MALVERN, Pa., Dec. 20 /PRNewswire-FirstCall/ -- Auxilium Pharmaceuticals,
Inc. (Nasdaq: AUXL), a specialty pharmaceutical company, today announced that
it has exercised its option to expand its rights to an additional indication
of AA4500, Auxilium's injectable enzyme, to include frozen shoulder syndrome
(adhesive capsulitis). Pursuant to the terms of the development and license
agreement with BioSpecifics Technologies Corp., Auxilium receives exclusive
global rights to develop and commercialize AA4500 for the frozen shoulder
indication having exercised its option. Auxilium also has an exclusive global
license to develop and commercialize AA4500 for the treatment of Dupuytren's
and Peyronie's Diseases, and both indications have been granted orphan drug
status by the U.S. Food and Drug Administration.
BioSpecifics Technologies has conducted a phase II clinical trial using
the injectable enzyme in the treatment of frozen shoulder syndrome. Three
different doses of the enzyme were compared to placebo in this prospective,
randomized trial in 60 subjects. The results from this trial suggest that
local injection of the enzyme is well-tolerated and may be effective in
patients suffering from frozen shoulder syndrome. Additional studies are
needed to assess the optimal dose and dosing regimen of AA4500 in this
indication.
"AA4500 is a very important product candidate for Auxilium, and we believe
the addition of a third indication for this development program enhances the
commercial potential of AA4500," said Gerri Henwood, Chief Executive Officer
of Auxilium.
About Frozen Shoulder Syndrome
Frozen shoulder syndrome is a disorder of diminished shoulder motion,
characterized by restriction in both active and passive range of motion of the
shoulder joint. It is estimated that 3% of people develop frozen shoulder
syndrome over their lifetime and that women tend to be affected more
frequently than men. The literature indicates that frozen shoulder usually
affects patients aged 40-70 years. A higher incidence of frozen shoulder
exists among patients with diabetes (10-20%) compared to the general
population (2-5%). Incidence among patients with insulin-dependent diabetes is
even higher (36%), with an increased frequency of bilateral shoulder
involvement.(1-3)
About Dupuytren's Disease
Dupuytren's Disease is a condition that involves contracture of joints,
predominantly in the hand, due to the growth of scar tissue around tendons and
ligaments, commonly described as the development of a "cord." For patients
that have Dupytren's Disease involving their hands, as the disease progresses,
the patient's ability to straighten affected fingers is lost, and the
functionality of the hand is impaired. The incidence of Dupuytren's Disease
is highest in Caucasians, historically those of Northern European descent.
Most cases of Dupuytren's Disease occur in patients older than 50 years.(4)
About Peyronie's Disease
Peyronie's Disease is characterized by the formation of a scar or hard
plaque in the shaft of the penis that causes curvature, and distortion, of the
penis while erect. The incidence of Peyronie's Disease has been estimated to
be approximately 1-3% of men, although studies indicate that the incidence is
higher. It is believed that prevalence may be higher because of reluctance to
seek medical attention for the condition and failure to report in cases with
mild symptoms. Peyronie's Disease is most common in men between the ages of
45 and 60.(5)
About Auxilium
Auxilium Pharmaceuticals, Inc. is a specialty pharmaceutical company with
a current focus on urology and sexual health. Auxilium markets Testim(R) 1%,
a topical testosterone gel, for the treatment of hypogonadism through its
approximately 120 person sales and marketing team. Auxilium is developing two
products currently in Phase II, one for treatment of Peyronie's Disease and
Dupuytren's Disease, and the second for testosterone replacement using its
licensed transmucosal film delivery system. Auxilium has a product in Phase I
of development for the treatment of overactive bladder using its licensed
transmucosal film delivery system. Auxilium is evaluating formulations for
pain product candidates using its licensed transmucosal film delivery system,
products for androgen replacement and other products for urologic and sexual
health. For additional information, visit http://www.auxilium.com.
(1) Galarraga B. Adhesive capsulitis of the shoulder. CPD Rheum. 2002;
3:54-58.
(2) Dahan THM, Roy A, Fortin L and Dahan B. Adhesive capsulitis.
eMedicine. 2005
http://www.emedicine.com/pmr/topic8.htm#section~author_information
(3) Gilliland B. Periarticular disorders of the extremities. In
Braunwald E, Fauci AS, Kasper DL, Hauser SL, Longo DL and Jameson JL
(ed): Harrison's Principles of Internal Medicine 15th Edition. New
York, McGraw-Hill, 2001 pp 2017-2018.
(4) 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)
(5) Gholami, S. S., Gonzalez-Cadavid, N. F. et al., Peyronie's Disease: A
Review, The Journal of Urology, (April 2003;vol. 169:1234-1241)
Safe Harbor Statement
This release contains "forward-looking-statements" within the meaning of
The Private Securities Litigation Reform Act of 1995, including statements
regarding the development of AA4500 for the treatment of Frozen Shoulder
Syndrome; the interpretation of clinical results; the development of Testim;
products in development for treatment of Peyronie's and Dupuytren's Diseases;
products in development for testosterone replacement, overactive bladder and
pain using a transmucosal film delivery system, as well as other products for
urology and sexual health. 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, statements
regarding forward-looking financial information 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 Quarterly Report on Form 10-Q for the quarterly period ended
September 30, 2005 under the heading "Factors That May Affect Our Future
Results", 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.
-0- 12/20/2005
/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/
/Web site: http://www.auxilium.com /
(AUXL)
CO: Auxilium Pharmaceuticals, Inc.
ST: Pennsylvania
IN: MTC HEA
SU: PDT
EA
-- NYTU018 --
9773 12/20/2005 08:00 EST http://www.prnewswire.com
