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Biotech / Medical : CollaGenex (CGPI) FDA PENDING -- Ignore unavailable to you. Want to Upgrade?

To: nigel bates who wrote (106)	4/9/2004 9:03:39 AM
From: Luke	Respond to of 142

Does anyone have an understanding of how if at all this settlement affects the future MR once-daily formulation? In particular I am wondering whether this may effectively clear the generics issue once and for all from a regulatory standpoint. I had the impression that FDA will only allow ANDAs only if there is a currently approved version of the product. So, once CGPI gets MR approved they can request cancellation of their current periostat mkt authorisation so that no new ANDAs can get approved. Mutual will mkt CGPIs product and not have an approved ANDA (or will it have approval but just not market the product, since the ANDA is still pending in the FDA?), and maybe though not clear from the PR, CGPI can terminate this agmt with Mutual in May 2007 after it cancels the authorisation. After the patents expire in 2007 in the US Mutual, can Mutual go ahead w. the ANDA if CGPI has cancelled its authorisation? If not, I guess it's less/unlikely that a company will do an expensive trial if they will face MR in the market therafter. In the meantime, until MR in 06-07, hopefully no other generics show up. Presumably CGPI knows that none have put together a filing so far, and the fact that CGPIs agmt with Mutual permits M to market of file for marketing of a generic if another generic is on the market is yet another deterrent to new generics. It's like the debate on removing the 6mo excl period in Hatch-W; when generics know that there will be fierce price competition it makes it less or not worthwhile to prepare a filing+litigation, etc. Thus if current periostat never goes generic, will CGPI be able to switch to MR and not compete ever with the current formulation? Of course to a large extent this not be an issue at all b/c there seems to be a major therapeutic advantage of the MR but the security would help.