# New Drug From Pfizer



## M&M (Jan 20, 2002)

This was posted to the Co-Cure Email List:***********************************************01-12-2005New drug from Pfizer may be a blockbusterFirm to use Lyrica for nerve disordersBY KIM NORRISFREE PRESS BUSINESS WRITERA new drug with the potential of helping millions of people battle chronicnerve pain, epileptic seizures and, possibly anxiety disorder was developedin the Ann Arbor research facilities of giant pharmaceutical maker Pfizer Inc.Soon to be sold under the brand name Lyrica, for treating nerve pain,Pfizer's newest drug is expected to achieve at least $1 billion in sales,with the potential for much more if federal regulators approve more usesfor the drug.The Ann Arbor research facility could be the incubator for futuregroundbreaking drugs that employ the unique characteristics of Lyrica totreat a broad range of illnesses and disorders, researchers hope. Pfizerreceived approval from the Food and Drug Administration Dec. 31 to marketLyrica in the United States for two uses: the nerve pain associated withdiabetic neuropathy and pain that often accompanies shingles.But because of the way Lyrica works -- through the central nervous system-- it has a potentially broad spectrum of uses, some of which are still inthe development stages, says Toni Hoover, a psychologist and vice presidentand development site head of Pfizer Global Research and Development in AnnArbor. Hoover has been leading the development team on Lyrica since 1998.Hoover described the way Lyrica works as "like a blanket to dampen thehighly excited nerve endings," that cause not only pain, but also seizuresand psychiatric disorders such as anxiety.Hoover said Lyrica could be a potential treatment for the pain associatedwith fibromyalgia, for which there is no treatment, as well as spinal cordinjuries."And we're undertaking other studies to see if it can treat other kinds ofpain as well as disorders, all from the theory that there are many thingscaused by excited nerve endings and can be treated through the centralnervous system," Hoover said.How big Lyrica becomes depends in large part on how many uses it receivesapproval for."It's definitely a blockbuster -- a billion-dollar product," said TrevorPolischuk, pharmaceutical analyst with money manager ObriMed Advisors."Whether it will be a mega blockbuster -- a multibillion-dollar product isstill open to question."Lyrica's approved applications for nerve pain alone can generate $1 billionin sales.Nearly half of the 18 million Americans with diabetes will develop someform of diabetic neuropathy and about 3 million diabetics will experiencepainful neuropathy, often described as burning, tingling, stabbing, and apins-and-needles feeling in the feet, legs, hands or arms. An estimated50,000 Americans develop nerve pain from shingles, which is a skin diseasecaused by reaction to the same virus that causes chicken pox.Currently, there is no drug on the market to treat those two most commoncauses of nerve pain. Pfizer's Neurontin, which recently lost its patentprotection, opening the doors to generic competitors, is approved for usein treating epilepsy and the pain associated with shingles, but was neverformally approved for additional uses.Lyrica is the next generation drug in the same class as Neurontin -- aclass developed and controlled by Pfizer alone, called Alpha 2 Delta Ligands.More than 10 years in the making, Lyrica has been the purview almostentirely of Ann Arbor, first as the R&D labs of Parke-Davis thenWarner-Lambert, then Pfizer, as each was swallowed by its successor. Lyricawas developed from a chemical acquired from Northwestern University in 1992.Hoover estimated close to 500 colleagues around the world have worked onthe drug over the last 12 years, taking it from a chemical to a testedproduct that could be mass marketed worldwide, performing clinical studiesand complying with arduous FDA application processes.Given the potential uses for the class of drugs, the Ann Arbor researchfacility, which employs 2,600, stands to be a critical location for futurePfizer products."We found that with our experiences in trying to understand why Neurontinworks we could apply to Lyrica," Hoover said. "Ann Arbor did all the workon Neurontin. We have a great deal of expertise in Michigan in thedevelopment in this class of agent."If Lyrica is ever to achieve mega blockbuster status, it needs to beapproved for uses beyond the nerve pain treatment.Another proposed use for Lyrica -- to control epileptic seizures -- couldbe a $500-million market.But the most lucrative application for Lyrica -- because it has the widestpotential consumer demand -- is as a treatment for general anxietydisorder, which could be a $2-billion market, Polischuk estimated.Approval to use Lyrica to treat epilepsy is pending with the FDA and couldcome soon.However, federal regulators declined to approve Lyrica for treating anxiety.Pfizer spokesman Rick Chambers said the company will sit down with the FDAto find out what its concerns are regarding the use of Lyrica in treatinganxiety and remains hopeful it will get approval. Pfizer also was surprisedwhen Lyrica was tagged by the federal Drug Enforcement Agency to bescheduled as a controlled substance, a designation that could impactPfizer's ability to market the drug."Based on our data collected in animal and human studies, we expect Lyricato have a low potential for misuse or abuse," Chambers said. Lyrica couldprovide a needed shot in the arm to Pfizer, which has lost or is losing itspatent monopoly on some of its biggest-selling drugs and dealing withdeclining sales in its blockbuster arthritis drug Celebrex following theremoval of rival product, Vioxx, from the market.Source: Detroit Free Press


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