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FINOX Biotech Release: r-FSH Biosimilar Submitted for European Medicines Agency Review


12/20/2012 9:53:54 AM

Burgdorf, Switzerland, December 20th, 2012 – FINOX Biotech (Finox AG) announced today that it has submitted the Marketing Authorisation Application (MAA) for its biosimilar recombinant Follicle Stimulating Hormone (r-FSH) to the European Medicines Agency (EMA) on October 30th 2012.

The submission of the MAA is a major milestone for FINOX Biotech and its lead-product r-FSH BEMFOLA (development code “AFOLIA”). The BEMFOLA MAA was based on a comprehensive clinical development program in which BEMFOLA was demonstrated to be statistically equivalent to the reference product in patients participating in an Assisted Reproductive Technology (ART) pivotal Phase 3 clinical trial.

Anjan Selz, Chief Executive Officer of FINOX Biotech commented: "The recent eCTD submission represents five years of concentrated development efforts. I am very pleased that the very positive results obtained allowed us to achieve this important milestone. We now focus on working together with the Health Authorities in order to give the European ART patients access to this valuable medicine as soon as possible.”

About BEMFOLA

BEMFOLA (development code “AFOLIA”) is a new “biosimilar” medicine: an almost exact copy of the originator product 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 a substantially more attractive injector device. The BEMFOLA injector pen is a single-use, one-a-day disposable device, which presents compliance and safety advantages. The self-injection process is reduced to only three steps, which enhances ease-of-use and patient acceptance.

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®. Currently, FINOX Biotech identifies strategic partners to market BEMFOLA in Europe, USA and other regions of the world as well as financial investors to support to aggressive growth strategy of the company. FINOX Biotech was founded in 2007 with the vision to become the new force in fertility therapies by specifically combining high quality medicines with dedicated devices.

For further information please visit www.finox.ch or contact our CEO, Anjan Selz

(anjan.selz@finox.ch / 0041 79 434 91 00)



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