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

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  3. [verwijderd] 9 augustus 2007 14:13

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    GTC Biotherapeutics Reports Second Quarter 2007 Financial Results
    Thursday August 9, 8:00 am ET


    FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) reported today its financial results for the second quarter ended July 1, 2007. The total net loss for the quarter was $10.6 million, or $0.14 per share, compared with $9.1 million, or $0.15 per share, in the second quarter of 2006. The total net loss for the first six months of 2007 was $18.1 million, or $0.23 per share, compared to $17.6 million, or $0.29 per share, for the first six months of 2006.
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    "Our European partner for ATryn®, LEO Pharma A/S, has made good progress in the quarter in introducing the product to the physician community in Europe for the hereditary deficiency indication while also initiating the Phase II clinical study for the large market indication in disseminated intravascular coagulation, or DIC, associated with severe sepsis," stated Geoffrey F. Cox, Ph.D., GTC's Chairman of the Board and Chief Executive Officer. "We are also making strong progress in developing our follow-on biologic strategy. We have added a CD20 monoclonal antibody program to the recombinant factor VIIa program in our partnership with LFB Biotechnologies. Both of these programs may be eligible for development as follow-on biologics once appropriate legislation is enacted and regulatory guidance is established in the US and EU."

    ATryn® Commercial Launch Activities and Clinical Progress

    LEO Pharma initiated the launch of ATryn® at the International Society on Thrombosis and Haemostasis Congress held in Geneva in July. This introduction included a symposium, poster presentations, an exhibit booth and press conferences. LEO is in the process of establishing prices in various European countries. The first commercial sales are anticipated to be in the United Kingdom and will occur in additional countries as pricing is established.

    LEO has opened clinical sites and initiated patient enrollment for the Phase II dose ranging study in approximately 200 DIC patients. DIC is the widespread formation of clots within blood vessels, which often leads to organ failure, and is often associated with severe sepsis. In this indication, the infection and resulting septic condition consume much of the patient's own antithrombin. This antithrombin deficiency then results in DIC. In addition to a number of research studies that support the potential therapeutic value of antithrombin for this indication, DIC is an approved indication for plasma-derived antithrombin in Japan. DIC occurs in an estimated 500,000 severe sepsis cases in the US and European Union each year, of which up to 50% are fatal, representing a major unmet medical need of significant interest in critical care. We estimate the market size of the DIC indication in the US is $2 billion to 3 billion with additional similarly sized markets in Europe and Japan.

    GTC is nearing completion of the Phase III study to support a Biologic License Application in the hereditary deficiency indication in the US. The patients have been identified for data collection to satisfy the required number of historical cases treated with plasma-derived antithrombin products. Sufficient patients in the ATryn® treatment arm have been identified to complete the study and the schedule supports the planned availability of top line results before the end of the year.

    Antithrombin is used in patients with hereditary deficiency to reduce the risk of the formation of a blood clot known as a deep vein thrombosis, or DVT, during high risk procedures. The primary endpoint of the U.S. study is based on the observation of clinical symptoms of a DVT together with the comparison to historical data. The results from the 14 patients treated in the hereditary deficiency study for Europe will be combined with data from the current study to give a minimum of 31 evaluable patients.

    The data on childbirth patients gathered in this phase III study for the U.S. is planned to be used in a subsequent filing with the EMEA in 2008 to request expansion of the approved label to include childbirth procedures in the European Union.

    Follow-on Biologics

    Follow-on biologics, which are referred to as biosimilars in Europe, are a strategic development area where the economic advantages of our transgenic production technology may enable appropriate pricing of these products. In addition, the antibody dependent cell-mediated cytotoxicity, or ADCC, characteristics of our technology may offer clinical benefits for follow-on monoclonal antibody products. While the enabling legislation and associated regulatory guidance are not fully established, we have begun the development of two products under our agreement with LFB Biotechnologies that may be eligible for consideration as follow-on biologics. The recombinant factor VIIa program was initiated in the fourth quarter of 2006 to begin developing a product similar to NovoSeven®. GTC and LFB have recently begun a program to develop a CD20 monoclonal antibody that is expected to have target specificity similar to Rituximab (Rituxan®, Mabthera®) with relatively higher ADCC.

    Financial Results

    Revenues for the second quarter 2007 were $2.8 million, a significant increase from the $0.4 million in the second quarter 2006. This increase was driven by revenues from our contracts with PharmAthene and Merrimack Pharmaceuticals, as well as by revenue from LEO for clinical supplies of ATryn®. Revenues totaled $8.3 million for the first six months of 2007 compared to $2.6 million in the first six months of 2006, an increase of 216%. The six-month increase is primarily due to our contract with PharmAthene and the clinical supply of ATryn® to LEO.

    Costs of revenue and operating expenses totaled $13.5 million in the second quarter 2007, approximately 42% higher
  6. [verwijderd] 9 augustus 2007 14:36

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    vind ik niet echt Ray.

    cashburn vond ik erg hoog
    2,9 miljoen schadepost onbruikbare Atryn
    geld nodig (2008 is het op)

    zal weer genoeg voer zijn om zaak te drukken

    heb ze niet meer na verkoop 1,20 zone en hoef ze niet terug ook op dit moment.
    ben nog steeds niet overtuigd.
    deals en samenwerkingen lijken steeds aardig.. maar ik zie nergens de weg naar profitability terug, en heb steeds het gevoel dat dit allemaal bizar veel kost

    revenues waren redelijk
    Homosidesneh
  10. [verwijderd] 9 augustus 2007 17:11

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    Ray probeer een ander aandeel te vinden want dit is echt hopeloos. Je had Optv kunnen kopen op 1,25 eergisteren. Nu 1,74. Blijf andere aandelen volgen is me advies..
  11. [verwijderd] 9 augustus 2007 20:23

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    Yank maak je maar geen zorgen, handel hele dagen in opties en andere aandelen. Gtcb heb ik omdat ik echt denk dt het wat kan worden en als het gaat, gaat het snel :)
    Ik heb er ook niet echt verlies op, denk alleen dat je ze moet hebben
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