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Pfizer's Maraviroc to Receive Accelerated Regulatory Reviews in the U.S. and Europe

Geschrieben am 13.02.2007 - [Nächster Artikel]

New York (ots/PRNewswire) -

- If Approved, Maraviroc will be the First in a New Class of
Medications Available for HIV Treatment

Pfizer announced today that marketing authorization applications
for maraviroc will receive accelerated review in both the United
States and Europe. Accelerated reviews are granted to potential
medicines that, if approved, would represent significant improvements
over current therapies.

If approved by the regulatory agencies, maraviroc will be the
first in a new class of HIV/AIDS treatments called CCR5 antagonists
that work by blocking viral entry. Rather than fighting HIV inside
white blood cells, CCR5 antagonists prevent the virus produced by
infected cells from entering uninfected cells by blocking its
predominant entry route, the CCR5 co-receptor.

"There is a profound global need for new medicines to help
HIV/AIDS patients," said John LaMattina, president, Pfizer Global
Research and Development. "We expect that CCR5 antagonists, like
maraviroc, will become critically important new treatment options for
patients who are resistant or intolerant to their current HIV/AIDS
therapies."

The U.S. Food and Drug Administration (FDA) priority review
process takes place within a six-month period. Pfizer submitted the
U.S. and EU maraviroc marketing applications in December 2006. An FDA
Advisory Panel is scheduled for April 24. Pfizer has begun pursuing
regulatory approval for maraviroc in other countries to enable broad
access to the drug.

Moving with Urgency

The discovery of maraviroc dates back to 1997 when Pfizer research
scientists in Sandwich, UK designed the molecule following the
publication of two significant research findings. A study was
published in 1996 that described resistance to HIV-1 infection in
certain Caucasian subjects, and in the same year, another journal
reported the binding of HIV to the CCR5 receptor. Scientists noted
that about one percent of Europeans who lacked the genes for CCR5
receptors were the very ones who were resistant to acquiring HIV
infection. This finding suggested that blocking the virus's entry
through this gateway may lead to a breakthrough therapy. Based on
these emerging scientific insights and patient need, the maraviroc
team significantly accelerated development time.

"This is the kind of targeted science that underscores our
commitment to research and development in a range of infectious
diseases where there is high human cost due to drug resistance," said
Dr. Ethan Weiner, senior vice president, Pfizer Global Research and
Development. "Maraviroc is an outstanding example of rapid
development and continuous innovation through which Pfizer
researchers quickly translated a scientific hypothesis into a
promising compound in this area of great medical need."

Maraviroc is the seventh Pfizer new drug application to receive
"Priority Review" status from the FDA over the past two years. Other
priority review FDA approvals include Sutent for advanced kidney
cancer and gastrointestinal stromal tumors, Chantix for smoking
cessation, Revatio for pulmonary arterial hypertension, and Macugen
for age-related macular degeneration which can lead to blindness in
elderly patients.

Pivotal Trials

The marketing applications follow Pfizer's review of efficacy and
safety data from two pivotal phase 3 trials. The trials, MOTIVATE-1
and 2 (Maraviroc plus Optimized Therapy In Viremic Antiretroviral
Treatment-Experienced patients), represent 24-week data comparing
Optimized Background Therapy, with or without maraviroc, in over
1,000 highly treatment-experienced patients with CCR5-tropic HIV-1.
These study results have been accepted for presentation at an
upcoming HIV conference.

In addition, the independent Data Safety Monitoring Board (DSMB)
for maraviroc met on January 15, 2007 and continues to monitor the
ongoing clinical program. The DSMB recommended that the maraviroc
Phase 3 registrational trials, in both treatment-naïve and
treatment-experienced patients, continue as currently designed.

Update on Expanded Access Program

In December 2006, Pfizer announced plans to establish a
multi-national Expanded Access Program to provide maraviroc to
patients with limited available treatment options based on its safety
and efficacy observed in clinical trials to date. The program is now
open for enrollment with a target to enroll patients from over 30
countries.

Through partnerships and focused philanthropic efforts, Pfizer
strives to support HIV prevention efforts, build improved healthcare
infrastructure, and further access to HIV/AIDS medicines. Current
initiatives include the U.S. Southern States HIV/AIDS Prevention
Initiative; the building of the Infectious Disease Institute in
Kampala, Uganda; the Pfizer Global Health Fellows Program; and the
Diflucan(R) Partnership Program. For more information on these and
other Pfizer initiatives, go to www.pfizer.com.

DISCLOSURE NOTICE: The information contained in this release is as
of February 13, 2007. Pfizer assumes no obligation to update any
forward-looking statements contained in this release as the result of
new information or future events or developments.

This release contains forward-looking information that involves
substantial risks and uncertainties regarding a product candidate,
including its potential benefits, that is under review by the United
States Food and Drug Administration (FDA), the European Medicines
Evaluation Agency (EMEA) and certain other regulatory authorities.
Such risks and uncertainties include, among other things, whether and
when the FDA, the EMEA and other regulatory authorities will approve
the product candidate, their decisions regarding labeling and other
matters that could affect its availability or commercial potential,
as well as competitive developments.

A further list and description of risks and uncertainties can be
found in Pfizer's Annual Report on Form 10-K for the fiscal year
ended December 31, 2005 and in its reports on Form 10-Q and Form 8-K.

Web site: http://www.pfizer.com

ots Originaltext: Pfizer Inc.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Shreya Prudlo, +1-212-733-4889. Company News On-Call: Pfizer's press
releases are available through PR Newswire's Company News On-Call
service on PRN's Web Site. Visit
http://www.prnewswire.com/comp/688250.html/ Photo: A free corporate
logo to accompany this story is available immediately via Wieck Photo
Database to any media with telephoto receiver
or electronic darkroom, PC or Macintosh, that can accept overhead
transmissions. To retrieve a logo, please call +1-972-392-0888.
 
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