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

To: jeffbas who wrote (3074)	5/27/1999 4:57:00 PM
From: BMcV	Respond to of 10280

>>what do you think the chances are that SEPR improved versions might indeed be limited to just a select group of side effect suffering patients, causing future estimates to be grossly overstated?<< It depends on the drug. For Seldane/Allegra, Hismanal/Norastemazole, Propulsid/Noracisapride, where the side effect is a rare fatal event, there is absolutely no reason to keep the parent drug on the market once the ICE is available. As you know, the FDA did pull Seldane from the market, so this model has already been demonstrated. For a drug like Claritin, where the problem is that if used in a sufficient dose to be really effective, it becomes sedating, SEPR's DCL could allow for an extra-strength dose that would be readily marketable, especially by SGP, a very strong marketing company. SGP has licensed the rights, is in trials, and could bring the product out before Claritin's patents run out, allowing them to switch most patients to DCL before their patient base gets eroded by generics. Claritin didn't get to be a $3 billion drug based on its merits, but on SGP's innovative marketing, including direct-to-the-consumer ads, so patients recommend the prescription to the doctor, not the other way around. That won't change with DCL. But in some cases, it will no doubt turn out that a generic is as good as the SEPR ICE, except in some subgroup of patients who are especially sensitive, have certain risk characteristics, etc. Xopenex may not have been the best example, since with further studies there is a chance SEPR will be able to document their claim that the inactive isomer actually decreases lung function over time. But that is yet to be proven to the FDA's satisfaction. So initially, doctors might start to offer patients Xopenex only if they report having problems with albuterol. And if they get good results, the drug will do well, regardless of the labeling. Every product has a unique patent situation, pharmacological benefit, marketing opportunity, partnering situation, so it is a mistake to generalize. It is also unique for a company of this size to bring two patented drugs to market in just a few years, one of which has $500 million in sales already. I don't doubt they will bring many others to market in the next decade.