-New Phase 3 Data Support Potential Efficacy, Safety and Pharmacokinetics of Long-Lasting Factor Product Candidates-
-Ten Oral Presentations Highlight Clinical Data and New Early-Stage Research from Hemophilia Development Program-
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB) will showcase new data from a number of development and early-stage research programs at the XXIV International Society on Thrombosis and Haemostasis (ISTH) Congress. Researchers will present 33 abstracts on clinical and pre-clinical research in hemophilia, the breadth of which reflects the company’s commitment to innovation and the scientific advancement of hemophilia treatment and care. The ISTH Congress will be held June 29 through July 4 in Amsterdam, The Netherlands.
“There are significant unmet needs in hemophilia A and B, rare chronic diseases that have a tremendous impact on the lives of patients and their families,” said Glenn Piece, M.D., Ph.D., senior vice president, Global Medical Affairs and chief medical officer at Biogen Idec. “The robust research being showcased at ISTH reflects our commitment to the community to address these unmet needs through innovative research and science. This includes striving to bring the first major advances in hemophilia treatment in more than fifteen years.”
Biogen Idec and Swedish Orphan Biovitrum (Sobi) will present new analyses of the phase 3 A-LONG study of ELOCTATE* and B-LONG study of ALPROLIX**, results of which add to the growing body of evidence supporting the potential efficacy and safety of these long-lasting clotting factor candidates for the treatment of hemophilia A and B.
The company will also share pre-clinical findings from new factor VIII molecules that achieved a circulating half-life of 30 hours in mice, representing a four-fold improvement over factor VIII. Additionally, new data will be presented from the company’s long-lasting factor VIIa program targeting development of a potential new option for patients with hemophilia who have inhibitory antibodies that make factor replacement ineffective.
Notable data from Biogen Idec at ISTH 2013 include:
- Population Pharmacokinetic Analysis of Long-Lasting Recombinant Factor VIII Fc fusion Protein (rFVIIIFc) in Patients with Severe Haemophilia A – e-Poster PA 2.06-3 –Tuesday, July 2 – 17:00-18:30 (CEST)
- Evaluation of the Thrombin Generation Potential of a Recombinant Factor VIII Fc Fusion Protein in a Phase III Multi-National Clinical Trial – Oral Platform OC 64.3 – Wednesday, July 3 – 08:30-08:45 (CEST)
- Evaluation of Whole Blood Clotting Activity of Recombinant Factor VIII Fc Fusion Protein by ROTEM Analysis in a Multi-Center Phase 3 Clinical Trial – Oral Platform AS 26.1 – Wednesday, July 3 – 13:30-13:45 (CEST)
- Treatment of Bleeding Episodes in Subjects with Haemophilia A with Long-Lasting Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Phase 3 A-LONG Study – e-Poster PB 4.37-3 – Thursday, July 4 – 13:30-15:00 (CEST)
- Long-Lasting Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) for Perioperative Management of Subjects with Haemophilia A in the Phase 3 A-LONG Study
– e-Poster PA 4.07-2 – Thursday, July 4 – 13:30-15:00 (CEST)
- Long-Lasting Recombinant Factor FIX Fc Fusion (rFIXFc) for Perioperative Management of Subjects with Haemophilia B in the Phase 3 B-LONG Study – e-Poster PA 2.07-4 – Tuesday, July 2 – 17:00-18:30 (CEST)
- Clinical Implications of Population Pharmacokinetics of rFIXFc in Routine Prophylaxis, Control of Bleeding and Perioperative Management for Haemophilia B Patients – e-Poster PA 2.07-5 – Tuesday, July 2 – 17:00-18:30 (CEST)
- Treatment of Bleeding Episodes in Subjects with Haemophilia B with the Long-Lasting Recombinant Factor IX Fc Fusion Protein (rFIXFc) in the Phase 3 B-LONG Study – e-Poster PA 2.07-6 – Tuesday, July 2 – 17:00-18:30 (CEST)
- A Platelet-Targeted Factor VIIa – XTEN Fusion Protein with Increased Circulating Half-Life and Improved Clotting Activity – e-Poster PB 1.58-1 – Monday, July 1 – 17:00-18:30 (CEST)
- Engineering A Novel rFVIII-VWF D’D3 Fusion Protein to Enhance Stability and Improve Pharmacokinetic Properties of FVIII – Oral Platform OC 37.5 – Tuesday – July 2, 09:00-09:15 (CEST)
- A New Class of Coagulation Factor VIII Molecules that Achieved Four-Fold Longer Half-Life than Recombinant FVIII in Hemophilia A Mice – Oral Platform AS 45.1 – Thursday, July 4 – 16:00-16:15 (CEST)
- VWF Affects the Clearance and Biodistribution of Recombinant Factor VIII Fc Fusion (rFVIIIFc) – e-Poster PA 4.13-6 – Thursday, July 4 – 13:30-15:00 (CEST)
Hemophilia Health Outcomes and Resource Utilization Research
- Adherence to clotting factor treatment among patients with haemophilia A or B – e-Poster PB 1.37-4 – Monday, July 1 – 17:00-18:30 (CEST)
- Comparing projected prophylactic consumption and effects of recombinant factor VIII Fc Fusion (rFVIIIFc) and shorter half-life FVIII products in haemophilia – e-Poster PB 3.55-5 – Wednesday, July 3 – 17:00-18:30 (CEST)
Biogen Idec and SOBI-Sponsored Educational Symposia
- Microphysiology of Joint Damage: Surrogate Measures of Joint Damage and Inflammation – Co-Chair Glenn Pierce, MD, PhD, senior vice president of Global Medical Affairs and chief medical officer of Biogen Idec’s hemophilia therapeutic area; Monday, July 1, 18:30-20:00 (CEST)
- Novel Therapy Development in Hemophilia – Co-Chair George Scangos, PhD, chief executive officer of Biogen Idec; Tuesday, July 2, 18:30-20:00 (CEST)
Full session details and data presentation listings for the 2013 Congress can be found on the ISTH website at http://www.isth2013.org/.
ELOCTATE and ALPROLIX Global Regulatory Status
Biologics License Applications (BLAs) for Biogen Idec’s long-lasting hemophilia product candidates ELOCTATE and ALPROLIX are currently under review with the U.S. Food and Drug Administration (FDA) for the treatment of hemophilia A and B, respectively.
Marketing Applications for ELOCTATE and ALPROLIX have been submitted in Australia for the treatment of hemophilia A and B, respectively. A Marketing Application for ALPROLIX has been submitted in Canada for the treatment of hemophilia B. Additional global filings are planned.
About the Fc Fusion Technology Platform
ELOCTATE and ALPROLIX are clotting factors under development using Biogen Idec’s novel and proprietary monomeric Fc fusion technology, which makes use of a naturally occurring pathway that delays the breakdown of factor in the body and cycles it back into the bloodstream, resulting in a longer circulating half-life. Fc fusion technology is used in seven FDA-approved products for the treatment of chronic diseases including rheumatoid arthritis, psoriasis and platelet disorders.
About Hemophilia A
Hemophilia A is a rare, inherited disorder in which the ability of a person's blood to clot is impaired. Hemophilia A occurs in about one in 5,000 male births annually and is caused by having substantially reduced or no factor VIII activity, which is needed for normal blood clotting. People with hemophilia A experience bleeding episodes that can cause pain, irreversible joint damage and life-threatening hemorrhage. Injections of factor VIII can restore the coagulation process, control bleeding, and prevent new bleeding episodes. The Medical and Scientific Advisory Council of the National Hemophilia Foundation recommends prophylaxis as the optimal therapy for people with severe hemophilia A. Currently, prophylaxis in hemophilia A typically requires injections every two to three days to maintain a sufficient circulating level of clotting factor.
About Hemophilia B
Hemophilia B is a rare, inherited disorder in which the ability of a person’s blood to clot is impaired. Hemophilia B occurs in about one in 25,000 male births annually and is caused by having substantially reduced or no factor IX activity, which is needed for normal blood clotting. People with hemophilia B experience bleeding episodes that can cause pain, irreversible joint damage and life-threatening hemorrhage. Injections of factor IX can restore the coagulation process, control bleeding, and prevent new bleeding episodes. The Medical and Scientific Advisory Council of the National Hemophilia Foundation recommends prophylaxis as the optimal therapy for people with severe hemophilia B. According to the World Federation of Hemophilia, prophylaxis in hemophilia B typically requires injections up to three times per week to maintain a sufficient circulating level of clotting factor.
About the Biogen Idec and Sobi Collaboration
Biogen Idec and Swedish Orphan Biovitrum (Sobi) are partners in the development and commercialization of ELOCTATE in hemophilia A and ALPROLIX in hemophilia B. Biogen Idec leads development, has manufacturing rights, and has commercialization rights in North America and all other regions excluding the Sobi territory. Sobi has the right to opt in to assume final development and commercialization in Europe (including 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, and the company generates more than $5 billion in annual revenues. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
This press release contains forward-looking statements, including statements about the potential impact and therapeutic effect of our long-lasting hemophilia product candidates and regulatory filings. These statements may be identified by words such as "believe," "expect," "may," "plan," "potential," "will" and similar expressions, and are based on our current beliefs and expectations. Drug development and commercialization involve a high degree of risk. Factors which could cause actual results to differ materially from our current expectations include the risk that unexpected concerns may arise from additional data or analysis, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates, or we may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with our drug development and commercialization activities, please review the Risk Factors section of our most recent annual or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
*ELOCTATETM Antihemophilic Factor (Recombinant Fc Fusion Protein)
**ALPROLIXTM Coagulation Factor IX (Recombinant Fc Fusion Protein)