FINOX Biotech Release: CHMP Adopts Positive Opinion For BEMFOLA® For Treatment Of Infertility
1/23/2014 11:26:54 AM
Burgdorf, Switzerland, January 23rd 2014 – FINOX Biotech (Finox AG) announced today that the Committee
for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency
(EMA), has adopted a positive opinion on the company’s Marketing Authorisation Application (MAA) for
BEMFOLA® (follitropin alfa solution for injection in pre-filled pens), a biosimilar follicle stimulating hormone
used for the treatment of infertility. The CHMP’s recommendation will now be reviewed by the European
Commission, which has the authority to approve medicines for use in the 28 countries of the European Union
(EU). If approved, BEMFOLA® could be available in the EU in the second quarter of 2014
To date, nearly 400 patients have received at least one dose of BEMFOLA® in Phase I or III studies. The
MAA for BEMFOLA® is supported primarily by data from one Phase III study, in which BEMFOLA® therapy
was found to be similar to the currently available treatment with 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, CEO of FINOX Biotech commented, “We are thrilled that the CHMP has given a
positive opinion for BEMFOLA®. This is a great achievement for FINOX Biotech and for our investors. We
can now look forward to offering IVF Specialists and patients more choice in their product and delivery
Dr. h.c. Willy Michel, President of the Board of FINOX Biotech added, “Finox Biotech have done
extraordinarily well in bringing a recombinant protein to a CHMP positive opinion in the European Union. This
demonstrates the commitment of the team to delivering a high quality medicine that will use a Swissengineered
state-of–the-art delivery device”.
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. Accordingly the BEMFOLA® Pen won a ‘Red-Dot’
design award as an indication of just how successfully it fulfils its brief.
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’ 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, award-winning delivery devices.
For further information please visit www.finox.ch or contact our CEO, Gavin Jelic-Masterton
(firstname.lastname@example.org / +41 79 444 4110)
FINOX Biotech / Technikumstrasse 2 / 3401 Burgdorf / Switzerland
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