Article Excerpt:
TWST: We would like to begin with a brief historical sketch of GTC Biotherapeutics and a picture of the things you are doing at the present time.Dr. Cox: GTC came into being in 1991, when it was spun out of Genzyme Corporation. We went public in 1993. Genzyme still has an ownership and equity stake in GTC of about 9%, but GTC Biotherapeutics is an independent company and Genzyme does not have a controlling influence over the company either through its equity stake or through the Board. Nonetheless, Genzyme has continued to be a very supportive entity for GTC over the years. The company has a strategic focus in the area of recombinant plasma proteins and monoclonal antibodies, and they leverage the particular characteristics of our transgenic technology. This is the production of therapeutic proteins in the milk of transgenic animals. We are one of the very few companies in the world that are leveraging this particular technology. We do believe that we are the leading company in the world for this technology. The technology is unique because it enables you to produce large volumes of therapeutic proteins, which are difficult to manufacture in other manufacturing systems such as CHO or yeast. It also has the added ability to produce proteins with lower capital costs for the manufacturing capacity and a low cost of goods. Over the years, the company has moved from being a platform technology to being more of a contract manufacturer in the mid- to late 1990s. Over the last four or five years, we have been very focused on developing our own proprietary products. Our lead product is a product called ATryn', which is a recombinant form of human antithrombin. At the most recent CHMP meeting, we actually received a positive opinion from the EMEA in Europe for the review of our antithrombin action program. That will lead to our marketing authorization somewhere in the September time frame to enable us to market this product in Europe. Four or five years ago, we felt that it was very important for us to take responsibility for developing our own regulatory strategy and demonstrating that we could bring these programs through to regulatory approval. This is a very important inflection point for the company, demonstrating the validity of the technology and the first transgenicly derived therapeutic proteins approved by any regulatory agency anywhere in the world. We believe this is a tremendous achievement, one of which we are very proud and which not only unlocked the value of antithrombin in the ATryn program, but also unlocked the value of the whole technology platform, which was started 15 years ago.
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