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GTCB - GTC Biotherapeutics - Deel 12

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  1. jurpsy 6 mei 2009 14:16

    • jurpsy

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    May 06, 2009 08:00 AM Eastern Daylight Time
    ATryn Available for Patients with Hereditary Antithrombin Deficiency, a Rare Blood Clotting Disorder
    Lundbeck Inc. offers recombinant antithrombin treatment option

    DEERFIELD, Ill.--(BUSINESS WIRE)--Lundbeck Inc., a wholly owned subsidiary of H. Lundbeck A/S in Denmark (LUN: Copenhagen Stock Exchange), announced today that ATryn® (Antithrombin [Recombinant]) is now available in the United States. In February 2009, the U.S. Food and Drug Administration (FDA) granted marketing approval of ATryn, developed through recombinant technology, 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. The product is marketed in the U.S. by Lundbeck Inc. and manufactured by GTC Biotherapeutics, Inc. (NASDAQ: GTCB).

    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. Prior to the availability of ATryn, HD AT patients undergoing surgery or giving birth requiring an antithrombin therapy relied on a human plasma derived product. ATryn is not formulated with human plasma proteins.

    “Lundbeck is pleased to bring ATryn to people living with this rare clotting disorder,” said Jeffrey S. Aronin, CEO, Lundbeck Inc. “As a recombinant form of antithrombin therapy, ATryn offers an alternative to human plasma-derived antithrombin. Lundbeck is well positioned to ensure a safe and reliable supply for those who need it, when they need it. In bringing ATryn to market, we remain committed to addressing the medical needs of orphan patient populations.”

    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.

    "ATryn may make a meaningful difference in the lives of patients with hereditary antithrombin deficiency who are at increased risk of blood clots, especially during major surgical procedures or childbirth,” said Dr. Stephan Moll, hematologist, University of North Carolina and Medical Director of the National Alliance for Thrombosis and Thrombophilia. “During these situations, the risk of a patient with hereditary antithrombin deficiency to develop a venous thromboembolism is increased about 20 times compared to the normal population."

    www.businesswire.com/portal/site/goog...
  4. sappas 6 mei 2009 14:41

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    “We are delighted to have reached this important milestone with the launch of ATryn in the US, which is the first transgenically produced therapeutic product to reach the marketplace,” stated Geoffrey F. Cox, Ph.D., GTC’s Chief Executive Officer and Chairman of the Board. “We look forward to working with Lundbeck to deliver this important new product.”

    Groetjes,

    Sappas
  7. ludwig mack 6 mei 2009 15:00

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    quote:

    Bio-Bob schreef:

    Krijgt GTCB nog een milestone payment hiervoor (naast eventuele royalties bij verkoop uiteraard)
    uit p.b. 30/3/09:

    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
  9. [verwijderd] 6 mei 2009 15:04

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    quote:

    ludwig mack schreef:

    [quote=Bio-Bob]
    Krijgt GTCB nog een milestone payment hiervoor (naast eventuele royalties bij verkoop uiteraard)
    [/quote]

    uit p.b. 30/3/09:

    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

    Thanks!
  10. ludwig mack 6 mei 2009 15:32

    • ludwig mack

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    0,4700 15:30 500
    +/- 0,0600 14,63%
    Slot 0,4100 05-05-09
    Open 0,48 15:30
    Hoog 0,52 15:30
    Laag 0,47 15:30
    Bied
    Laat
    Volume 117.200

    inmiddels 48, 17% plus, valt mee.
    komt goed.

    gr
  13. sappas 6 mei 2009 15:44

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    quote:

    beur schreef:

    Bedankt Lundbeck, om dit zo netjes te verzorgen allemaal!
    Weer back in town en goede vakantie gehad?

    Groetjes,

    Sappas
  14. [verwijderd] 6 mei 2009 15:51

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    Jazeker Sap,vannacht teruggekeerd. En het is natuurlijk helemaal leuk als bij terugkomst van de bok de geitjes gaan steigeren...

    De stijging van vorige week misschien geinduceerd door voorkennis bij Lundbeck-lui?
  17. [verwijderd] 6 mei 2009 16:27

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    GTC BIOTHERAPEUTICS REPORTS LAUNCH OF ATRYN® IN THE U.S. BY LUNDBECK INC.


    FRAMINGHAM, MA – May 6, 2009 -- ATryn® (Antithrombin [Recombinant]) is now available commercially through Lundbeck Inc. of Deerfield, IL,a wholly ownedsubsidiary of H. Lundbeck A/S in Denmark (LUN: Copenhagen Stock Exchange),GTC Biotherapeutics, Inc.’s ("GTC", NASDAQ: GTCB) commercialization and development partner in the United States. GTC is due to receive a total of $1 million from Lundbeck for its initial inventory of ATryn.


    This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the Lundbeck’s commercial prospects for ATryn and the receipt of funds for product supply. Such forward-looking statements are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to, the risks and uncertainties discussed in GTC's most recent Annual Report on Form 10-K and its other periodic reports filed with the Securities and Exchange Commission, *including the risks and uncertainties associated with dependence upon the actions of collaboration partners. GTC cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and GTC undertakes no obligation to update or revise the statements, except as may be required by law.

    *"including the risks and uncertainties associated with dependence upon the actions of collaboration partners", wordt vet gedrukt weergegeven. Voor het eerst?




  18. [verwijderd] 6 mei 2009 18:01

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    Posted by: read_this_n0w
    Date: Wednesday, May 06, 2009 10:56:40 AM
    Post 18778

    Wingnut: Whats with the cheers?
    Financing is still a very big problem for gtcb.


    Leuk hé krak, heb intussen reeds, de 124e keer jou zelfde zinnetje mogen lezen. Met dien verstande, de ene maal in het Engels, de andere keer in het Nederlands, en omgekeerd!
    Maar goed, je bent waarschijnlijk in dat opzicht, een zéér bezorgde kerel? En als je dat leuk mocht vinden, dan blijf je dat toch gewoon herhalen hé jongen!?
  20. jurpsy 6 mei 2009 19:23

    • jurpsy

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    HEALTH AWARENESS

    --------------------------------------------------------------------------------

    Patient With Potentially Life-Threatening Blood Clotting Disorder Shares Her Story

    (NAPSI)-Leigh Logan felt the first of many bouts of excruciating pain and swelling in her calf as an 18-year-old college sophomore. She was diagnosed with deep vein thrombosis (DVT), a potentially fatal blood clot in a deep vein that strikes more than 380,000 people annually in the United States. Doctors were puzzled about the cause of her DVT because she didn't have the typical risk factors (she was not obese or on birth control pills, and she had not recently sustained an injury or been immobilized for an extended period of time, such as on a long plane ride).

    After extensive testing, Logan was diagnosed with hereditary antithrombin deficiency, a rare blood clotting disorder that strikes approximately one in 2,000 to one in 5,000 people in the general population. Because she doesn't produce enough antithrombin, a protein that functions as a natural anticoagulant, Logan was prone to developing blood clots and would face a heightened risk if she were to undergo surgery or give birth.

    Logan was placed on a blood-thinning agent, allowing her to manage her disease. Things changed, however, when she became pregnant.

    "I was in a difficult position, because I needed to continue taking a blood-thinning medication to prevent a DVT but this particular medication could cause severe birth defects," Logan said. "I switched to another anticlotting medication. Even so, I developed a DVT during my sixth month. To prevent another DVT, doctors planned to treat me with antithrombin before and after my C-section, but the stock of human plasma-derived antithrombin had run out."

    Fortunately for Logan, a new therapeutic option for hereditary antithrombin deficiency called ATryn® (Antithrombin [Recombinant]) was being developed in the U.S. "After receiving special approval from the U.S. Food and Drug Administration [FDA] for the compassionate use of ATryn, I delivered a healthy baby boy without experiencing any clotting complications," Logan said.

    Since Logan gave birth to her son, ATryn was approved in early 2009 by the FDA for the prevention of blood clots during surgery or childbirth in hereditary antithrombin-deficient patients. ATryn was developed and is manufactured by GTC Biotherapeutics, Inc. and is marketed in the U.S. by Lundbeck Inc., which recently introduced it in this country.

    "I'm so glad that others with this disease will now have access to ATryn when they need it most," said Logan.

    For full prescribing information on ATryn or to learn more about hereditary antithrombin deficiency, visit www.lundbeckinc.com.

    Indications and Usage:

    ATryn (Antithrombin [Recombinant]) is indicated for the prevention of perioperative and peripartum 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 antiithrombin 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 postprocedural). 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 at www.lundbeckinc.com.

    ® Trademark of Lundbeck Inc. in the United States

    www.napsnet.com/articles/61346.html
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