Biovitrum AB (STO: BVT) and Syntonix Pharmaceuticals, Inc., a subsidiary of Biogen/Idec (NASDAQ: BIIB) announced the initiation of a phase I/IIa open-label, dose escalation study of a long-acting, recombinant Factor IXFc (FIXFc) protein in patients with hemophilia B. The study is ongoing at clinics in the United States and will assess the safety, tolerability and pharmacokinetics of Factor IXFc in this patient population.
This FIXFc compound, which pre-clinical studies have shown to have an extended half-life, could enable effective treatment with less frequent injections for both prophylaxis and on-demand therapy in hemophilia B. The current global market for Factor IX products is USD 600 million per year.
“We are excited about developing FIXFc together with Syntonix since hemophilia is a prioritized therapeutic and business area within Biovitrum. In addition, we are developing a recombinant Factor VIIIFc hemophilia product with Syntonix. Both these programs fit well with Biovitrum’s long experience and broad knowledge within the area of protein therapeutics and our specialist care business strategy.” said Martin Nicklasson, CEO of Biovitrum.
“We are pleased to have moved the FIXFc program, which is based on our SynFusionTM technology, into clinical studies. The purpose of both the FIXFc and Factor VIIIFc programs is to improve the lives of hemophilia patients and their families,” said Matt Ottmer, General Manager of Syntonix.
About Hemophilia
Hemophilia is a rare hereditary disorder in which the ability of patients’ blood to clot is impaired. As a result, the patient suffers from excessive bleeding and uncontrolled internal bleeding, leading to pain and eventual permanent damage to joints and muscles. One form, Hemophilia B results from mutations that impair the production of Factor IX. It has been reported that even with “proper treatment” the life expectancy of hemophilia patients is about 10 years less than for individuals without hemophilia. Increasingly, the normal mode of treatment for younger patients is a prophylaxis regimen where patients are infused two or three times per week to maintain a better circulating level of coagulation factor. Long term studies demonstrate that such regimens greatly reduce if not eliminate progressive joint deterioration.
About SynFusionTM Technology
The SynFusion technology is based on Syntonix’s proprietary Fc-fusion technologies to create longer-acting biopharmaceuticals. Well-known and validated traditional Fc-fusion drugs, such as Enbrel® (etanercept) for the treatment of rheumatoid arthritis, consist of two copies of a biopharmaceutical linked to the Fc region of an antibody to improve pharmacokinetics, solubility, and production efficiency. SynFusion drugs consist of a novel Fc-fusion construct, called a monomer that links only a single copy of the drug to the Fc region on an antibody to optimize the pharmacokinetic and pharmacodynamic properties of the biopharmaceutical when compared to traditional Fc-fusion constructs
About Biovitrum
Biovitrum is a specialty pharmaceutical company with operations in Sweden and in the UK. Biovitrum markets a range of specialist pharmaceuticals primarily in the Nordic countries. The company has a research portfolio with several projects in clinical and preclinical phases for a number of well defined specialist indications. Biovitrum has the expertise and experience to take its projects all the way to the market. Biovitrum develops and produces protein-based drugs and also has small molecule research expertise and capabilities. Biovitrum has revenues of approximately SEK 1.2 billion and around 500 employees. Biovitrum’s share is listed on the OMX Nordic Exchange in Stockholm. For more information see biovitrum.
About Syntonix
Syntonix Pharmaceuticals, Inc. (Waltham, MA, USA) is a wholly-owned subsidiary of Biogen Idec. Syntonix is developing next generation biopharmaceuticals that enable better treatment options for patients with devastating chronic diseases such as hemophilia and autoimmune disorders. The company applies its core technologies to develop long-acting biopharmaceuticals that may be injected less frequently, and to discover novel drugs to treat antibody-mediated autoimmune and inflammatory disorders. The resulting proteins, peptides and antibodies are being commercialized through internal development programs and collaborations with biotechnology and pharmaceutical partners.
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