BioSante Pharmaceuticals Stocks (BPAX) Jumps after Receiving FDA Orphan Drug Designation for GVAX

BioSante Pharmaceuticals Inc. (NASDAQ: BPAX) today announced that it received an Orphan Drug designation from the U.S. FDA’s Office of Orphan Products Development for its GVAX CML Vaccine in the treatment of chronic myeloid leukemia (CML). Orphan Drug designation is granted to a product that is used in treating rare disease or condition that affects less than 200,000 people in the U.S. The designation gives the maker of the drug a seven year marketing exclusivity.

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The orphan drug designation for GVAX came after BioSante made its third GVAX regulatory submission since acquiring the portfolio of cancer vaccines in October 2009. The company already has orphan designations for its vaccines to treat acute myeloid leukemia and pancreatic cancer.

In a statement, Stephen M. Simes, President and CEO of BioSante, said that the company was continuing to develop its vaccine portfolio in cooperation with the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. Simes said that clinical trials of GVAX cancer vaccines have been conducted to treat pancreatic cancer, breast cancer and leukemia.

Following the announcement, the BioSante Pharmaceuticals Inc. stock jumped in pre-market trading today. It was trading 4.64% higher at $2.03 in pre-market trading on volume of 65,000. The stock has a 52-week range of $1.33-$2.70, with a beta of 1.19. The stock’s 50-day moving average is $2.02, while its 200-day moving average is $1.77. The support level for the stock is at around $1.88 and the resistance level is at around $1.99. The stock has broken its resistance level in pre-market trading today.

The consensus rating on the stock is Buy and it has 1 Buy and 1 Outperform rating, currently.

About BioSante Pharmaceuticals Inc.

BioSante Pharmaceutical Inc. is a developer of products for female sexual health and oncology. The company is headquartered in Lincolnshire, Illinois. The company’s lead products include LibiGel® , which is in Phase 3 clinical trial under the U.S. FDA’s Special Protocol Assessment, and Elestrin™, which has been developed through FDA approval.

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