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Replies to #98229 on Biotech Values
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biomaven0

07/01/10 5:02 PM

#98230 RE: tony111 #98229

There is no reason to prescribe a riskier drug with better efficacy before trying out the safer one.



The two constituents of Qnexa are low doses of old drugs that are very well understood, having been used on millions of people over decades. Arena's drug is new, and so by definition is not well understood, having been used only on thousands of people to date over periods measured mostly in months. So why would you say that Arena's drug is safer?

Not saying Qnexa is wart-free from an investment perspective (combination drug, only a use patent, constituents available for prescription separately, some other patent concerns), but from a medical perspective I'd say it appears to have better efficacy and a better-understood safety profile.

Peter
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turtlepower

07/02/10 6:11 PM

#98285 RE: tony111 #98229

ARNA - Regarding ARNA's efficacy, one risk for ARNA is that the FDA requests additional efficacy data since the BLOSSOM trial only met 1 of the 3 requirements to satisfy efficacy, ie 5% was more than 35% but not double of placebo (63-35 lorcaserin-placebo) and mean weight loss difference was 4% (<5% requirement).

http://invest.arenapharm.com/releasedetail.cfm?ReleaseID=410040

Edit : I looked at the per-protocol results. The ITT results are slightly better at 47.2 to 25 but barely passes the requirement.