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.
