The Food and Drug Administration has given Nova Pharmaceutical Corp. permission to charge for an experimental drug that destroys cancer cells in human bone marrow.
Since 1989, Baltimore-based Nova had been providing Pergamid free of charge to physicians doing cancer research, company spokeswoman Kira Bacon said yesterday. Now, Nova can charge $1,068 for 200-milligram doses of the drug. Pergamid is used on bone marrow taken from cancer patients and is not injected directly into the body.
"As the research into the use of bone marrow transplants . . . has increased, requests for Pergamid have gone up dramatically," Ms. Bacon said. "In order for Nova to support this expanding research, it . . . became necessary for us to recover the costs associated with researching, manufacturing and distributing Pergamid."
An application will be submitted to the FDA this year to market the drug on a non-experimental basis, Ms. Bacon said.
Pergamid is used in what are known as autologous bone marrow transplants, involving cancer patients who receive "transplants" of their own bone marrow. The procedure is done because radiation and chemotherapy tend to kill bone marrow, which produces blood cells.
In autologous transplants, marrow taken from a patient is treated with Pergamid to destroy cancerous cells and is returned to the body once the cancer is in remission.
About 2,000 to 3,000 autologous bone marrow transplants take place each year worldwide, Ms. Bacon said.
"This product is addressing a real small market, so even after full approval, its sales wouldn't be that large," Legg Mason analyst Eugene Melnitchenko said. "In itself it's not going to add high revenues and profits" for the company.
However, the FDA ruling tends to back Nova's scientific credibility, Mr. Melnitchenko said. "Based on this decision, it . . . appears that Pergamid will probably be approved [for general market sales] sometime next year."
Up until "this point, Nova Pharmaceutical has been a developmental-stage company," Mr. Melnitchenko said. "It's a pharmaceutical research company, so it's been burning cash. It's been investing money in research, in its prominent new drugs."
One such product is the Gliadel implant, a polymer wafer designed to be implanted in the brain, where it releases an anti-tumor chemical. The implant is one of several Nova projects that should generate significant revenue for the company in a few years, Mr. Melnitchenko said.