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GTC Biotherapeutics - Deel 13

1. ludwig mack 16 april 2010 10:30

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   dat is het verschil tussen een pessimist en een optimist, en laatste zijn gelukkig veel amerikanen, en dat waardeer ik wel.
   zie ook obama
   
   ;-)
   
   dag france, buiten schijnt vandaag geen zon, een verloren dag dus voor je, jammer man .....
   
   gr
2. ludwig mack 12 mei 2010 16:04

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   Press Release Source: GTC Biotherapeutics, Inc. On Wednesday May 12, 2010, 8:00 am EDT
   
   FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ("GTC", OTCBB: GTCB) today reported its financial results for the first fiscal quarter ended April 4, 2010. The total net loss for the first quarter was $7.7 million, or $0.26 per share, compared to $10.4 million, or $0.99 per share, for the first quarter of 2009.
   
   “GTC has continued to make good operational progress in its key programs during the first quarter,” stated Geoffrey Cox, Ph.D., Chairman, President and CEO of GTC Biotherapeutics. “Of particular importance are the preparations for the Phase I study for rhFVIIa which is on track for initiation in this second quarter.”
   
   Program Updates:
   
   Factor VIIa
   
   GTC, together with its collaboration partner LFB Biotechnologies, has established the transgenic rabbit production system for its human coagulation factor VIIa (rhFVIIa) program and is well advanced in the preparations to initiate a Phase I study in the 2nd quarter of 2010. This is planned to be a safety, pharmacokinetic and pharmacodynamic study of rhFVIIa in comparison with NovoSeven®, in normal healthy volunteers. On the basis of current plans, GTC expects to have results from this study in the fourth quarter of 2010.
   
   Alpha-Fetoprotein (AFP)
   
   GTC in-licensed the AFP program in the middle of 2009 and has established a herd of goats that produce this protein in significant quantities in their milk. Animal model tests are currently being conducted that are considered to be predictive for efficacy in autoimmune diseases such as myasthenia gravis and multiple sclerosis. GTC’s plan is to initiate a Phase II study in myasthenia gravis in the second half of 2010 providing a partnering arrangement has been obtained.
   
   ATryn®
   
   Lundbeck Inc. (Lundbeck), continues its commercialization of ATryn® in the hereditary deficiency indication in the USA. In addition, GTC is seeking to develop a protocol for a pivotal study in patients with acquired antithrombin deficiency who are undergoing cardiac surgery, with the objective of imitating a clinical trial in this indication in the second half of 2010.
   
   In Europe, GTC is seeking to establish an alternative partnering arrangement for the commercialization and further development of ATryn® following the termination of GTC’s contract with LEO Pharma. At this time there is no final decision in the LEO arbitration proceedings which GTC initiated with the International Chamber of Commerce.
   
   Monoclonal Antibodies and Follow-on Biologics
   
   GTC, together with its collaboration partner LFB, has established transgenic goat production systems for the production of TG20, a monoclonal antibody that targets CD20. TG20, which is not identical to Rituximab (Rituxan®), has demonstrated in in-vitro studies that it has an approximately 10-fold greater antibody dependent cell-mediated cytotoxicity, referred to as ADCC, than Rituximab. This may translate into improved efficacy or reduced dosage in hematologic malignancies. GTC is seeking a partner to support its share of the commercialization and clinical development of TG20.
   
   GTC has established production animals which express Trastuzumab (Herceptin®) in their milk, and this protein is currently being characterized. GTC is also developing transgenic animals for the production of Adalimumab (Humira®), and, together with our collaboration partner AgResearch in New Zealand, transgenic animals for the production of Cetuximab (Erbitux®). For each of these products we will be seeking partners to support further clinical development and commercialization.
   
   This portfolio of product candidates addresses markets with total annual sales currently in excess of $16 billion. For our product candidates addressing oncology indications, the natural glycosylation of the transgenic production system may provide advantages in ADCC. GTC plans to characterize each of these proteins as they become available and to initiate non-clinical studies in support of future partnering activities.
   
   Other Financial Results
   
   Revenues were approximately $346,000 for the current quarter, compared to approximately $198,000 for the first quarter of 2009. First quarter revenues in 2010 were primarily from the ATryn® program with Lundbeck as well as from GTC’s program with PharmAthene for services provided for their Protexia® program.
   
   Costs of revenue and operating expenses were $7.6 million for the current quarter, compared to $9.7 million for the first quarter of 2009, a decrease of 22% year-over-year. As previously reported, the reduction in force that GTC implemented in the fourth quarter of 2009, together with other expense reductions, is expected to produce approximately $6 million in expense savings in 2010.
   
   Research and development expenses were $4.8 million for the current quarter compared to $7 million for the first quarter of 2009. The year-over-year decrease in research and development expense included a $2.2 million increase in spending on our joint development programs with LFB (recombinant factor VIIa, recombinant factor IX, recombinant alpha-1 antitrypsin and CD-20 monoclonal antibody), offset by $1.9 million of LFB funding of the joint program expenses as well as a $1.9 million decrease in spending on the ATryn® program and a net reduction of approximately $600,000 in other development programs.
   
   Selling, general and administrative expenses were $2.8 million for the current quarter, compared to $2.5 million for the first quarter of 2009. The year-over-year increase in expense was primarily due to consulting expenses incurred for partnering and financing efforts.
   
   For comparison purposes, the per share results mentioned above for all periods reflect the 1-for-10 reverse stock split effected in May 2009. The weighted average number of shares outstanding increased from 10.4 million shares in the first quarter 2009 to 30.3 million shares in the first quarter 2010 due to the financing activities completed in 2009 as well as the conversion by LFB in January 2010 of its remaining holdings of Series E Convertible Preferred Stock into common stock. GTC had approximately 30.4 million common shares outstanding as of May 6, 2010.
   
   Cash Position
   
   Cash at April 3, 2010 totaled $4.9 million, a $1.1 million increase compared to $3.8 million at January 3, 2010. In February 2010, GTC obtained $7 million of new funding from LFB in the form of a 4%, 36-month term loan with a single payment of principal and interest at maturity. With this new funding from LFB and anticipated receipts from existing partnering agreements, GTC projects that its cash resources will be sufficient to support its operations to the end of the second quarter of 2010, exclusive of future cash proceeds from any potential new partnering agreements or additional financing arrangements.
   
   Transfer to Over-The-Counter Bulletin Board (OTCBB)
   
   On March 19, 2010, GTC transferred trading in its common stock from the NASDAQ Capital Market to the Over-the-Counter Bulletin Board (“OTCBB”), an electronic quotation service operated by the Financial Industry Regulatory Authority (“FINRA”). The symbol for GTC’s common stock remains GTCB; however, in some systems investors will be required to enter GTCB.OB to obtain a quote.
3. [verwijderd] 13 mei 2010 15:47

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   quote:

   ludwig mack schreef:

   dat is het verschil tussen een pessimist en een optimist, en laatste zijn gelukkig veel amerikanen, en dat waardeer ik wel.
   zie ook obama
   
   ;-)
   
   dag france, buiten schijnt vandaag geen zon, een verloren dag dus voor je, jammer man .....
   
   gr
   

   Zo te lezen ook een verloren kwartaal voor gtcb.
   
   Tjongejonge wat een troosteloze bende dat bedrijf.
   
   Godallemachtig wat zijn we door die club ( IR ) genaaid zeg.
   
   Van dit persbericht druipt de triestigheid af.
   
   Het beste Ludwig.
   
   
   
   
4. ludwig mack 13 mei 2010 16:09

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   dank!
   
   overal worden financiële verbanden aangelegd en is het elders in de jongere bio niet veel beter; het fundament van mijn eerst belegging in gtcb is er nog ....
   
   groet
   
5. welshterrier 5 16 juni 2010 15:37

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   GTC BIOTHERAPEUTICS ANNOUNCES NEW $7 MILLION FINANCING, COMPANY RESTRUCTURING AND MANAGEMENT CHANGES
   
   Framingham, MA, June 16, 2010: GTC Biotherapeutics, Inc. (“GTC”, OTCBB: GTCB) announced the closing of a new $7 million secured convertible debt financing by its strategic partner, LFB Biotechnologies SAS (“LFB” Les Ulis, France), in connection with a restructuring of GTC’s operations which will result in a downsizing of approximately 30 full-time positions at its headquarters and an additional 20 positions at its farm facility. In addition, Geoffrey Cox and several other members of the current senior management team will be leaving GTC. Board member William Heiden has been named Chairman, CEO and President.
   
   
   
   The convertible debt will mature on June 15, 2013 and will bear interest at an annual rate of 4%, with a single payment of principal and interest at maturity. LFB may convert the debt into GTC common stock at a conversion price of $ 0.42 per share at any time.
   
   
   
   “We are pleased to announce this financing, which is a strong show of support from our strategic partner LFB Biotechnologies. At the same time, I would like to thank the departing members of management and employees for all of their hard work and diligent efforts on behalf of GTC,” commented in-coming CEO William Heiden. “Looking ahead, GTC will concentrate its efforts on achieving three key goals: to progress the Factor VIIa program into first-in-man studies, currently expected to begin late this year; to improve the financial performance of ATryn®, the first product developed, approved (in the US and EU) and manufactured using GTC’s transgenic technology; to leverage the power of our transgenic platform to advance additional protein therapeutic candidates, especially in the area of ‘bio-similar’ product candidates. I believe that GTC is uniquely positioned to deliver improved versions of existing biotherapies, at lower cost and with greater manufacturing flexibility than other production systems. In summary, narrowing our focus and reducing the size of operations will significantly decrease our on-going financial resource requirements and enhance our ability to achieve our longer term strategic goals.”
   
   
   
   Christian Béchon, President and CEO of LFB, stated “This investment is a demonstration of our continuing commitment to the GTC transgenic technology platform and our joint programs, including Factor VIIa. I would also like to extend my sincere thanks to Geoff Cox and the other departing GTC employees for all of their efforts on behalf of the Company. I am looking forward to a bright future at GTC under the leadership of GTC’s new CEO, Mr. William Heiden. I have known Bill for several years and have great confidence in his ability to successfully lead GTC into its next chapter.”
   
   
   
   William Heiden is an experienced pharmaceutical and biotechnology executive. He served most recently as president and CEO of Elixir Pharmaceuticals, and prior to that as President and COO of Praecis (acquired by GSK), which he had joined in May 2002. From 1987 to 2002, he progressed through various positions of increasing responsibility at Schering Plough (now Merck), including Managing Director of a number of businesses in the U.S., Europe and Canada. Mr. Heiden holds an MBA from Cornell University’s Johnson Graduate School of Management, an MS degree from the University of Louvain and a Bachelors degree from the University of Florida. He serves on the Board of Directors of LFB Biotechnologies in Les Ulis, France, Conjuchem Biotechnologies, Inc. in Montreal, Canada (CJB.TO) and two private pharmaceutical companies.
   
   
6. ludwig mack 18 juni 2010 14:44

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   had een paar dagen pech met mijn p.c. of beter gezegd, mijn beeldscherm, en kan nu pas reageren;
   blijkbaar de enige ......
   de bezuinigingen zijn verder uitgewerkt, verloren illusies ook voor hen ....., maar de strijd voor een 2e product gaat door;
   hoe de kostenstructuur nu wordt met die ontslagen, is mij nog niet geheel duidelijk, wellicht bij de volgende cijfers.
   
   de arbitrage met de denen, is vervelend, en je vraagt je af waarom een stichting een commercieel bedrijf tegen kan zitten ......., terwijl ze zien dat het moeilijke tijden in de biotech zijn ...
   
   gr
7. [verwijderd] 18 juni 2010 14:50

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   probleem gtc is al veel eerder begonnen in veronderstelling dat er altijd geld uit de markt gehaald kon worden zonder tijdig te bezuinigen EN door ontwikkelpartner te willen zijn vs productieplatform
   
   groot mismanagement hier
8. ludwig mack 18 juni 2010 15:05

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   ontwikkeling hebben ze toch al veel eerder losgelaten (zie de fransen), platform niet .....;
   dat het nu wel kan, en een 6 mnd bijvoorbeeld geleden niet ........
   men had hoop op de snelle arbitrage, denk ik dan maar .............
9. ludwig mack 23 juni 2010 23:17

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   • ludwig mack

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10. [verwijderd] 25 juni 2010 09:35

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    Zo,het Pharming product eindelijk goedgekeurd. Ik ben er blij mee. Verbrede toepassing dus van de transgene technologie. Wel inmiddels bijna 300 miljoen aandelen daar.
    
    Bij GTC, een forse reorganisatie en eindelijk die belachelijk grote board met die wat vreemde Cox weg. Minder kosten, leningen van de sturende Franse moeder tegen gunstige voorwaarden(4%) en een niet verkeerde pijplijn.
    Ik vermoed dat we het dieptepunt wel gezien hebben.
    En ja: ik heb de stukjes nog echt allemaal hoor.
11. ludwig mack 25 juni 2010 17:45

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    die strijker, die zich destijds bij snorkle liet gaan, en zie pharming nu zelf ...........
    
    als het te lang duurt, is de extase weg, en dus ook de koers, en hebben anderen te lang hun tactiek kunnen voorbereiden, en de kleine belegger heeft het nakijken ..... ........
    
    gtcb; gelukkig komen de eerst cijfers van de usa en uitkomst arbitrage moet nu ook komen, anders kunnen ze net zo goed via de rechtbanken het gaan regelen, dan even lang durend ......
    
    de denen willen bloed zien, maar er valt niets te plukken, als ze al een claim zouden hebben voor die paar maanden werk, eerder voor toekomstige winstverwachtingen, oh ironie .................. lachen toch.
    
12. [verwijderd] 28 juni 2010 19:56

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    We staan weer eens boven de 0,50!
    Laten we hopen dat het niet voor "even" is.
13. sappas 13 juli 2010 17:37

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    quote:

    Beur schreef:

    We staan weer eens boven de 0,50!
    Laten we hopen dat het niet voor "even" is.
    

    We staan weer op 0,40 :-(
    
    Groetjes,
    
    Sappas
14. sappas 16 juli 2010 14:41

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    GTC BIOTHERAPEUTICS REGAINS US RIGHTS TO ATryn®; THE FIRST RECOMBINANT ANTITHROMBIN PRODUCT APPROVED IN THE WORLD
    
    ATryn is approved for use in patients with hereditary antithrombin deficiency, a rare and potentially life threatening condition (see important safety information below)
    
    FRAMINGHAM, MA –July 16, 2010-- GTC Biotherapeutics, Inc. ("GTC", OTCBB: GTCB.OB) announced today that it has signed a definitive agreement whereby the Company has regained US commercialization rights to ATryn from Lundbeck, Inc., a wholly owned subsidiary of H. Lundbeck A/S in Denmark (Copenhagen Stock Exchange: LUN). The two companies have agreed to a defined transition period of up to six months wherein Lundbeck will perform certain services on behalf of GTC in order to ensure that ATryn will continue to be available to physicians and their patients in an uninterrupted fashion as commercialization responsibilities are smoothly transitioned to GTC. Thereafter, Lundbeck will earn a royalty on net sales beginning in two years, with a predefined cumulative maximum.
    
    William Heiden, Chairman, President & CEO at GTC stated, “Our collaboration with Lundbeck has been excellent and I would like to thank the Lundbeck team which has worked so diligently on the successful launch of ATryn in the US. Both parties agree that it is now the right time and in the best interests of both companies, given their respective strategic objectives, to transfer ATryn rights back to GTC. We look forward to working through this transition with Lundbeck to ultimately take on full responsibility for the commercialization of ATryn in the US. Looking to the future, GTC is committed to maximizing the commercial potential for ATryn in the US marketplace.”
    
    About ATryn
    
    ATryn® (Antithrombin [Recombinant]) was granted U.S. marketing approval in February 2009 by the Food and Drug Administration (FDA). ATryn is approved for the prevention of peri-operative and peri-partum thromboembolic events in patients with hereditary antithrombin deficiency (HD AT), a rare and potentially fatal blood clotting disorder. ATryn is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.
    
    Antithrombin is a naturally occurring protein that helps regulate the blood clotting mechanism in the body. People with hereditary antithrombin deficiency have lower than normal levels of antithrombin, putting them at increased risk for venous thromboembolic events (VTE), including pulmonary embolism and deep vein thrombosis, which can be life threatening, particularly in the high-risk situations of surgery or childbirth. ATryn provides physicians an alternative to human plasma-derived antithrombin for HD AT patients undergoing surgery or giving birth requiring antithrombin therapy. ATryn is not formulated with human plasma proteins.
    
    Approximately one in 2,000 to one in 5,000 people have hereditary antithrombin deficiency. By the age of 50, approximately 50 percent of people with hereditary antithrombin deficiency will have experienced a VTE.
    
    Developed and manufactured by GTC Biotherapeutics, ATryn was created to provide a safe and reliable supply of recombinant antithrombin, an alternative to human plasma-derived antithrombin. ATryn is made by processing the human antithrombin protein from the milk of a select herd of transgenic goats.
    
    The process for producing ATryn involves scientists inserting DNA for the human antithrombin protein into a single-celled goat embryo. This embryo is implanted into a surrogate doe. The resulting transgenic offspring are able to produce high levels of human antithrombin in their milk.
    
    This protein is collected and purified from the milk to produce ATryn, which is administered to patients by intravenous infusion.
    
    Purified recombinant antithrombin has the same amino acid sequence as antithrombin derived from human plasma. Antithrombin (Recombinant) and plasma-derived antithrombin both contain six cysteine residues forming three disulphide bridges and 3-4 linked carbohydrate moieties. The glycosylation profile of ATryn is different from plasma-derived antithrombin, which results in an increased heparin affinity. When assayed in the presence of excess of heparin the potency of the recombinant product is not different from that of plasma-derived product.
    
    Indications and Usage
    
    ATryn (Antithrombin [Recombinant]) is indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.
    
    Important Safety Information
    
    ATryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins. Allergic-type hypersensitivity reactions are possible. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. If these symptoms occur during administration, treatment must be discontinued immediately. Adding ATryn to or withdrawing ATryn from anticoagulants that use antithrombin to exert their anticoagulative effects may alter this effect. To avoid excessive or insufficient anticoagulation, coagulation tests suitable for the anticoagulant used (e.g., aPTT and anti-Factor Xa activity) are to be performed regularly, at close intervals, and in particular in the first hours following the start or withdrawal of ATryn, in such situations, patients should be monitored for the occurrence of bleeding or thrombosis.
    
    The serious adverse reaction that has been reported in clinical studies is hemorrhage (intra-abdominal, hemarthrosis, and post procedural). The most common adverse events reported in clinical trials at a frequency of >5% are hemorrhage and infusion site reaction.
    
    For more information, please see full Prescribing Information atwww.lundbeckinc.com.
    
    About GTC Biotherapeutics
    
    GTC Biotherapeutics’ core technology enables the development and manufacture of therapeutic proteins produced through transgenic animal technology. ATryn®, GTC’s recombinant human antithrombin, has been approved for use in the United States and Europe. ATryn is the first and only therapeutic product produced in transgenic animals to be approved anywhere in the world. In addition to ATryn, GTC is developing a portfolio of recombinant human plasma proteins with known therapeutic benefits. These proteins include a recombinant form of human coagulation factor VIIa, which is being developed with partner LFB for the treatment of patients with hemophilia. GTC has also developed a portfolio of monoclonal antibodies (MABs) targeting HER2, EGFR and TNF, which address markets with total sales in excess of $16 billion, as well as a CD20 antibody with enhanced ADCC (antibody-dependent cell-mediated cytotoxicity).
    
    GTC’s intellectual property includes a patent in the United States through 2021 for the production of any therapeutic protein in the milk of any transgenic mammal. GTC’s transgenic production platform is particularly well suited to enable highly flexible and cost effective development of proteins that are difficult to express in traditional recombinant production systems, as well as proteins that are required in large volumes. Ad
15. ludwig mack 16 juli 2010 14:42

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    GTC BIOTHERAPEUTICS REGAINS US RIGHTS TO ATryn®; THE FIRST RECOMBINANT ANTITHROMBIN PRODUCT APPROVED IN THE WORLD
    
    
    ATryn is approved for use in patients with hereditary antithrombin deficiency, a rare and potentially life threatening condition (see important safety information below)
    
    
    
    FRAMINGHAM, MA –July 16, 2010-- GTC Biotherapeutics, Inc. ("GTC", OTCBB: GTCB.OB) announced today that it has signed a definitive agreement whereby the Company has regained US commercialization rights to ATryn from Lundbeck, Inc., a wholly owned subsidiary of H. Lundbeck A/S in Denmark (Copenhagen Stock Exchange: LUN). The two companies have agreed to a defined transition period of up to six months wherein Lundbeck will perform certain services on behalf of GTC in order to ensure that ATryn will continue to be available to physicians and their patients in an uninterrupted fashion as commercialization responsibilities are smoothly transitioned to GTC. Thereafter, Lundbeck will earn a royalty on net sales beginning in two years, with a predefined cumulative maximum.
    
    William Heiden, Chairman, President & CEO at GTC stated, “Our collaboration with Lundbeck has been excellent and I would like to thank the Lundbeck team which has worked so diligently on the successful launch of ATryn in the US. Both parties agree that it is now the right time and in the best interests of both companies, given their respective strategic objectives, to transfer ATryn rights back to GTC. We look forward to working through this transition with Lundbeck to ultimately take on full responsibility for the commercialization of ATryn in the US. Looking to the future, GTC is committed to maximizing the commercial potential for ATryn in the US marketplace.”
    
    About ATryn
    
    ATryn® (Antithrombin [Recombinant]) was granted U.S. marketing approval in February 2009 by the Food and Drug Administration (FDA). ATryn is approved for the prevention of peri-operative and peri-partum thromboembolic events in patients with hereditary antithrombin deficiency (HD AT), a rare and potentially fatal blood clotting disorder. ATryn is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.
    
    Antithrombin is a naturally occurring protein that helps regulate the blood clotting mechanism in the body. People with hereditary antithrombin deficiency have lower than normal levels of antithrombin, putting them at increased risk for venous thromboembolic events (VTE), including pulmonary embolism and deep vein thrombosis, which can be life threatening, particularly in the high-risk situations of surgery or childbirth. ATryn provides physicians an alternative to human plasma-derived antithrombin for HD AT patients undergoing surgery or giving birth requiring antithrombin therapy. ATryn is not formulated with human plasma proteins.
    
    Approximately one in 2,000 to one in 5,000 people have hereditary antithrombin deficiency. By the age of 50, approximately 50 percent of people with hereditary antithrombin deficiency will have experienced a VTE.
    
    Developed and manufactured by GTC Biotherapeutics, ATryn was created to provide a safe and reliable supply of recombinant antithrombin, an alternative to human plasma-derived antithrombin. ATryn is made by processing the human antithrombin protein from the milk of a select herd of transgenic goats.
    
    The process for producing ATryn involves scientists inserting DNA for the human antithrombin protein into a single-celled goat embryo. This embryo is implanted into a surrogate doe. The resulting transgenic offspring are able to produce high levels of human antithrombin in their milk.
    
    This protein is collected and purified from the milk to produce ATryn, which is administered to patients by intravenous infusion.
    
    Purified recombinant antithrombin has the same amino acid sequence as antithrombin derived from human plasma. Antithrombin (Recombinant) and plasma-derived antithrombin both contain six cysteine residues forming three disulphide bridges and 3-4 linked carbohydrate moieties. The glycosylation profile of ATryn is different from plasma-derived antithrombin, which results in an increased heparin affinity. When assayed in the presence of excess of heparin the potency of the recombinant product is not different from that of plasma-derived product.
    
    Indications and Usage
    
    ATryn (Antithrombin [Recombinant]) is indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.
    
    Important Safety Information
    
    ATryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins. Allergic-type hypersensitivity reactions are possible. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. If these symptoms occur during administration, treatment must be discontinued immediately. Adding ATryn to or withdrawing ATryn from anticoagulants that use antithrombin to exert their anticoagulative effects may alter this effect. To avoid excessive or insufficient anticoagulation, coagulation tests suitable for the anticoagulant used (e.g., aPTT and anti-Factor Xa activity) are to be performed regularly, at close intervals, and in particular in the first hours following the start or withdrawal of ATryn, in such situations, patients should be monitored for the occurrence of bleeding or thrombosis.
    
    The serious adverse reaction that has been reported in clinical studies is hemorrhage (intra-abdominal, hemarthrosis, and post procedural). The most common adverse events reported in clinical trials at a frequency of >5% are hemorrhage and infusion site reaction.
    
    For more information, please see full Prescribing Information atwww.lundbeckinc.com.
    
    About GTC Biotherapeutics
    
    GTC Biotherapeutics’ core technology enables the development and manufacture of therapeutic proteins produced through transgenic animal technology. ATryn®, GTC’s recombinant human antithrombin, has been approved for use in the United States and Europe. ATryn is the first and only therapeutic product produced in transgenic animals to be approved anywhere in the world. In addition to ATryn, GTC is developing a portfolio of recombinant human plasma proteins with known therapeutic benefits. These proteins include a recombinant form of human coagulation factor VIIa, which is being developed with partner LFB for the treatment of patients with hemophilia. GTC has also developed a portfolio of monoclonal antibodies (MABs) targeting HER2, EGFR and TNF, which address markets with total sales in excess of $16 billion, as well as a CD20 antibody with enhanced ADCC (antibody-dependent cell-mediated cytotoxicity).
    
    GTC’s intellectual property includes a patent in the United States through 2021 for the production of any therapeutic protein in the milk of any transgenic mammal. GTC’s transgenic production platform is particularly well suited to enable highly flexible and cost effective development of proteins that are difficult to express in traditional recombinant production systems, as well as proteins that are required in large volumes. Additional information
16. ludwig mack 16 juli 2010 14:45

    auteur info

    • ludwig mack

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    dit ging er aan vooraf:
    
    GTC BIOTHERAPEUTICS REPORTS PROGRESS IN PREPARATIONS TO LAUNCH ATRYN® IN THE U.S.
    FRAMINGHAM, MA – March 30, 2009 -- GTC Biotherapeutics, Inc. ("GTC", NASDAQ: GTCB) has received $3 million as a milestone payment from Lundbeck Inc. of Deerfield, IL, a subsidiary of H. Lundbeck A/S, as a result of the approval of ATryn® (Antithrombin [Recombinant]) by the Food and Drug Administration. Lundbeck Inc. was previously known as Ovation Pharmaceuticals, Inc. prior to being acquired by H. Lundbeck A/S.
    
    
    
    Manufacture and release of product to support the commercial launch of ATryn has been completed. An additional $1 million payment will be made by Lundbeck for this inventory to support the ATryn launch in the second quarter of this year.
    
    
    
    “Lundbeck is excited to lead the launch of ATryn in the United States,” stated Michael Burke, Chief Commercial Officer, Lundbeck Inc. “ATryn is a unique product providing an important new treatment option for patients with hereditary antithrombin deficiency who are undergoing surgery or childbirth procedures.”
    
    
17. ludwig mack 16 juli 2010 14:48

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    • ludwig mack

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    ik denk dat de verkopers niet agressief genoeg zijn om de markt te penetreren, en dat dat ook de breuk met denen voor europa heeft veroorzaakt .......
    
    
18. ludwig mack 27 juli 2010 14:30

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    GTC BIOTHERAPEUTICS REPORTS SECOND QUARTER 2010 FINANCIAL RESULTS
    
    
    
    FRAMINGHAM, MA – July 27, 2010 -- GTC Biotherapeutics, Inc. ("GTC", OTCBB: GTCB) today reported its financial results for the second fiscal quarter ended July 4, 2010. The total net loss for the second quarter improved to approximately $0.3 million, or $0.01 per share, compared to $10.8 million, or $1.03 per share, for the second quarter of 2009. The total net loss for the first six months of 2010 was $8.1 million, or $0.27 per share, compared to $21.1 million, or $2.03 per share, for the first six months of 2009. The decrease in the net loss in 2010 is primarily a result of the award of approximately $4.1 million to GTC from LEO Pharma, of which approximately a $3.8 million gain was recorded to other income, as well as the recognition of deferred revenue of approximately $4.4 million in connection with the International Chamber of Commerce (ICC) arbitration proceedings.
    
    
    
    “We recently announced that GTC is focused on achieving key goals related to Factor VIIa, ATryn® and our ‘bio-superior’ product candidates. I am pleased to report that the Company made good progress towards achieving these goals during the second quarter,” stated William K. Heiden, Chairman, President and CEO of GTC Biotherapeutics. “Of particular importance was the progress made in preparation for initiation of the Phase I study for rhFVIIa with our partner LFB, which is on track for initiation in the fourth quarter of 2010. As well, we have made progress towards our goal of improving the profitability of ATryn, with the recently announced return of U.S. marketing rights to GTC from Lundbeck Inc., a wholly owned subsidiary of H. Lundbeck A/S in Denmark (Copenhagen Stock Exchange: LUN).”
    
    
    
    Program Updates:
    
    
    
    Factor VIIa
    
    
    
    GTC, together with its collaboration partner LFB Biotechnologies, has established the transgenic rabbit production system for its recombinant form of human coagulation factor VIIa (rhFVIIa) which is being developed for the treatment of patients with hemophilia. Pre-clinical work is on-going in the preparation to initiate a Phase I study in the fourth quarter of 2010. This is planned to be a safety, pharmacokinetic and pharmacodynamic study of rhFVIIa in comparison with NovoSeven®, in normal healthy volunteers. On the basis of current plans, GTC expects to have results from this study in early 2011.
    
    ATryn®
    
    
    
    On July 16, 2010 GTC announced that it had regained the U.S. commercialization rights to ATryn® from Lundbeck Inc. There will be a transition period of up to six months wherein Lundbeck will perform certain services on behalf of GTC in order to ensure that ATryn® will continue to be available to physicians and their patients in an uninterrupted fashion as commercialization responsibilities are smoothly transitioned to GTC. Thereafter, Lundbeck will earn a royalty on net sales beginning in two years, with a predefined cumulative maximum.
    
    
    
    In Europe, GTC is in discussions with potential partners for the commercialization and further development of ATryn®.
    
    
    
    Bio-Superiors program (monoclonal antibodies and recombinant forms of plasma derived therapeutic proteins)
    
    
    
    Beyond ATryn®, GTC is developing a portfolio of bio-superior, recombinant forms of human plasma proteins with known therapeutic benefits. GTC has also developed a portfolio of monoclonal antibodies (MAbs) targeting HER2, EGFR and TNF, which address markets with total sales in excess of $16 billion, as well as a CD20 antibody with enhanced ADCC (antibody-dependent cell-mediated cytotoxicity). For example, GTC has established a transgenic goat production system for the production of TG20, a MAb that targets CD20. TG20, which is not identical to rituximab (Rituxan®), has demonstrated in in-vitro studies that it has an approximately 10-fold greater antibody dependent cell-mediated cytotoxicity, referred to as ADCC, than rituximab. This may translate into improved efficacy or reduced dosage in hematologic malignancies. GTC has established production animals which express trastuzumab (Herceptin®) in their milk, and this protein is currently being characterized. GTC is also developing transgenic animals for the production of adalimumab (Humira®) and cetuximab (Erbitux®). GTC will be seeking partners to support further clinical development and commercialization for these programs.
    
    
    
    Other Financial Results
    
    
    
    Revenues were approximately $4.9 million for the current quarter, compared to approximately $0.7 million for the second quarter of 2009. Revenues were approximately $5.3 million for the first six months of 2010 compared to approximately $0.9 million for the first six months of 2009, an increase of approximately $4.4 million. The revenue increases in 2010 were primarily from approximately $4.4 million of previously deferred revenue related to our agreement with LEO Pharma. We recognized this revenue once we received a favorable award in the ICC arbitration proceedings at the end of the second quarter.
    
    
    
    Costs of revenue and operating expenses were approximately $8.5 million for the current quarter, compared to approximately $10.3 million for the second quarter of 2009, a decrease of 18% year-over-year. Costs of revenue and operating expenses were approximately $16 million for the first half of 2010, approximately 20% lower than $20.1 million for the first half of 2009. The lower expenses in 2010 were primarily due to decreased costs on the ATryn® program.
    
    The reductions in force that GTC implemented in the fourth quarter of 2009 and the second quarter of 2010, together with other expense reductions, are expected to produce expense savings of approximately $13 million to $15 million per year on an annualized basis.
    
    Research and development expenses were $5.2 million for the current quarter compared to $6.8 million for the second quarter of 2009. Research and development expenses were approximately $9.9 million for the first half of 2010 compared to $13.8 million for the first half of 2009. The decrease in research and development expense occurred despite a $1.7 million quarterly increase and a $3.9 million year-to-date increase in spending on our joint development programs with LFB (recombinant factor VIIa, recombinant factor IX, recombinant alpha-1 antitrypsin and CD-20 monoclonal antibody). The quarterly decrease was due to approximately $0.9 million of LFB funding of the joint program expenses in the second quarter of 2010, as well as a decrease of approximately $1.8 million in spending on the ATryn® program and a net reduction of approximately $0.6 million in other development programs. The yearly decrease was due to approximately $2.8 million of LFB funding on the joint program expenses in the first half of 2010 as well as a decrease of approximately $3.4 million in spending on the ATryn program and a net reduction of approximately $1.6 million in other development programs.
    
    Selling, general and administrative expenses were $2.8 million for the current quarter of 2010, compared to $3.1 million for the second quarter of 2009 and $5.5 million for the first half of 2010, compared to $5.6 million for the first half of 2009. The quarterly decrease in expenses was primarily due to the absence in 2010 of the legal costs associated with the LEO arbitration in 2009.
    
    The weighted average number of shares outstanding increased from
19. ludwig mack 27 juli 2010 14:33

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    • ludwig mack

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    de arbitrage heeft dus geld opgeleverd, en een p.b. daarover hebben ze niet gemaakt, en nu als verrassing .....
    
    wat er met de verkopen usa gebeurt, begrijp ik niet goed; kan iemand daar zijn mening over geven wat de bedoeling is, want ondanks terug naar af, provisieberekening, wellicht voor gebruikmaking van hun netwerk, dat gtcb mist ..........
20. ludwig mack 27 juli 2010 14:38

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    • ludwig mack

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    vervolg
    
    The weighted average number of shares outstanding increased from 10.4 million shares in the three and six month periods of 2009 to 30.4 million shares in the three and six month periods of 2010. The increase in shares outstanding is due to the financing activities completed in 2009 as well as the conversion by LFB in January 2010 of its remaining holdings of Series E Convertible Preferred Stock into common stock. GTC had approximately 30.4 million common shares outstanding as of July 4, 2010.
    
    
    
    Cash Position
    
    
    
    Cash at July 4, 2010 totaled $6.2 million, a $2.4 million increase compared to $3.8 million at January 3, 2010. In February 2010, GTC obtained $7 million of new funding from LFB in the form of a 4%, 36-month term loan with a single payment of principal and interest at maturity. In June 2010, GTC obtained $7 million of new funding from LFB in the form of a 4%, 36-month convertible loan with a single payment of principal and interest at maturity. With our current cash position today, which includes the net award from the ICC arbitration proceedings, and anticipated receipts from existing partnering agreements, service contracts and sales of ATryn®, GTC projects that its cash resources will be sufficient to support its operations to the middle of the fourth quarter of 2010, exclusive of future cash proceeds from any potential new partnering agreements or additional financing arrangements.
    
    
    
    Transfer to Over-The-Counter Bulletin Board (OTCBB)
    
    
    
    On March 19, 2010, GTC transferred trading in its common stock from the NASDAQ Capital Market to the Over-the-Counter Bulletin Board (“OTCBB”), an electronic quotation service operated by the Financial Industry Regulatory Authority (“FINRA”). The symbol for GTC’s common stock remains GTCB; however, in some systems investors will be required to enter GTCB.OB to obtain a quote.