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03/05/10 1:26 PM

#32585 RE: bladerunner1717 #32582

I followed Neuromed for a long time, and know this program fairly well( it was a relatively later inlicensing)--I agree with that clinician's opinion. This is from NI's 2009 pain review:
<<JNJ’s ‘OROS’ reformulation of extended release hydromorphone was launched in the EU, but the FDA wanted another pivotal trial in the US. Neuromed Pharmaceuticals licensed that program, and has recently completed that Phase III for ‘Exalgo’, hitting all endpoints. The OROS formulation has advantages in terms of abuse-resistance and effect-duration that could give it a substantial advantage in the US market, and its pace of uptake in Europe may augur for healthy adoption in the US. But first they must submit the response to the previous ‘Approvable’ letter during 2H:09, and then wait for approval, by mid-2010. The next step will be to sign a pharma marketing partner, which should not be a problem, given its OROS heritage and solid data package.>>

They have that partner, Covidien, and the FDA gave them less hassle than I had expected. Frankly, I had never paid attention to CombinatoRx until the merger, but the Neuromed components are appealing.

NeuroInvestment