What kind of milestones should investors look for in the next 12-18 months?
Look for primary end-point data for the iCo-007 Phase 2 iDEAL study –visual acuity at eight months in a very large population. Our last related press release noted over forty patients per treatment arm (n=174), arguably on par with Genentech’s READ-2 study of Lucentis. Genentech’s drug Lucentis is currently the only approved drug in the US for DME and is a blockbuster therapy. Notably JDRF, our partner with iCo-007, was involved with the development of Lucentis.
Investors should also watch for primary end-point data for an iCo-008 Phase 2 ulcerative colitis study run and financed by our Israeli partner, Immune Pharmaceuticals. They have announced initiation of the study in 90 patients in Israel and we should hear more about that development as they progress. They have also proposed a merger with a NASDAQ-listed company. We hold a significant percentage of Immune and are also owed $32M in milestone payments as they progress through product development. We also maintain rights to uses in the eye for this candidate, which has become the focus of several discussions with pharmaceutical companies interested serious eye allergies and macular degeneration.
Investors can also look for further confirmatory studies related to our Amphotericin B delivery system. We are working with a generic drug and attempting to convert the formulation from intravenous to oral. We know the drug works, we need to re-examine its safety profile in this formulation as well as investigate potential intriguing uses of this drug for non-life-threatening fungal infections and life-threatening parasitic infections. It is the later use which has become very interesting to the Gates Foundation and other granting groups that have helped finance this program with minimal dilution.
Finally, look for more partnerships. We are meeting all the right players interested in eye diseases. We want the right deals, and the right partner or partners. So we continue to have discussions in earnest with respect to our clinical staged assets. In the area of retinal diseases, on which iCo-007 is focused, we have seen recent deals in the range of $25-45M upfront and hundreds of millions in milestone payments and royalties through development.
