Celgene seeking to recast drug for new FDA approval

WARREN, NJ: Thalidomide, the drug that decades ago produced tragic birth defects in babies, is undergoing clinical trials for approval as a cancer treatment.

WARREN, NJ: Thalidomide, the drug that decades ago produced tragic birth defects in babies, is undergoing clinical trials for approval as a cancer treatment.

But repositioning the drug as a life-saving agent is no enviable PR task. Pharmaceutical firm Celgene, which markets thalidomide under the name Thalomid, is preparing for those challenges as it gets ready to submit the drug for expanded FDA approval.

Thalomid is now approved to treat only a specific side effect of leprosy. But the drug is undergoing phase 3 clinical trials for multiple myeloma, a cancer of the plasma cells.

Thalidomide made headlines in the consumer press this month, when the Mayo Clinic's peer-reviewed journal, Proceedings, published three studies, an editorial, and a commentary about it.

These studies, as well as presentations at major medical meetings, have caused renewed interest in the drug.

Brian Gill, Celgene's director of IR and PR, noted that the company has prepared an online press kit for the media.

"Here we do have the most heinous drug of all time that basically defined the FDA as it exists today," Gill said, adding that communications have been difficult because the company is prohibited from promoting the drug for uses not approved by the FDA. Instead, the company is spotlighting the science.

"Nothing speaks as loudly as the clinical trials," Gill said.

Thalomid received a boost in 2001, when one-time VP candidate Geraldine Ferraro revealed that she was being treated with it for multiple myeloma.

Thalidomide was prescribed to pregnant women in the 1950s as a treatment for morning sickness and caused 10,000 infants worldwide to be born with deformities. It was not approved in the US at the time.

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register
Already registered?
Sign in

Would you like to post a comment?

Please Sign in or register.