Burgdorf, Switzerland, December 17th 2013 – FINOX Biotech (Finox AG) announced today that the first patients have been recruited into their pivotal Phase III study in the USA.
FINOX Biotech has agreed with the US-FDA to conduct the pivotal phase III study (FIN3002) for registration of BEMFOLA® in the USA. FIN3002 is an investigator and assessor-blinded multi-centre study to compare the efficacy and safety of BEMFOLA® vs. GONAL-f® in normal ovulatory women undergoing in vitro fertilisation. A total of 1,106 patients undergoing a maximum of three treatment cycles will be enrolled. “The start of FIN3002 is the culmination of discussions with the FDA and leading clinicians and will be one of the largest studies ever conducted in the USA using daily-injected recombinant FSH. We are therefore very excited about the scale of data collection for this study, which will provide a solid platform for our US NDA filing” explained Dr Manfred Rettenbacher, Finox Biotech’s Senior Vice-President, Head of Medical Science.
Gavin Jelic-Masterton, CEO of FINOX Biotech commented, “Starting this robust and pivotal study in the USA is an important day in the history of Finox Biotech – it means that we are now entering the next phase of the development of the company – which is to produce quality data to enable us to file our product in the world’s largest and most important market for gonadotropins”.
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. The BEMFOLA® Pen was designed to be a simple, single-use disposable device, which allows the patient to self-inject and the physician to be sure that the patient has injected the correct dosage of their medication every day.
About BEMFOLA® in other clinical development programs
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.
About FINOX Biotech
FINOX Biotech (FINOX AG) is a biopharmaceutical company with its corporate headquarters in Burgdorf, Switzerland. FINOX Biotech’s 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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