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Swedish Orphan Biovitrum AB (publ): Auxilium and Sobi announce encore presentation of Xiapex data at European Association of urology congress

- Encore data highlighted from trials evaluating Xiaflex/Xiapex, the first and
only FDA approved treatment for Peyronie's Disease.

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) and Swedish Orphan Biovitrum AB
(publ) (Sobi) today announced that encore data were presented from multiple
clinical trials evaluating the use of Xiapex/Xiaflex® (collagenase
clostridium histolyticum or CCH) in adult patients with Peyronie's disease
(PD). These data were presented at the 29th Annual European Association of
Urology (EAU) Congress being held 11-15 April, 2014 in Stockholm, Sweden.

Poster presentations on Xiapex/Xiaflex included analysis from the pivotal
Phase 3 IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy
and Safety Studies) trials which evaluated Xiapex/Xiaflex for the treatment
of PD. Xiaflex is the first and only FDA-approved treatment proven effective
for PD in men with a palpable plaque and a curvature deformity of 30 degrees
or greater at the start of therapy. Work is on-going by Sobi to potentially
file for approval of Xiapex in the EU for the treatment of PD. Xiapex is
approved by the EMA for the treatment of Dupuytren's contracture, and as the
Market Authorization Holder in Europe, Sobi intends to submit a Variation to
the EMA to extend the Xiapex label to include Peyronie's disease.

Highlights of the data related to the use of Xiapex/Xiaflex in PD include:

* A post-hoc analysis of the pooled data from the IMPRESS I and II Phase 3
trials showed improved clinical outcomes following CCH-treatment regardless
of subjects' baseline PD treatment history, erectile function scores,
and/or prostatectomy history. These data were also presented at the Sexual
Medicine Society of North America (SMSNA) 19th Annual Fall Scientific
Meeting held 21-24 November, 2013 in New Orleans.
* The global safety analysis of seven clinical trials of CCH for the
treatment of PD shows that the adverse events were mostly localized to the
penis, non-serious and resolved without intervention before the next
injection. Serious adverse events (SAEs) related to treatment were also all
localised to the penis in these clinical studies. A total of 60 (5.7%) of
CCH-treated subjects experienced at least one treatment-emergent SAE, 0.9%
experienced treatment-related SAEs (five penile hematoma and four corporal
rupture). These data were also presented at the American Urological
Association (AUA) Meeting held 4-8 May, 2013 in San Diego.

Additional details about the presentations and the meeting can be found at:


About 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 phasei. The incidence
of PD is estimated between 3 and 9 percentii; however the disease is thought
to be underdiagnosed and undertreatedi.

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

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

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:
Sobi's plans to submit a request to potentially expand the label of Xiapex to
include Peyronie's disease;
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
T: +46 707 297 327 T: +1 347-224-0819, +1
charlotte.afklercker@sobi.com jorgen.winroth@sobi.com

Auxilium Contacts:

Keri P. Mattox Nichol L. Ochsner
(484) 321-5900 (484) 321-5900
kmattox@auxilium.com nochsner@auxilium.com

---------------------------------------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

Xiapex at the European Association of Urology Congress


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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