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

To: rkrw who wrote (9019)	11/19/2005 6:15:04 PM
From: kenhott	Respond to of 10280

I see SEPR being on the other side of the balance now regarding definitive trials of X vs. A. From a business perspective, I would find it hard to justify such a move. I don't have to tell you the potential cost to such an attempt, both $$$ and risks. Different time and/or different place, the answer may be different. Of course that should not stop SEPR from doing "little" trials to keep greasing the system. Your post had me thinking about T and ELN. If I were ELN, I would get ready a T vs. R and C trial and start to get the message out. Risky but T is in a risky position. Short term T will get needed useful mileage from such an effort. Longer term proven efficacies vs. current treatments would be a golden shield. Lacking such a piece of protection, another case or two of PML, random or not (likelihood increases with use) likely turns T into a shadow. Plus adding certainty will entrench T vs. the oral compounds. I guess this would mostly be a BIIB decision. Which likely means no such program.

To: rkrw who wrote (9019)	11/20/2005 3:06:09 PM
From: Biomaven	Respond to of 10280

xopenex superior on cardiac safety Would be exceedingly difficult to demonstrate given that albuterol is a very safe drug in the first place. There have been a few fatalities associated with albuterol over-use, but it's not really clear if they were totally cardiac-based. From the albuterol label: 4. Cardiovascular Effects: PROVENTIL HFA Inhalation Aerosol, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of PROVENTIL HFA Inhalation Aerosol at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QT c interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, PROVENTIL HFA Inhalation Aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. 5. Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected. We are talking event rates that must be something like a few in a million doses. Based on the recent hospital studies, I do believe they could show an efficacy advantage in severe asthma. To date they've never really demonstrated an efficacy advantage except in dosing frequency, and I assume the same held for the MDI trials or we would have heard about it. It's amazing they have been able to develop the traction they have given the very small label differentiation they have to work with. Peter

To: rkrw who wrote (9019)	11/20/2005 11:23:26 PM
From: Mike McFarland	Respond to of 10280

Xopenex always sounded great to me too (I'm an albuterol junkie) but the side effects from albuterol just don't seem any worse than, say, one too many cups of coffee for me. I do seem to lose interest in using new the prescription drugs. Benadryl and melatonin replaced Ambien for me. More puffs of the cheap albuterol seem to work better than anything else for knocking down my asthma. Provigil has been the biggest disappointment. It gives me a little warm rush, but I am not sure I am getting anything more than a placebo effect on the graveyard shift. Tomorrow I am going to try a Lunesta to sleep rather than my regular cocktail. But I don't expect any miracles. Well, sorry for the mostly off-topic banter. I sold my stock several years ago--not too far from the low. Someday I will forgive myself, and maybe then I will start to sleep better <g>.