Biopartners Holdings AG today announced that it has submitted a
marketing authorization application for Biferonex(R) (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).
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.
