Federal inspection finished at Wyeth’s Puerto Rico plant
Federal regulators have finished re-inspecting Wyeth's troubled manufacturing plant in Puerto Rico and handed the drug-maker some "inspection observations" to address, the company said today.
Federal regulators have finished re-inspecting Wyeth's troubled manufacturing plant in Puerto Rico and handed the drug-maker some "inspection observations" to address, the company said today.
Problems at the plant in Guayama have cast a shadow over both distribution and approval of several Wyeth products - including its antidepressant, Effexor; a planned new antidepressant, Pristiq; and a planned contraceptive, Lybrel.
News that the problems may be coming to an end, along with expectations that Wyeth would get approval for a new kidney cancer drug, Torisel, buoyed Wyeth's stock on Wall Street. Its shares were up 44 cents, or about 1 percent, to $52.91 in morning New York Stock Exchange trading.
FDA inspectors formally warned Wyeth in June about persistent packaging and other problems at the plant, including discovery of a screw in a drug bottle.
Wyeth has said it is addressing the problems and has made management changes at the facility, apparently including deploying employees there from the Philadelphia area, where the company has its pharmaceutical headquarters.
In its statement, Wyeth said: "Based on the nature of the inspection observations issued by the FDA, Wyeth is hopeful that it can respond to the remaining concerns and that the agency will be able to determine in the near future that the Warning Letter issues have been satisfactorily resolved."
The Madison, N.J., company said it intends to respond "no later than mid-April and then will seek to continue its discussions with the agency regarding the overall compliance status of the facility."
Bernard Poussot, president and vice chairman of Wyeth, was quoted as saying: "The company believes we are in a position to submit adequate responses to the inspection observations."
The FDA did not immediately respond to requests for comment today.
On March 26, the FDA's counterparts from the European Medicines Agency, or EMEA, inspected the Puerto Rico plant and gave Wyeth a "positive evaluation of the site's compliance" with European manufacturing rules, Wyeth said.
Wyeth's experimental cancer treatment, Torisel, has been shown to extend survival by almost four months in patients with severe renal cell carcinoma. Bear Stears analyst John Boris, in a note to investors, predicted Torisel would "command premium pricing" for Wyeth, as do most new cancer drugs.
