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Biotech / Medical : Sepracor-Looks very promising -- Ignore unavailable to you. Want to Upgrade?


To: EyeDrMike who wrote (1229)10/4/1998 6:44:00 PM
From: chirodoc  Respond to of 10280
 
from yahoo

Oct 1 1998
8:16PM EDT
What is your source for the conclusion that the Xopenex/Albuterol branding approval will be sometime in November? My understanding was any day now. If it does happen soon, as I believe TB indicated on the box and the filing last week communicated, that would be a big positive, as it would indicate a wide labeling. Also, recall that the target launch was for the 4th quarter, and we are now officially in it, so I *think* it should be imminent. The later we get, the more indication that there is a negotiation occurring between sepr and the FDA on the range of the label.

As for Prozac, everything I've heard seems to indicate that sepr is unwilling to get bent over in the deal by Lilly and that they will have to go this one alone or go with a competitor. The implications of the latter strategy are huge, as that would be sort of a waging of war by the big pharmas. Imagine SCP putting $300M into the sepr ICE for Prozac... That could get some people fired at Lilly for blowing it if it turned out to be a big success. My guess is that Lilly is trying to see whether they can bluff a deal out of our boys, but they are probably very far apart, hence the messages that this may be the next one that they go solo.

Just some thoughts, but I expect either piece of news coming soon would be a big plus. Of course, if we wait until after 11/1 for Xopenex, that may mean narrow labeling, which could hurt us.

Also, in a recent conversation with sepr it was clarified that sepr has ICEs on most of the top 25 selling drugs today, and there really is only one ICE per drug that only includes the active, positively affecting, isomer. That ICE eliminates all the effects of the other isomers, and if it is patented by sepr, there is no way that anyone else can come in and patent a similar isomer which is a "one off". You either have it, or you don't. So, you may throw out the good with the bad when isolating, which many speculate is the case with oxy, in which case chiral technology doesn't work well for that drug. But, if it's done correctly on a drug that is a good candidate, there's little intellectual property or "one off" risk. The reason for multiple ICEs existing is that there are different treatments being targetted, not that one may be better than another for the same application.

Good luck to all on the short term (long term no luck is needed), but I've learned my lesson about going to sleep without a big helping of sepr - you could miss a big run, and timing the dips is gut wrenching.

-Art Vandelay, AIA