XIAPEX(R) (Collagenase Clostridium Histolyticum) Receives Positive CHMP Opinion

By Pfizer Inc., PRNE
Wednesday, December 15, 2010

Collagenase Clostridium Histolyticum Recommended for Approval in the European Union (EU) for the Treatment of Dupuytren's Contracture in Adult Patients with a Palpable Cord(1)

NEW YORK and MALVERN, Pennsylvania, December 16, 2010 - Pfizer Inc. (NYSE: PFE) has received a positive opinion from the European
Medicines Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) recommending European Union (EU) approval for XIAPEX(R) (collagenase
clostridium histolyticum) as treatment for Dupuytren's contracture in adult
patients with a palpable cord.(1) Collagenase clostridium histolyticum is the
first injectable treatment to be recommended for approval in the EU for the
treatment of Dupuytren's contracture, a condition that has been primarily
treated by invasive surgical therapies. Pfizer has the marketing rights to
collagenase clostridium histolyticum in Europe and Auxilium Pharmaceuticals
Inc. (Nasdaq: AUXL) has the rights in the rest of the world.

    (Logo: photos.prnewswire.com/prnh/20100416/PFIZERLOGO)
    (Logo: photos.prnewswire.com/prnh/20101216/NY18766LOGO)

The CHMP's positive recommendation will be reviewed by the European
Commission, which has authority to approve medicines for the European Union.
Pfizer anticipates a final decision from the European Commission by the end
of the first quarter of 2011. The positive CHMP opinion is based on results
from two pivotal studies, Collagenase Option for Reduction of Dupuytren's
(CORD I and CORD II).(2,3)

Dupuytren's disease affects up to 13% of the European population.(4-7) It
is a slowly progressive condition affecting the connective tissue in the palm
of the hand and the fingers.(8) Early in the disease, the formation of
nodules leads to an increase in collagen deposits, and later the formation of
pathological cords, which cause debilitating joint contractures and
fixed-flexion deformities (where the finger is permanently bent inwards into
the palm of the hand), known as Dupuytren's contracture.(8) Once contracture
has occurred, the affected finger often impacts on the ability to carry out
everyday tasks.(8)

Notes to Editors

About Dupuytren's contracture

Dupuytren's disease is a slowly progressive connective tissue disorder
that affects the tissue in the palm of the hand and the fingers.(8) An
increase in collagen deposits leads to the formation of nodules that form
early in the disease, and later, pathological cords, which cause debilitating
joint contractures and fixed-flexion deformities (where the finger is
permanently bent inwards into the palm of the hand), known as Dupuytren's
contracture.(8) Once contracture has occurred, the affected finger often gets
in the way of everyday tasks such as face washing, putting the hand in a
pocket or glove, driving or playing sports.(9)

Dupuytren's disease is found more frequently in people of white northern
European descent(10) and the highest prevalence has been seen in northern
Scotland, Iceland and Norway.(11,12) Most cases of Dupuytren's disease occur
in patients older than 50 years(10), and the condition is more common in men
who also tend to be more severely affected by Dupuytren's disease than female

Dupuytren's disease can affect up to 20% of men who are over 60 years of
age, and 20% of women who are over 80 years of age.(8) This means that as the
ageing population increases, so does the incidence of Dupuytren's disease.(9)

About XIAPEX(R) (Collagenase clostridium histolyticum)

Collagenase clostridium histolyticum is a combination of two purified
collagenases (collagenase is an enzyme capable of breaking down collagen),
derived from the bacterium Clostridium histolyticum.(14) It is the first
pharmacological treatment to be developed for Dupuytren's contracture and may
be an alternative to invasive and often complicated surgery for patients in
the EU.(15) Collagenase clostridium histolyticum is administered by local
injection directly into the Dupuytren's cord - a procedure which can be
carried out in an outpatient setting.(14) It works by breaking down the
structure of the cord and 24 hours after injection, a finger extension
procedure can be carried out as necessary to break the cord and allow
extension of the finger.(14) If contracture remains four weeks after
treatment, another injection can be administered into the same cord, and the
finger extension procedure can be carried out again. Injections and finger
extension procedures may be administered up to three times per cord, at
approximately four-week intervals.(14)

Pfizer has the marketing rights to collagenase clostridium histolyticum
in Europe and Auxilium Pharmaceuticals Inc. (Nasdaq: AUXL) has the rights in
the rest of the world. Collagenase clostridium histolyticum has been approved
in the U.S. by the Food and Drug Administration (tradename in the US
XIAFLEX(R)) for treatment of adult patients with Dupuytren's contracture.(14)

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About Auxilium

Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company
with a focus on developing and marketing products to predominantly specialist
audiences, such as urologists, endocrinologists, certain targeted primary
care physicians, hand surgeons, subsets of orthopedic, general, and plastic
surgeons who focus on the hand, and rheumatologists. Auxilium markets
XIAFLEX(R) (collagenase clostridium histolyticum) for the treatment of adult
Dupuytren's contracture patients with a palpable cord and Testim(R) 1%, a
topical testosterone gel, for the treatment of hypogonadism. Auxilium has
four projects in clinical development. XIAFLEX is in phase III 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) and its fentanyl pain product using its transmucosal delivery system
are in phase I of development. The Company is currently seeking a partner to
further develop these product candidates. Auxilium has rights to 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 www.auxilium.com.

Disclosure Notice: The information contained in this release is as of
December 16, 2010. 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,
collagenase clostridium histolyticum, that is under review by regulatory
authorities in the EU. Such risks and uncertainties include, among other
things, whether and when such regulatory authorities will approve collagenase
clostridium histolyticum, their decisions regarding labelling 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,
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 release.

Auxilium Safe Harbor Statement

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 approval for XIAPEX for the treatment of Dupuytren's
contracture in Europe; Pfizer's ability to commercialize XIAPEX for
Dupuytren's contracture in the EU; the potential benefits and effectiveness
of XIAFLEX for Dupuytren's contracture; the number of people suffering from
Dupuytren's contracture; 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, 2009 and in Auxilium's Quarterly
Report on Form 10-Q for the period ended September 30, 2010 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 www.sec.gov or by means of Auxilium's home
page on the Internet at 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.


(1) Meeting highlights from the Committee for Medicinal Products for
Human Use (CHMP), December 2010 www.emea.europa.eu

(2) Hurst LC, Badalamente MA, Hentz VR et al. Injectable collagenase
clostridium histolyticum for Dupuytren's contracture (CORD I). NEJM 2003;
361: 968-79

(3) Gilpin D, et al. Injectable Collagenase Clostridium Histolyticum: A
New Nonsurgical Treatment for Dupuytren's Contracture. J Hand Surg 2010;
35(12): 2027-2038

(4) Attali P, Ink O, Pelletier G, et al. Dupuytren's contracture, alcohol
consumption, and chronic liver disease. Arch Intern Med 1987; 147(6):

(5) Bergenudd H, Lindgarde F, Nilsson BE. Prevalence of Dupuytren's
contracture and its correlation with degenerative changes of the hands and
feet and with criteria of general health. J Hand Surg [Br] 1993; 18(2):

(6) Godtfredsen NS, Lucht H, Prescott E, Sorensen TI, Gronbaek M. A
prospective study linked both alcohol and tobacco to Dupuytren's disease. J
Clin Epidemiol 2004; 57(8): 858-863

(7) Finsen V, Dalen H, Nesheim J. The prevalence of Dupuytren's disease
among 2 different ethnic groups in northern Norway. J Hand Surg [Am] 2002;
27(1): 115-117

(8) NHS Choices website. Dupuytren's contracture. Available from:

Last accessed 26.04.10

(9) Bayat A and McGrouther DA. Management of Dupuytren's disease - clear
advice for an elusive condition. Ann R Coll Surg Engl 2006; 88: 3-8

(10) Townley WA, et al. Dupuytren's contracture unfolded. BMJ 2006; 332:

(11) Hart MG, Hooper G. Clinical associations of Dupuytren's disease.
Postgrad Med J 2005; 81: 425-428

(12) Trojian TH, Chu SM. Dupuytren's disease: diagnosis and treatment. Am
Fam Physician 2007; 76: 86-9

(13) Gudmundsson KG, et al. Epidemiology of Dupuytren's disease:
clinical, serological, and social assessment. The Reykjavik Study. J Clin
Epidemiology 2000; 53: 291-6

(14) XIAFLEX(R) prescribing information.
www.xiaflex.com/docs/pi_medguide_combo.pdf Last accessed 09.11.10

(15) US Food and Drug Administration press release, 2nd February 2010.
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm199736.htm Last
accessed 26.04.10

Pfizer Media, Emma Lynn, +44-7815-955471, emma.lynn at pfizer.com, or Curtis Allen, +1-212-733-2096, curtis.l.allen at pfizer.com; or Pfizer Investors, Jennifer Davis , +1-212-733-0717, jennifer.m.davis at pfizer.com; or Auxilium, Will Sargent, +1-484-321-5926, wsargent at auxilium.com

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