Making a drug more convenient to take by producing an extended-release version can help drive sales. But things become more complicated when the extended-release version has to compete with a generic immediate-release version. Popping twice as many pills may be an acceptable trade-off for patients if the copay for the drug is cheaper.
But Impax has one big advantage: IPX066 appears to work much better than immediate-release carbidopa-levodopa. In phase 3 data released yesterday afternoon, IPX066 substantially improved symptoms of Parkinson's disease patients compared to the immediate-release version. Reducing the number of times the drug had to be taken from five times a day down to about 3.5 times per day was just an added bonus.
There are already generic versions of the extended-release version of the combo, Sinemet CR, which was originally developed by Merck
Impax plans to file its marketing application to the Food and Drug Administration in the fourth quarter. It'll market the drug on its own in the U.S., where it already has a sales force in place because it has a co-promotion agreement with Pfizer
We'll get a better look at the data at upcoming medical meetings, but considering the data we've seen so far, it doesn't look like Impax should have any problems getting IPX066 approved.
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