Extending the Competition in Parkinson's Disease

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.

Impax Laboratories (Nasdaq: IPXL  ) is in that situation with its extended-release version of carbidopa-levodopa, called IPX066. Generic versions of the combo drug to treat Parkinson's disease have been on the market for years.

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 (NYSE: MRK  ) , but it doesn't work as quickly as IPX066 and is generally only used at night. Impax should have no problem competing with Sinemet CR or the immediate-release generic, although it will have to compete with other Parkinson's disease drugs like Novartis' (NYSE: NVS  ) Stalevo.

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 (NYSE: PFE  ) to sell Lyrica. Outside of the U.S. and Taiwan, Impax has already licensed the drug to GlaxoSmithKline (NYSE: GSK  ) .

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.

Interested in keeping track of Impax as it goes for an FDA approval of IPX066? Click here to add it to My Watchlist, which will help you keep track of all our Foolish analysis on the stock.

Pfizer is a Motley Fool Inside Value pick. GlaxoSmithKline and Novartis are Motley Fool Global Gains recommendations. The Fool owns shares of GlaxoSmithKline. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors.

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool has a disclosure policy.


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  • Report this Comment On March 15, 2011, at 10:40 PM, any20stocks wrote:

    i have had parkinson's for 10 years and take a combination of IR and CR generic sinemet which works fine and is very cheap which is nice since i have no insurance. CR is widely used during the day as far as i know and i am baffled how they can get the drug approved by MEDICARE/MEDICAID without going head to head against that regime. i can see the advantage of a single pill which gives a quicker and more even delivery and reduces the number of daily pills but i have to laugh at how motley fool repeats info from IPXL that is blatantly misleading in my opinion. one also has to look at what else is being developed for parkinson's such as a "sinemet" patch, an agonist patch and improved agonists. plus DBS and some in-development gene therapies.

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