Dubai, 1 September 2014,
Genpharm Services and the Swiss pharmaceutical company Finox Biotech, have signed a multiyear agreement for the commercialization of Bemfola® in the Middle East and North Africa (MENA) region.
Bemfola® is the first Swiss biosimilar recombinant FSH, approved by the European Medicinal Agency (EMA) for the treatment of couples suffering from Infertility.
Bemfola comes with an innovative and award winning injector device. The BEMFOLA® injector pen is a single-use, one-a-day disposable device, which is smaller and presents compliance and safety advantages. The self-injection process is reduced to only three steps, which enhances ease-of-use and patient acceptance.
Finox Biotech conducted a comprehensive clinical development program involving nearly 400 patients in which, Bemfola® was demonstrated to be statistically equivalent to the reference product (Gonal-F) in patients participating in an Assisted Reproductive Technology (ART) pivotal Phase 3 clinical trial. Data from a phase III found Bemfola® to be similar to Gonal-F®, based on the numbers of oocytes retrieved after completing FSH therapy. Similar efficacy and safety profiles were also observed between the two study arms and similar numbers of live babies were born to patients who became pregnant following completion of therapy.
“We are thrilled to have Bemfola® as the most recent addition to our specialty portfolio. Women’s health is part of our focus and Fertility is a major issue in MENA. It leads to significant societal and economic costs. Helping couples realize their dream of having a child is inspiring and gratifying. Bemfola® presents an effective treatment alternative. We look forward to putting our expertise and knowledge of the Assisted Reproduction Techniques (ART) at the service of these patients”, said Mr. Karim Smaira, CEO of Genpharm.
“We are delighted to expand our footprint into the MENA Markets. Genpharm’s expertise and knowledge in fertility fits perfectly with our commitment to bringing familiar, Swiss quality products with added value – and delivering professional service to patients and physicians alike” commented Gavin Jelic-Masterton, CEO of Finox Biotech, he added ‘We believe this partnership has the potential to allow more patients to be treated successfully through a cost-effective and simple drug delivery system across more geographical areas”.
About Genpharm Services
GENPHARM is a specialty pharmaceutical marketing company. It provides fast-track market access to innovative and specialty pharmaceutical companies looking to expand into the Middle East and North Africa (MENA) region. We focus on areas of unmet medical need, particularly in rare and genetic diseases with niche and orphan drugs.
Genpharm operates exclusively through evidence-based medicine and high ethical standards. With an experienced management and a team of dedicated MSLs Genpharm has operations extending across the Middle East and North Africa region. Our current partners are companies including GSK, Genzyme, Aegerion, Stallergenes, Tigenix, Lifecodexx and Sintetica.
GENPHARM is based in the Dubai Biotechnology and Research Park (DuBiotech), U.A.E. For more info please call +971 4 4227010 or visit us at www.genpharmservices.com
About Finox Biotech
Finox Biotech (FINOX AG) is a biopharmaceutical company with its corporate headquarters in Burgdorf, Switzerland. Finox’ first product is 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.