Auxilium Pharmaceuticals, Inc. and FCB I LLC Announce the Issuance of Composition of Matter Patent Covering Testim
MALVERN, Pa. and MAHWAH, N.J., May 17, 2012 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) ("Auxilium") and FCB I LLC ("FCB") today announced that the United States Patent and Trademark Office ("USPTO") has issued U.S. Patent No. 8,178,518 covering, among other things, Testim® 1% testosterone gel, marketed by Auxilium under license from FCB. The newly issued patent, which claims certain pharmaceutical compositions comprising testosterone, is expected to expire in April 2023. Auxilium has also submitted the patent for listing in the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration.
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"We are very pleased that, in addition to the nine previously issued patents covering methods using Testim, the franchise is now further protected by a composition patent," said Mr. Adrian Adams, Chief Executive Officer and President of Auxilium. "This further strengthens our Testim patent estate which we intend to vigorously defend by pursuing all available legal and regulatory options in defense of Testim, including enforcement of all intellectual property rights and approved labeling."
About Auxilium
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical
company with a focus on developing and marketing products to
predominantly specialist audiences. Auxilium markets XIAFLEX®
(collagenase clostridium histolyticum) for the treatment of adult
Dupuytren's contracture patients with a palpable cord and
Testim® 1%, a testosterone gel, for the topical treatment of
hypogonadism in the U.S. Pfizer has marketing rights for
XIAPEX® (the EU tradename for collagenase clostridium
histolyticum) in Europe; Asahi Kasei Pharma Corporation has
development and commercial rights for XIAFLEX in Japan; and
Actelion Pharmaceuticals Ltd has development and commercial rights
for XIAFLEX in Canada, Australia, Brazil and Mexico. Ferring
International Center S.A. markets Testim in the EU and Paladin Labs
Inc. markets Testim in Canada. Auxilium has three projects in
clinical development. XIAFLEX is in phase III of development for
the treatment of Peyronie's disease, phase IIa of development for
the treatment of Frozen Shoulder syndrome (Adhesive Capsulitis) and
phase Ib of development for the treatment of cellulite (edematous
fibrosclerotic panniculopathy). Auxilium also has rights to pursue
additional indications for XIAFLEX. For additional information,
visit http://www.auxilium.com.
About FCB I LLC
FCB is an indirect, majority-owned subsidiary of Xstelos Holdings,
Inc. (OTC Pink Sheets: XTLS.PK).
AUXILIUM SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES
LITIGATION REFORM ACT OF 1995
This news release contains forward-looking statements as defined by
the Private Securities Litigation Reform Act of 1995, which discuss
matters that are not facts, and may include words to indicate their
uncertain nature such as "believe," "expect," anticipate,"
"intend," "plan," "should," "could," "estimate," "project," "will,"
and "target." Auxilium's forward-looking statements convey
management's expectations, beliefs, plans and objectives regarding
future performance of Auxilium and are based upon preliminary
information and management assumptions. No specific assurances can
be given with respect to whether patents covering Auxilium's
products will remain in force until their expected expiration dates
or whether Auxilium will pursue any of the legal or regulatory
options available to it in defense of the patents covering Testim,
including enforcement of the intellectual property rights and
approved labeling, or whether Auxilium will be successful in any of
those efforts that it does choose to pursue. While Auxilium may
elect to update the forward-looking statements made in this news
release in the future, Auxilium specifically disclaims any
obligation to do so. Such forward-looking statements are subject to
a wide range of risks and uncertainties that could cause Auxilium's
results to differ in material respects, including those relating to
product development, revenue, expense and earnings expectations,
intellectual property rights, litigation strategies, and the timing
and content of decisions made by regulatory authorities, including
the U.S. Food and Drug Administration, and those risks discussed in
Auxilium's reports on file with the Securities and Exchange
Commission (the "SEC"). Auxilium's SEC filings may be accessed
electronically by means of the SEC's home page on the Internet at
http://www.sec.gov
or by means of Auxilium's home page on the Internet at http://www.auxilium.com
under the heading "For Investors - 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.
FCB I LLC SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES
LITIGATION REFORM ACT OF 1995
This news release contains forward-looking statements as defined by
the Private Securities Litigation Reform Act of 1995. These
forward-looking statements are based on FCB's parent companies'
current estimates and assumptions and, as such, involve uncertainty
and risk. Forward-looking statements include the information
concerning FCB and its parent companies' possible or assumed future
results of operations and also include those preceded or followed
by the words "anticipates," "believes," "could," "estimates,"
"expects," "intends," "may," "should," "plans," "targets" and/or
similar expressions. These statements relate to future events or
future financial performance and involve known and unknown risks,
uncertainties and other factors that could cause FCB or its parent
companies' actual results, levels of activity, performance or
achievement to differ materially from those expressed or implied by
these forward-looking statements. These risks and uncertainties
include, among others, competition from existing products or new
products that may emerge, regulatory difficulties relating to
products that have already received regulatory approval, potential
product liability claims, dependency on third-party manufacturers
to supply or manufacture products, ability to establish or maintain
collaborations, licensing or other arrangements, Xstelos' ability
and third parties' abilities to protect intellectual property
rights, limitation on the ability to utilize net operating losses,
compliance with obligations under intellectual property licenses
with third parties, ability to successfully invest for future
growth, and those risks discussed in Xstelos' reports on file with
the SEC. The forward-looking statements are not guarantees of
future performance, events or circumstances, and actual results may
differ materially from those contemplated by these forward-looking
statements. For these reasons, one should not place undue reliance
on any forward-looking statements. Xstelos' SEC filings may be
accessed electronically by means of the SEC's home page on the
Internet at http://www.sec.gov
Auxilium Contacts:
James E. Fickenscher / CFO
William Q. Sargent, Jr. / V.P., IR
Auxilium Pharmaceuticals, Inc.
Auxilium Pharmaceuticals,
Inc.
(484) 321-5900
(484) 321-5900
jfickenscher@auxilium.com
wsargent@auxilium.com
FCB I LLC Contacts:
Jonathan M. Couchman, President
FCB I LLC
(603) 658-6100 x502
SOURCE Auxilium Pharmaceuticals, Inc.
Web Site: http://www.auxilium.com
Posted: May 2012
