The company claims that Biferonex is a pH neutral and human serum albumin (HSA) free formulation providing an interferon beta treatment solution for patients suffering from relapsing remitting multiple sclerosis (RRMS). Biopartners believes that this formulation will enhance the tolerability and efficacy of the drug.
The submission was welcomed by Professor Otto Hommes, chairman of the European Charcot Foundation, which co-ordinates 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 has a low incidence of neutralizing antibodies, therefore optimizing drug treatment effectiveness, according to the company. Additionally, its neutral pH minimizes the risk of injection site reactions, which should lead to an enhanced tolerability.