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Sunday, June 03, 2018 1:03:43 PM
A couple of things worthy of noting.
First, you asked how the SunGen tech platform might help differentiate the product and, while an interesting question, remember that SunGen is all about 505(b)2 development; it is what they did for Athenex. And, as it relates to generics, what sells generics is not their level of uniqueness or differentiation but their lower cost. Given the issues with drug pricing this is a major point because it has been argued that the reason that generic sales are down across the board, even for big firms (Teva < 23%, Sun Pharma < 34%, Endo < 39%), is not that the FDA is not approving them but they are being priced too high. On that point, I have sent an email to Dianne asking Nasrat to recognize pricing any approvals appropriately will be the key to market share. And, on that point...
There is and will be barriers to entry to existing product markets that have novel and/or generic products with a head start of 3 years or more. If less than 3 years, it can be made up. But more than 3 years is harder, though the well priced generic can get there and that was the reason for my email to Elite. But, before ending let me make two points. First, the CNS market...
CNS is projected to be $82 B by 2020 and it includes, attention deficit, sleeping disorders (one of the fastest growing), narcolepsy, diet/obesity/appetite suppression, blood pressure, heart rate, and depression. On obesity…If current trends continue, 27 years from now approximately one-quarter of the world's population will be obese. In the United States, the obesity rate will climb from 39% of the population in 2017 to 55% of the population in 2045 and with it will be higher diabetes rates.
Second, about the $1.6 B market (whether Ritalin or not), again the issue is of barriers to entry and catch up, with the question how much market share might Elite capture. Well, it so happens that based on some other research I have been doing on other companies I have a means to compare.
For a product entering a growth market with existing product market leaders having more than a three year lead time, there has been a first year average market capture of 8.7%. If we extrapolate that to Elite and the CNS ER (Ritalin) product for the $1.6 B market it is (that's right) $139.2 Million in the first year. And, with the Glenmark partnership as the commercialization engine, it could be better that the other two I found in my research, because Glenmark is more capable than the other two had as commercial partners.
Any discussion of what is happening with the share price right now is just another version of telling you to not pay attention to the facts. And, the fact is no pharma company has drugs approved until they do. What we can take from this all is that Elite is building its infrastructure and path toward success.
Fellow investors, enjoy the week...
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