FINOX Biotech (Finox AG) announced today that at a meeting of shareholders a capital raise of 20MCHF was agreed upon.
The capital was jointly raised through Finox AG majority shareholder, Dr. h.c. Willy Michel, with a contribution of approximately 17MCHF and through existing shareholders and employees. Gavin Jelic-Masterton, CEO of Finox Biotech, commented: “This shareholders agreement for the capital raise is an important milestone in the history of the company. It allows Finox Biotech to push ahead at full speed with the launch of BEMFOLA® in Europe and to complete FIN3002, our pivotal Phase III study in the USA, which is the world’s biggest market for rFSH”.
FINOX Biotech received approval for their application for Marketing Authorisation Application (MAA) for its biosimilar recombinant Follicle Stimulating Hormone
(r-FSH) BEMFOLA® from the European Medicines Agency (EMA) on March 28th 2014 and are currently launching the product across the European Union countries.
Dr. h.c. Willy Michel, President of the Board of FINOX Biotech, commented; “Finox Biotech are now in a full commercial phase in Europe and are growing rapidly. We, the Board, are cognisant of the investment that this requires. This capital raise further proves our commitment to supporting BEMFOLA® through it’s development and launch”.
BEMFOLA® (development code “AFOLIA”) is a new “biosimilar” medicine that 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. BEMFOLA® has a number of key beneficial characteristics. i.e. equivalent clinical efficacy and safety vs. Gonal-f®, but using an innovative and award winning injector device. The BEMFOLA® injector pen is a single-use, one-a-day disposable device, which is smaller and more discreet. It allows the patient to inject using only the minimal numbers of steps – and has therefore been designed to increase patient confidence by limiting the number of potential errors.
About BEMFOLA® in other clinical development programs
FINOX Biotech has agreed with the US-FDA via a Special Protocol Assessment to conduct a pivotal phase III study (FIN3002) for registration of BEMFOLA® (AFOLIA) in the USA. A US IND was filed and the FIN3002 study is in progress.
About FINOX Biotech
FINOX Biotech (FINOX AG) is a biopharmaceutical company with its corporate headquarters in Burgdorf, Switzerland. Finox’ first product will be 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 and award winning delivery devices.