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

To: M. Ramle who wrote (2139)	3/26/1999 10:27:00 AM
From: Biomaven	Read Replies (4) \| Respond to of 10280

I missed the beginning of the conference call, but here's what I gathered: 1. They didn't get pediatric labelling - over 12 only. They are currently running peds studies, and will pursue peds labelling with the FDA. How significant is this? The only albuterol with peds labelling currently is Proventil, and they have only 3% of the market. Thus clearly doctors happily prescribe non-peds labelled albuterol to the kiddies. No peds labelling clearly makes promotion more awkward, but I don't think this is going to be a major hindrance in practical terms, and they will undoubtedly eventually get it. 2. Perhaps more significant, they did get better side-effect labelling than albuterol - in particular for tremors and bronchospasm. No mention of partnering the MDI, and vague on foreign partners. Seems like they are lagging a little here for some reason. 3. Pricing same as brand name; sounded (from pre-caffeinated memory)like about 25% higher than generic. Bottom line on Xopenex: I think they will ultimately do very well, but full penetration of this > $1 billion market will definitely take time. They still need approval for multiple dose vials, oral formulation and MDI formulation. Haven't yet gotten peds labelling or nailed down their long-term efficacy advantage, and still lack a marketing partner. So lots of work still ahead. Peter