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FRAMINGHAM, Mass.–(BUSINESS WIRE)–GTC Biotherapeutics, Inc. (GTC) (a wholly-owned subsidiary of LFB Biotechnologies S.A.S., Les Ulis, France), announced today that the United States Patent and Trademark Office (USPTO) granted (to GTC) a patent covering DNA constructs for the production of any therapeutic protein in the milk of any transgenic animal. This “Broad DNA” patent extends to 2027. GTC’s intellectual property position also includes a United States Patent extending to 2021 covering methods for the production of any therapeutic protein in the milk of non-human transgenic mammals. With this event, GTC’s intellectual property (estate) includes patents in the United States expiring as late as 2027 covering DNA constructs and methods for the production of any therapeutic protein in the milk of transgenic mammals.

“Economic assessments of new health technologies are becoming more and more prevalent in the biopharmaceutical industry. The news of enhanced patent protection for GTC’s core technology, which delivers the highest quality protein therapeutics at lower cost, is extremely important for the LFB Group.”

Commenting on the news, William Heiden, GTC CEO stated “We are very pleased by the news granting us further protection for our core technology through 2027. We have worked very hard over many years perfecting the technology and this news reinforces GTC’s position as the world leader in transgenic therapeutic protein production. We are now leveraging the platform to develop low-cost recombinant forms of a number of plasma-derived proteins, bio-better monoclonal antibodies, as well as novel antibodies.”

Christian Bechon, CEO of LFB Group stated “Economic assessments of new health technologies are becoming more and more prevalent in the biopharmaceutical industry. The news of enhanced patent protection for GTC’s core technology, which delivers the highest quality protein therapeutics at lower cost, is extremely important for the LFB Group.”

In addition, GTC is announcing that it has been granted another United States patent for its lead product ATryn® (recombinant human antithrombin). ATryn was the first – and is still the only, transgenically produced therapeutic protein approved by both the FDA and EMA authorities. The claims of this new patent relate to a method of treating subjects having an antithrombin III deficiency or inflammation with the administration of recombinant antithrombin III produced in the mammary gland of a non-human mammal.

About LFB

LFB is a biopharmaceutical group that develops, manufactures and markets medicinal products for the treatment of serious and often rare diseases in several major therapeutic fields, namely Hemostasis, Immunology and Intensive Care. The LFB Group is the leading manufacturer of plasma-derived medicinal products in France and 6th worldwide and is also among the leading European companies for the development of monoclonal antibodies and new-generation proteins based on biotechnologies. With its strong focus on research, the LFB Group is pursuing a growth strategy that seeks to extend its activities at the international level and develop innovative therapies. In 2010, the LFB Group reported total turnover of 411.6 million euros, up 9.6%, and invested 86.5 million euros in product development. The LFB Group markets its products in 20 countries around the world.

About GTC Biotherapeutics

GTC is a wholly-owned subsidiary of LFB Biotechnologies. GTC Biotherapeutics develops, supplies and commercializes 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. Building upon the 2009 FDA approval of ATryn, GTC is commercializing ATryn® in the United States.

GTC’s transgenic production platform is particularly well suited to enable 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 is available on the GTC web site, http://www.gtc-bio.com.

Contacts

GTC Biotherapeutics, Inc.
William Heiden, 508-370-5277
william.heiden@gtc-bio.com

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