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Millenium Pharmaceutical


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CompanyDateOpeningLast PriceVariationHighLowVolume
MLNM2004-09-2712.9613.17-0.4213.3712.872075409

Article added on: 2003-06-15

Millennium's obtains Velcade Approval from FDA


Untitled Document

Millennium's Short Road For Velcade Approval On 13 May 2003 The Food and Drug Administration yesterday approved Millennium Pharmaceuticals' cancer drug Velcade to treat multiple myeloma, a deadly blood cancer. The FDA approved Velcade in a record four months. Roughly 14,000 people get the disease annually, and most die within five years. Impressively, Velcade was invented less than eight years ago. Usually, getting a drug from the laboratory to the market takes a decade and a half.

The FDA approval comes without a controlled clinical trial which is usually required for a regulatory OK. But in studies, Velcade clearly helped a third of multiple myeloma patients who had failed two or more previous therapies--a stunning result in such a lethal disease. "It's the first drug of its class," says Ken Anderson, director of the Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute, "and we are hopeful that more potent, second-line derivatives are coming in the pipeline. We're anxious now to test Velcade together with conventional as well as other novel therapies, as well as use it to treat patients with myeloma earlier in their disease course." Velcade was concocted at a tiny, Cambridge, Mass.-based startup called ProScript in 1995 by a team led by chemist Julian Adams, who had cooked up the AIDS drug Viramune at Boehringer Ingleheim. Velcade targeted an obscure complex of enzymes, called the proteasome, which acts as a kind of cellular maid. If the proteasome stopped its house-cleaning duties, scientists reasoned, cancer cells would give up.

By 1998, the drug, then known as PS-341, had advanced into early-stage human testing. But ProScript ran low on money. In 1999, the firm was folded into another Cambridge company, LeukoSite, which was purchased four months later by Millennium (nasdaq: MLNM - news - people ). Most drugs would have been lost in the shuffle, but Velcade had two advantages: strong data in human beings, and the enthusiastic Adams, who has since become Millennium's director of target discovery.

Already, a coalition was forged between Adams and academics at the Dana-Farber Cancer Institute and the National Cancer Institute. logo_millenniumMillennium Chief Executive Mark Levin made Velcade his company's most-funded drug. .

"This is an exceptional model in public-private partnership," says Kathy Giusti, head of the Multiple Myeloma Research Foundation. The MMRF poured $2 million into Velcade's development. Giusti, who was diagnosed with multiple myeloma in 1996, is a former sales executive at Merck (nyse: MRK - news - people ) and G.D. Searle, which is now part of Pfizer (nyse: PFE - news - people ). She is aware that drug companies often balk at relatively small diseases.

But she points out that her organization and others have been eager to help biotech companies like Millennium and Celgene (nasdaq: CELG - news - people ) study myeloma, and that studying multiple myeloma, which can be measured with a simple blood test, can be used as a launching pad for understanding how drugs work and how they might be used in other cancers. "That's exactly what Millennium did," Giusti says.

"They were very smart." Now, Millennium is raring to go. Barry Greene, Millennium's general manager for oncology, says that the company has trained 75 salespeople to sell the drug, despite the early timing of the approval.

"We were confident when we filed the new drug application," he says. The main task needed before getting the drug out is printing up the drug's FDA-approved label and shipping it with the vials, Greene says. Further studies of Velcade are still needed. A controlled trial verifying the current results should be completed in 2005. In a few years, VELCADE_logoVelcade could be tested as a frontline treatment in previously undiagnosed myeloma patients. Velcade will also be tested in other cancers, and genomic tests included in late-stage trials could make it possible to pick out those who will respond to the drug from those who will not. "I think it's years off," says Dana-Farber's Anderson. "We believe the broad opportunity really is a tremendous opportunity for the financials of Millennium," Greene says.

Millennium has previously forecast that it would break even in 2006. That forecast factored in an approval for Velcade. Roughly a quarter of the 45,000 Americans with multiple myeloma are eligible for treatment with Velcade under the drug's current label. On average, treating one patient with the drug costs $20,000.

 

 


 

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  • Millennium's obtains Velcade Approval from FDA



    Article References
    author: webmaster of daytraderbusiness.com
    source: internal
    first published: 14-05-2003