It is anticipated that the review process in Argentina is expected to be completed within a fast-tracked period of no less than six months from the filing of the dossier with the regulatory authorities. The dossier will be similar to that which was successfully submitted to the FDA.
All expenses incurred with respect to the filing, prosecution and obtaining of the sales authorizations will be borne by Bio Sidus. However, a product license agreement for the supply of material and marketing rights will be negotiated separately.
Geoffrey Cox, chairman, president and CEO of GTC Biotherapeutics, said: “This agreement demonstrates the continued worldwide interest in ATryn as the only recombinant form of antithrombin. We are very excited to be working closely with Bio Sidus, a well-respected commercial biotechnology company, based in Latin America, with a strong international presence and an established interest in the production of therapeutic proteins using transgenic production technology.”
Marcelo Arguelles, president of Bio Sidus, said: “We are extremely pleased to enter into this landmark agreement with GTC which will lead to the satisfaction of unmet clinical demands in our region. The approval of ATryn will also likely lead to acceptance by regulatory authorities, prescribers and the public of proteins derived from transgenic animals.
“We are confident that the transgenic production technology for targeted therapeutic proteins will be a key tool to obtain more affordable biomedicines. Biohormon, Bio Sidus’ somatropin product obtained from the milk of transgenic cows, is also under review for marketing authorisation in the near term.”