Orphan Drug Status Granted for Melanoma Vaccine

(NOAA)

BioSante Pharmaceuticals Inc. said today it received from the U.S. Food and Drug Administration orphan drug designation for its melanoma cancer vaccine to treat stage IIb to IV melanoma. BioSante Pharmaceuticals is a specialty pharmaceutical company in Lincolnshire, Illinois.

Orphan drug designation, as granted by the 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.

Biosante says the orphan drug status for its melanoma cancer vaccine is the company’s fourth such designation for cancer vaccines. The company also received orphan drug designations for its vaccines to treat pancreatic cancer, acute myeloid leukemia, and chronic myeloid leukemia.

The National Cancer Institute estimates that in the U.S., more than 68,000 people were diagnosed with and 8,700 died of melanoma in 2010. While it is more common in Caucasian populations living in sunny climates, it can be found in almost any groups, including those who use tanning salons. Melanoma is considered the most serious form of skin cancer, but can be treated if diagnosed early.

Read more:

• Fund Established to Develop Cancer Vaccines
• Biotech Company Awarded Grant for Melanoma Immunotherapy

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