Two Pharmacia Drugs Facing Problems
Adam Feuerstein
05/18/01 - 07:58 PM EDT
It's been a couple of tough days for
Pharmacia(PHA Quote).
Late Friday, the pharmaceutical giant said it had received a "not approvable" letter from the U.S
. Food and Drug Administration for Vestra, the company's investigational anti-depressant drug.
No reason was given for the rejection of Vestra's application, which was first submitted to the FDA in April 1998. Pharmacia said the FDA has agreed to convene an advisory committee meeting of outside experts later this year to review the drug. Vestra is already approved in 50 countries.
The Vestra setback comes 24 hours after problems cropped up in tests of Pharmacia's colon cancer drug, Camptosar, also known as irinotecan..
Physicians testing the drug in patients with advanced stages of the cancer found an unusually high number of deaths, according to a letter from the doctors sent to the
New England Journal of Medicine.
The tests, sponsored by the
National Cancer Institute, involved administering Camptosar with two other chemotherapy drugs. The death rate was not statistically significant, but high enough to recommend a halt to the tests, the letter said.
Camptosar sales reached $137 million in the first quarter. Pharmacia say it is working with researchers to investigate the findings, adding that earlier tests of the drug found it to be as safe as other colon cancer chemotherapy drugs.
Shares in Pharmacia closed Friday up 11 cents to $49.60. Shares were down fractionally to $49 in after-hours trading.