European Commission Grants Marketing Authorisation for Finox Biotech’s bemfola

Finox Biotech (Finox AG) announced today the European Commission has granted Marketing Authorisation (MA) for bemfola (follitropin alfa solution for injection in pre-filled pens), a recombinant follicle stimulating hormone used for the treatment of infertility. Today’s marketing authorisation follows a positive opinion by the European Medicines Agency, and allows for the marketing of bemfola in all of the 31 countries of the European Union (EU) and European Economic Area (EEA).

To date, nearly 400 patients have received at least one dose of bemfola in Phase I or III studies. The MA for bemfola was supported by data from a large Phase III study, in which bemfola therapy was found to be similar to the currently available treatment - GONAL-f, based on the numbers of oocytes retrieved after completing FSH therapy. In this Phase III study, similar efficacy and safety profiles were observed between the two study arms and similar numbers of live babies were born to patients who became pregnant following completion of therapy.

Gavin Jelic-Masterton, Chief Executive Officer of Finox Biotech commented, “the marketing authorisation of bemfola is an important step forward in the management of infertility in Europe, enabling many more patients the opportunity to obtain the treatment they need. We are confident that IVF Patients and Doctors across Europe will benefit from Finox Biotech’s commitment to quality, cost effectiveness and easy-to-use fertility medicines. bemfola will be a great success for our company”.

Dr. h.c. Willy Michel, President of the Board of Finox Biotech added, “This is the culmination of many years commitment to bringing a Swiss Quality r-FSH to the market in Europe and I believe that with the cost effectiveness of the product and our state-of-the-art delivery system bemfola will be very popular with physicians and patients. This also gives us the positive impetus to our ongoing development and registration efforts for the USA and Rest of World”.

About Finox Biotech
Finox Biotech (Finox AG) is a biopharmaceutical company with its corporate headquarters in Burgdorf, Switzerland. Finox’ first product is bemfola, a biosimilar r-FSH of GONAL-f. Finox Biotech was founded in 2007 with a vision to become a leading company in the field of fertility therapies, by combining high quality Swiss medicines with innovative, award-winning delivery devices.