VANCOUVER and PHILADELPHIA, Dec. 8 /PRNewswire-FirstCall/ - MIGENIX Inc. (TSX: MGI - News; OTC: MGIFF - News), a clinical-stage developer of drugs for infectious and degenerative diseases, and Cutanea Life Sciences, Inc., (“Cutanea”) a private, dermatological pharmaceutical company based in metropolitan Philadelphia, Pennsylvania, have entered into a License Agreement to develop and commercialize MX-594AN for a number of dermatological indications. The compound is currently in clinical development for the treatment of mild to moderate acne vulgaris.
MIGENIX will receive a small up-front payment and up to approximately US$21 million in development and commercialization milestone payments, as well as royalties on net sales. Under the terms of the agreement, Cutanea will have exclusive worldwide rights to develop and market MX-594AN and its analogues. Future development activities will focus on the treatment of dermatological conditions with inflammatory and infectious etiologies. Cutanea will take full responsibility for funding all development activities including all formulation, clinical, regulatory, and commercialization costs.
Jim DeMesa, M.D., President and CEO of MIGENIX stated, “This agreement achieves our objective of securing an experienced partner for the development and the commercialization of MX-594AN for the treatment of acne and other dermatological indications. Cutanea’s proven team of recognized individuals, led by Robert Bitterman, the former President and General Manager of Dermik Laboratories (a division of Sanofi-Aventis and a global leader in the dermatology market), is well positioned to advance the development of MX-594AN to a first-in-class market leader.”
Robert Bitterman, President and CEO of Cutanea, stated, “MX-594AN is a compound with unique characteristics, including multiple modes of action. We are excited to include this molecule in our development portfolio and we are anxious to commence its development across a number of target conditions. Our goal as a new company is to bring innovation to the prescription dermatology market.” Mr. Bitterman has 14 years of leadership experience in the global dermatology market and over 28 years of experience in a variety of positions in the pharmaceutical industry. Under Mr. Bitterman’s leadership, Dermik was able to gain approval and launch 7 new drug and device products. He and his team will now continue their proven successful approach to dermatological development at Cutanea.
About MX-594AN and Acne
MX-594AN is an antimicrobial cationic peptide in development as a topical prescription treatment for mild to moderate acne vulgaris. MX-594AN has completed five clinical trials in the US - three Phase I studies and two Phase II studies. The Phase II trials demonstrated evidence of efficacy against all acne lesion types. It is estimated that 45 million people in the United States have acne, which is the most common skin disorder of adolescence and early adulthood (ages 15-24 years) with a prevalence of approximately 85%. The U.S. market for prescription acne medications was approximately US$1.6 billion in 2002 (US$900MM Topical Rx Products, US$500MM oral Rx Products and US$250MM OTC products) and is forecasted to increase to US$1.9 billion by 2006. The global market for prescription anti-acne products reached US$2.0 billion in 2001 and is forecast to reach revenues of US$3.3 billion in 2006.
About Cutanea Life Sciences, Inc.
Cutanea Life Sciences, Inc. is a newly formed private company focusing on the acquisition, development and commercialization of innovative dermatology related products. Located in the Philadelphia area Cutanea’s mission is to develop and commercialize novel, proprietary products to improve skin health, appearance and overall well-being. Cutanea is comprised of an experienced team of scientific and commercial professionals with over 60 years of combined experience in the successful development and commercial launch of products in the healthcare space.
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), 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
CONTACT:
Jonathan Burke Dian Griesel, Ph.D. MIGENIX Inc. Investor Relations Group Tel: (604) 221-9666 Tel: (212) 825-3210 Extension 241 Theproteam@aol.com jburke@migenix.com
Cutanea Life Sciences, Inc. Tel: (212) 554-4306
Certain statements in this news release contain forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact may be deemed to be forward-looking statements. Forward- looking statements frequently, but not always, use the words “intends”, “plans”, “believes”, “anticipates” or “expects” or similar words; that events “will”, “may”, “could” or “should” occur; and/or include statements concerning our strategies, goals, plans and expectations. Forward-looking statements in this MD&A include, but are not limited to statements concerning: the Company receiving up to approximately US$21 million in development and commercialization milestone payments, as well as royalties on net sales. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Factors that could cause actual events or results expressed or implied by such forward looking statements to differ materially from any future results expressed or implied by such statements include, but are not limited to: dependence on corporate collaborations; the possibility that Cutanea will not successfully develop any products; 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 commenced and completed, will not establish the safety or efficacy of the products; risks relating to requirements for approvals by government agencies such as the FDA and/or Health Canada before products can be tested in clinical trials and ultimately marketed; the possibility that such government agency approvals will not be obtained in a timely manner or at all or will be conditioned in a manner that would impair the ability to advance development and/or market the product successfully; 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 then presently anticipated and other uncertainties related to predictions of future cash requirements; management of growth; dependence on key personnel; the possibility that advances by competitors will cause the proposed products not to be viable, the risk that our patents could be invalidated or narrowed in scope by judicial actions or that our technology could infringe the patent or other intellectual property rights of third parties; the possibility that any products successfully developed by Cutanea will not achieve market acceptance; 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 Annual Information Form and Annual Report on Form 20-F 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.
Source: MIGENIX Inc.
