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Swedish Orphan Biovitrum AB (publ): Sobi becomes market authorisation holder for Xiapex in Europe

Stockholm, Sweden and Chesterbrook, Pa., 7 April, 2014 --Swedish Orphan
Biovitrum AB (publ) (Sobi) andAuxilium 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

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

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
. 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

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

Sobi becomes MAH for Xiapex in Europe


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Swedish Orphan Biovitrum AB (publ) via Globenewswire


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