Biogen Idec and Swedish Orphan Biovitrum AB announced their intent to produce one billion international units (IUs) of clotting factor therapy for humanitarian aid programs in the developing world at the World Federation of Hemophilia (WFH) 2014 World Congress. Initially, the companies have committed to donating up to 500 million IUs to the World Federation of Hemophilia over five years to support its efforts to raise the standard of care for people with hemophilia in the developing world. The remaining 500 million IUs of clotting factor will be made available for future distribution.
This donation is expected to enable a predictable, sustained humanitarian supply of factor therapy and improve the quality of patient care and outcomes in the developing world. Hemophilia is a rare, chronic, inherited disorder in which the ability of a person’s blood to clot is impaired. This can lead to recurrent and extended bleeding episodes. According to the WFH, an estimated 400,000 people worldwide are living with hemophilia and of these, more than 300,000 individuals live in areas where there is limited access to diagnosis and treatment. The commitment of one billion IUs of factor is intended to enable physicians to treat more than 75,000 joint bleeding episodes, more than 2,000 life threatening bleeding episodes as well as conduct thousands of elective surgical procedures that would not be possible without access to clotting factor.
“All of us at Biogen Idec are dedicated to making life better for people living with hemophilia,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “Hemophilia occurs all over the world, and this donation will provide some level of care to thousands of people who otherwise would not have access to treatment.”
“Our dialogue with the hemophilia community consistently highlights sustainable global equity as a major unmet need in the field,” said Geoffrey McDonough, president and chief executive officer of Sobi. “This donation is consistent with our patient-centered approach, and has the potential to transform the treatment model for people with hemophilia in developing countries. We are proud to partner with the WFH in their work.”
“The WFH humanitarian aid program would exist in name only if not for the generous donations we receive from companies such as Biogen Idec and Sobi,” said WFH President Alain Weill. “Their generosity today brings us 500 million steps closer to making the WFH vision of treatment for all a reality.”
Biogen Idec and Sobi are partners in the development and commercialization of treatments for hemophilia. Biogen Idec, which is responsible for product supply under the collaboration, will designate one billion IUs of clotting factor therapy for use in humanitarian programs over the next decade.
Under the terms of the agreement with WFH, at least 85 percent of donated factor will be Antihemophilic Factor VIII (Recombinant), Fc Fusion Protein for the treatment of hemophilia A, with the remainder comprised of Coagulation Factor IX (Recombinant), Fc Fusion Protein for the treatment of hemophilia B. The donation of Antihemophilic Factor VIII (Recombinant), Fc Fusion Protein is contingent upon approval of a Biologics License Application currently under review by the U.S. Food and Drug Administration (FDA). Shipments for humanitarian programs are expected to begin in the second half of 2015.
Countries eligible for the WFH program use less than 1 IU of FVIII per capita. Due to the lack of treatment, people with severe hemophilia in these countries often do not survive to adulthood.
About the World Federation of Hemophilia
For 50 years, the World Federation of Hemophilia (WFH), an international not-for profit organization, has worked to improve the lives of people with hemophilia and other inherited bleeding disorders. Established in 1963, it is a global network of patient organizations in 122 countries and has official recognition from the World Health Organization. Visit WFH online at www.wfh.org.
About the Biogen Idec and Sobi Collaboration
Biogen Idec and Swedish Orphan Biovitrum (Sobi) are partners in the development and commercialization of treatments for hemophilia. Biogen Idec leads development, has manufacturing rights, and has commercialization rights in North America and all other regions in the world excluding the Sobi territory. Sobi has the right to opt in to assume final development and commercialization in Europe, Russia, the Middle East and Northern Africa.
About Biogen Idec
Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
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 two late stage biological development projects within hemophilia. 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 2013, Sobi had total revenues of SEK 2.2 billion ($ 334 M) and about 550 employees. The share (STO: SOBI) is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com.
Biogen Idec Safe Harbor
This press release contains forward-looking statements, including statements about the amount of clotting factors to be supplied and the timing thereof. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including the risk that regulatory authorities fail to approve or delay approval of the Antihemophilic Factor VIII (Recombinant), Fc Fusion Protein drug candidate, the risk of manufacturing problems and the other risks and uncertainties that are described in the Risk Factors section of Biogen Idec’s most recent annual or quarterly report filed with the U.S. Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and Biogen Idec assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.