MALVERN, Pa., Dec. 12 /PRNewswire-FirstCall/ -- Auxilium Pharmaceuticals,
Inc. (Nasdaq: AUXL) today announced an exclusive agreement with Paladin Labs
(TSX: PLB) for the Canadian distribution rights to Testim(R), its topical
testosterone gel, indicated for the treatment of patients with hypogonadism.
"We are pleased to have Paladin as a partner, given their specialty
urology focus, their existing commercial infrastructure in Canada, and the
successful track record they have established in acquiring and launching
differentiated products in that territory," said Armando Anido, Chief
Executive Officer and President of Auxilium. "This agreement enables us to
bring our innovative testosterone replacement product to Canadian patients and
to continue to expand the reach of our Testim franchise outside the United
States."
Under the agreement, Auxilium will be responsible for manufacturing and
supplying Testim to Paladin. Paladin will be responsible for all sales,
marketing and distribution activities in Canada. Financial details of the
agreement were not disclosed.
Testim is approved for sale in 15 countries outside the United States.
The Company and Bayer Inc. of Canada recently agreed to mutually terminate
their distribution agreement for Testim in Canada.
About Hypogonadism
According to a 2001 article published in The Journal of Clinical
Endocrinology & Metabolism, hypogonadism affects approximately 20% of the U.S.
male population over age 50. 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. The
U.S. Food and Drug Administration estimates that only 5% of men with
hypogonadism currently receive testosterone replacement therapy.
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 180-person sales and marketing team. Auxilium has four projects
in clinical development. Auxilium believes that AA4500, an injectable enzyme,
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 has two pain products using its
transmucosal film delivery system in pre-clinical development. Auxilium has
rights to six additional pain products and products for hormone replacement
and urologic disease using its transmucosal film delivery system, and options
to all indications using AA4500 for non-topical formulations. For additional
information, visit http://www.auxilium.com.
Safe Harbor Statement
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 Paladin Labs in Canada, the effect of the distribution agreement
with Paladin on the Company's revenues, the ability of Paladin Labs to fulfill
its obligations under the distribution agreement, and the timing for the
commencement of various clinical trials for Auxilium's product candidates,
including AA4500, during 2006. 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, 2005 and the Company's Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2006 under the heading "Risk Factors",
which is 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.
SOURCE Auxilium Pharmaceuticals, Inc.
CONTACT:
James E. Fickenscher
Chief Financial Officer of Auxilium
Pharmaceuticals, Inc.
+1-484-321-5900, jfickenscher@auxilium.com;
or
Gregory
Gin
of Lazar Partners, Ltd.
+1-212-867-1762, ggin@lazarpartners.com
for
Auxilium Pharmaceuticals, Inc.