"The regulatory route for this reformulated drug is through the FDA's 505(b)2 pathway because the drug is already on the market, so Cynapsus doesn't have to generate a lot of efficacy data. It has go to the FDA with similar blood plasma bioequivalence and biomarker data as for the injectable apomorphine, to show the new formulation gets the drug into the blood at the right concentration. The company also has to demonstrate long-term safety, but we see this as a relatively low hurdle given the history of Apokyn. . .I think it could be a $500M or more opportunity. Parkinson's is an enormous indication, and almost all Parkinson's patients experience this on/off phenomenon. Apokyn was an orphan drug, protected for seven years, so no one has been able to develop an additional formulation. As soon as Apokyn came off orphan protection, Cynapsus got the patent for the sublingual formulation. This is a very clean, low-risk story, and I love the way Cynapsus has pulled this off, being the first to patent this delivery. If this were a U.S. stock, it would be four or five times the price it is now, but because it's in Canada, no one knows about it. Cynapsus reminds me a lot of Cipher when it was trading at $0.64 and no one was looking at it. All of a sudden, people started to take notice. That's where Cynapsus is right now."
As a result, Cynapsus will be presenting APL-130277 at Elsevier's Therapeutic Area Partnerships meeting, to be held Nov. 28–30 in Boston. Together these developments give me a significantly higher degree of confidence that Cynapsus will be able to raise the money it needs. If the drug is as big as the CEO believes, the company could very well be worth more than CA$200M in three to five years. And remember, the company’s capital requirements are much lower because it can use the 505(b)(2) pathway, not the typical NDA pathway."
Although Amarin did not use the 505(b)(2) pathway to get FDA approval for its drug, I think the financial market strategy Amarin employed is a great model for many existing biotechs. . .Cynapsus is raising $500K to $1M to bridge it to this larger round, while a number of biotech funds do due diligence. I put a small amount into this bridge, and am doing what I can to help in other ways. . .if Cynapsus can raise the money it needs, I expect it will create shareholder value in the $100–300M range within two to three years. As far as drug development is concerned, Cynapsus is low risk. The biggest risk is financing at this point. If a large fund comes along to remove the financing risk, I expect the company will be well rewarded."