Established Marketing Partnerships for Eleven Additional Countries - Labopharm signed an agreement with iNova Pharmaceuticals, its marketing partner for Australia and New Zealand, for distribution of the Company's product in Singapore, Hong Kong, Malaysia, Philippines, Thailand, Taiwan and Indonesia. iNova plans to submit regulatory applications in each of these jurisdictions. The Company also signed licensing and distribution agreements for Portugal, Brazil, Denmark and Sweden.
-------------------------------------- (1) Includes France, Germany, the United Kingdom, Spain and Italy.
Novel Trazodone Formulation
NDA Under Review by FDA/Company in Ongoing Discussions for U.S. Marketing Partnership - Labopharm's New Drug Application (NDA) for its novel trazodone formulation is under review by the U.S. Food and Drug Administration (FDA) with an action date under the Prescription Drug User Fee Act (PDUFA) of July 18, 2009. The Company is in ongoing discussions with potential marketing partners towards establishing a licensing and distribution agreement for the United States.
Three-Month Period Ended March 31, 2009
Revenue for the first quarter of fiscal 2009 increased to $5.0 million from $3.2 million for the first quarter of fiscal 2008. Revenue from product sales increased to $3.8 million from $2.2 million for the first quarter of fiscal 2008. The increase in revenue from product sales was primarily the result of higher sales volumes and higher average selling prices in the first quarter of fiscal 2009.
Adjusted gross margin (as a percentage of revenue from product sales) for the first quarter of fiscal 2009 was 57% compared with 58% for the first quarter of fiscal 2008. Adjusted gross margin for the first quarter of fiscal 2009 excludes the reversal of $240
|SOURCE Labopharm Inc.|
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