Based on the links at the bottom of the post the 2 current Phase II trials will end in July and then the results will be available near the end of 2012. If results are positive, Allergan will gear up for Phase III immediately so they may be able to begin Phase III in very early 2013. In fact, the quote in the CBS link below suggests that Phase III could start to be geared up well prior to the end of Phase II.......i.e. as soon as they "start getting any positive feedback". But as Scott Whitcup (head of R&D) says in the transcript, two Phase III trials will be required. What is not addressed is whether those trials can run concurrently, although I see no reason why they can't as I have read about other companies running trials concurrently. Phase II began in June of 2011 and will end in July 2012 so you would have to estimate at least a year for Phase III. If the two Phase III trials ran concurrently and began in early 2013, it is conceivable that Phase III could be completed in early 2014. Assuming negligible side effects on a par with what they had w/ Latisse which has already been approved, you could probably expect quick approval from the FDA so I would say mid to late 2014 at best or 2015 is a reasonable possibility.
I am not sure what the possible side effects of a prostaglandin analog are in general but I would guess that one of the big safety issues would concern whether when going from 1 drop on each eyelid to coverage of the entire scalp, there might be a much greater chance of a toxic level of systemic absorption. However, it appears that "Bimatoprost undergoes minimal systemic absorption"
http://www.drugs.com/pregnancy/bimat...phthalmic.html and since Allergan has already cleared Phase I, this issue may not turn out to be a problem.
ALLERGAN EARNINGS CALL Transcript (August 2011): Larry, clearly, this is a program that we've optimally resourced, given the huge market potential. So the Phase I was just testing the overall formulation, making sure that it was stable, making sure that it was tolerated. So we probably have some of the Phase I data at R&D Day. But it's really the Phase II data that will be proof of concept. That depending on enrollment and feedback probably won't be available till end of sort of, I'd say, latter part of next year. Clearly, we'll be monitoring this and as we start getting any positive feedback, we'll gear up, so that once we get the proof of concept data, we could go to Phase III right away. The good news is that the FDA regulatory pathway is well delineated as there are other products that have been approved. The negative is it's not quick. You've got to go through all of the steps that FDA requires and that will be 2 Phase III trials following a proof of concept study. And as you pointed out, we see a potential market, not only for male-pattern baldness which is a huge market, but the animal data suggests that for female hair thinning, that could be a very beneficial product as well.
See also
http://www.cbsnews.com/8301-505123_1...the-hard-part/ suggesting an earlier possible release date in 2013 or 2014.
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