BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced the receipt of Orphan Drug designation for GVAX CML Vaccine in the treatment of chronic myeloid leukemia (CML) from the FDA's Office of Orphan Products Development. Orphan drug designation, as granted by the U.S. Orphan Drug Act, is for a product to treat a rare disease or condition that affects fewer than 200,000 people in the U.S. Orphan drug designation qualifies the sponsor of the product for tax credits and seven years of marketing exclusivity, among other benefits.
“Clinical trials of GVAX cancer vaccines are being conducted to treat leukemia, pancreatic cancer and breast cancer, among other cancer types. In addition, we recently announced reinitiation of the GVAX Prostate cancer vaccine program.”
The orphan drug designation for the GVAX CML Vaccine resulted from BioSante's third GVAX regulatory submission since acquiring this portfolio of cancer vaccines in October 2009. This is the third orphan drug designation for BioSante; the company also has received orphan drug designations for its vaccines to treat pancreatic cancer and acute myeloid leukemia.
"We continue to develop our vaccine portfolio in cooperation with the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center," said Stephen M. Simes, president and chief executive officer of BioSante. "Clinical trials of GVAX cancer vaccines are being conducted to treat leukemia, pancreatic cancer and breast cancer, among other cancer types. In addition, we recently announced reinitiation of the GVAX Prostate cancer vaccine program."