UPDATE 1-Endo says patch fails 2 late-stage trials; shares fall
(Adds details, share movement)
July 11 (Reuters) - Endo Pharmaceuticals Inc., a unit of Endo Pharmaceuticals Holdings Inc. (ENDP.O), said its pain patch for treatment of soft-tissue injuries failed two late-stage trials, and its shares fell more than 5 percent.
The company said it was withdrawing its outlook related to the expected filing date of the new drug application for its topical ketoprofen patch. It had previously expected to file the application in the first half of 2008.
The delay has no impact on the company's previously issued 2007 financial outlook, it said in a statement.
Shares of the company were trading at $32.69 in late electronic trade, after closing at $34.70 on the Nasdaq.
The two late-stage trials of the ketoprofen patch evaluated it for the treatment of ankle sprains and strains, and pain related to inflammation of the shoulder, elbow or knee joints.
In both cases, the ketoprofen patch failed to perform significantly better than the dummy patch.
Endo said two other late-stage studies of the patch were ongoing. One was to test it as a treatment of pain related with inflammation of the shoulder, elbow or knee, and the other to test its safety in patients with knee arthritis.
Endo already markets a pain patch, Lidoderm, its biggest product, which contributed more than 60 percent to the company's net sales in the first quarter. (Reporting by Varsha Tickoo in Bangalore)