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***** GTCB 2007 ******

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  2. [verwijderd] 3 mei 2007 14:12

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    GTC Biotherapeutics Reports First Quarter 2007 Financial Results
    Thursday May 3, 8:00 am ET


    FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) reported today its financial results for the first quarter ended April 1, 2007. The total net loss for the quarter was $7.5 million, or $0.10 per share, compared with $8.5 million, or $0.14 per share, in the first quarter of 2006.

    "Partnering to support our development programs and product commercialization opportunities is an important strategic activity for GTC. We have significantly increased our business development resources during the quarter to support this strategy," stated Geoffrey F. Cox, Ph.D., GTC's Chairman of the Board and Chief Executive Officer. "Our two strategic collaborations, with LFB Biotechnologies and LEO Pharma A/S, are making important contributions to the growth of our business. The Factor VIIa program with LFB made good progress in the quarter and we look forward to LEO's commercial introduction of our first approved product, ATryn®, in July in conjunction with the International Society of Thrombosis and Haemostasis in Geneva."

    During the quarter, Rick Finnegan, Vice President of Commercial Development, and Ashley Lawton, PhD, Vice President of Business Development, joined GTC to expand our business development and product commercialization capabilities. Rick Finnegan is focusing on market introduction strategies for our products, including through collaboration partners. Ashley Lawton is focusing primarily on additional collaborative partnering for our proprietary programs, including monoclonal antibodies, as well as developing our strategy for follow-on biologics, or FOBs. Based on the evolving legislative deliberations in defining a regulatory path for FOBs, we believe that this area of protein production will become increasingly important. The cost advantages of our transgenic production technology may broadly enable development of FOBs that otherwise may not be economically attractive.

    ATryn®, our recombinant form of human antithrombin, was approved by the European Commission for the prophylactic treatment of deep vein thrombosis in patients with hereditary antithrombin deficiencies that are undergoing surgical procedures. LEO is preparing ATryn® for commercial launch in this indication. LEO is conducting a dose ranging Phase II study with ATryn® to find the optimum dose to use in a subsequent Phase III trial to treat disseminated intravascular coagulation, or DIC, associated with severe sepsis. This indication is a large unmet medical need with approximately 500,000 cases annually in Europe and the US with about 50% mortality. LEO anticipates enrolling the first patient into the Phase II study in the second quarter with patient enrollment expected to take approximately 12 months. We completed delivery of the initial supply of clinical material to LEO in the first quarter of 2007.

    Separately, we are conducting a Phase III study that we anticipate will support filing for approval of ATryn® in the US in the hereditary deficiency indication. In parallel to studying patients that receive our drug, we are conducting a comparative retrospective, or historical, study in the same indication of patients treated with plasma derived antithrombin. The objective is to establish non-inferiority in the comparison between our recombinant antithrombin product and antithrombin derived from human plasma. Although recruitment into these studies has taken longer than originally planned due to the rare patient population and the strict entrance requirements, we anticipate obtaining top line data in the fourth quarter of 2007.

    We estimate the total worldwide potential annual market for ATryn® in all indications is $500 to 700 million.

    We have begun development with LFB of recombinant human factor VIIa, or rhFVIIa, a blood clotting factor. The first indication planned for this program is in the treatment of type A and type B hemophilia where patients have developed inhibitors to clotting factors VIII or IX. We are establishing transgenic rabbits that use our beta casein promoter technology to evaluate as founders of a production herd. An independent analyst report estimates the total worldwide market for rhFVIIa could be $2 billion by 2012, which is the year when the patents on the current marketed product, NovoSeven®, expire.

    We have also entered agreements with PharmAthene to license our transgenic production technology patents and provide clinical supply manufacturing services in their development of Protexia®, a recombinant form of human butyrylcholinesterase, as a potential biodefense product to treat nerve agent toxicity. The process development work on Protexia® began this quarter.

    We continue to strengthen and expand our intellectual property position. We recently entered into a license agreement with Start Licensing, Inc. for patents originally developed at Roslin Institute to ensure we have freedom to operate in applying nuclear transfer to the development of transgenic mammals that produce therapeutic proteins in their milk. Nuclear transfer may be used as an alternative to micro-injection. We expect that in many cases it can provide greater schedule predictability in developing the first animal that incorporates into its genome the transgene for a therapeutic protein to be expressed in milk. Nuclear transfer may also be used to speed the development of large scale transgenic production capacity.

    Our cash and marketable securities at the end of the first quarter of 2007 totaled approximately $39.6 million, a $4.2 million decrease compared to the $43.8 million total at the end of 2006. During the quarter, we received $4.5 million of proceeds from the final installment of LFB's investment in GTC. Exclusive of the LFB investment, we used approximately $8.7 million of cash and marketable securities in
  4. [verwijderd] 3 mei 2007 14:18

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    Although recruitment into these studies has taken longer than originally planned due to the rare patient population and the strict entrance requirements, we anticipate obtaining top line data in the fourth quarter of 2007.

  5. [verwijderd] 3 mei 2007 14:21

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    We have also entered agreements with PharmAthene to license our transgenic production technology patents and provide clinical supply manufacturing services in their development of Protexia®, a recombinant form of human butyrylcholinesterase, as a potential biodefense product to treat nerve agent toxicity. The process development work on Protexia® began this quarter.


  17. [verwijderd] 3 mei 2007 16:53

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    Hij gaat weer gweldig..lang leve de transgene shit

    GTC Biotherapeutics, Inc.
    Last 1.12 Bid/Tick 1.11
    Change -0.05 Ask 1.12
    Volume 272,664 Bid/Ask Size 2,200.00 X 3,800.00

    Day's High 1.19 Open 1.17
    Day's Low 1.10 Close 1.17
    Real-Time Intraday Chart StockScouter Rating 7

    Nasdaq National Market


  19. [verwijderd] 3 mei 2007 17:04

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    Haha Ray, zo dacht ik vorig jaar ook. Nog een lange weg te gaan voor dat transgene shit werkelijk serieus genomen wordt. Je wordt gewoon niet goed van de konijnen en geiten. :)


  20. [verwijderd] 3 mei 2007 17:11

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    ach en de heren pinto en cocks varen er wel bij...lekker knutselen en ondertussen zelf bakken geld verdienen.Ook nog eens geld van anderen ook...misselijk makende figuren...af en toe een paar loze kreten en voor de rest niks dat uitkomt.
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