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

To: M. Ramle who wrote (2381)	4/16/1999 3:22:00 PM
From: Biomaven	Respond to of 10280

Mazen, I think the somewhat weak label they got was not necessarily reflective of the drug's real activity. If levalbuterol had been developed with a big pharma partner, the size and scope of the trials would have been much bigger, and I think they would have gotten a stronger label. If you look at the amounts J&J and SGP are spending on trials of their licensed SEPR products you can see they are a different order of magnitude altogether. Now remember SEPR is still running Xopenex trials to try to nail down its long-term advantage. If these are successful, SEPR will have a much easier time dominating the albuterol market. SEPR just didn't have the financial strength a few years ago to run big enough trials to nail down the advantages upfront. Similarly, if a big pharma had been developing Xopenex, we wouldn't be a few years away from MDI and other formulations. Going it alone has its costs as well as its rewards. Each drug is going to be labelled based on it's own activity. The FDA is pretty tough when it comes to claims that one product is superior to another - most trials compare only to a placebo and show only safety and efficacy. Showing statistically better efficacy or side-effects than another approved drug typically needs bigger (and more expensive) trials than you need for just approval. Peter