CAMBRIDGE, Mass. & STOCKHOLM--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum (STO: BVT) today announced that they have restructured the collaboration agreement for the companies’ long-acting, recombinant Factor VIII Fc fusion protein (rFVIIIFc) in hemophilia A patients and the recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia B patients.
Under the amended agreement, Biogen Idec will assume full development responsibilities and costs, as well as manufacturing rights for the rFVIIIFc and rFIXFc programs. Biogen Idec also gains marketing responsibility for the rest-of-world territories that had previously been shared between the two companies, in addition to its existing commercial rights in North America. Swedish Orphan Biovitrum will retain commercial rights in Europe, Russia, Turkey and the Middle East. The cross-royalty rate has been reduced for both companies. The royalty rates will be further adjusted until Biogen Idec’s increased costs are reimbursed.
“Biogen Idec’s clinical and manufacturing expertise, combined with its global commercial organization, continue to make it an ideal partner for us in the hemophilia disease area, an area with high medical needs,” said Martin Nicklasson, CEO of Swedish Orphan Biovitrum. “Additionally, we will now be able to focus on delivering value in the rest of our exciting and promising development pipeline and current commercial product portfolio, while improving our near term cost-base."
“We appreciate our evolving and continued partnership with Swedish Orphan Biovitrum, which is focused on the very important mission of treating patients with rare diseases,” said James C. Mullen, President and CEO of Biogen Idec. “The updated agreement fits with Biogen Idec’s recognition of the potential of these innovative products to make a significant difference in the lives of people with hemophilia A and B and with our own strengths in manufacturing, development and the global commercialization of products.”
Hemophilia is a rare, inherited disorder in which the ability of a person's blood to clot is impaired. Hemophilia A occurs in about 1 in 10,000 male births annually and is caused by having substantially reduced or no Factor VIII protein, which is needed for normal blood clotting. Hemophilia B occurs in about 1 in 25,000 male births annually and is caused by having substantially reduced or no Factor IX protein. People with hemophilia A and B therefore need injections of Factor VIII and Factor IX, respectively, to restore the coagulation process and prevent frequent bleeds that could otherwise lead to pain, irreversible joint damage and life-threatening hemorrhages. Prophylaxis treatment for hemophilia A and B requires infusions two or three times a week to maintain a sufficient circulating level of coagulation factor, and long-term studies demonstrate that such regimens increase the patient's life expectancy and greatly reduce if not eliminate progressive joint deterioration.
About the rFVIIIFc and rFIXFc programs
rFVIIIFc and rFIXFc are long-acting, fully-recombinant clotting factors developed using Biogen Idec's novel and proprietary monomeric Fc-fusion technology. rFVIIIFc is currently being evaluated in a Phase I/IIa open-label study to assess the safety, tolerability and pharmacokinetics of rFVIIIFc in severe, previously-treated, hemophilia A patients.
rFIXFc is the first long-acting Factor IX therapy to enter registrational trials. The registrational trial, called B-LONG, will determine the efficacy of rFIXFc in the prevention and treatment of bleeding in patients with severe hemophilia B. The study will also evaluate the efficacy of rFIXFc in on-demand and surgical settings, and compare the pharmacokinetics of a single dose of rFIXFc with a single dose of a commercially available recombinant Factor IX product. For information on the rFVIIIFc and rFIXFc trials, please visit www.biogenidechemophilia.com.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients worldwide benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
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.
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 February 18, 2010 at 08:00 a.m. CET.
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