MALVERN, PA and SAINT-PREX, SWITZERLAND, Dec 01, 2008 (MARKET WIRE via COMTEX News Network) -- 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(R), 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(R) 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(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) (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.
CONTACT:
Auxilium Pharmaceuticals
James E. Fickenscher
Chief Financial Officer
Auxilium Pharmaceuticals, Inc.
+1-484-321-5900
Email Contact
William Q. Sargent Jr.
Vice-President, Investor Relations and Corporate Communications
+1-484-321-5900
Email Contact
Ferring Pharmaceuticals
Michael George
Senior Corporate Communications Manager
+41 58 301 0053
Email Contact
SOURCE: Auxilium Pharmaceuticals, Inc.