The deal will involve sales of Bayer’s low-dose gestodene and ethinyl-estradiol containing a transdermal contraceptive patch in the European Union, other European countries and also certain Latin American countries, under the trademark of Lisvy®, a press release from Richter said.
In line with the agreement, Richter is required to make an upfront payment followed by further milestone payments, and Richter is also required to pay sales related royalties to Bayer, the release said. Richter said it will be responsible for conducting and funding the PASS Study (Post-Authorisation Safety Study), as required by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC).
“We remain committed to the development and commercialization of female healthcare products, aiming towards the improvement of the quality of life for the female population in all age groups,” said Erik Bogsch, managing director of Gedeon Richter Plc.. “This agreement is considered as a further step to enhance our existing branded female healthcare franchise worldwide, being a paramount strategic initiative for our company.”
Scott Sherriff, head of women’s healthcare at Bayer HealthCare Pharmaceuticals, said: “As a leading company in hormonal contraception, we have a rich portfolio in short-term, long-term and permanent contraceptive choices for women. However, in order to realize the full potential of the female contraceptive patch we have decided to partner with Gedeon Richter, who will cover Region Europe and certain countries in Latin America.”
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