Pfizer: Does it Need a Future Substitute for Lyrica?

Jorge is a member of The Motley Fool Blog Network -- entries represent the personal opinion of the blogger and are not formally edited.

The gigant biopharmaceutical company Pfizer (NYSE: PFE) is obtaining surprising results from its drug Lyrica. This biopharmaceutical company described in an SEC filing that Lyrica (Pregabalin) could be used to treat epilepsy, post-herpetic neuralgia, diabetic peripheral neuropathy and fibromyalgia. Lyrica is considered to have a low potential for abuse, and a limited dependence liability if misused, and is thus classified as a Schedule V drug in the U.S.

Lyrica was invented by medicinal chemist Richard Bruce Silverman at Northwestern University.  Silverman headed the team of scientists that discovered novel compounds of vigabatrin (CPP-115 aminotransferase inhibitors and derivatives of vi­ga­ba­trin) This compound is being developed by Catalyst Pharmaceutical Partners under the patents licensed from North­west­ern in August 2009. 

Pregabalin (Lyrica, Pfizer) was approved in the European Union in 2004, and received U.S. FDA approval for use in treating epilepsy, diabetic neuropathic pain, and post-herpetic neuralgia in December of that year, first appearing on the U.S. market in fall 2005. In June 2007, the FDA approved Lyrica as a treatment for fibromyalgia. It was the first drug to be approved for this indication and remained the only one until duloxetine (Cymbalta) gained FDA approval for the treatment of fibromyalgia in June 2008. Lyrica's patent will expire in March 2018.

In the following chart, we can see Lyrica's historic revenues since 2010.

As you can see, Lyrica provides a high percentage of income to Pfizer. I believe that the company will need to look for a substitute in the short term to ensure the market of Lyrica. One of my favorite candidates for Pfizer is Z160 to N-type calcium channel blocker for chronic pain. This novel compound is being developed by Zalicus (NASDAQ: ZLCS).

Z160 has demonstrated broad preclinical efficacy and clinical safety. This compound is effective in multiple neuropathic and inflammatory pain models. Zalicus showed that Z160 is well tolerated in prior Phase I and Phase IIa trials in approximately 200 subjects. Currently, Z160 is located in two Phase IIa clinical trials in neuropathic pain indications. Z160 has the potential for an Orphan Drug Designation with a clear regulatory path. This market is dominated by Lyrica (pregabalin), Neurontin (gabapetin), Cymbalta (duloxetine), and Lidoderm ( 5% lidocaine patch). These drugs are commonly used to treat all forms of neuropathy. The market of neuropathic pain is a $2 billion market and growing in the US only. For these reasons I think that Z160 will be a future candidate, which may be interesting for Pfizer.

The history of the compound (Z160) shows interest from major pharmaceuticals. Z160, previously known as NMED160, was a development of Neuromed. This company and CombinatoRX (Zalicus) merged in July of 2009. Neuromed came to the agreement in 2006 to license this product to Merck (NYSE: MRK) for NMED160. This deal was originally valued at $475 million, plus ongoing worldwide royalties. NMED160 targeted N-type calcium channel blockers for chronic pain. It was later de-prioritized in Phase II trials because of bioavailability issues and was released from Merck. Zalicus solved the problems of bioavailability with the help of European experts and relaunch the development.

I believe that Pfizer is following this development. Z160 could resolve the future of Pfizer and Lyrica's expiring patent, which will be lost in 2018.


Jorge Aura owns shares of Zalicus and Catalyst Pharmaceutical Partners The Motley Fool has no positions in the stocks mentioned above. 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. The Motley Fool has a disclosure policy. Is this post wrong? Click here. Think you can do better? Join us and write your own!

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