Sobi files for EU approval of Xiapex for Peyronies disease

| Source: Swedish Orphan Biovitrum AB
Swedish Orphan Biovitrum AB (publ) (Sobi) and Auxilium Pharmaceuticals, announced that Sobi has filed for an extension of the label for
Xiapex® (collagenase clostridium histolyticum) with the European Medicines
Agency (EMA) to include the indication of Peyronie's disease.

The filing is based on positive safety and efficacy outcome data from two
double-blind placebo-controlled studies,IMPRESS I and II (The Investigation for
Maximal Peyronie's Reduction Efficacy and Safety Studies) which evaluated Xiapex
for the treatment of Peyronie's disease. The EMA filing follows the approval
from the United States Food and Drug Administration (FDA) in December 2013 of
Xiaflex® (collagenase clostridium histolyticum) 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. Xiaflex is the tradename for Xiapex
used in the United States.

"We believe that Xiapex, if approved for this new indication, has the clinical
profile to make a major contribution to the field in Peyronie's disease," says
Anders Edvell, MD, PhD, Vice President Sobi Partner Products.

Xiapex is approved in Europe for the treatment of Dupuytren's contracture in
adult patients with a palpable cord.Sobi is Marketing Authorisation Holder (MAH)
for Xiapex in 28 EU member countries, as well as Norway and Iceland. Sobi holds
the exclusive rights to commercialise Xiapex for Dupuytren's contracture and
Peyronie's disease indications in these countries subject to applicable
regulatory approvals.


About Peyronie's disease
Peyronie's Disease (PD) is a condition that involves the development of collagen
plaque, or scar tissue, on the shaft of the penis. The scar tissue, known as a
Peyronie's plaque, may harden and reduce flexibility, which may cause bending or
arching of the penis during erection. PD can result in varying degrees of penile
curvature deformity and disease "bother" (encompassing concern about erection
appearance, erection pain and the impact of PD on intercourse and on frequency
of intercourse). PD is a disease with an initial inflammatory component. This
inflammatory phase is poorly understood with a somewhat variable disease course
and spontaneous resolution occurring in less than 13 percent of cases[i]. After
approximately 12 months of disease, the disease is reported to often develop
into a more chronic, stable phase(i). The incidence of PD is estimated between
3 and 9 percent(ii); however the disease is thought to be underdiagnosed and

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.

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

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(®) (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. To
learn more, please visit

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 the EMA will approve Xiapex for the treatment of Peyronie's disease
and the effectiveness of such treatment, if approved; 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"), as
updated from time to time by Auxilium's Quarterly Reports on Form 10-Q and,
where applicable, Current Reports on Form 8-K, and in other public filings with
the 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.

For more information please contact

 Sobi contacts:
 Media relations               Investor relations

 Charlotte af Klercker,        Jörgen Winroth, Vice President,
 Senior Communications Manager Head of Investor Relations

 +46 70 729 73 27              +1 347-224-0819, +1 212-579-0506

Auxilium Contacts:
Keri P. Mattox / SVP, IR &                            Nichol L. Ochsner / Senior
Director, IR
Corporate Communications                          & Corporate Communications
Auxilium Pharmaceuticals, Inc.                     Auxilium Pharmaceuticals,
+1 (484) 321-5900                                        +1 (484) 321-5900                       


( i) L.A. Levine Peyronie's Disease: A Guide to Clinical Management. Humana
Press: 10-17, 2007.

( ii )Ralph D et al. J Sex Med. 2010;7(7):2359-2374.
 (iii )SDI and data on file, Auxilium