Tentative OK for Abraxis Drug

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Abraxis BioScience Inc. said its generic version of Pfizer Inc.’s anticonvulsant Cerebyx has received tentative approval from the U.S. Food and Drug Administration.


The injectible drug, also known as fosphenytoin sodium, treats convulsions or seizures associated with epilepsy. Abraxis said Thursday that it expects final approval for the drug when Pfizer’s patent expires, which would be in August unless the company is successful in obtaining a patent extension.


Sales of fosphenytoin sodium in the United States exceeded $73 million in 2006, according to the industry tracking service IMS Health.


Earlier in the week in Los Angeles, Abraxis presented pre-clinical data on an experimental cancer drug during the annual meeting of the American Association of Cancer Researchers. The company plans to commence first stage clinical trials of nab-rapamycin in 2007.


The company already has one brand-name drug on the market, Abraxane, which is FDA-approved as a second-tier treatment for breast cancer. The company at the conference presented promising pre-clinical data on the potential for improving outcomes by combining Abraxane with Genentech’s Avastin, which is approved for colorectal cancer.


Shares of Abraxis closed up 14 cents to $27.56 Thursday on the Nasdaq Stock Market.

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