Gedeon Richter, Hungary’s leading pharmaceutical producer, has announced on Tuesday that it acquired for five million Swiss francs the intellectual property rights, relevant studies, related data and documents of Bemfola / Afolia, for the use in the United States.
Richter announced today that it has concluded a sale and purchase agreement with Fertility Biotech AG, a Swiss corporation, in connection with the transfer of intellectual property rights, relevant studies, related data and documents of r-hFSH containing product, BEMFOLA® / AFOLIA, for the use in the United States.
The parties valued the transaction at CHF 5 million.
On 30 June 2016 Richter acquired Finox Holding, a privately held Swiss biotech company focused on development and commercialisation of innovative and cost effective products addressing female fertility, obtaining global rights for BEMFOLA® except for the US. At that time the product was already commercialised in the European Union, in Israel, in the Middle East and in Australia. US rights were transferred to Fertility Biotech, a company whose main shareholder is Dr h.c. Willy Michel, the Founder, and previous Chairman of the Board and previous majority shareholder of Finox Holding.
Zsuzsa Beke, head of government relations and PR at Richter, told Portfolio that while Richter had acquired Finox Holding along with Bemfola in 2016, it had not purchased the rights to the United States. She underlined that infertility is a major issue in the USA, and Richter decided the conditions to purchase rights for the U.S. market were just right.
Beke also noted that Richter is looking for a partner to introduce Bemfola in the U.S., and if the Phase III study necessary for the subsequent launch of the product is successful, registration of Bemfola could start three years from now.
BEMFOLA® is 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® was granted marketing authorisation in EU in May 2014 and is currently registered in 40 countries.
The European MA for BEMFOLA® was supported by data from a large Phase III study, in which BEMFOLA® therapy was found to be similar to the reference product - 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. BEMFOLA® is available in 5 single use monodose presentations available in the following dosage forms: 75, 150, 225, 300 and 450 IU. BEMFOLA® is supplied in a single-use, unique, state-of-the-art delivery system which results in a simple, once-a-day disposable device, allowing the patient to self-inject.