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MIGENIX and Schering-Plough Sign Agreement for MX-3253 Hepatitis C Drug Development and License Option
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This press announcement was distributed today.
Vancouver, BC, CANADA & San Diego, CA, USA - July 13, 2005- MIGENIX Inc. (TSX: MGI; OTC: MGIFF), a clinical-stage developer of drugs for infectious and degenerative diseases, has completed a Material Transfer and License Option Agreement ("Agreement") with Schering-Plough Corporation (NYSE: SGP) of Kenilworth, N.J., related to celgosivir (MX-3253), MIGENIX's first-in-class compound in Phase II clinical development for the treatment of chronic Hepatitis C Virus (HCV) infections.
Under the terms of the Agreement, Schering-Plough will supply PEGETRONTM (peginterferon alfa-2b powder for solution plus ribavirin 200 mg capsules) as well as provide certain technical and laboratory support and other services for MIGENIX's upcoming MX-3253 Phase II combination study in chronic HCV patients. In addition, the Agreement grants Schering-Plough limited periods of exclusivity for data review of clinical trial results and for the negotiation of a license agreement.
"We expect to benefit greatly from Schering-Plough's leadership in the field of HCV and their contribution to our upcoming Phase II HCV combination study,"stated Jim DeMesa, M.D., President and CEO of MIGENIX. "With their expertise in HCV, this agreement can help ensure a solid assessment of MX-3253 in combination with PEGETRON for the treatment of HCV patients who have not responded to first-line therapy".
About MX-3253 and the Proposed Phase II Combination Study
MX-3253 (celgosivir) is an alpha-glucosidase I inhibitor and is currently the only oral drug in development that acts through host-directed glycosylation. In preclinical studies, celgosivir has demonstrated strong synergy with interferon-alpha plus ribavirin and has the potential to be included as part of a combination approach to therapy to improve efficacy. Celgosivir is currently being evaluated in a Phase II monotherapy study in chronic HCV patients in Canada.
The Phase II combination study of MX-3253 will be a randomized, multi-center, active-controlled, 12 week evaluation of MX-3253 in three treatment arms of up to 20 chronic HCV patients each: celgosivir plus peginterferon alfa-2b plus ribavirin (3-way combination); celgosivir plus peginterferon alfa-2b (2-way combination); and placebo plus peginterferon alfa-2b plus ribavirin (control). Patients will be selected based on having genotype 1 chronic HCV and having failed to respond to pegylated alpha interferon plus ribavirin therapy (non-responders). Patients who respond to therapy during the trial will also have the option to continue on treatment for up to 48 weeks. The study will measure viral load at various time points as well as a number of safety parameters. The study is currently expected to commence during the third quarter of calendar 2005.
About MIGENIX
MIGENIX is committed to advancing therapy, improving health, and enriching life by developing and commercializing drugs in the areas of infectious and degenerative diseases. The Company's clinical programs include drug candidates for the treatment of chronic HCV infections (Phase II), the prevention of catheter-related infections (Phase III), the treatment of neurodegenerative diseases (Phase I) and the treatment of acne (Phase II). MIGENIX is headquartered in Vancouver, British Columbia, Canada with US operations in San Diego, California. Additional information can be found at www.migenix.com.
"Jim DeMesa"
James M. DeMesa, M.D.
President & CEO
CONTACTS
Jonathan Burke
MIGENIX Inc.
Tel: (604) 221-9666
Extension 241
jburke@migenix.com
Gino de Jesus or
Dian Griesel, Ph.D.
Investor Relations Group
Tel: (212) 825-3210
Theproteam@aol.com
John Boidman
Renmark Financial
Tel: (514) 939-3989
jboidman@renmarkfinancial.com
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