New drug from Pfizer may be a blockbuster
Firm to use Lyrica for nerve disorders
BY KIM NORRIS
FREE PRESS BUSINESS WRITER
A new drug with the potential of helping millions of people battle chronic nerve pain, epileptic seizures and, possibly anxiety disorder was developed in 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 uses for the drug.
The Ann Arbor research facility could be the incubator for future groundbreaking drugs that employ the unique characteristics of Lyrica to treat a broad range of illnesses and disorders, researchers hope.
Pfizer received approval from the Food and Drug Administration Dec. 31 to market Lyrica in the United States for two uses: the nerve pain associated with diabetic 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 in the development stages, says Toni Hoover, a psychologist and vice president and development site head of Pfizer Global Research and Development in Ann Arbor. Hoover has been leading the development team on Lyrica since 1998.
Hoover described the way Lyrica works as “like a blanket to dampen the highly excited nerve endings,” that cause not only pain, but also seizures and psychiatric disorders such as anxiety.
Hoover said Lyrica could be a potential treatment for the pain associated with fibromyalgia, for which there is no treatment, as well as spinal cord injuries.
“And we’re undertaking other studies to see if it can treat other kinds of pain as well as disorders, all from the theory that there are many things caused by excited nerve endings and can be treated through the central nervous system,” Hoover said.
How big Lyrica becomes depends in large part on how many uses it receives approval for.
“It’s definitely a blockbuster — a billion-dollar product,” said Trevor Polischuk, pharmaceutical analyst with money manager ObriMed Advisors. “Whether it will be a mega blockbuster — a multibillion-dollar product is still open to question.”
Lyrica’s approved applications for nerve pain alone can generate $1 billion in sales.
Nearly half of the 18 million Americans with diabetes will develop some form of diabetic neuropathy and about 3 million diabetics will experience painful neuropathy, often described as burning, tingling, stabbing, and a pins-and-needles feeling in the feet, legs, hands or arms. An estimated 50,000 Americans develop nerve pain from shingles, which is a skin disease caused by reaction to the same virus that causes chicken pox.
Currently, there is no drug on the market to treat those two most common causes of nerve pain. Pfizer’s Neurontin, which recently lost its patent protection, opening the doors to generic competitors, is approved for use in treating epilepsy and the pain associated with shingles, but was never formally approved for additional uses.
Lyrica is the next generation drug in the same class as Neurontin — a class developed and controlled by Pfizer alone, called Alpha 2 Delta Ligands.
More than 10 years in the making, Lyrica has been the purview almost entirely of Ann Arbor, first as the R&D labs of Parke-Davis then Warner-Lambert, then Pfizer, as each was swallowed by its successor.
Lyrica was developed from a chemical acquired from Northwestern University in 1992.
Hoover estimated close to 500 colleagues around the world have worked on the drug over the last 12 years, taking it from a chemical to a tested product that could be mass marketed worldwide, performing clinical studies and complying with arduous FDA application processes.
Given the potential uses for the class of drugs, the Ann Arbor research facility, which employs 2,600, stands to be a critical location for future Pfizer products.
“We found that with our experiences in trying to understand why Neurontin works we could apply to Lyrica,” Hoover said. “Ann Arbor did all the work on Neurontin. We have a great deal of expertise in Michigan in the development in this class of agent.”
If Lyrica is ever to achieve mega blockbuster status, it needs to be approved for uses beyond the nerve pain treatment.
Another proposed use for Lyrica — to control epileptic seizures — could be a $500-million market.
But the most lucrative application for Lyrica — because it has the widest potential consumer demand — is as a treatment for general anxiety disorder, which could be a $2-billion market, Polischuk estimated.
Approval to use Lyrica to treat epilepsy is pending with the FDA and could come soon.
However, federal regulators declined to approve Lyrica for treating anxiety.
Pfizer spokesman Rick Chambers said the company will sit down with the FDA to find out what its concerns are regarding the use of Lyrica in treating anxiety and remains hopeful it will get approval.
Pfizer also was surprised when Lyrica was tagged by the federal Drug Enforcement Agency to be scheduled as a controlled substance, a designation that could impact Pfizer’s ability to market the drug.
“Based on our data collected in animal and human studies, we expect Lyrica to have a low potential for misuse or abuse,” Chambers said.
Lyrica could provide a needed shot in the arm to Pfizer, which has lost or is losing its patent monopoly on some of its biggest-selling drugs and dealing with declining sales in its blockbuster arthritis drug Celebrex following the removal of rival product, Vioxx, from the market.
Source: Detroit Free Press