Biolex Therapeutics Selects Cook Pharmica as Contract Manufacturer of Locteron(R) Drug Substance for Phase 3 Trials
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PITTSBORO, NC, Aug 27 (MARKET WIRE) --
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(R), 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.
Biolex Contacts:
Media:
Michelle Linn
Linnden Communications
508-362-3087
Email Contact
Investors:
Dale Sander
Chief Financial Officer
858-663-6993
Email Contact
Cook Contacts:
Media:
Marsha Lovejoy
Public Relations Coordinator
Cook Medical
812-339-2235, ext. 2750
Email Contact
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