Stockholm, Sweden and Chesterbrook, Pa., 7 April, 2014 -- Swedish Orphan
Biovitrum AB (publ) (Sobi) and Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL)
today announced that Sobi became the Market Authorisation Holder (MAH) for
Xiapex® (collagenase clostridium histolyticum), in 28 EU member countries,
Norway, and Iceland on 3 April, 2014.
Xiapex/ Xiaflex® is a first-in-class biologic approved in the US, EU, Canada and
Australia for the treatment of adult Dupuytren's contracture patients with a
palpable cord and in the US for the treatment of adult men with Peyronie's
disease with a palpable plaque and curvature deformity of at least 30 degrees at
the start of therapy. As the MAH, Sobi may now if it so elects, file for market
authorisation for Xiapex for the treatment of Peyronie's disease and work is
ongoing for that filing in the EU. Sobi holds the exclusive rights to
commercialise Xiapex for the Dupuytren's contracture and Peyronie's disease
indications, in these countries subject to applicable regulatory approvals.
---
About Dupuytren's Contracture
Dupuytren's contracture is a progressive condition affecting the hand,
specifically the layer of tissue just under the skin of the palm and fingers.
While this layer of tissue normally contains collagen, in patients with
Dupuytren's there is an increase in the amount of collagen produced. Abnormal
collagen build-up results in nodule and cord formation that worsens over time.
Eventually, rope-like collagen cords may form, thicken and shorten, causing the
fingers to be drawn in toward the palm. This thickening and shortening of the
Dupuytren's cord can reduce the finger's range of motion (how much a person can
move or straighten them). Once the Dupuytren's collagen cord can be felt, it is
referred to as a "palpable cord."
About Xiapex
Xiapex (collagenase clostridium histolyticum), is a pharmacological treatment
for Dupuytren's contracture and may be an alternative to invasive and often
complicated surgery for patients. Xiapex is a combination of two purified
clostridial collagenases for injection that enzymatically disrupts the
contracting cord and reduces the contraction. It is administered by local
injection directly into the Dupuytren's cord - a procedure which can be carried
out in an outpatient setting. Twenty-four hours after the injection, a finger
extension procedure can be carried out as necessary to break the cord and allow
extension of the finger.
In addition, work is on-going to potentially file for approval of Xiapex in the
EU for the treatment of Peyronie's disease, the development of collagen plaque,
or scar tissue, on the shaft of the penis.
About Sobi
Sobi is an international specialty healthcare company dedicated to rare
diseases. Our mission is to develop and deliver innovative therapies and
services to improve the lives of patients. The product portfolio is primarily
focused on Inflammation and Genetic diseases, with three late stage biological
development projects within Haemophilia and Neonatology. We also market a
portfolio of specialty and rare disease products for partner companies. Sobi is
a pioneer in biotechnology with world-class capabilities in protein biochemistry
and biologics manufacturing. In 2013, Sobi had total revenues of SEK 2.2 billion
(€253 M) and about 550 employees. The share (STO: SOBI) is listed on NASDAQ OMX
Stockholm. More information is available at www.sobi.com.
About Sobi Partner Products
Sobi Partner Products (SPP) is a business unit within Sobi which offers a unique
commercial platform for partners with niche and specialty products. SPP provides
extensive knowledge and local experience through our direct presence across EU,
Eastern Europe, Russia, Middle East and North Africa. We apply an integrated
commercial, medical, and market access approach to products which address
important unmet needs, spanning from named patient use (NPU) programs, through
to reimbursement and full commercialisation, primarily in the Centre of
Expertise setting.
About Auxilium
Auxilium Pharmaceuticals, Inc. is a fully integrated specialty biopharmaceutical
company with a focus on developing and commercializing innovative products for
specialist audiences. With a broad range of first- and second-line products
across multiple indications, Auxilium is an emerging leader in the men's
healthcare area and has strategically expanded its product portfolio and
pipeline in orthopedics, dermatology and other therapeutic areas. Auxilium now
has a broad portfolio of 12 approved products. Among other products in the U.S.,
Auxilium markets edex® (alprostadil for injection), an injectable treatment for
erectile dysfunction, Osbon ErecAid®, the leading device for aiding erectile
dysfunction, STENDRA(TM) (avanafil), an oral erectile dysfunction therapy,
TESTIM® (testosterone gel) for the topical treatment of hypogonadism, TESTOPEL®
(testosterone pellets) a long-acting implantable testosterone replacement
therapy, XIAFLEX® (collagenase clostridium histolyticum or CCH) for the
treatment of Peyronie's disease and Xiaflex for the treatment of Dupuytren's
contracture. The Company also has programs in Phase 2 clinical development for
the treatment of Frozen Shoulder syndrome and cellulite. Auxilium's mission is
to improve the lives of patients throughout the world by successfully
identifying, developing and commercializing innovative specialty
biopharmaceutical products. To learn more, please visit 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, including statements made with respect
to: whether and when Sobi will file for approval of Xiapex for the treatment of
Peyronie's disease and the success of any such filings; and other statements
regarding matters that are not historical facts, and involve predictions. These
statements involve known and unknown risks, uncertainties and other factors that
may cause actual results, performance, achievements or prospects to be
materially different from any future results, performance, achievements or
prospects expressed in or implied by such forward-looking statements. In some
cases you can identify forward-looking statements by terminology such as
''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'',
''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'',
''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms
or similar expressions, although not all forward-looking statements contain
these identifying words. Although forward-looking statements are based on
Auxilium's current plans or assessments that are believed to be reasonable as of
the date of this press release, they inherently involve certain risks and
uncertainties. These forward-looking statements are subject to a number of risks
and uncertainties, including those discussed under ''Risk Factors'' in
Auxilium's Annual Report on Form 10-K for the year ended December 31, 2013 on
file with the United States Securities and Exchange Commission ("SEC"). 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.
Auxilium's SEC filings may be accessed electronically by means of the SEC's home
page on the Internet at http://www.sec.gov. 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.
Sobi Contacts:
Media relations Investor relations
Charlotte af Klercker, Jörgen Winroth,
Sr Communications Manager VP, Head of Investor Relations
T: +46 707 297 327 T: +1 347-224-0819, +1 212-579-0506,
charlotte.afklercker@sobi.com jorgen.winroth@sobi.com
Auxilium Contacts:
Keri P. Mattox / SVP, IR & Nichol L. Ochsner / Senior Director, IR
&
Corporate Communications Corporate Communications
Auxilium Pharmaceuticals, Inc. Auxilium Pharmaceuticals, Inc.
(484) 321-5900 (484) 321-5900
kmattox@auxilium.com nochsner@auxilium.com
[HUG#1774879]
