Pfizer Obtains Exclusive Rights in 46 European and Eurasian Countries; Auxilium to Hold Conference Call Tomorrow, December 18, 2008 at 8:00 a.m. ESTMALVERN, PA and NEW YORK, NY, Dec 17, 2008 (MARKET WIRE via COMTEX News Network) -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) and Pfizer, Inc.
(NYSE: PFE) announced today that they have entered into a strategic
alliance for the development, commercialization and supply of
XIAFLEX(TM) (clostridial collagenase for injection), a novel,
first-in-class, late-stage biologic, for the treatment of Dupuytren's
contracture and Peyronie's disease. Under the terms of the
agreement, 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.
Auxilium has completed Phase III trials for XIAFLEX in Dupuytren's
contracture and expects to file a U.S. biologics license application
(BLA) for the treatment of Dupuytren's contracture with the U.S. Food
and Drug Administration in early 2009. Pfizer expects to file XIAFLEX
for approval for the treatment of Dupuytren's contracture in Europe
in 2010. XIAFLEX is also being evaluated in a Phase IIb trial for
Peyronie's disease with top line data expected in late 2009.
"Today, Pfizer and Auxilium have forged a compelling partnership and
together we believe we have the opportunity to offer the first,
effective non-surgical treatment for two diseases," said Armando
Anido, Chief Executive Officer and President of Auxilium. "With the
strength of Pfizer's commercialization and development organization,
this relationship greatly enhances our ability to effectively
introduce this potentially groundbreaking technology for the
treatment of Dupuytren's contracture and Peyronie's disease in
Europe."
Under the agreement, Pfizer will make an up-front payment of $75
million to Auxilium and up to $410 million in potential milestone
payments, with $150 million tied to regulatory milestones and $260
million based on sales milestones. Auxilium will receive increasing
tiered royalties based on sales of XIAFLEX in Pfizer's territories.
"Our partnership with Auxilium is a testament to Pfizer's commitment
to draw on the best external science for innovative products that
complement our existing portfolio and fill unmet medical needs," said
Olivier Brandicourt, President and General Manager of Pfizer's
Specialty Care Business Unit. "We look forward to combining our
strengths to further the potential for XIAFLEX as an advanced new
treatment for patients suffering from Dupuytren's contracture and
Peyronie's disease."
Auxilium will remain primarily responsible for the global development
of XIAFLEX and will be responsible for all clinical and commercial
drug manufacturing and supply. Pfizer will share clinical development
costs for certain trials required for the EU and be responsible for
all discretionary development within the countries for which it has
exclusive rights to commercialize XIAFLEX. Pfizer will have a right
of negotiation to obtain exclusive rights to commercialize XIAFLEX
pipeline indications in its territories.
Conference Call
Auxilium will hold a conference call tomorrow, December 18, 2008 at
8:00 a.m. EST, to discuss the partnership. The conference call will be
simultaneously web cast on Auxilium's web site and archived for
future review until January 18, 2009.
Conference call details:
Date: Thursday, December 18, 2008
Time: 8:00 a.m. EST
Dial-in (U.S.): 866-362-4820
Dial-in (International): 617-597-5345
Web cast: http://www.auxilium.com
Passcode: AUXILIUM
To access an audio replay of the call:
Access number (U.S.): 888-286-8010
Access number (International): 617-801-6888
Replay Passcode #: 49496900
About XIAFLEX
XIAFLEX (clostridial collagenase for injection) is an investigational
new drug that has completed phase III clinical trials for the
treatment of Dupuytren's contracture, is in Phase IIb of development
for the treatment of Peyronie's disease and is in Phase II of
development for the treatment of Frozen Shoulder syndrome (Adhesive
Capsulitis). As an investigational non-surgical treatment for these
conditions, XIAFLEX is a combination of several subtypes of
collagenase, derived from clostridium histolyticum, in specific
proportion. Together, they work synergistically to break the bonds of
the triple helix collagen structure more effectively than human
collagenase.
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
contracture is highest in Caucasians, historically those of Northern
European descent, with a global prevalence of three to six percent of
the Caucasian population.(1) Most cases of Dupuytren's contracture
occur in patients older than 50 years.(2)
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. There are
currently no drugs approved by the U.S. Food and Drug Administration
for Dupuytren's contracture, which is treated primarily by an open
surgical procedure.
(1) American Academy of Orthopaedic Surgeons.
http://orthoinfo.aaos.org/topic.cfm?topic=A00008
(2) Badalamente, M. A., Hurst, L. C. et al., Collagen as a Clinical
Target: Nonoperative Treatment of Dupuytren's Disease, The Journal of
Hand Surgery, (2002;27A:788-798)
About Peyronie's Disease
Peyronie's disease is the development of collagen plaque, or scar
tissue, on the shaft of the penis that hardens and reduces
flexibility, thus causing pain and forcing the penis to bend or arc
during erection. This often can prevent sexual intercourse. In
addition to difficulty with sexual intercourse, Peyronie's disease
may also be associated with emotional distress, loss of self-esteem
and depression. In certain populations, the estimated number of men
affected by Peyronie's Disease may be as high as 9 percent in men
over 60 years of age and 3 percent in men over 30.(3)
(3) L.A. Levine Peyronie's Disease: A Guide to Clinical Management.
Humana Press: 10-17, 2007.
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. XIAFLEXTM (clostridial collagenase for injection),
formerly referred to as AA4500, has completed phase III clinical
trials for the treatment of Dupuytren's contracture, 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. The Company is currently seeking a partner to
further develop this product candidate. Auxilium also has one pain
product (fentanyl) using its transmucosal film delivery system in
phase I of development. Auxilium has rights to seven additional pain
products and products for hormone replacement and urologic disease
using its transmucosal film delivery system. Auxilium also has
options to all indications using XIAFLEX for non-topical
formulations. For additional information, visit
http://www.auxilium.com.
About Pfizer
Founded in 1849, Pfizer is the world's largest research-based
pharmaceutical company. Pfizer is taking new approaches to advancing
better health as it discovers, develops, manufactures and delivers
quality, safe and effective prescription medicines to treat and help
prevent disease for both people and animals. Pfizer also partners
with healthcare providers, governments and local communities around
the world to expand access to medicines and to provide better quality
health care and health system support. For more information visit
www.pfizer.com
Auxilium Safe Harbor Statement
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995
This release contains "forward-looking-statements" within the meaning
of The Private Securities Litigation Reform Act of 1995, including
statements regarding the timing of filing of the biologics license
application for XIAFLEX for the treatment of Dupuytren's contracture
with the U.S. Food and Drug Administration; the timing of filing for
approval for XIAFLEX for the treatment of Dupuytren's contracture in
Europe; the timing of results from the Phase IIb trial for XIAFLEX
for the treatment of Peyronie's; Pfizer's ability to develop,
register for approval and commercialize XIAFLEX for Dupuytren's
contracture and Peyronie's disease in the licensed territory;
Auxilium's receipt of milestone payments and royalties from Pfizer;
the benefits of the strategic alliance between Auxilium and Pfizer;
the potential benefits and effectiveness of XIAFLEX for Dupuytren's
contracture and Peyronie's disease; the number of people suffering
from Dupuytren's contracture and Peyronie's disease; and all other
statements containing projections, statements of future performance
or expectations, or statements of plans or objectives for future
operations (including statements of assumption underlying or relating
to any of the foregoing). You can identify these statements by the
fact that they use 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, 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 regulatory 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,
2007 and in Auxilium's Quarterly Report on Form 10-Q for the period
ended September 30, 2008 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 "Investor
Relations -- 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," which were provided by Pfizer for inclusion in this release.
Pfizer Safe Harbor Statement
The information contained in this release is as of December X, 2008.
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 about an agreement
to market a product candidate, including its potential benefits, that
involves substantial risks and uncertainties. Such risks and
uncertainties include, among other things, the uncertainties inherent
in research and development; decisions by regulatory authorities
regarding whether and when to approve any drug applications that may
be filed for such product candidate as well as their decisions
regarding labeling and other matters that could affect its
availability or commercial potential; 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, 2007 and in its reports on Form 10-Q and Form 8-K.
CONTACT:
Auxilium:
James E. Fickenscher
Chief Financial Officer, Auxilium Pharmaceuticals, Inc.
+1-484-321-5900
jfickenscher@auxilium.com
or
William Q. Sargent Jr.
Vice-President, Investor Relations and Corporate Communications
+1-484-321-5900
wsargent@auxilium.com
Pfizer:
Media
Joan Campion
212-733-2798
Joan.Campion@Pfizer.com
or
Investors
Suzanne Harnett
212-733-8009
Suzanne.Harnett@Pfizer.com
SOURCE: Auxilium Pharmaceuticals, Inc.
mailto:jfickenscher@auxilium.com
mailto:wsargent@auxilium.com
mailto:Joan.Campion@Pfizer.com
mailto:Suzanne.Harnett@Pfizer.com