GTC Biotherapeutics, Inc. announced that it is restructuring its organization to support its focus on clinical development and commercialization of its internal pipeline of proprietary products and its portfolio of external programs. GTC's internal pipeline of products includes ATryn, recombinant human serum albumin, and the MSP-1 malaria vaccine.
Under the restructuring plan, GTC is reducing its headcount approximately 20 per cent from 159 to 127 full time equivalent employees. With the restructuring, GTC plans to use approximately $20 million of cash in 2004 as it participates in the regulatory review of ATryn and further develops its other commercial programs. A restructuring charge of approximately $950,000 will be recorded in the first quarter of 2004.
"The restructuring that we are announcing today is designed to support our strategic position as a commercial products company and to support the regulatory review process for ATryn," stated Geoffrey Cox, GTC's chairman of the Board and chief executive officer. "In addition to conserving cash during the regulatory review process for ATryn, this restructuring provides us with the flexibility to consider the strategic option of adding a small sales force in Europe for commercialization in the hereditary antithrombin deficiency indication."
GTC recently submitted a Market Authorization Application (MAA) to the European Medicines Evaluation Agency (EMEA) for ATryn, its recombinant human antithrombin product. Acceptance and review of the submission is pending.
GTC has entered into about a dozen programmes in its external portfolio for development of transgenic production of a partner's therapeutic protein. Ten of these programmes have already successfully reached founder status where the first animals capable of supporting expansion to clinical production have been generated. Four of the ten programmes with founders are considered successfully completed with no additional development work anticipated. The MM-093 programme with Merrimack Pharmaceuticals, Inc. has completed phase I clinical studies using material produced and purified by GTC. Additional clinical studies in this programme are anticipated in 2004. In addition, the undisclosed programme with Centocor has begun expansion to provide a supply of product for preclinical evaluation.