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Labopharm reports results for first quarter fiscal 2004

- Company Enters Labeling Discussions for Once-Daily Tramadol with French Regulatory Authorities Following Favourable Review of Clinical Component of Marketing Authorization Application -

LAVAL, QC, May 9, 2004
Labopharm Inc. reported its results for the first quarter ended March 31, 2004. Net loss for the quarter ended March 31, 2004 was $7,569,000, or $0.21 per share, compared with $7,817,000, or $0.25 per share, for the quarter ended March 31, 2003. The decrease in net loss is the result of lower expenses related to the clinical trial program for once-daily tramadol, which was partially offset by the total stock-based compensation expense of $411,000 for the current quarter and an increase in depreciation, amortization, and interest expense.

Once-Daily Tramadol European Commercialization Program: Labopharm today also announced that it has entered formal labeling discussions with regulatory authorities in France (the Agence Française de Sécurité Sanitaire des Produits de Santé) following a favourable review of the clinical component of the Company's Marketing Authorization Application (MAA) for its once-daily formulation of tramadol. Upon successful completion of the review of the chemistry, manufacturing and control (CMC) portion of the MAA, the Company would expect to receive full approval of its regulatory Application in due course.

"The favourable review of the clinical component of our regulatory dossier is a considerable step toward full marketing approval and the launch of our once-daily tramadol product in Europe," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "Regulatory approval in France both initiates the start of the commercialization process as well as the Mutual Recognition Procedure which provides for rapid marketing approval by other European Union countries."

Source : www.medicinenet.com
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