West Coast Editor

Labopharm Inc.'s shares took a significant hit on word from the FDA that could mean the agency will need more data on the controlled-release opioid analgesic tramadol before approval.

In Canada, where Laval, Quebec-based Labopharm is listed on the Toronto Stock Exchange (TSX:DDS), shares sank C$1.76 cents Friday, to close at C$6.35 (US$5.67).

Company officials could not be reached, but Labopharm said in a press release that the FDA's approvable letter wants the "resolution of certain issues" that might not require more trials, though "potential outcomes" include "the need to generate additional data."

Labopharm submitted its new drug application for the once-daily tramadol, already approved in the European Union, in November 2005. The product uses Labopharm's Contramid technology (based on cross-linked, high amylose starch) and boasts fewer side effects than the approved version, along with less frequent dosing. Purdue Pharma LP, of Stamford, Conn., is Labopharm's tramadol partner, through a $170 million deal signed last year.

Dosing with ordinary tramadol, available in generic form, is necessary at least three times per day. Another Canadian player, Biovail Corp. (with partner Ortho-McNeil Inc.), won the race to market with a once-daily tramadol when Ultram ER gained FDA approval in October 2005.

Biovail, though, struck an intellectual property licensing deal with Purdue under which Labopharm, in exchange for the IP rights, would not be hindered by Ultram's three-year exclusivity in the $1.6 billion U.S. market. The combined IP of Biovail, Ortho-McNeil (a unit of New Brunswick, N.J.-based Johnson & Johnson) and Purdue gives Ultram ER patent protection through 2014.

Biovail's stock, which also lists on the Toronto exchange (TSX:BVF), closed Friday at C$17, down C63 cents.

Yet another would-be competitor to the north, Cipher Pharmaceuticals Inc., of Mississauga, Ontario, had its extended-release version of tramadol blow up in a Phase III trial earlier this month. Cipher's shares on the Toronto exchange (TSX:DND) closed Friday at C$3.34, up C56 cents.

No Comments