So, just to get all my ducks in a row.
Novartis held the antifungal back and didn't submit a NDA to the FDA for some unstated reason. That's the day the stock fell tremendously. Since then we got news of a patent and a 3.5 mil milestone payment for the drug.
So looking at the CC, we hear the following.
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For antifungal product that's licensed to Novartis, we announced in October that we received a notice of allowance on our U.S. patent application for the product and trigger the long awaited $3.5 million from Novartis. This patent when issued provides Novartis important protection on the commercial product. In light of the significant delay in the review and approval of our product, the U.S. Patent Office added 756 days to the life of the patent coverage for protection that's now out to April of 2026.
Novartis recently completed their analysis of two Phase III studies. They have agreed that they would share the data with us with the provision that for competitive reasons we cannot share the data with anyone outside of the company. Contractually, the data is theirs, so we have to abide by their wishes. In the meantime, they have assured us that they will complete patient testing and ongoing Phase III comparative study in Europe, which is scheduled to conclude in early 2009. They are also very actively exploring various options for the U.S. and we will keep you updated as we progress with Novartis.
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Key Points:
- Novartis holds the NM100060 and doesn't submit NDA to FDA
- NEXMED receives [LATE] patent for NM100060
- NEXMED states in CC that patent provides Novartis important protection on the commercial product.
- NEXMED states in CC they can't share data from Phase III of Novartis studies
- NEXMED states in CC Novartis continues ongoing comparative study in Europe for Phase III
Reading between the lines of what was said, I can make a lot of assumptions. Novartis possibly was holding back NDA because of no patent. Novartis is waiting on Phase III studies in Europe before submitting to FDA in U.S. Here's a key point though, Novartis continues COMPARATIVE studies in Europe, meaning that there is the probability that those Phase III studies in the U.S. were a success. We don't know because that data is held back from the public, but the studies continue in Europe so obviously something must have gone right.
