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Elan Corporation, plc Message Board

  • biotechsuperstar biotechsuperstar Oct 20, 2008 5:15 AM Flag

    DDSS..2 x US approvals within 10 months..Read

     

    Please do your own research ..

    Labopharm (DDSS )

    Marketcap ... 45.6 million $
    Cash ... 55.3 million $
    Price: 0,80 $


    Labopharm's once daily version of Tramadol(Pain) has been launched in 14 countries, including Canada, and is approved in 18 others.

    Outlook 3Q 2008 - 1Q 2009

    Partnering agreement Trazadone (Depression )
    Partnering agreement Tramadol-Acetaminophen (Acute Pain)
    Tramadol-Acetaminophen Phase III results in 4Q 2008
    Once a Day Tramadol US approval in 2 Jan 2009
    Once a Day Trazodone (Depression) US approval in 22 July 2009

    Recent Developments

    Once-Daily Tramadol Global Commercialization Program


    Product Continues to Steadily Gain Market Share - Labopharm's product continues to steadily gain market share in Europe and Canada as evidenced by May 2008 data. Overall share of the European(2) tramadol market(3) continued to exhibit solid growth. Moreover, Labopharm's product moved into the number one position in the once-daily segment of the market with a 45% share. Growth continues to be particularly strong in France, where the product's share of the tramadol market(3) reached 7.3%. In Canada, sequential monthly growth in the number of prescriptions for the Company's product averaged 25% in March, April and May 2008 and the product's share of the tramadol market increased to 17.5%.

    Both the European and Canadian markets for tramadol products continue to grow, with standard unit sales in Europe growing at a compound annual rate of 12% over the last five years and the number of prescriptions in Canada increasing by an average of 13% per month over the period of January to May 2008.

    Product Launched in Four Additional Countries - Labopharm's product was launched in South Korea under the brand name TramaConti CR(R), in Australia under the brand name Durotram XR(R), in Austria and Romania under the brand name Noax(R) Uno. The launches bring the total number of countries in which the product is being sold to 14, representing almost 55% of the global market(4) for tramadol products.

    Reacquired Sales and Marketing Rights for UK - Labopharm reacquired the sales and marketing rights to its product (Tradorec XL(R)) for the United Kingdom from Recordati Ireland Ltd. The Company plans to relaunch the product this fall.

    Submitted Complete Response to FDA and Assigned New PDUFA Action Date - Labopharm submitted a complete response to the U.S. Food and Drug Administration (FDA) that centered on the additional analysis of existing data using the methodology previously put forward by the Agency. The response was subsequently accepted as a complete, Class 2 response and the action date assigned under the Prescription Drug User Fee Act (PDUFA) is January 2, 2009.

    DDS-04A Containing Trazodone for Treatment of Depression

    Finalizing NDA for Submission in Third Quarter 2008 - Labopharm is in the process of finalizing the New Drug Application (NDA), which it expects to submit in the third quarter of 2008. The Application will include the results of the positive Phase III clinical trial, which, in addition to achieving statistical significance for the primary endpoint (p value of 0.0183) for efficacy in the treatment of depression, demonstrated improvement in the overall quality of sleep. The study also showed that DDS-04A was statistically superior to placebo by the end of the first week of treatment. The Company is also in discussions with respect to establishing a marketing partner for the United States.

    Twice-Daily Tramadol-Acetaminophen Combination Product

    Phase III Clinical Trial Continues - Enrolment for the North American Phase III clinical trial (study 06CCL3-001) continues, as do discussions with potential marketing partners for distribution of the product globally.

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    • Wow......This is impressive. I got in at $13. Waiting for now as the market is horrid. I think that good companies with products that improve patient care will be valuable in any market.

      Why is your recomendation to Hold?? I am a buy.....maybe.

 
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