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Biotech / Medical : ATIS is on the move! -- Ignore unavailable to you. Want to Upgrade?

To: Cacaito who wrote (1392)	2/1/1998 4:54:00 PM
From: Marshall Teitelbaum	Respond to of 2205

Cacaito, This is one that has already been discussed here in much detail, although I thank you for the response. I am more interested in which products David was referring to which are still in development which are being worked on for the indication for diabetic foot ulcers, etc. I am always concerned when there are hints without the info, as these are not as helpful for the thread. Regranex gel should be nice for J&J/Chiron revenues, but it is not likely to be a blockbuster treatment for diabetic foot ulcers on a clinical basis, the indication it was approved for. It mostly was approved due to the lack of danger and the likelihood of slight benefit in healing, even though there was a fairly significant recurrence rate if memory serves. As you mentioned, there is always the possibility of aumgentation for treatment. The key for approval was that it is an area of major need without any really good treatments available at this time, a fact that may be lost on many. The key concern in all of the articles I saw about dermagraft following the fda panel recommendation was that the panel was not convinced of the efficacy of dermagraft at this time, although safety is not an issue. If they can make sure to prove the efficacy with their post-marketing study, they will do just fine. I believe that the studies have shown efficacy from all of the data, especially when broken down, as some of the numbers from that first study are still being used against atis....and this isn't truly reflective at all of the quality of dermagraft in its current state. My concern regarding assuming other skin products being worked on will be major competition, such as CHAI, IART, LIFC, etc. is that this would still be an assumption. They have products which serve purposes, but still need to prove that they have products which work for specific indications to get reimbursement, and they are all well behind ATIS on this, if their products do indeed work for this indication. They all have their niches at this time. However, since I am not able to get every last detail about every product in existence, I would like to hear more about those being studied for major indications at this time, such as diabetic foot ulcers, venous stasis ulcers, pressure sores, etc., and with what efficacy and how far away the commercial availability might be from those who are informed. For cartilage, right now GENZL has carticel, but this isn't by arthroscopic procedure at this time. They are working on other methods of application at this time. ATIS is also to begin their cartilage study for humans at some point this year, but they aren't the only ones working in this area obviously. This doesn't mean that more than one company can't survive or that any one is necessarily better than the other at this time. Obviously, the sooner any company gets out with a very good product, the easier it is easy to establish themselves as market leaders in their sector. Get out with a couple of good products and the path gets even easier. I don't usually see these companies deciding that they'd rather be in the up and coming competitors' positions, as this is a much more difficult place to be, although you can never rest on your laurels, much as with technology companies in general. Regards, Marshall