Auxilium Pharmaceuticals, Inc. and Xstelos Holdings, Inc. Receive 505(b)(2) Paragraph IV Certification Notice from Upsher-Smith

 Auxilium Pharmaceuticals, Inc. and Xstelos Holdings, Inc. Receive 505(b)(2)
  Paragraph IV Certification Notice from Upsher-Smith Laboratories, Inc. for
                                   Testim®

PR Newswire

MALVERN, Pa. and NEW YORK, Jan. 3, 2013

MALVERN, Pa. and NEW YORK, Jan. 3, 2013 /PRNewswire/ --Auxilium
Pharmaceuticals, Inc. (NASDAQ: AUXL)("Auxilium") and Xstelos Holdings, Inc.
(OTCQB: XTLS) ("Xstelos") today announced that they have received a notice
from Upsher-Smith Laboratories, Inc. ("USL") that advises them of USL's filing
of a 505(b)(2) New Drug Application (NDA) containing a Paragraph IV
certification under 21 U.S.C. Section 314.52(c) for testosterone gel. This
Paragraph IV certification notice refers to the ten U.S. patents, covering
Testim®, 1% testosterone gel, that are listed in the Approved Drug Products
with Therapeutic Equivalence Evaluations (commonly known as the Orange Book),
published by the U.S. Food and Drug Administration. These ten patents are
owned by FCB I LLC, an indirect majority owned subsidiary of Xstelos. Xstelos
holds the assets of CPEX Pharmaceuticals, Inc., the predecessor owner of the
patents. The referenced Testim patents will expire between 2023 and 2025.

(Logo: http://photos.prnewswire.com/prnh/20101202/MM10881LOGO )

Auxilium and Xstelos are currently reviewing the details of this notice from
Upsher Smith. Auxilium and Xstelos intend to pursue all available legal and
regulatory options in defense of Testim, including enforcement of their
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 Testim® 1% (testosterone gel) for the topical
treatment of hypogonadism and XIAFLEX® (collagenase clostridium histolyticum)
for the treatment of adult DC patients with a palpable cord in the U.S. GSK
co-promotes Testim with Auxilium in the U.S. Ferring International Center S.A.
markets Testim in certain countries of the EU and Paladin Labs Inc. markets
Testim in Canada. Pfizer has marketing rights for XIAPEX® (the EU tradename
for collagenase clostridium histolyticum) in 46 countries in Eurasia through
April 24, 2013; 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. The
sBLA for XIAFLEX for the treatment of PD was submitted to the FDA on November
6, 2012 and has been accepted for Standard review with a PDUFA date of
September 6, 2013. Additionally, collagenase clostridium histolyticum (CCH) is
in 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 CCH. For additional information, visit
http://www.auxilium.com.

About Xstelos

Xstelos is a holding company formed for the purpose of holding the assets of
CPEX Pharmaceuticals, Inc., an indirect, majority owned subsidiary of Xstelos.

Subject to certain exceptions, including prior exemption by Xstelos' board of
directors, Xstelos' Certificate of Incorporation prohibits and makes void ab
initio certain transfers of its common stock, to the extent that after giving
effect to such purported transfer (i) the purported transferee would become a
4.75% or greater holder of its common stock, (ii) the ownership of a 4.75%
stock holder's common stock, prior to giving effect to the purported transfer,
would be increased or (iii) the transfer creates a new "public group" under
Treasury Section 1.382-2T(j)(3)(i).

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 Auxilium will pursue any of the legal or regulatory
options available to it in defense of the ten patents covering Testim,
including enforcement of their 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 the 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.

XSTELOS SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995

This press release contains statements that are forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of
1995.These statements are based on current expectations, estimates and
projections about Xstelos' business based, in part, on assumptions made by
management.These statements are not guarantees of future performance and
involve risks, uncertainties and assumptions that are difficult to
predict.Therefore, actual outcomes and results may differ materially from
what is expressed or forecasted in such forward-looking statements due to
numerous factors, including those described above and the following:the
expectation that Xstelos' business and operations will continue as presently
conducted; 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; Xstelos' dependency
on third-party manufacturers to supply or manufacture Xstelos' products;
Xstelos' ability to establish or maintain collaborations, licensing or other
arrangements; Xstelos' ability and third parties' abilities to protect
intellectual property rights; limitations of Xstelos' ability to utilize its
net operating losses; compliance with obligations under intellectual property
licenses with third parties; Xstelos' ability to successfully invest for
future growth; and other risks discussed from time to time in Xstelos'
Securities and Exchange Commission filings and reports.In addition, such
statements could be affected by general industry and market conditions and
growth rates, and general domestic and international economic
conditions.Such forward-looking statements speak only as of the date on
which they are made, and Xstelos does not undertake any obligation to update
any forward-looking statement to reflect events or circumstances after the
date of this release.

Auxilium Contacts:
James E. Fickenscher/CFO
Auxilium Pharmaceuticals, Inc.
(484) 321-5900
jfickenscher@auxilium.com

William Q. Sargent Jr./ VP IR
Auxilium Pharmaceuticals, Inc.
(484) 321-5900
wsargent@auxilium.com

Xstelos Contact:
Xstelos Holdings, Inc.
Jonathan M. Couchman
President, Chief Executive Officer and Chief Financial Officer
(212) 729-4962

SOURCE Auxilium Pharmaceuticals, Inc.

Website: http://www.auxilium.com
 
Press spacebar to pause and continue. Press esc to stop.