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MIGENIX to Present at BioFinance and Rodman & Renshaw Conferences in May
Vancouver, BC Canada and San Diego, CA, USA | May 6, 2008 | MIGENIX Inc. (TSX: MGI, OTC: MGIFF), a clinical-stage developer of drugs for infectious diseases, has been notified by their partner for Omigard(TM) in North America and Europe; Cadence Pharmaceuticals, Inc. (“Cadence”), that full enrollment of the pivotal Phase III confirmatory study for preventing catheter-related infections has been reached (see “Cadence’s Press Release” below). Top-line results of this trial are expected in the second half of 2008.
Jim DeMesa, M.D., President and CEO of MIGENIX stated, “This milestone represents a significant event for us since the successful completion of enrollment in this trial marks the beginning of a process which is expected to advance Omigard(TM) to regulatory submissions to pursue market approvals in the US and Europe. With US$27 million in potential milestone payments from our agreement with Cadence - starting with these submissions - and double digit royalty on sales upon commercialization, we can begin to realize revenues from Omigard(TM) for more than a decade to come. With positive results from this trial, we would also expect to license our Japan and rest of world rights to the product, which is expected to bring additional revenue into the company. We therefore view Omigard as an important foundational product for us, with the potential to establish a solid revenue base for growing the company going forward. And, with the great benefit it could provide patients and hospitals by reducing catheter-related infections, MIGENIX could become one of the relatively few biotech companies with revenue from a product on the market which addresses an important medical need.”
Cadence’s Press Release
The following is an extract of Cadence’s May 6, 2008 announcement on the completion of enrollment:
Cadence announced that it completed its goal of enrolling 1,850 patients in a Phase III clinical trial of Omigard for the prevention of catheter-related infections.
“Reaching the patient enrollment target in our Phase III clinical trial of Omigard for the prevention of catheter-related infections is a major milestone in our clinical development program for this product candidate,” stated James Breitmeyer, M.D., Ph.D., Executive Vice President, Development and Chief Medical Officer of Cadence. “If approved, we believe that Omigard will address a rapidly growing need for more effective ways to lower hospital acquired infection rates, including the dangerous and costly complications from infections related to intravascular catheters.”
Cadence’s confirmatory Phase III clinical trial of Omigard (omiganan pentahydrochloride 1% gel), known as the Central Line Infection Reduction Study, or CLIRS, is a randomized, evaluator-blinded study in hospitalized patients whose medical condition requires a short-term central venous catheter. The primary objective of CLIRS is to evaluate the efficacy and safety of Omigard compared to 10% povidone-iodine in reducing local catheter site infections. The company achieved its goal of enrolling 1,850 patients at 58 clinical trial sites in the United States and Europe. CLIRS is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration (FDA).
Omigard(TM) Clinical Program Update
Cadence currently expects to announce top-line data from CLIRS in the second half of 2008 and, if the results are positive, submit an NDA for Omigard to the FDA in the first half of 2009.
Cadence Conference Call and Webcast Details
Cadence management will host a conference call on May 6, 2008 at 5:30 a.m. Pacific Time (8:30 a.m. Eastern Time) and interested investors may participate in the conference call by dialing 877-675-4750 (US) or 719-325-4865 (international). To access the webcast, please visit Cadence’s website at www.cadencepharm.com and go to the Investor Relations page. A replay of the webcast will be available approximately two hours after the call.
MIGENIX Upcoming Conference Presentations
MIGENIX will present at the following conferences in May:
MIGENIX Inc. – NEWS RELEASE – May 6, 2008 Page 2 of 2
• BioFinance 2008 being held at the Toronto Marriott Eaton Centre Hotel, Toronto, May 6-8, 2008. Bill Milligan, Chief Business Officer, will present on Wednesday, May 7th at 10:00 am Eastern Time (7:00 am Pacific Time). A copy of the presentation will be available on the Company’s web site at www.migenix.com the day of the presentation.
• Rodman and Renshaw: 5th Annual Global Healthcare Conference being held at Le Meridien Beach Plaza Hotel, Monte Carlo, May 19-20, 2008. Dr. Jim DeMesa, President and Chief Executive Officer, will present on May 19th at 10:45 am Monte Carlo time (4:45am Eastern Time). An audio webcast and a copy of the presentation will be available on the Company’s web site at www.migenix.com the day of the presentation.
About MIGENIX
MIGENIX is committed to advancing therapy, improving health, and enriching life by developing and commercializing drugs primarily in the area of infectious diseases. The Company's programs include drug candidates for: the prevention of catheter-related infections (end of Phase III), the treatment of chronic hepatitis C infections (Phase II and preclinical), the treatment of dermatological diseases (end of Phase II), the treatment of serious gram positive bacterial infections (preclinical) and the treatment of hepatitis B infections (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.
SOURCE: MIGENIX Inc. |
