VANCOUVER and SAN DIEGO, March 13 /PRNewswire-FirstCall/ - MIGENIX Inc. (TSX: MGI; OTC: MGIFF), a clinical-stage developer of drugs for infectious diseases, reports financial results for the three and nine months ended January 31, 2008 and an update on its programs.
Jim DeMesa, M.D., President & CEO of MIGENIX stated, "With the conclusion of our third fiscal quarter and now being halfway through our fourth quarter, we are looking forward to the completion of enrollment in the Phase III Omigard registration trial for preventing catheter-related infections being conducted by our partner, Cadence Pharmaceuticals. With completion of this trial, we expect to enter into a very important time of clinical results over the next half of the year (with both Omigard and celgosivir, our Phase II hepatitis C drug candidate) followed by our potential entry into the regulatory approval process in 2009 with Omigard."
UPDATE ON DRUG DEVELOPMENT PROGRAMS
Omiganan 1% gel (Omigard(TM)/CPI-226/MX-226; topical cationic peptide;
prevention of catheter-related infections): A pivotal Phase III study being
conducted by our development and commercialization partner Cadence
Pharmaceuticals is in progress in the United States under a Special
Protocol Assessment (SPA) agreement with the US FDA and in Europe. Cadence
expects they will complete enrollment of the 1,850 patients planned for the
trial in the second quarter of 2008, with results available in the second
half of 2008. If the results of the trial are positive, Cadence expects to
submit a New Drug Application ("NDA") for omiganan 1% gel in the first half
of 2009. Under the terms of the agreement with Cadence, MIGENIX will
receive up to US$27 million in development and commercialization milestone
payments, upon the achievement of specified milestones, starting with the
US and European regulatory submission process; and a double-digit royalty
on net sales. MIGENIX has been and continues to be in discussions with
|SOURCE MIGENIX Inc.|
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