Key Developments: Labopharm Inc (DDSS.O)
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Latest Key Developments
Labopharm Inc. Receives FDA Approval For OLEPTRO
Labopharm Inc. announced the U.S. Food and Drug Administration (FDA) has approved OLEPTRO (trazodone hydrochloride) Extended Release Tablets, a once-daily formulation of the antidepressant trazodone, for the treatment of major depressive disorder (MDD) in adults. OLEPTRO utilizes CONTRAMID, Labopharm's clinically validated technology that controls the release of active substances within oral medications.
Labopharm Inc. Completes Distribution And Supply Agreement With MSD For Tradorec XL
Labopharm Inc. announced that its wholly owned subsidiary, Labopharm Europe Limited, has completed a distribution and supply agreement with Merck Sharp & Dohme Limited (MSD), a United Kingdom (U.K.) subsidiary of Merck & Co., Inc., under which MSD will distribute and market Tradorec XL (once-daily tramadol based on Labopharm's proprietary Contramid technology). Under the terms of the agreement, MSD has the exclusive right to market and sell Tradorec XL in England, Northern Ireland, Scotland, Wales, the Channel Islands and the Isle of Man. Labopharm will supply MSD with finished, packaged product at a fixed transfer price inclusive of gross margin. Labopharm will also receive an up-front payment of 650,000 British pounds.
Labopharm Inc. Announces Updates On Standby Equity Distribution Agreement
Labopharm Inc. announced that it has provided YA Global Master SPV Ltd. with notice of its intention to draw down $1 million under its standby equity distribution agreement (SEDA). Based on the minimum share price, the maximum number of shares to be issued under this drawdown is 500,000. The drawdown and issuance of shares is subject to a minimum share price of $2.00 per share.
Labopharm Inc. Initiates Regulatory Approval Process For Twice-Daily Tramadol-Acetaminophen In Europe
Labopharm Inc. announced it has initiated the regulatory approval process for its twice-daily tramadol-acetaminophen formulation in Europe under the Decentralized Procedure (DCP). The DCP provides an efficient mechanism that allows a company to simultaneously pursue regulatory approval for a medicinal product in multiple jurisdictions in Europe.
Labopharm Inc. Completes Distribution And Supply Agreement With Grunenthal For Twice-Daily Tramadol-Acetaminophen For A Number Of European Countries
Labopharm Inc. announced that its wholly owned subsidiary, Labopharm Europe Limited, has completed a distribution and supply agreement with Grunenthal GmbH for its twice-daily tramadol acetaminophen formulation for a number of countries in Europe. Under the terms of the agreement, Grunenthal has the exclusive right to market and sell Labopharm's twice-daily tramadol-acetaminophen formulation in a number of European countries. Labopharm will supply Grunenthal with unpackaged tablets and will receive a fixed transfer price inclusive of gross margin. Labopharm will receive EUR3.5 million, on signature and up to EUR4 million, in payments upon achievement of certain regulatory and product reimbursement approvals prior to the launch of the product.
Labopharm Inc. Announces Its Trazodone API Supplier Has Resolved Outstanding Manufacturing Issues With The FDA
Labopharm Inc. announced that it has been informed by Angelini, the manufacturer of the active pharmaceutical ingredient (API) for the Company's trazodone formulation, that it has received a letter from the U.S. Food and Drug Administration (FDA) stating that Angelini has appropriately addressed all deficiencies cited by the FDA following its inspection of the manufacturing facility in June and July of this year. The letter further states that Angelini's manufacturing facility has been classified as acceptable. Labopharm received a complete response letter from the FDA on July 17, 2009, indicating the Company's new drug application (NDA) for its novel trazodone formulation could not be approved in its present form due to the deficiencies at the API supplier's manufacturing facility. The letter did not raise any efficacy or safety issues. Labopharm's novel formulation of trazodone is currently under regulatory review in the U.S. with an action date under the Prescription Drug Users Fee Act (PDUFA) of February 11, 2010.
Labopharm Inc. Receives Notice Of ANDA Submission With Paragraph IV Certification For Generic Of Ryzolt
Labopharm Inc. announced that it has received notice from Sun Pharma Global FZE advising that Sun has submitted an Abbreviated New Drug Application (ANDA) to the United States Food and Drug Administration (FDA) for approval to market 100, 200 and 300 mg generic versions of Ryzolt (tramadol hydrochloride extended-release 100, 200 and 300 mg tablets) in the United States. Under the Drug Price Competition and Patent Term Restoration Act (known as the Hatch-Waxman Act), Ryzolt has a new dosage form market exclusivity period that prevents final approval of Sun's ANDA until the exclusivity period expires on December 31, 2011.
Labopharm Inc.'s Response For Trazodone Formulation Accepted By FDA As Complete - Designated As Class 2 Resubmission
Labopharm Inc. announced the U.S. Food and Drug Administration (FDA) has accepted Labopharm's response regarding its formulation of the antidepressant trazodone as complete and designated it as a Class 2 resubmission. The FDA has assigned Labopharm a new Prescription Drug User Fee Act (PDUFA) action date of February 11, 2010.
Labopharm Inc. Submits Response To FDA For Novel Antidepressant
Labopharm Inc. announced that it has submitted its response to the U.S. Food and Drug Administration's (FDA) complete response letter regarding the Company's novel formulation of the antidepressant trazodone. As previously announced, Labopharm received a complete response letter from the FDA on July 17, 2009 indicating the Company's new drug application (NDA) for its novel trazodone formulation could not be approved in its present form due to deficiencies following the FDA's inspection of the active pharmaceutical ingredient (API) manufacturing facility. The letter did not raise any efficacy or safety issues. The FDA is expected to notify Labopharm within 14 days as to whether or not the Company's response has been accepted for review. Once accepted and in accordance with the Prescription Drug User Fee Act (PDUFA), the FDA will assign Labopharm a new action date.
Labopharm Inc. Files New Drug Submission with Health Canada For Novel Antidepressant
Labopharm Inc. announced that it has filed a New Drug Submission with the Therapeutic Products Directorate of Health Canada for its novel formulation of the antidepressant trazodone. Labopharm's NDS is based on data from five pivotal pharmacokinetic studies and the positive results from a North American Phase III placebo controlled clinical trial, which enrolled more than 400 patients. The eight-week randomized, double-blind, two-arm, multi-centre Phase III study in patients with major unipolar depressive disorder demonstrated the efficacy of Labopharm's formulation as a treatment for depression, as well as its positive effect on quality of sleep. The primary efficacy endpoint of the study was to compare the change in the Hamilton Rating Scale for Depression total score from baseline to the end of the study in the trazodone group versus the placebo group. Statistical significance was achieved for the primary endpoint. The majority of the secondary efficacy end points, including the HAMD-17 depressed mood item, the Clinical Global Impressions Severity scale, the Montgomery Asberg Depression Rating Scale total score and a Responder's Analysis showed statistical significance in favor of the group administered Labopharm's trazodone. In addition, patients on Labopharm's trazodone demonstrated significant improvements versus placebo in all three quality of sleep end points, with an improvement by the first week of therapy in overall quality of sleep and awakening during the night.
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