Auxilium Pharmaceuticals, Inc. and Swedish Orphan Biovitrum AB (publ) enter a collaboration agreement for XIAPEX® in 71 Eurasian and African countries
-Sobi Obtains Exclusive Rights for One Commercial and One Development Indication
for XIAPEX-
-In Addition to Royalties, Auxilium to Receive up to $40 M in Potential
Aggregate Sales Milestones-
Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) and Swedish Orphan Biovitrum
AB (publ) (STO: SOBI) announced today that they have entered into a long-term
collaboration for the development, supply and commercialization of XIAPEX
(collagenase clostridium histolyticum), a novel, first-in-class biologic for the
treatment of Dupuytren's contracture. In addition, work is on-going to file for
approval of XIAPEX for the treatment of Peyronie's disease in the EU.
Under the terms of the collaboration agreement, Sobi will receive exclusive
rights to commercialize XIAPEX for these two indications, subject to applicable
regulatory approvals, in 28 EU member countries, Switzerland, Norway, Iceland,
18 Central Eastern Europe/Commonwealth of Independent countries, including
Russia and Turkey, and 22 Middle Eastern & North African countries. Since
2011, XIAPEX has been approved for the treatment of Dupuytren's contracture in
28 EU member countries, Switzerland, and Norway. Sobi, via its Partner Products
business unit, will be primarily responsible for the applicable regulatory,
clinical and commercialization activities for XIAPEX in Dupuytren's contracture
and Peyronie's disease in these countries.
XIAFLEX(®)/XIAPEX has been approved by the U.S. Food and Drug Administration,
Health Canada and the European Medicines Agency as a treatment for Dupuytren's
contracture for adult patients with a palpable cord, and is also in phase III
development in Japan. In addition, a XIAFLEX submission has been filed for
approval in Australia for the treatment of Dupuytren's contracture.
"Today, Sobi and Auxilium have established a broad relationship, which we
believe will build on the momentum and growth of XIAPEX in the EU territories
and to also offer, subject to regulatory approval, the first, effective
nonsurgical treatment for two diseases in multiple new geographies," said Adrian
Adams, Chief Executive Officer and President of Auxilium. "With the proven
strength of Sobi's commercialization and development organization in these
diverse markets, this relationship should further enhance our ability to bring
this innovative product to a global audience."
"This relationship has been designed to leverage Sobi's extensive regulatory
and marketing expertise, as well as our established local operating companies in
many of these markets," said Geoffrey McDonough, Chief Executive Officer and
President of Sobi. "XIAPEX already has a growing Dupuytren's physician base in
the EU territories, and we plan to build on our track-record of achieving
sustainable patient access to new and innovative treatments to make XIAPEX a
sustainable global solution for patient communities with few treatment options
today."
Under the terms of the collaboration agreement, Auxilium will receive
significant tiered double-digit royalties based on sales of XIAPEX in Sobi's
territories, which will also cover payment for product supply. Additionally,
Sobi could make up to $40 million in potential sales milestone payments to
Auxilium.
Auxilium will remain primarily responsible for the global development of XIAPEX
in Dupuytren's contracture and Peyronie's disease and will be responsible for
drug manufacturing and supply. Sobi will be responsible for clinical
development and regulatory activities and associated costs corresponding to any
additional trials required in its licensed territories.
---
About Dupuytren's contracture
Dupuytren's contracture is a chronic condition that affects the connective
tissue that lies beneath the skin in the palm. The disease is progressive in
nature. Typically, skin pits then nodules develop in the palm as collagen
deposits accumulate. As the disease progresses, the collagen deposits form a
cord that stretches from the palm of the hand to the base of the finger. Once
this cord develops, the patient's fingers contract and the function of the hand
is impaired. The incidence of Dupuytren's disease, inclusive of pits, nodules
and cords, is highest in Caucasians, historically those of Northern European
descent, with a global prevalence of four to six percent of the Caucasian
population(1). Most cases of Dupuytren's contracture occur in patients older
than 50 years(2).
1. The most frequently affected parts of the hand associated with Dupuytren's
contracture are the joints called the Metacarpophalangeal Joint, or MP
joint, which is the joint closest to the palm of the hand and the Proximal
Interphalangeal Joint, or the PIP joint, which is the middle joint in the
finger. The little finger and ring finger are most frequently involved.
XIAFLEX is the only drug approved by the U.S. Food and Drug Administration,
European Medicines Agency and Health Canada for treatment of Dupuytren's
contracture, which has historically been treated primarily by an open
surgical procedure. Hurst, L. C. et al., Injectable Collagenase Clostridium
Histolyticum for Dupuytren's Contracture, New England Journal of Medicine,
(2009; 361:968-979)
2. Badalamente, M. A., Hurst, L. C. et al., The Journal of Hand Surgery, (2002;
27A:788-798)
About Peyronie's Disease
PD can be a physically and psychosocially devastating disorder that results in
varying degrees of penile curvature deformity and disease bother associated with
painful erections, erection appearance, impact on intercourse, and intercourse
frequency. PD is the development of collagen plaque, or scar tissue, on the
shaft of the penis that may harden and reduce flexibility, thus occasionally
causing pain and causing the penis to deform in a bend or arc during erection.
PD is a heterogeneous disease with an initial inflammatory component. This
inflammatory phase is poorly understood with a somewhat variable disease course
and occasional spontaneous resolutions of not greater than 13%(1). After 12-18
months of disease, the disease is reported to often develop into a more chronic,
stable phase(1). The estimated prevalence of PD in adult men has been reported
to be approximately 5%(2); however the disease is thought to be underdiagnosed
and undertreated(1). Based on U.S. historical medical claims data, it is
estimated that between 65,000 and 120,000 PD patients are diagnosed every year,
but only 5,000 to 6,500 PD patients are treated with injectables or surgery
annually(3).
(1) L.A. Levine Peyronie's Disease: A Guide to Clinical Management. Humana
Press: 10-17, 2007.
(2) Bella A. Peyronie's Disease J Sex Med 2007;4:1527-1538
(3) SDI and data on file, Auxilium
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 2012, Sobi had total revenues of SEK 1.9 billion
(€ 215 M) and about 500 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 commercialization, primarily in the Centre of
Expertise setting.
About Auxilium
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a
focus on developing and marketing products to predominantly specialist
audiences. Auxilium markets Testim® 1% (testosterone gel) for the topical
treatment of hypogonadism in the U.S. and XIAFLEX® (collagenase clostridium
histolyticum (CCH)) for the treatment of adult Dupuytren's contracture patients
with a palpable cord in the U.S. GlaxoSmithKline LLC co-promotes Testim with
Auxilium in the U.S., while Ferring International Center S.A. markets Testim in
certain countries of the EU and Paladin Labs Inc. markets Testim in Canada.
Swedish Orphan Biovitrium AB (publ) has marketing rights for XIAPEX® (the EU
tradename for collagenase clostridium histolyticum) in 71 Eurasian and African
countries. Asahi Kasei Pharma Corporation has development and commercial rights
for XIAFLEX in Japan; and Actelion Pharmaceuticals Ltd has development and
commercial rights for XIAFLEX in Canada and Australia. As a result of its
recent acquisition of Actient Holdings, LLC, Auxilium now markets TESTOPEL®, the
only long-acting implantable testosterone replacement therapy, Edex®, the
leading branded non-oral drug for erectile dysfunction, Striant®, a buccal
system for testosterone delivery, and Osbon ErecAid®, a device for aiding
erectile dysfunction, and also has a non-promoted respiratory franchise,
including Theo-24® and Semprex®-D, along with three other non-promoted
products. Auxilium has three projects in clinical development. XIAFLEX is in
phase III of development for the treatment of Peyronie's disease. CCH is in
phase II of development for the treatment of Frozen Shoulder syndrome (adhesive
capsulitis) and phase II of development for the treatment of cellulite
(edematous fibrosclerotic panniculopathy). Auxilium also has rights to pursue
additional indications for XIAFLEX. For additional information, visit
http://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, which discuss matters that are not
facts, and may include words to indicate their uncertain nature such as
"believe," "expect," anticipate," "intend," "plan," "should," "could,"
"estimate," "project," "will," and "target." Our forward-looking statements
convey management's expectations, beliefs, plans and objectives regarding future
performance of the Company and are based upon preliminary information and
management assumptions. No specific assurances can be given with respect to
whether: we will develop XIAPEX/XIAFLEX for the treatment of multiple potential
indications, achieve the results or indicated timing of clinical trials for
XIAPEX/XIAFLEX for the additional indications or be successful in
commercializing XIAPEX/XIAFLEX for the additional indications; our collaboration
with Sobi will improve on the growth of XIAPEX in the EU territories; regulatory
approval will be obtained for XIAPEX in any of Sobi's licensed territories
within the anticipated timeframes, if at all; our collaboration with Sobi will
enable us to bring XIAPEX to a global market; Sobi will be successful in
developing and commercializing XIAPEX in its licensed territories; or we will
receive the indicated milestone or royalty payments from Sobi. While the
Company may elect to update the forward-looking statements made in this news
release in the future, the Company specifically disclaims any obligation to do
so. Such forward-looking statements are subject to a wide range of risks and
uncertainties that could cause results to differ in material respects, including
those relating to product development, revenue, expense and earnings
expectations, intellectual property rights, results and timing of clinical
trials, success of marketing efforts, the need for additional research and
testing, and the timing and content of decisions made by regulatory authorities,
including the U.S. Food and Drug Administration, and those risks discussed in
our reports on file with the Securities and Exchange Commission (the "SEC").
Our SEC filings may be accessed electronically by means of the SEC's home page
on the Internet at http://www.sec.gov or by means of the Company's home page on
the Internet at http://www.auxilium.com under the heading "For Investors - SEC
Filings." There may be additional risks that the Company does not presently
know or that the Company 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:
Media relations Investor relations
Oskar Bosson, Head of Jörgen Winroth, Vice President, Head of Investor
Communications Relations
T: +46 70 410 71 80 T:
+1 347-224-0819, +1 212-579-0506, +46 8 697 2135
oskar.bosson@sobi.com jorgen.winroth@sobi.com
Auxilium:
James E. Fickenscher William Q. Sargent Jr.
Chief Financial Officer Vice-President, Investor Relations and Corporate
Communications
T+1-484-321-5900 T+1-484-321-5900
jfickenscher@auxilium.com wsargent@auxilium.com
