium drug, approved by the FDA in 2003, generated $1.4 billion in worldwide sales in 2009, and is on pace to eclipse $3 billion by 2015, according to BCC Research. About 20,000 people are diagnosed with myeloma each year in the U.S., and 10,000 die from it annually, according to the American Cancer Society.

“There are all kinds of ramifications that will make this quite an attractive option for patients,” Deborah Dunsire, the CEO of Millennium, said last week in an interview at the JP Morgan Healthcare Conference in San Francisco.

The whole idea of packaging Velcade in a new way wasn’t something that came from Millennium scientists, and they didn’t expect it would make much difference. The idea for developing a subcutaneous form came after a nurse in France improvised when it was too difficult to find a vein in an elderly patient, Dunsire says. It turned out the patient did well on this improvised injection, and the doctor decided to try to study the new injection mode further, she says.

When Millennium got wind of some promising early results, it designed a study of 222 patients to compare those on standard Velcade with patients on the new subcutaneous version, to see if they were roughly the same. A subcutaneous version, after all, has a natural convenience advantage in that patients don’t have to … Next Page »

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