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Bristol-Myers' Skin Cancer Drug Gets FDA Nod

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More than a dozen companies are testing similar immune-system therapies to fight cancer.

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Bristol-Myers Squibb's (BMY) experimental drug ipilimumab for melanoma is the second treatment approved in a year that uses the body's immune system to fight cancer. But there are more than a dozen companies testing treatments in the late stages of human studies that aim to do the same thing.

The US Food and Drug Administration approved Bristol's drug today, giving an important spark to Bristol's pipeline of new treatments. (See Bristol-Myers Gains on Skin Cancer Treatment). The drug will be sold under the brand name Yervoy.

Dendreon's (DNDN) prostate cancer vaccine Provenge hit the market last year after the FDA gave it the OK. The treatment was a breakthrough for cancer therapies, helping patients to live longer without the many side effects of chemotherapy. Known as active immunotherapies, the treatments stimulate the immune system to attack cancer cells.

Bristol's treatment for advanced stages of skin cancer also is an active immunotherapy that's shown effectiveness in human trials. The drug does have some nasty side effects, including severe diarrhea, but it also is seen as an advance in cancer therapies.

Amgen (AMGN) just acquired closely held BioVex Group to gain a late-stage cancer vaccine, OncoVex, for melanoma and head and neck cancer. If the drug is approved and hits sales targets, the deal would be worth up to $1 billion.

Other companies developing skin cancer vaccines include GlaxoSmithKline (GSK), small-cap company Vical (VICL) and Pink Sheet company AVAX. (Each company is working separately.)

"Melanoma is a pretty crowded marketplace," says Michael Becker, senior partner at MB Becker Partners LLC.

Given the number of drug candidates, Becker sees at least three more US approvals of active immunotherapies in the next few years.

Several companies are testing vaccines for non-small cell lung cancer:Oncothyreon (ONTY) is working with Germany's Merck, French company Transgene is partnered with Novartis (NVS) and closely held Novarx is developing a therapy on its own.

Other companies conducting late-stage studies of cancer vaccines: Celldex Therapeutics (CLDX) is testing a therapy for brain cancer; Cel-Sci (CVM) is developing a head and neck product; Pink Sheet firm Biovest International is studying a non-Hodgkin lymphoma drug; Danish company Bavarian Nordic is developing a prostate cancer treatment; and UK-based Oxford BioMedica is testing the drug Trovax for kidney cancer.

Celldex was partnered with Pfizer (PFE) until last year when the pharmaceutical giant decided to scrap the program because it wasn't a big enough opportunity. (See Copying Dendreon). Becker says Pfizer's decision shouldn't be looked at as a signal that the Celldex treatment, rindopepimut, doesn't have potential. It just may not develop into a $1 billion drug, he says.


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