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

To: bazer who wrote (967)	7/6/1998 11:45:00 PM
From: Ed Ajootian	Respond to of 10280

Bazer, Thanks again for the very helpful comments. Will be interesting if the FDA lets them include special dosages for the kids. This would make sense based on SEPR's pediatric study but you never know what the FDA is thinking. I talked with a pretty high-level biotech executive at one point about FDA actions and this person said that the FDA is tacitly run by the large pharmaceutical companies. The large pharma's are the companies that have trained all of the FDA staff and also are the ones that hire the FDA staff when those guys wanna cash in their chips. Ergo, the theory goes that when a biotech company presents an NDA to the FDA, especially for a drug that will compete with large pharma's drugs, and especially for a drug where that biotech company has not collaborated with any large pharma to develop, the FDA is gonna be nasty as hell with the application. Would be interested in folks' thoughts on this speculation. Re: Dr. Dan, I'm gonna e-mail him and let him know how famous he is now <g>! Plus, at least then the guy can defend himself if he wants to.

To: bazer who wrote (967)	7/7/1998 7:01:00 PM
From: Sleepman	Read Replies (4) \| Respond to of 10280

BAZER: This is addressed to you specifically, and then the tread as a whole. First, I see that you are a registered Respiratory Therapist, and therefore, I presume that you have a pretty good knowledge of the treatment of both COPD and asthma. Beta agonists play an important role in the treatment of these, but are not always of benefit for those with COPD. As I am sure that you are aware, COPD is a blanket term for chronic bronchitis and emphysema. In this this setting, beta agonists, only help those who have bronchoreactivity. I am sure that when you looked at alot of the COPE'ers PFTs, you will have noticed that there is frequently little reactivity. Never-the-less, we give them anyway---largely because they may provide benefit, and have very low toxicities. Really, the best drug for these patients are usually anticholinergics. I am not aware of any study looking at the use of levalbuterol in the COPD setting, but think that it probably be like other beta agonists, only more expensive. ---An they'll still get to the point where they want to refuse it. Perhaps, this should be looked at. As for cost: I beg to differ with you that cost does not matter. Increasingly, hospitals and payers are defining what is available for the practitioner to prescribe. This is particularly prevalent in the inpatient arena. SEPR will have to demonstrate, and may well over time, that this is sooooo much better. I think that that will take time, and I am not sure that they will be able to show such a clear cost advantage for quite a while. Now, that being said, do not get me wrong, I think that there will be a role for this drug. It is safe, it is effective, and it offers rapid onset action with medium duration for patients with reactive airways disease. Time will tell as to whether it will make it big. But I sure wish that I bought the stock when it was in the high teens. I still like the long term prospects of this company-largley for the antihistamines, where the market is huge and growing. Dan