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From: ME/CFS and Fibromyalgia Information Exchange Forum
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Sent: Wednesday, January 12, 2005 12:05
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Subject: [CO-CURE] MED: New Drug From Pfizer May Be an Option for FM
Pain
01-12-2005
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
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