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Biotech / Medical : Sepracor-Looks very promising
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To: Harold Engstrom who wrote (7283)1/14/2004 3:04:42 PM
From: Biomaven  Read Replies (1) of 10280
 
I got both sound and slides today, using this link:

mapdigital.com

Key nuggets I heard:

Something about movement by the FDA on banning CFC MDIs, with 2005 as a possible target date. I hadn't heard anything recently about it - I could find nothing new at the FDA site. If this happens it will be very significant, as there is no reason why Xop shouldn't get the majority of the MDI market until a generic shows up.

On Estorra, there was some comment about the second six-month trial being to get labelling for long-term use, so it sounds to me like they are expecting only a short-term label (but I assume with their six-month study referenced).

On their pipeline, I note that Norvasc is back to prominence, this time in possible combo with an ARB. There aren't that many of those around (about half-a-dozen, all still on patent). So that could only happen with a partnership. Forest Labs has an ARB (Benicar) - that could be a good long-term partnership (or more).

Also on their pipeline there's suddenly prominence to three early stage compounds. I only recognize one of these (a Zopiclone metabolite) - don't know if the others are ICEs or home-grown. All these indications (restless leg, sleep apnea and anxiety/muscle spasticity) are great - very significant unmet needs. A good drug in any of these indications would be a blockbuster.

Finally, I note that their single-isomer oxybutynin drug was missing form the list although it has had one Phase III already. Must be some issue here aside from lack of resources?

Peter
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