Biopartners Submits Its Novel Interferon beta-1a, Biferonex®, To The EMEA
BAAR, Switzerland--(BUSINESS WIRE)--Biopartners Holdings AG today announced that it has submitted a marketing authorization application for Biferonex® (interferon beta-1a) to the EMEA. Biferonex represents a fully innovative, pH neutral and human serum albumin (HSA) free formulation providing an optimized interferon beta treatment solution for patients suffering from relapsing remitting multiple sclerosis (RRMS).
“Most impressive are the effects of Biferonex in reducing the size and the activity of inflammatory regions in the brain of MS patients as shown by MRI. This may reduce progression of the disease”
The submission was welcomed by Professor O. R. Hommes, Chairman of the European Charcot Foundation which coordinates MS research in Europe. “Most impressive are the effects of Biferonex in reducing the size and the activity of inflammatory regions in the brain of MS patients as shown by MRI. This may reduce progression of the disease” he stated.
Interferon beta has been extensively studied in multiple sclerosis, exhibiting beneficial effects in both the relapsing-remitting and progressive forms of the disease by inhibiting inflammatory activity and thereby reducing nerve cell damage. It is also thought to inhibit damage to the myelin sheath by both preventing a T cell-mediated auto-immune response to myelin, and reducing the effect of other naturally-occurring compounds that can enhance the auto-immune response.
The Biferonex HSA-free formulation boasts a low incidence of neutralizing antibodies (NABs) therefore optimizing drug treatment effectiveness. Additionally, its neutral pH minimizes the risk of injection site reactions, which should lead to an enhanced tolerability.
About the MS market:
The World Health Organization estimates that multiple sclerosis affects 2.5 million people worldwide and is one of the most common neurological disorders and causes of disability of young adults, especially in Europe and North America.
About Biopartners Holdings AG
Headquartered in Baar, Switzerland, with an affiliate in Germany, Biopartners is a global biopharmaceuticals company and a leader in the emerging field of multi-source biopharmaceuticals. Biopartners’ mission is to develop biopharmaceuticals and innovative formulations of “first generation” biopharmaceuticals as well as advanced delivery systems that may improve patient compliance. Biopartners is developing a comprehensive range of biopharmaceutical products that may offer life-saving therapeutic benefits across many therapeutic areas. By now, Biopartners has submitted three dossiers to the EMEA and has a fourth product in phase III on the way. In March 2007, Biopartners was acquired by a Polish biotechnology company, Bioton S.A.