GTC has exercised its right to have its application re-examined, and expects the re-examination to conclude in mid-2006. However, in a public statement by a spokesperson for the EMEA who was quoted in a February 24 article published in Nature.com, the negative opinion was not related to the source of the product being from a transgenic animal.
In November 2005, GTC and LEO Pharma entered into a collaboration to develop and market ATryn® in Europe, Canada, and the Middle East. LEO is responsible for clinical development of ATryn® in an acquired antithrombin deficiency indication in Europe. GTC is responsible for ATryn® production and will receive a transfer payment from LEO for all product used in the acquired deficiency clinical study and a royalty on future commercial sales. The acquired deficiency indication to be studied is expected to be selected by mid-2006.
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