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Labopharm Gets Long-Awaited Approval of Once-Daily Tramadol
(BioWorld Today Via Acquire Media NewsEdge) Third Time is a Charm
After three years and two approvable letters, Labopharm Inc. finally got FDA approval of Ryzolt, its once-daily, extended-release formulation of the pain drug tramadol.
Shares of the Laval, Quebec-based company (NASDAQ: DDSS) jumped 47 cents, or 34.8 percent, to close at $1.82 on Wednesday. But investors appeared to anticipate the good news. After trending down for most of last year and hitting a 52-week low of 32 cents in early December, Labopharm's shares quadrupled in the weeks leading up the FDA decision.
Labopharm's once-daily tramadol is marketed in 14 countries, including Canada and the five largest markets in Europe. Sales of the product brought Labopharm revenues of C$9.9 million (US$8 million) for the first nine months of 2008.
Despite its ex-U.S. approvals, Ryzolt's path with the FDA has been bumpy. Labopharm first submitted its new drug application in November 2005, but the company received an approvable letter in late 2006 posing questions about its data analyses. Labopharm submitted a complete response to the agency and attempted to appeal the approvable decision, but the appeal failed, and a second approvable letter cited faulty statistical methodology. (See BioWorld Today, Oct. 2, 2006, and June 4, 2007.)
Once again, Labopharm attempted to appeal the decision through the FDA's formal dispute resolution process. And once again, the appeal failed. But discussions with John Jenkins, director of the FDA's Office of New Drugs, suggested that an additional statistical analysis of existing data potentially could satisfy the agency's requirements and lead to an approval. Later, Douglas Throckmorton, deputy director of the FDA Center for Drug Evaluation and Research, confirmed that regulatory path in writing, and Labopharm moved quickly to submit another complete response. (See BioWorld Today, July 1, 2008.)
The third time proved to be the charm for Labopharm, and the FDA approved Ryzolt for moderate to moderately severe chronic pain.
Labopharm's U.S. marketing partner, Purdue Pharma LP, expects to launch the drug in the second quarter of 2009. Under the 2005 deal, Labopharm got $20 million up front and would have received $40 million if the product had gained FDA approval by April 1, 2007. That milestone decreased to $20 million had the approval happened by Sept. 30, 2007 and $10 million if the approval came by Sept. 30, 2008.
Labopharm executives were not available to discuss whether any money remained to be triggered by the Dec. 31, 2008, approval.
The Purdue deal also called for Labopharm to receive sales-based milestone payments of up to $110 million, as well as royalties of 20 percent to 25 percent on U.S. sales and certain co-promotion rights.
Ryzolt is formulated using Labopharm's Contramid delivery technology, which uses a cross-linked, high amylose starch to control the release of oral drugs, allowing for less-frequent dosing and optimized bioavailability.
The product will compete against generic tramadol, which is dosed several times per day, as well as Ultram ER, a once-daily tramadol formulation from Biovail Corp. and partner Ortho-McNeil Inc., a unit of Johnson & Johnson, which gained FDA approval in 2005.
Purdue struck an intellectual property licensing deal with Biovail that would have allowed Ryzolt to launch despite Ultram's three-year exclusivity in the U.S. market, although Ryzolt's long and bumpy road to FDA approval may have made that a moot point.
Another extended-release formulation of tramadol is being developed by Mississauga, Ontario-based Cipher Pharmaceuticals Inc. The company received an approvable letter in 2007 and unsuccessfully appealed before filing a revised approval application. A decision was expected in October, but the company said the FDA needs additional time to inspect its manufacturing facilities.
Labopharm said the U.S. is the largest market for tramadol products, with combined sales of $650 million for the 12 months ended September 2008. However, the company predicted that Ryzolt also will compete against other chronic pain medications.
Ryzolt is Labopharm's first product to gain FDA approval - but the company is hoping it won't be the last. Labopharm's once-daily formulation of trazodone, a serotonin-antagonist-reuptake inhibitor, is under FDA review for major depressive disorder with an action date of July 18, 2009.
The company also is developing various formulations of tramadol and acetaminophen, as well as abuse-resistant opioids and reformulated cancer drugs.
Labopharm reported cash, equivalents and marketable securities of C$44.1 million as of Sept. 30, 2008, after posting a net loss of C$6 million for the quarter. n
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