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Biolex Therapeutics has entered into an agreement with Cook Pharmica under which Cook will manufacture drug substance for use in Biolex's Phase III trials of Locteron.
August 27, 2009
By: Tim Wright
Editor-in-Chief, Contract Pharma
Biolex Therapeutics has entered into an agreement with Cook Pharmica under which Cook will manufacture drug substance for use in Biolex’s Phase III trials of Locteron. Locteron is a controlled-release interferon alpha 2b, designed to improve patient care with a more convenient dosing schedule and reduced side effects associated with pegylated interferons, the current standard of care. “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. “We are very excited to be the service provider of choice for Biolex in support of their Phase III 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 is also conducting a Phase IIb trial of Locteron for the treatment of chronic hepatitis C and expects results in 4Q09. With the completion of GMP manufacturing of Phase IIb clinical supply for Locteron, and the transfer of production capabilities to Cook Pharmica, Biolex will be terminating the majority of its manufacturing operations at its facility in Pittsboro, NC. R&D, manufacturing management, and collaboration support activities, will continue in Pittsboro. Sign up today for Contracting & Outsourcing 2009! contractpharma.com/2009conference
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