Auxilium Pharmaceuticals, Inc. and Actelion Pharmaceuticals Ltd. enter a collaboration agreement for XIAFLEX in Canada, Australia, Brazil and Mexico
(Thomson Reuters ONE) -
Actelion Pharmaceuticals Ltd /
Auxilium Pharmaceuticals, Inc. and Actelion Pharmaceuticals Ltd. enter a
collaboration agreement for XIAFLEX in Canada, Australia, Brazil and Mexico
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.
* Actelion obtains exclusive rights for two potential indications
* Auxilium to receive up to $68.5 million in aggregate upfront, regulatory,
pricing, reimbursement and sales milestones
MALVERN, PA and ALLSCHWIL/BASEL, SWITZERLAND - 23 February 2012 - Auxilium
Pharmaceuticals, Inc. (NASDAQ: AUXL) and Actelion Ltd. (SIX: ATLN) announced
today that they have entered into a long-term partnership for the development,
supply and commercialization of XIAFLEX(®) (collagenase clostridium
histolyticum), a novel, first-in-class biologic for the potential treatment of
Dupuytren's contracture and Peyronie's disease. Under the terms of the
agreement, Actelion will receive exclusive rights to commercialize XIAFLEX for
the treatment of Dupuytren's contracture and Peyronie's disease in Canada,
Australia, Brazil and Mexico upon receipt of the respective regulatory
approvals. Actelion will be primarily responsible for the applicable regulatory
and commercialization activities for XIAFLEX in these countries.
XIAFLEX has been approved by the U.S. Food and Drug Administration and the
European Medicines Agency as a treatment for Dupuytren's contracture, and is
also in development in Japan. In addition, XIAFLEX has been accepted for review
by Health Canada for the treatment of Dupuytren's contracture in Canada and
regulatory action is expected in the second half of 2012. Actelion expects to
file for approval of XIAFLEX for the treatment of Dupuytren's contracture in
Australia, Brazil and Mexico over the next 12 months. XIAFLEX is also being
evaluated in a global phase III development program for Peyronie's disease with
top-line data expected in late second quarter 2012.
Adrian Adams, Chief Executive Officer and President of Auxilium commented:
"Today, Actelion and Auxilium have forged a partnership, which we believe has
the opportunity to offer, subject to regulatory approval, the first, effective
nonsurgical treatment for two diseases in multiple new geographies. With the
strength of Actelion's commercialization and development organization in these
diverse and far-ranging markets, this relationship should further enhance our
ability to bring this potentially groundbreaking product to a global audience."
Philippe de Lavenne, VP, Head of Europe, Canada, Latin America, Middle East &
Africa commented: "This tailored partnership has been designed to leverage
Actelion's regulatory and marketing expertise, as well as our established local
operating companies in these markets. Auxilium has done an outstanding job in
the development of this innovative product, and we look forward to contributing
to making XIAFLEX a global success."
Under the terms of the agreement, Actelion will pay Auxilium $10 million upfront
and will also make up to $16 million in potential regulatory, pricing and
reimbursement milestone payments and $42.5 million in potential sales milestone
payments. Auxilium will also receive increasing tiered double-digit royalties
based on sales of XIAFLEX in Actelion' territories and will supply product to
Actelion at a predetermined cost.
Auxilium will remain primarily responsible for the global development of XIAFLEX
in Peyronie's disease and will be responsible for all clinical and commercial
drug manufacturing and supply. Actelion will be responsible for clinical
development activities and associated costs corresponding to any additional
trials required for specific territories.
###
Notes to the Editor
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, in phase IIa of development for the treatment
of Frozen Shoulder syndrome (Adhesive Capsulitis) and is in 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.
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." Our forward-looking statements
convey management's expectations, beliefs, plans and objectives regarding future
performance of the Company and are based upon preliminary information and
management assumptions. No specific assurances can be given with respect to
whether we will develop XIAFLEX for the treatment of multiple potential
indications or achieve the results or indicated timing of clinical trials for
XIAFLEX for the additional indications; regulatory approval will be obtained for
XIAFLEX in any of Actelion's licensed territories within the anticipated
timeframes, if at all; Actelion will be successful in developing and
commercializing XIAFLEX in its licensed territories; or we will receive the
indicated milestone or royalty payments from Actelion. While the Company may
elect to update the forward-looking statements made in this news release in the
future, the Company specifically disclaims any obligation to do so. Such
forward-looking statements are subject to a wide range of risks and
uncertainties that could cause results to differ in material respects, including
those relating to product development, revenue, expense and earnings
expectations, intellectual property rights, results and timing of clinical
trials, success of marketing efforts, the need for additional research and
testing, and the timing and content of decisions made by regulatory authorities,
including the U.S. Food and Drug Administration, and those risks discussed in
our reports on file with the Securities and Exchange Commission (the "SEC"). Our
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 the Company'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 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.
About Actelion
Actelion Ltd is a biopharmaceutical company with its corporate headquarters in
Allschwil/Basel, Switzerland. Actelion's first drug Tracleer®, an orally
available dual endothelin receptor antagonist, has been approved as a therapy
for pulmonary arterial hypertension. Actelion markets Tracleer® through its own
subsidiaries in key markets worldwide, including the United States (based in
South San Francisco), the European Union, Japan, Canada, Australia and
Switzerland. Actelion, founded in late 1997, is a leading player in innovative
science related to the endothelium - the single layer of cells separating every
blood vessel from the blood stream. Actelion's over 2,500 employees focus on the
discovery, development and marketing of innovative drugs for significant unmet
medical needs. Actelion shares are traded on the SIX Swiss Exchange (ticker
symbol: ATLN) as part of the Swiss blue-chip index SMI (Swiss Market Index
SMI®).
Actelion SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995
The above information contains certain "forward-looking statements", relating to
the company's business, which can be identified by the use of forward-looking
terminology such as "estimates", "believes", "expects", "may", "are expected
to", "will", "will continue", "should", "would be", "seeks", "pending" or
"anticipates" or similar expressions, or by discussions of strategy, plans or
intentions. Such statements include descriptions of the company's investment and
research and development programs and anticipated expenditures in connection
therewith, descriptions of new products expected to be introduced by the company
and anticipated customer demand for such products and products in the company's
existing portfolio. Such statements reflect the current views of the company
with respect to future events and are subject to certain risks, uncertainties
and assumptions. Many factors could cause the actual results, performance or
achievements of the company to be materially different from any future results,
performances or achievements that may be expressed or implied by such forward-
looking statements. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual results
may vary materially from those described herein as anticipated, believed,
estimated or expected.
For further information please contact:
Auxilium contact:
James E. Fickenscher
Chief Financial Officer
+1-484-321-5900
jfickenscher(at)auxilium.com
or
William Q. Sargent Jr.
Vice-President, Investor Relations and Corporate Communications
+1-484-321-5900
wsargent(at)auxilium.com
Actelion Contact:
Roland Haefeli
Senior Vice President, Head of Investor Relations & Public Affairs
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
+1 650 624 69 36
www.actelion.com
Press Release PDF:
http://hugin.info/131801/R/1588234/498339.pdf
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other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Actelion Pharmaceuticals Ltd via Thomson Reuters ONE
[HUG#1588234]
Unternehmensinformation / Kurzprofil:
Datum: 23.02.2012 - 07:00 Uhr
Sprache: Deutsch
News-ID 117634
Anzahl Zeichen: 12788
contact information:
Town:
Allschwil
Kategorie:
Business News
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