Burgdorf, Switzerland, October 22nd 2013 – FINOX Biotech (Finox AG) announced today that at a meeting of shareholders a capital raise of 22MCHF was agreed.
The capital was jointly raised through Finox AG majority shareholder, Dr. h.c. Willy Michel, with approximately 12MCHF contribution, through BV Group, with approximately 10MCHF and through employee shareholding. 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, as it will allow Finox Biotech to push ahead with our pivotal study in the USA, which is the world’s biggest market for rFSH, as well us giving us the financial platform on which to launch BEMFOLA® in Europe”.
FINOX Biotech submitted their application for Marketing Authorisation Application (MAA) for its biosimilar recombinant Follicle Stimulating Hormone (r-FSH) BEMFOLA® to the European Medicines Agency (EMA) on October 30th 2012 and are expecting to receive a CHMP opinion by end of Q1 2014.
Dr. h.c. Willy Michel, President of the Board of FINOX Biotech commented, ‘Finox Biotech have to this point done extraordinarily well in bringing a recombinant protein to submission in the European Union and entering into Phase III clinical trials in the USA. This capital raise further proves our commitment to supporting BEMFOLA® through it’s development and launch’
About BEMFOLA®
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, more discreet and 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.
For further information please visit www.finox.ch or contact our CEO, Gavin Jelic-Masterton
(gavin.jelic-masterton@finox.ch / +41 79 444 4110)
FINOX Biotech / Technikumstrasse 2 / 3401 Burgdorf / Switzerland
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