SOURCE: Swedish Orphan Biovitrum AB (publ)

December 20, 2010 02:40 ET

Swedish Orphan Biovitrum to increase the availability of Willfact® to von Willebrand patients as LFB BIOMEDICAMENTS has received additional European regulatory approvals

STOCKHOLM, SWEDEN--(Marketwire - 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 EUR376 million, of which EUR76 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.


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.





Press release dec 20 in PDF format: http://hugin.info/134557/R/1474026/410433.pdf




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Source: Swedish Orphan Biovitrum AB (publ) via Thomson Reuters ONE

[HUG#1474026]

Contact Information

  • For more information please contact:

    Swedish Orphan Biovitrum:
    Kennet Rooth, CEO
    Phone +46 8 412 98 43
    Email Contact

    Erik Kinnman, VP Investor Relations and Public Affairs
    Phone: +46 73 422 15 40
    Email Contact