VANCOUVER, Sept. 15 /PRNewswire-FirstCall/ - MIGENIX Inc. (the "Company" or "MIGENIX") (TSX: MGI; OTC: MGIFF), a clinical-stage developer of drugs for infectious diseases, reports financial results for the three months ended July 31, 2008 and provides a corporate update on its programs and other matters.
UPDATE ON DRUG DEVELOPMENT PROGRAMS
Omiganan 1% gel (Omigard(TM)/CPI-226/MX-226; topical cationic peptide;
prevention of catheter-related infections): Cadence Pharmaceuticals, Inc.
("Cadence"), our development and commercialization partner, has today
announced that it is engaged in discussions with the US Food and Drug
Administration ("FDA") regarding the statistical analysis plan for the
Central Line Infection Reduction Study ("CLIRS") Phase III trial and that
these discussions, which are being conducted under a Special Protocol
Assessment, must be completed prior to unblinding the data from the trial.
As a result, Cadence revised its guidance for reporting the results of the
CLIRS trial from the fourth quarter of calendar 2008 to the first quarter
of calendar 2009. With positive results in the CLIRS trial, Cadence
continues to expect to submit a New Drug Application ("NDA") for OmigardTM
to the FDA in the second quarter of calendar 2009. Upon successful
completion of various milestones in this program (starting with FDA
acceptance of the NDA for filing), we can receive up to US$27MM in
development and commercialization milestone payments and a double-digit
royalty on net sales. Cadence's commercialization focus is on the United
States market and thus Cadence intends to establish a strategic
partnership(s) for the commercialization of Omigard(TM) for the rights it
has outside of the United States. Our management and Board are working to
out- license Omigard(TM) rights that lie outside of the Cadence agreement
either in combination with Cadence's rights outside the US to prospective
global partners or to potential regional partners for rest of w
|SOURCE MIGENIX Inc.|
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