|
Pfizer and Auxilium Announce
Commencement of European Regulatory Review of XIAFLEXTM for the
Treatment of Dupuytren's Contracture
COLLEGEVILLE, Pa. & MALVERN, Pa., Jan 21, 2010 (BUSINESS WIRE)
-- Pfizer Inc. (NYSE: PFE) and Auxilium Pharmaceuticals, Inc.
(NASDAQ: AUXL) today announced that Pfizer received notification
from the European Medicines Agency that the Marketing
Authorization Application (MAA) for XIAFLEX(TM) (collagenase
clostridium histolyticum), a novel, first-in-class, biologic for
the treatment of Dupuytren's contracture (a condition resulting
in the contracture of the fingers into the palm), has completed
the validation phase successfully. As a result, the
scientific/technical review procedure commenced on 21 January
2010.
"We are pleased to partner with Auxilium to bring forward what
potentially could be the first approved pharmaceutical treatment
option for patients suffering with Dupuytren's contracture, a
condition which can significantly impact patients' ability to
perform everyday tasks with their hands and therefore impacts
quality of life," said Michael Berelowitz, M.D., senior vice
president, Clinical Development and Medical Affairs, Pfizer
Specialty Care Business Unit. "XIAFLEX, if approved, will be an
important addition to the Specialty Care Business Unit's
portfolio of medicines in Europe designed to offer true clinical
value to patients and healthcare providers who need them."
Armando Anido, Chief Executive Officer and President of Auxilium
said, "We believe that commencement of the regulatory review
procedure is a notable milestone in our effort to bring the
first approved minimally-invasive, nonsurgical treatment option
to Dupuytren's contracture patients in Europe. We look forward
to working with our partner Pfizer as the EU regulatory review
process for the product moves forward."
Based on the completion of the validation phase and today's
confirmation from the European Medicines Agency of the start of
the regulatory review procedure, Auxilium will receive a $15
million milestone payment from Pfizer.
Under the terms of the strategic alliance agreement between
Pfizer and Auxilium, Pfizer will receive exclusive rights to
commercialize XIAFLEX in the 27 member countries of the European
Union (EU) and 19 other European and Eurasian countries. In
addition, Pfizer will be primarily responsible for regulatory
activities for XIAFLEX in these countries.
About Dupuytren's Contracture
Dupuytren's contracture is a condition that affects the
connective tissue that lies beneath the skin in the palm. The
disease is progressive in nature. Typically, nodules develop in
the palm as collagen deposits accumulate. As the disease
progresses, the collagen deposits form a cord that stretches
from the palm of the hand to the base of the finger. Once this
cord develops, the patient's fingers contract and the function
of the hand is impaired. Currently, surgery is the only
effective treatment. The incidence of Dupuytren's disease,
inclusive of pits, nodules and cords, is highest in Caucasians,
historically those of Northern European descent, with a global
prevalence of three to six percent of the Caucasian population.
Most cases of Dupuytren's contracture occur in patients older
than 50 years and a hereditary component exists in approximately
40% of patients.
The most frequently affected parts of the hand associated with
Dupuytren's contracture are the joints called the Metacarpal-Phalangeal
Joint, or MP joint, which is the joint closest to the palm of
the hand and the Proximal Intra-Phalangeal Joint, or the PIP
joint, which is the middle joint in the finger. The little
finger and ring finger are most frequently involved and about
half of patients have bilateral disease. There are currently no
drugs approved by the U.S. Food and Drug Administration or in
the European Union for the treatment of Dupuytren's contracture,
which is treated primarily by an open surgical procedure.
About Auxilium
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical
company with a focus on developing and marketing to urologists,
endocrinologists, orthopedists and select primary care
physicians. Auxilium markets Testim(R) 1%, a topical
testosterone gel, for the treatment of hypogonadism through its
approximately 190-person sales and marketing team. Auxilium has
five projects in clinical development. XIAFLEX(TM) (collagenase
clostridium histolyticum), formerly referred to as AA4500, has
completed phase III clinical trials for the treatment of
Dupuytren's contracture, and the biologics license application
is under review at the FDA for the treatment of Dupuytren's
contracture. The compound is in phase IIb of development for the
treatment of Peyronie's disease and is in phase II of
development for treatment of Frozen Shoulder syndrome (Adhesive
Capsulitis). Auxilium's transmucosal film product candidate for
the treatment of overactive bladder (AA4010) is in phase I of
development. Auxilium also has one pain product (fentanyl) using
its transmucosal film delivery system in phase I of development.
Auxilium has rights to additional pain products and products for
hormone replacement and urologic disease using its transmucosal
film delivery system. The Company is currently seeking a partner
to further develop these transmucosal film product candidates.
Auxilium also has options to all indications using XIAFLEX for
non-topical formulations. For additional information, visit
http://www.auxilium.com.
About 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
Wyeth is now a wholly owned subsidiary of Pfizer Inc. The merger
of local Wyeth and Pfizer entities may be pending in various
jurisdictions and is subject to completion of various local
legal and regulatory obligations.
More information is available at
www.pfizer.com.
AUXILIUM SAFE HARBOR STATEMENT
This release contains "forward-looking-statements" within the
meaning of The Private Securities Litigation Reform Act of 1995,
including statements regarding the value of XIAFLEX, if
approved, to Pfizer's Specialty Care Business Unit's portfolio;
working with Pfizer to secure the approval of XIAFLEX in the EU;
Auxilium's receipt of a $15 million milestone payment from
Pfizer; the number of patients with Dupuytren's contracture;
products in development for Peyronie's disease, Frozen Shoulder
syndrome, overactive bladder, pain, hormone replacement and
urologic disease; and all other statements containing
projections, statements of future performance or expectations,
our beliefs or statements of plans or objectives for future
operations (including statements of assumption underlying or
relating to any of the foregoing). Forward-looking statements
can generally be identified by words such as "believe,"
"appears," "may," "could," "will," "estimate," "continue,"
"anticipate," "intend," "should," "plan," "expect," and other
words and terms of similar meaning in connection with any
discussion of projections, future performance or expectations,
beliefs, plans or objectives for future operations (including
statements of assumption underlying or relating to any of the
foregoing). Actual results may differ materially from those
reflected in these forward-looking statements due to various
factors, including further evaluation of clinical data, results
of clinical trials, decisions by authorities as to whether and
when to approve drug applications, and general financial,
economic, regulatory and political conditions affecting the
biotechnology and pharmaceutical industries and those discussed
in Auxilium's Annual Report on Form 10-K for the year ended
December 31, 2008, in Auxilium's Quarterly Report on Form 10-Q
for the period ended June 30, 2009 and in Auxilium's Quarterly
Report on Form 10-Q for the period ended September 30, 2009
under the heading "Risk Factors", which are on file with the
Securities and Exchange Commission (the "SEC") and may be
accessed electronically by means of the SEC's home page on the
Internet at http://www.sec.gov or by means of Auxilium's home
page on the Internet at http://www.Auxilium.com under the
heading "For Investors -- SEC Filings." There may be additional
risks that Auxilium does not presently know or that Auxilium
currently believes are immaterial which could also cause actual
results to differ from those contained in the forward-looking
statements. Given these risks and uncertainties, any or all of
these forward-looking statements may prove to be incorrect.
Therefore, you should not rely on any such factors or
forward-looking statements.
In addition, forward-looking statements provide Auxilium's
expectations, plans or forecasts of future events and views as
of the date of this release. Auxilium anticipates that
subsequent events and developments will cause Auxilium's
assessments to change. However, while Auxilium may elect to
update these forward-looking statements at some point in the
future, Auxilium specifically disclaims any obligation to do so.
These forward-looking statements should not be relied upon as
representing Auxilium's assessments as of any date subsequent to
the date of this release.
Auxilium disclaims responsibility for statements above in "About
Pfizer Inc.:Working together for a healthier world(TM)", which
were provided by Pfizer for inclusion in this press release.
PFIZER SAFE HARBOR STATEMENT UNDER THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995
The information contained in this release is as of January 21,
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 a
product candidate, XIAFLEX, including its potential benefits,
that involves substantial risks and uncertainties. Such risks
and uncertainties include, among other things, whether and when
the European Medicines Agency will approve the applications that
have been filed with it for XIAFLEX as well as its decisions
regarding labeling and other matters that could affect the
availability or commercial potential of XIAFLEX; 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, 2008 and in its reports on Form 10-Q and Form 8-K.
Pfizer disclaims responsibility for statements above in "About
Auxilium," which were provided by Auxilium for inclusion in this
press release.
Photos/Multimedia Gallery Available:
http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6149734&lang=en
Source
Pfizer Inc.
Pfizer:Gwen Fisher (Media)
O: 484-865-5160
C: 215-407-1548
Gwen.Fisher @pfizer.com
or
Fanny La Monica (European Media)
+39.06.33182452
Fanny.LaMonica @pfizer.com
or
Suzanne Harnett (Investors)
212-733-8009
Suzanne.Harnett @pfizer.com
or
Auxilium:
James E. Fickenscher/CFO
Auxilium Pharmaceuticals, Inc.
(484) 321-5900
jfickenscher @auxilium.com
or
William Q. Sargent Jr./ VP IR
(484) 321-5926
wsargent @auxilium.com
|
