Biolex Therapeutics Selects Cook Pharmica LLC as Contract Manufacturer of Locteron(R) Drug Substance for Phase 3 Trials
Published: Aug 27, 2009
PITTSBORO, NC--(Marketwire - August 27, 2009) - Biolex Therapeutics, Inc. announced today that it has entered into an agreement with Cook Pharmica LLC under which Cook will manufacture drug substance for use in Biolex's planned Phase 3 clinical trials of Locteron. Locteron, controlled-release interferon alpha 2b, is designed to improve patient care by providing a more convenient once-every-two week dosing schedule and by reducing the side effects, including flu-like symptoms, associated with pegylated interferons, the current standard of care. Biolex completed enrollment of the SELECT-2 Phase 2b trial of Locteron for the treatment of chronic hepatitis C in June 2009, and first results are expected in the fourth quarter of 2009.
"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," said Jan Turek, Biolex's President and Chief Executive Officer. "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(SM) 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."
"We are very excited to be the service provider of choice for Biolex in support of their Phase 3 clinical trial program for Locteron. Our team is looking forward to partnering with Biolex on this project and is committed to supporting Locteron's long-term success," said Tedd Green, Cook Pharmica's President.
Biolex's patented LEX System is used to develop and manufacture follow-on biologics, hard-to-make therapeutic proteins and to optimize monoclonal antibodies. The LEX System is a novel technology that genetically transforms the aquatic plant Lemna to enable the expression of biologic product candidates. The LEX System provides a number of advantages over traditional expression systems, including the ability to produce complex proteins, glyco-engineering to optimize antibodies, freedom to operate, and capital cost reduction.
Biolex also announced 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, North Carolina. Research and development, manufacturing management and collaboration support activities will continue in Pittsboro.
Locteron is an investigational therapeutic candidate and has not been approved for sale by the United States Food and Drug Administration 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.
About Biolex Therapeutics
Biolex is a clinical-stage biopharmaceutical company that uses its patented LEX System(SM) to develop follow-on biologics, hard-to-make therapeutic proteins and to optimize monoclonal antibodies. The LEX System is a novel technology that genetically transforms the aquatic plant Lemna to enable the production of biologic product candidates. The company's product candidates are designed to provide superior efficacy/tolerability profiles and to address large, proven pharmaceutical markets. Biolex's lead product candidate, Locteron®, is in Phase 2b clinical testing for the treatment of chronic hepatitis C. Biolex has also developed two other product candidates that capitalize on the benefits of the LEX System which it is advancing toward clinical trials: BLX-155, a direct-acting thrombolytic designed to dissolve blood clots in patients; and BLX-301, a humanized anti-CD20 antibody it is optimizing for the treatment of non-Hodgkin's B-cell lymphoma and other diseases.
About Cook Pharmica
Cook Pharmica is a biopharmaceutical contract development and manufacturing organization (CDMO) manufacturing biologics based drug substance and a broad array of biopharmaceuticals in support of drug product manufacturing for pre-clinical through commercial use. Cook Pharmica also offers cell line/strain development, clone selection, cell line adaptation, media optimization, process development, analytical development, cell banking/storage, stability testing/storage and regulatory submission support. Founded in 2004, Cook Pharmica is part of Cook Medical, the world's largest privately held medical manufacturing company.
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