Biolex Therapeutics has entered into an agreement with Cook Pharmica under which Cook will manufacture drug substance for use in Biolex’s planned phase 3 clinical trials of Locteron. Biolex completed enrollment of the SELECT-2 phase 2b trial of Locteron for the treatment of chronic hepatitis C in June 2009. The first results are expected in the fourth quarter of 2009.
Biolex also said that with the completion of GMP manufacturing of phase 2b clinical supply for Locteron, and the transfer of GMP production capabilities to Cook Pharmica, it will be terminating the majority of its manufacturing operations at its facility in Pittsboro. Research and development, manufacturing management and collaboration support activities will continue as usual.
Locteron is an investigational therapeutic candidate and has not been approved for sale by the FDA or by any international regulatory agency. The commencement of planned phase 3 testing of Locteron is dependent upon the results of ongoing phase 2b trials as well as clearance by regulatory agencies.
Jan Turek, president and CEO of Biolex, said: “We evaluated a number of potential contract manufacturers and were extremely impressed with the personnel and infrastructure assembled by Cook Pharmica, as well as the strong commitment to the Locteron program exhibited by senior management, the establishment of Locteron drug substance manufacturing at Cook Pharmica represents a major milestone for our core manufacturing platform.
As a novel protein expression platform, our proprietary LEX System provides many advantages over traditional expression systems. Our ability to transfer this manufacturing platform outside of Biolex demonstrates the robustness and scalability that has been achieved as a result of extensive experience with the system, including five years of GMP manufacturing to support our interferon clinical trials. As we prepare for manufacturing of phase 3 clinical supply and ultimately for the potential commercial launch of Locteron, we determined that utilizing the advanced GMP capabilities and systems established at Cook Pharmica was more efficient than building this fixed infrastructure in-house.”