Advertisement
Jim DeMesa, M.D., President and CEO of MIGENIX stated, "Since announcingour strategic plan in 2002, management has maintained a focus on achieving theobjectives outlined in that plan to build long-term value for ourshareholders. Familiar to all in the biotech space, drug development is along, risky process with many setbacks. We have been navigating that courseand are now on the verge of some of the results of our strategy. Importantly,we are very close to a pivotal milestone for our latest-stage productcandidate - Omigard(TM), with Phase III clinical results expected before theend of the calendar year (see "Program Update" below). Armed with positiveresults from this study, our partner in this program, Cadence Pharmaceuticals,plans to submit a New Drug Application (NDA) for marketing approval ofOmigard(TM) in the United States in the first half of calendar 2009 - which isa significant event for any biotech or pharmaceutical company. Also, withpositive Phase III results, we expect to partner the additional commercialrights to Omigard to maximize revenue to the Company for further valuecreation. This is in addition to the potential US$27MM in milestone paymentsunder our agreement with Cadence and double digit royalty revenue on net salesafter approval of the product. This is a significant value opportunity forMIGENIX and was made possible only through the perseverance and commitment ofthe current management team and board of directors. Those knowledgeable aboutthe biotech industry and the product development process understand thatclinical success is required for value creation in drug development companies.We are no exception and have confidence in our strategy and in our ability tocontinue following through with the value opportunities we have created,regardless of the challenges inherent in this industry."
Advertisement
Program Update
Management and the Board have built a solid portfolio (pipeline) ofprograms to maximize value potential and mitigate development risk. The statusof these programs is as follows:
Omigard(TM) (1% topical omiganan pentahydrocloride for preventingcatheter-related infections): Patient enrolment in the Phase III US andEuropean registration clinical trial conducted by Cadence Pharmaceuticals (whois fully funding the Omigard development program) is complete (see May 6, 2008press release). Cadence expects to announce top-line data from this trial inthe second half of 2008 and, with positive results, submit a new drugapplication for Omigard(TM) to the FDA in the first half of 2009. Uponsuccessful completion of various milestones in this program (starting with FDAacceptance of the NDA for filing), we can receive up to US$27MM in developmentand commercialization milestone payments and a double-digit royalty on netsales. Cadence's commercialization focus is on the United States market andthus Cadence intends to establish a strategic partnership(s) for thecommercialization of Omigard(TM) for the rights it has outside of the UnitedStates. MIGENIX management and Board are working to out-license Omigard(TM)rights either in combination with Cadence's rights outside the US toprospective global partners or to potential regional partners for rest ofworld territories. We expect a license agreement or agreements with up-frontpayment(s), milestones and royalty terms to be
