PROHOST    FILTER

GTC's (GTCB) most critical times

 GTC has not slept long lately, as it is busy filing a response to the European Medicines Agency's (EMEA) List of Outstanding Issues generated during review of GTC's Market Authorization Application (MAA) for ATryn®, its recombinant form of human antithrombin. GTC estimates that the EMEA will make a determination on the MAA before the end of October.

The firm is determined not to sleep, but instead, work with the EMEA to bring its submission to a positive conclusion, i.e., approval, which will be the most important milestone of its life; the transition from a development-stage firm into a commercial products company. 

Good work and intention towards a happy ending of the antithrombin drug, which is a plasma protein with anticoagulant and anti-inflammatory properties. To get to develop this product, GTC, which is an old expert in transgenic animal technology, had to develop goats that have the human antithrombin gene linked to a milk-protein promoter so that they express the antithrombin protein in their milk. Recombinant forms of proteins, such as antithrombin, that are difficult to express in conventional production methods are being produced in sufficient quantities. Besides ATryn®, GTC’s antithrombin product, GTC is developing other recombinant human plasma proteins, include recombinant human alpha-1 antitrypsin and recombinant human albumin.

GTC seems to be satisfied with the efficacy of its ATryn® so that it has begun to recruit patients for another pivotal clinical study of the drug for the hereditary antithrombin deficiency indication as allowed by the FDA. This study builds upon the clinical data that was submitted in the MAA. A successful outcome of this study and a historical control comparison is expected to provide the clinical basis for filing a Biologics License Application (BLA) with the FDA.

A Market Authorization Application is under review by the European Medicines Agency for the use of ATryn® in patients with a hereditary antithrombin deficiency. Besides the ATryn® program, the recombinant human alpha-1 antitrypsin, the recombinant human albumin, the firm is developing malaria vaccine, and a CD137 antibody to stimulate the immune system as a potential treatment for solid tumors.

Comments: This is the moment for this firm’s transition from developing-stage firm into a successful industrial productive and moneymaking biotech. The successful outcome of the EMEA and the U.S. filing and approvals   will surely bring income to this struggling firm, in addition to bringing more customers to its external programs and services. These programs develop customers’ transgenic products and transgenic production of large-volume protein therapeutics as well as products that are difficult to produce in significant quantities from conventional recombinant production systems. 

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