Contact Information: CONTACT: Auxilium Pharmaceuticals James E. Fickenscher Chief Financial Officer Auxilium Pharmaceuticals, Inc. +1-484-321-5900 William Q. Sargent Jr. Vice-President, Investor Relations and Corporate Communications +1-484-321-5900 Ferring Pharmaceuticals Michael George Senior Corporate Communications Manager +41 58 301 0053
Auxilium Pharmaceuticals, Inc. Announces Distribution and License Agreement for Testim(R) in Europe With Ferring Pharmaceuticals
| Source: Auxilium Pharmaceuticals, Inc.
MALVERN, PA and SAINT-PREX, SWITZERLAND--(Marketwire - December 1, 2008) - Auxilium
Pharmaceuticals, Inc. (NASDAQ : AUXL ) and Ferring International S.A. today
announced an exclusive agreement between them for the European distribution
and license rights to Testim®, a proprietary, topical 1% testosterone
once-a-day gel indicated for the treatment of hypogonadism.
"We are very pleased to have Ferring as our partner, given the strength of
their European specialty urology and endocrinology franchises, their
existing commercial infrastructure across Europe, and the successful track
record they have established in commercializing differentiated products in
the European Union," said Armando Anido, Chief Executive Officer and
President of Auxilium. "This agreement enables us to bring our innovative
testosterone replacement product to patients in all of the 15 countries
where Testim has been approved and potentially in additional new countries
within Europe, thus expanding the reach of our Testim franchise outside the
United States."
"Testim will be an excellent complement to our urology portfolio, where we
already have Minirin® for primary nocturnal enuresis and hope to receive
approval for our prostate cancer treatment, degarelix, in the first half of
next year," commented Ferring's Chief Operating Officer, Michel Pettigrew.
"It is a great pleasure to have cemented this partnership with Auxilium,
with whom we share a commitment to the field of urology and a strong focus
on patients."
Under the agreement, Auxilium will be responsible for manufacturing and
supplying Testim to Ferring, while Ferring will be responsible for all
regulatory, sales, marketing and distribution activities in Europe. Under
the agreement with Ferring, Auxilium will receive a combination of upfront,
milestone and royalty payments. Financial details of the agreement were not
disclosed. Testim is currently approved for sale in 15 countries in Europe.
The Company and Ipsen Pharma GmbH recently agreed to mutually terminate
their distribution agreement for Testim in Europe and other countries
outside North America and Japan.
About Testim
Testim is a novel, topical gel formulation that normalizes low levels of
testosterone in men with hypogonadism, a condition that occurs when a man's
body does not produce adequate amounts of testosterone. Men with
hypogonadism or androgen deficiency may suffer from a decrease in energy,
reduced muscle mass, an increase in abdominal fat, decline in libido,
decreased sexual function, anemia, fatigue, depression and reduced bone
density that may result in an increased risk of osteoporosis.
Testim was developed by Auxilium using a proprietary technology licensed
from CPEX Pharmaceuticals, Inc. (NASDAQ : CPEX ), and was launched in the
U.S. by Auxilium's sales force in the first quarter of 2003. Auxilium
received its first European regulatory approval for Testim in the UK in
2003 and currently has regulatory approval in 15 countries in Europe
through the Mutual Recognition Procedure.
About Hypogonadism
A 2006 study that was published in The International Journal of Clinical
Practice showed 39% of men over 45 years of age have low testosterone
(total testosterone levels below 300 ng / dL). Hypogonadism is defined as
reduced or absent secretion of testosterone which can lead to symptoms such
as loss of libido, adverse changes in body composition, irritability and
poor concentration. Auxilium research estimates that approximately 10% of
men with hypogonadism currently receive TRT and that this low diagnosis
rate stems primarily from low patient and physician awareness of the
symptoms, treatment options and monitoring requirements
About Ferring Pharmaceuticals
Ferring is a Swiss-based, research driven, specialty biopharmaceutical
group active in global markets. The company identifies, develops and
markets innovative products in the areas of urology, gastroenterology, and
infertility. In recent years Ferring has expanded beyond its traditional
European base and now has offices in 45 countries. To learn more about
Ferring or our products please visit http://www.ferring.com.
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®
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 (clostridial collagenase for
injection), formerly referred to as AA4500, is in phase III of development
for the treatment of Dupuytren's contracture and is in phase II of
development for the treatment of Peyronie's disease and 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.
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, but not
limited to, statements regarding the size of the market for Testim, the
sales of Testim by Ferring in Europe, the effect of the distribution
agreement with Ferring on the Company's revenues, the ability of Ferring to
fulfill its obligations under the distribution agreement, and products in
development for the treatment of Dupuytren's contracture, Peyronie's
disease, Frozen Shoulder syndrome, overactive bladder and pain. All
statements other than statements of historical facts contained in this
release, including but not limited to, statements regarding future
expectations, plans and prospects for the Company, financial guidance and
other statements containing the words "believe," "may," "could," "will,"
"estimate," "continue," "anticipate," "intend," "should," "plan," "expect,"
and similar expressions, as they relate to the Company, constitute
forward-looking statements. Actual results may differ materially from those
reflected in these forward-looking statements due to various factors,
including general financial, economic, regulatory and political conditions
affecting the biotechnology and pharmaceutical industries and those
discussed in the Company's Annual Report on Form 10-K for the period ended
December 31, 2007 and the Company'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 the Company's home page on the Internet
at http://www.auxilium.com under the heading "Investor Relations - SEC
Filings." There may be additional risks that the Company does not presently
know or that the Company 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 the Company's expectations,
plans or forecasts of future events and views as of the date of this
release. The Company anticipates that subsequent events and developments
will cause the Company's assessments to change. However, while the Company
may elect to update these forward-looking statements at some point in the
future, the Company specifically disclaims any obligation to do so. These
forward-looking statements should not be relied upon as representing the
Company's assessments as of any date subsequent to the date of this
release.