Xiapex approved by the EU Commission for the treatment of Peyronie's disease
Swedish Orphan Biovitrum AB (publ) (Sobi) today announced that the EU Commission
has approved Xiapex® (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. Peyronie's disease is a
condition that involves the development of collagen plaque, or scar tissue, on
the shaft of the penis.
"We are very pleased with the approval by the EU Commission and that we are now
able to expand the treatment options for patients with Peyronie's Disease.
Patients with severe symptoms of their disease, both physical and psychological,
can now be offered a therapeutic alternative to surgical intervention," says
Birgitte Volck, Senior Vice President & Chief Medical Officer at Sobi.
Xiapex was approved in December 2013 by the Food and Drug Administration (FDA)
in the United States for the treatment of Peyronie's disease with a palpable
plaque and curvature deformity of at least 30 degrees at the start of therapy.
Xiaflex® (collagenase clostridium histolyticum) is the trade name for Xiapex
used in the United States.
Xiapex is also approved in the European Union (EU) for the treatment of
Dupuytren's contracture in adult patients with a palpable cord. In 2013 Sobi and
Auxillium Pharmaceuticals Inc. signed an agreement giving Sobi the exclusive
rights to commercialise Xiapex for the treatment of Dupuytren's contracture and
Peyronie's disease in 71 Eurasian and African countries. Sobi is Marketing
Authorisation Holder (MAH) for Xiapex in the 28 EU Member States, as well as
Norway and Iceland.
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
Xiapex (collagenase clostridium histolyticum), is a pharmacological treatment
for Peyronie's disease and 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 collagen plaque and reduces the contraction. Xiapex is
administered by local injection directly into the Dupuytren's cord in the finger
or in the plaque on penis. 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 Dupytren's affected finger. As a complement to Xiapex injection
treatment for Peyronie's disease, modelling of the penis is needed. Modelling is
performed 24-72 hours after the second injection of the cycle in an attempt to
further disrupt the plaque and help straighten the penis.
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 two late-stage biological
development projects within Haemophilia. 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 that 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 that address
important unmet needs, spanning from named patient use (NPU) programmes, through
to reimbursement and full commercialisation, primarily in the Centre of
For more information please contact
Charlotte af Klercker
Senior Communications Manager
+46 70 729 73 27
Vice President, Head of Investor Relations
+1 347-224-0819, +1 212-579-0506, +46 8 697 2135
( 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.