Lead
Product Candidate, Tafamidis, in Registration in the European Union as First-in-Class
Oral Therapy for Transthyretin Amyloid Polyneuropathy
(ATTR-PN) PR
Newswire -- September 1, 2010
NEW
YORK and CAMBRIDGE, Mass., Sept. 1 /PRNewswire-FirstCall/ -- Pfizer Inc.
(NYSE:
PFE) and FoldRx Pharmaceuticals, Inc., a privately held drug discovery and clinical
development company, today announced that they have entered into an agreement
under which Pfizer will acquire FoldRx.
FoldRx's
portfolio includes clinical and pre-clinical programs for investigational compounds
to treat diseases caused by protein misfolding, which is increasingly recognized
as an underlying cause in many chronic degenerative diseases. The company's lead
product candidate, tafamidis meglumine, is in registration as an oral, disease-modifying
therapy for TTR amyloid polyneuropathy (ATTR-PN), a progressively fatal genetic
neurodegenerative disease, for which liver transplant is the only treatment option
that is currently available. FoldRx
has filed a marketing authorization application (MAA) for tafamidis with the European
Medicines Agency, and is currently in communication with the FDA to define its
pathway for filing in the U.S. Tafamidis has orphan drug designation in both the
U.S. and European Union (EU) and Fast Track designation in the U.S.
for the
treatment of ATTR-PN. "By
combining FoldRx's proprietary expertise in identifying and developing treatments
for protein misfolding diseases with Pfizer's commercial, medical and regulatory
expertise, and global strengths in patient services and reimbursement, we are
taking a significant step toward potentially bringing, for the first time, a non-surgical
treatment option for underserved patients affected by the deadly disease ATTR-PN,"
said Geno Germano, president and general manager, Pfizer Specialty Care Business
Unit. "This transaction will add another important component to the growing
portfolio of innovative in-line and investigational medicines for orphan and rare
diseases within Pfizer's Specialty Care Business, and will complement the current
and planned future research and clinical development taking place in Pfizer's
Specialty Care Neuroscience disease area," continued Mr. Germano. "Over
the past five years the FoldRx team has successfully developed tafamidis from
the bench stage to MAA submission," said Richard Labaudiniere, Ph.D., president
and chief executive officer of FoldRx. "Pfizer's strong clinical and regulatory
resources, global marketing reach, and commitment to the treatment of rare diseases
will significantly enhance the ability to pursue the goal of efficiently bringing
tafamidis to all patients affected by this devastating neurodegenerative disease." FoldRx
has employed its proprietary yeast-based drug target discovery platform to build
its portfolio of preclinical and clinical candidates. Its screening engine is
rapid and efficient in evaluating potential treatment candidates in a wide range
of diseases caused by misfolded proteins. Using this screening engine, FoldRx
is also actively engaged in an innovative early drug discovery program to identify
therapeutic agents for cystic fibrosis, Parkinson's disease and Huntington's disease. While
specific financial terms were not disclosed, Pfizer will make an upfront payment
and contingent payments if certain milestones are achieved. The closing of the
transaction is subject to regulatory approval in the United States and is expected
to occur later this year. Pfizer's
financial advisor for the transaction was Jefferies & Company, Inc., while
Ropes & Gray LLP was its legal advisor. Goldman Sachs & Co. served as
FoldRx's financial advisor, while Mintz, Levin, Cohn, Ferris, Glovsky and Popeo
P.C., served as its legal advisor. About
Transthyretin Amyloidosis (ATTR-PN) Transthyretin
(TTR) is an amyloidogenic protein secreted by the liver. Mutations in the TTR
gene have been linked to several amyloid conditions. Deposition of TTR amyloid
in the peripheral nerve tissue results in transthyretin amyloid polyneuropathy
(ATTR-PN), a sensory, motor and autonomic polyneuropathy. The disease usually
begins in the third or fourth decade with symptoms of peripheral and/or autonomic
neuropathy that inexorably progress to involve muscle strength with loss of ambulation.
The patient commonly experiences a profoundly diminished quality of life with
a markedly reduced life expectancy (approximately 10 years from first symptom).
Liver transplantation is the only accepted treatment, but it is not uniformly
effective, and is associated with significant mortality. It is estimated that
ATTR-PN affects at least 8,000 patients worldwide, the majority of whom are in
the European Union. About
tafamidis Tafamidis
is a new chemical entity, first-in-class, oral, disease-modifying agent that stabilizes
the protein transthyretin (TTR) and prevents dissociation of the tetramer, the
rate-limiting step in TTR amyloidosis. Tafamidis has orphan drug designation for
ATTR-PN in both the U.S. and European Union (EU) and Fast Track designation in
the U.S. FoldRx completed a 128 patient, international, multicenter Phase II/III
clinical study of tafamidis for the treatment of ATTR-PN along with additional
Phase 2 and 3 trials. Pfizer
Inc: Working together for a healthier world(TM) At
Pfizer, we apply science and our global resources to improve health and well-being
at every stage of life. We strive to set the standard for quality, safety and
value in the discovery, development and manufacturing of medicines for people
and animals. Our diversified global health care portfolio includes human and animal
biologic and small molecule medicines and vaccines, as well as nutritional products
and many of the world's best-known consumer products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness, prevention, treatments
and cures that challenge the most feared diseases of our time. Consistent with
our responsibility as the world's leading biopharmaceutical company, we also collaborate
with health care providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For more than 150
years, Pfizer has worked to make a difference for all who rely on us. To learn
more about our commitments, please visit us at www.pfizer.com. About
Pfizer's Specialty Care Business Pfizer's
Specialty Care Business Unit brings together an impressive team of colleagues
who are experts in their fields, a successful portfolio of market-leading, in-line
medicines and a rich pipeline of promising new compounds. With approximately $15
billion in global revenue, Specialty Care represents about one quarter of the
company's total revenues. Pfizer is now the world's largest specialty pharmaceuticals
business, with a commitment to the eradication, remission and relief of serious
disease. Pfizer's
Specialty Care Business is committed to bringing together the best scientific
minds to challenge the most feared diseases of our time. We have a robust portfolio
of therapies to treat rare diseases including hemophilia, pulmonary hypertension,
and specific endocrine disorders. About
Pfizer's Orphan and Genetic Diseases Research Unit In
2010, Pfizer created a new Orphan and Genetic Diseases Research Unitcharged with
discovering novel, lifesaving medicines for diseases affecting fewer than 200,000
patients in the United States and fewer than 5 patients in 10,000 in the EU. The
research unit builds on Pfizer's internal expertise in rare, orphan and genetic
disease drug development and pursues treatments across all therapeutic areas and
modalities. About
FoldRx FoldRx
is a development and discovery company focusing on first-in-class, disease-modifying,
small molecule therapeutics to treat diseases of protein misfolding and aggregation
(amyloidosis) based on the pioneer work of its scientific founders, Jeffery Kelly
(The Scripps Research Institute) and Susan Lindquist (Whitehead Institute). Protein
misfolding is increasingly being recognized as an underlying cause of many chronic
degenerative diseases. By applying FoldRx's proprietary expertise in protein folding
and its platform for drug and target discovery, the company is building a pipeline,
initially for neurodegenerative and respiratory conditions. FoldRx's pipeline
includes a program in advanced clinical development to treat genetic neurologic
and cardiovascular disorders, Transthyretin (TTR) Amyloid Polyneuropathy (ATTR-PN)
and TTR Amyloid Cardiomyopathy (ATTR-CM), and a discovery program in cystic fibrosis,
Parkinson's, and Huntington's disease based on its broad, proprietary, yeast-based
drug discovery platform. FoldRx investors include Alta Partners, Fidelity Biosciences,
Healthcare Ventures, Morgenthaler Ventures, Novartis Venture Funds, Novo Ventures,
and TPG Biotechnology. For more information on FoldRx, please visit the company's
web site at www.foldrx.com. DISCLOSURE
NOTICE: The information contained in this release is as of September 1, 2010.
Pfizer assumes no obligation to update forward-looking statements contained in
this release as the result of new information or future events or developments. This
release contains forward-looking information about an agreement by Pfizer to acquire
FoldRx, and about FoldRx's product candidate tafamidis, its other clinical and
preclinical development programs and its technology platform, including their
potential benefits, that involves substantial risks and uncertainties. Such risks
and uncertainties include, among other things, the satisfaction of conditions
to closing the agreement; the uncertainties inherent in research and development;
whether and when a new drug application for tafamidis will be filed with the FDA;
decisions by regulatory authorities regarding whether and when to approve any
drug applications that have been or may be filed for tafamidis and that may be
filed for any other product candidates that may be generated by FoldRx's technology
platform as well as their decisions regarding labeling and other matters that
could affect the availability or commercial potential of tafamidis and such other
product candidates; and competitive developments. A
further description of risks and uncertainties can be found in Pfizer's Annual
Report on Form 10-K for the fiscal year ended December 31, 2009 and in its reports
on Form 10-Q and Form 8-K.
SOURCE
Pfizer Inc.
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