BioSante cancer vaccine gets 'orphan drug' status

LINCOLNSHIRE, Ill. — BioSante Pharmaceuticals received orphan drug status for its potential pancreatic cancer treatment, the company announced March 15.

The company said the Food and Drug Administration designation applied to its GVAX Pancreas Vaccine, which is undergoing clinical trials with other anticancer agents for safety, survival and response rates.

The GVAX Pancreas Vaccine is a therapeutic vaccine that treats existing cancers. It does not prevent them.

Patients with pancreatic cancer have one of the poorest five-year survival rates for any form of cancer. Pancreatic cancer often is not diagnosed until the disease is advanced. Median survival after diagnosis is about three to six months.

The FDA gives orphan drug status to drugs aimed at rare conditions or conditions that have a lack of treatments on the market. Incentives include seven years of market exclusivity following FDA approval, assistance in clinical trial design, a reduction in user fees and tax credits.

A product can be designated an orphan drug if it is meant to treat an illness than affects fewer than 200,000 people.

BioSante, based in Lincolnshire, Ill., said it also is conducting clinical trials that measure the GVAX vaccine against other cancers, including leukemia and breast cancer.