VANCOUVER, BC & SAN DIEGO, CA, Jan. 22 /PRNewswire-FirstCall/ - MIGENIX Inc. has been notified by Cutanea Life Sciences, Inc. (“Cutanea”), its development and commercialization partner for CLS001 (topical omiganan), of the initiation of a Phase II clinical study in the treatment of rosacea. This study is being conducted in the United States by Cutanea, and is expected to be completed by the end of 2007.
“The start of this clinical trial represents further progress with our clinical stage pipeline”, stated Jim DeMesa, M.D., President and CEO of MIGENIX. “Along with celgosivir for hepatitis C (Phase II) and Omigard(TM) for preventing catheter-related infections (Phase III), his trial will provide us with clinical study results in three programs during 2007".
About CLS001 and Rosacea
CLS001 is in development as a prescription treatment for rosacea and other dermatological diseases. Prior to licensing CLS001 to Cutanea, MIGENIX had completed three Phase I and two Phase II clinical studies exploring the use of omiganan topically for the treatment of acne. The Phase II acne trials demonstrated favorable tolerability and evidence of efficacy against all acne lesion types. In 2006, Cutanea advised the Company that it would be pursuing rosacea as the first CLS001 clinical indication.
Rosacea is a chronic skin disease that affects over 14 million North Americans and 45 million people globally. The condition is characterized by both vascular (flushing) and dermal (occurrence of papular and pustular lesions) components involving the face and occasionally the neck and upper trunk. It most often affects adults between the ages of 30 and 50, and seems to be more common in women and people with fair skin. There is no cure and current therapies are aimed at managing symptoms and preventing further progression of the disease. The US rosacea prescription drug market is estimated at greater than US$200 million annually.
About the Phase II Trial
The Phase II trial is a randomized, vehicle-controlled, double-blind, multicenter study designed to evaluate the safety and efficacy of CLS001 in up to 240 subjects with papulopustular rosacea. The primary efficacy endpoint is the mean percent reduction in the number of inflammatory lesions.
License Agreement with Cutanea
In December 2005, we entered into a License Agreement with Cutanea for the development and commercialization of omiganan for dermatological diseases. Under the terms of the agreement, Cutanea has the exclusive worldwide rights to develop and market omiganan and its analogues for dermatological indications. In exchange for these rights, we received an upfront fee and can receive up to approximately US$21 million in development and commercialization milestone payments, as well as single digit royalties on net sales. Cutanea is responsible for funding all development activities including formulation, clinical, regulatory, and commercialization costs.
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 hepatitis C infections (Phase II and preclinical), the prevention of catheter-related infections (Phase III), the treatment of dermatological diseases (Phase II) and the treatment of neurodegenerative diseases (Phase I and preclinical). MIGENIX is headquartered in Vancouver, British Columbia, Canada with US operations in San Diego, California. Additional information can be found at www.migenix.com.
James M. DeMesa, M.D. President & CEO FORWARD-LOOKING STATEMENTS
This news release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, and forward looking information within the meaning of applicable securities laws in Canada, (collectively referred to as “forward-looking statements”). Statements, other than statements of historical fact, are forward-looking statements and include, without limitation, statements regarding our strategy, future operations, timing and completion of clinical trials, prospects, plans and objectives of management. The words “anticipates”, “believes”, “budgets”, “could”, “estimates”, “expects”, “forecasts”, “intends”, “may”, “might”, “plans”, “projects”, “schedule”, “should”, “will”, “would” and similar expressions are often intended to identify forward-looking statements, which include underlying assumptions, although not all forward-looking statements contain these identifying words. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other things contemplated by the forward-looking statements will not occur.
Although our management believes that the expectations represented by such forward-looking statements are reasonable, there is significant risk that the forward-looking statements may not be achieved, and the underlying assumptions thereto will not prove to be accurate. Forward-looking statements in this news release include, but are not limited to, statements concerning our expectations for: Cutanea Life Sciences completing a phase II CLS001 rosacea clinical trial in 2007; Cadence Pharmaceuticals completing the Omigard (TM) phase III study in the second half of 2007; and 4-week interim and 12-week data from the phase II combination study of celgosivir in treatment-naive patients in the first half of 2007.
With respect to the forward-looking statements contained in this news release, we have made numerous assumptions regarding, among other things: our partner Cutanea Life Sciences completing a phase II CLS001 rosacea clinical trial in 2007; our partner Cadence Pharmaceuticals completing the Omigard(TM) phase III clinical trial in the second half of 2007; and our ability to initiate and complete non-clinical and clinical studies within our expected timelines.
Actual results or events could differ materially from the plans, intentions and expectations expressed or implied in any forward-looking statements, including the underlying assumptions thereto, as a result of numerous risks, uncertainties and other factors including: dependence on corporate collaborations; uncertainties related to early stage of technology and product development; uncertainties as to the requirement that a drug be found to be safe and effective after extensive clinical trials and the possibility that the results of such trials, if completed, will not establish the safety or efficacy of our products; uncertainties as to future expense levels and the possibility of unanticipated costs or expenses or cost overruns; the possibility that opportunities will arise that require more cash than presently anticipated and other uncertainties related to predictions of future cash requirements; and other risks and uncertainties which may not be described herein. Certain of these factors and other factors are described in detail in the Company’s Final Prospectus dated November 29, 2006, Annual Information Form and Annual Report on Form 20-F for the year ended April 30, 2006 and other filings with the Canadian securities regulatory authorities and the U.S. Securities & Exchange Commission.
Forward-looking statements are based on our current expectations and MIGENIX assumes no obligations to update such information to reflect later events or developments.
The Toronto Stock Exchange has not reviewed and does not accept
responsibility for the adequacy or accuracy of this release.
CONTACT: Art Ayres, MIGENIX Inc., Tel: (604) 221-9666 Extension 233, aayres@migenix.com; Dian Griesel, Ph.D., Investor Relations Group, Tel: (212) 825-3210, Theproteam@aol.com
MIGENIX Inc.
CONTACT: Art Ayres, MIGENIX Inc., Tel: (604) 221-9666 Extension 233,aayres@migenix.com; Dian Griesel, Ph.D., Investor Relations Group, Tel:(212) 825-3210, Theproteam@aol.com
