STOCKHOLM, SWEDEN--(Marketwire - April 08, 2010) -
Stockholm, Sweden, Les Ulis, France - April 8 , 2010 - Swedish Orphan Biovitrum (STO: BVT) and LFB BIOMEDICAMENTS today announced the launch of Willfact® in Germany, a new product for treatment of the bleeding disorder von Willebrand disease. Swedish Orphan Biovitrum and LFB also announced the prolongation of the current distribution agreement through 2014.
Swedish Orphan Biovitrum will, under the agreement with LFB BIOMEDICAMENTS, distribute Willfact® in Germany, Sweden, Norway, Iceland, Denmark, Estonia, Latvia, Lithuania, Czech Republic, Slovakia, Hungary and Bulgaria. A Mutual Recognition Procedure is planned in the forthcoming months to secure marketing authorization in the majority of the other countries where Swedish Orphan Biovitrum has the right to distribute Willfact®.
“The opportunity of making Willfact® available to patients with von Willebrand disease in Germany and elsewhere will be a valuable contribution to improving the life of these patients. We look forward to a fruitful and continued partnership with LFB, as other products of value for rare diseases are also involved in this partnership and we see Willfact® as an important addition to our emerging Hemophilia franchise,” said Martin Nicklasson, CEO of Swedish Orphan Biovitrum Group.
“The know-how of Swedish Orphan Biovitrum in hospital care and therapeutic proteins marketing is a key asset in increasing the availability of our Willfact® product to the patient community in the selected countries. LFB as a key European player in bleeding disorders will benefit from this partnership,” said Pierre-Francois Falcou, Senior International Director of LFB Group.
About Willfact®
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 and is the only vWF concentrate almost completely free from Factor VIII, and thereby specifically designed for the treatment of vWD patients.
Willfact® was approved in Germany in mid-2009, the largest pharmaceutical market in Europe, by the German authorities (the Paul-Ehrlich-Institute) for the prevention and treatment of hemorrhage 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 Swedish Orphan Biovitrum.
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 2006 was 209 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
On January 14, 2010, Biovitrum AB (publ) completed the acquisition of Swedish Orphan International Holding AB and created Swedish Orphan Biovitrum - a leading company focused on treatment of rare diseases.
Swedish Orphan Biovitrum is a Swedish based specialty pharmaceutical company with an international market presence. The company is focused on providing and developing orphan and niche specialist pharmaceuticals to patients with high medical needs. The portfolio consists of about 60 marketed products and an emerging late stage clinical development pipeline within rare diseases. Swedish Orphan Biovitrum has pro-forma revenues 2009e of about 2 BSEK and approximately 500 employees. The head office is located in Sweden and the share (STO: BVT) is listed on NASDAQ OMX Stockholm. For more information please visit www.biovitrum.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.
For more information please contact: Swedish Orphan Biovitrum: Kennet Rooth, EVP Marketing & Sales Phone +46 8 412 98 43 kennet.rooth@swedishorphan.com Erik Kinnman, EVP Investor Relations Phone: +46 73 422 15 40 erik.kinnman@biovitrum.com Martin Nicklasson, CEO Phone: +46 8 697 20 00 LFB Group: Pierre-Francois Falcou, Senior International Director Phone +33 1 69 82 73 43 falcou@lfb.fr
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 April 8, 2010 at 8:30 a.m. CET.
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Press release April 8 in PDF format: http://hugin.info/134557/R/1401308/356396.pdf
