Swedish Orphan Biovitrum to increase the availability of Willfact® to von Willebrand patients as LFB BIOMEDICAMENTS has received additional European regulatory approvals
Stockholm, Sweden, December 20, 2010 - Swedish Orphan Biovitrum (STO: SOBI)
today announced that LFB BIOMEDICAMENTS (LFB) has received a positive review of
Willfact(®) under a Mutual Recognition Procedure (MRP), by the German regulatory
authority (the Paul-Ehrlich-Institute) representing the other European
authorities involved in the procedure.
Following final local regulatory approvals and pricing and reimbursement
processes, Swedish Orphan Biovitrum (Sobi) will launch Willfact in Sweden,
Norway, Denmark, Estonia, Latvia, Lithuania, Czech Republic, Slovakia, Slovenia
(Willefact(®)), and Hungary. Sobi expects to begin launching Willfact in some of
these countries as early as during the second quarter of 2011.
"The positive MRP review is a big step towards making Willfact available to von
Willebrand disease patients in additional countries in Europe and thereby an
opportunity to improve the life of these patients. We look forward to a fruitful
and continued partnership with LFB BIOMEDICAMENTS, and we see Willfact as an
important addition to our emerging Hemophilia franchise," said Kennet Rooth, CEO
of Sobi.
About Willfact(® )and the( )agreement with LFB BIOMEDICAMENTS
Willfact is a very high purity plasma derived human von Willebrand factor (vWF)
concentrate used to stop and prevent bleeding in severe von Willebrand disease
(vWD) patients. It is produced by LFB BIOMEDICAMENTS and is the only vWF
concentrate almost free from Factor VIII, and thereby specifically designed for
the treatment of vWD patients.
Willfact was approved in Germany in May 2009, the largest pharmaceutical market
in Europe, by the German authorities (the Paul-Ehrlich-Institute) for the
prevention and treatment of hemorrhages or surgical bleeding in vWD when
Desmopressin (DDAVP) treatment alone is ineffective or contraindicated. Willfact
is distributed in Germany by Swedish Orphan International GmbH, a subsidiary of
Sobi. Willfact was launched in Germany in April 2010.
Sobi will, under the agreement with LFB BIOMEDICAMENTS, distribute Willfact in
Germany, Sweden, Norway, Denmark, Estonia, Latvia, Lithuania, Slovenia, Czech
Republic, Slovakia and Hungary.
About von Willebrand Disease
Von Willebrand Disease (vWD) is characterized by a deficiency in the protein von
Willebrand Factor (vWF) that plays a role in primary hemostasis and stabilizes
Factor VIII, an essential blood coagulation factor. This disease requires
extensive diagnostic measures and therapeutic options are available which need
to be adapted to the individual needs of the patients. About one percent of the
population is affected by vWD and equally effects men and women. vWD is thereby
the most frequent inherited bleeding disorder. However, only 52.000 patients are
diagnosed globally. According to the Marketing Research Bureau the vWF market
2008 was 325 MUSD.
vWD is divided in three disease types: Type 1 is characterized by mildly or
moderately reduced vWF levels (60-80% of patients), whereas in Type 3 vWD
patients vWF levels are reduced more dramatically (less than 3% of patients).
Type 2 vWD (20-40% of patients) is characterized by qualitative deficiencies in
the vWF protein, thereby losing important protein functions. For Type 1 - and
many type 2 patients, desmopressin (DDAVP) is the current treatment of choice.
For some Type 1, many Type 2 - and all Type 3 vWD-patients, however, DDAVP
treatment alone is not sufficient or is contraindicated.
All three types of vWD may benefit from a substitution with a plasma-derived
vWF. In Germany, treatment options have been limited to blood plasma
concentrates containing a combination of vWF and Factor VIII. However, in vWD
patients the endogenous Factor VIII synthesis is intact and the deficiency of
Factor VIII is a secondary effect due to the lack or absence of vWF. Therefore a
substitution of Factor VIII is only needed in emergency situations with
significant blood loss. High levels of factor VIII may unnecessarily increase
the risk for thrombosis and thereby stroke.
About Swedish Orphan Biovitrum (Sobi)
Sobi is a Swedish based niche specialty pharmaceutical company with an
international market presence. The company is focused on providing and
developing specialist pharmaceuticals for rare disease patients with high
medical needs. The portfolio consists of about 60 marketed products and an
emerging late stage clinical development pipe-line. Our focus areas are:
hemophilia, inflammation/autoimmune diseases, fat malabsorption, cancer and
inherited metabolic disorders. Sobi had pro-forma revenues 2009e of about 2 BSEK
and approximately 500 employees. The head office is located in Sweden and the
share (STO: SOBI) is listed on NASDAQ OMX Stockholm. For more information please
visit www.sobi.com.
About LFB Group
LFB BIOMEDICAMENTS is part of LFB, a biopharmaceutical group that develops,
manufactures and markets medicinal products for the treatment of serious and
often rare diseases in several major therapeutic fields, namely Hemostasis,
Immunology and Intensive Care.
LFB Group is the leading manufacturer of plasma-derived medicinal products in
France and 6th worldwide and is also among the leading European companies for
the development of monoclonal antibodies and new-generation proteins based on
biotechnologies. With its strong focus on research, the LFB Group is pursuing a
growth strategy that seeks to extend its activities at international level and
develop innovative therapies.
LFB's 2009 turnover reaches €376 million, of which €76 million were dedicated to
the R&D effort. LFB markets its products in 20 countries and is present in
Germany and the UK since 2007 and in Brazil since 2004. Christian Béchon is
president and CEO of the LFB Group (1700 employees).For more information, please
visit www.lfb.fr/en/home.html.
For more information please contact:
Swedish Orphan Biovitrum:
Kennet Rooth, CEO
Phone +46 8 412 98 43
kennet.rooth@sobi.com
Erik Kinnman, VP Investor Relations and Public Affairs
Phone: +46 73 422 15 40
erik.kinnman@sobi.com
Swedish Orphan Biovitrum may be required to disclose the information provided
herein pursuant to the Swedish Securities Markets Act. The information was
provided for public release on December 20, 2010, 8.30 am CET.