The European Commission has granted Marketing Authorisation (MA) for Finox Biotech's bemfola (follitropin alfa solution for injection in pre-filled pens), a recombinant follicle stimulating hormone used for the treatment of infertility. This 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 sour 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”
Bemfola was produced using recombinant DNA technology. Both bemfola and the reference product GONAL-f are formulations of the naturally occurring hormone FSH, which plays a key role in human reproduction. bemfola is the result of a targeted drug development process aimed to replicate as closely as possible the reference product. The brief to the development engineers when designing the bemfola injector device was to produce a Pen that absolutely minimised the number of steps a patient needs to take when preparing the injection and to ensure that the patient and physician had maximum control and the least chance of a patient error. The result, the bemfola Pen, is therefore a simple, single-use, once-a-day disposable device, which allows the patient to self-inject.
Finox Biotech has agreed with the US FDA to conduct a pivotal phase III study (FIN3002) for registration of bemfola (AFOLIA) in the USA. A US IND has been opened and the FIN3002 study is now in progress.
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.