The Hungarian pharmaceutical company Gedeon Richter Plc. has announced on the website of the Budapest Stock Exchange that it expanded its partnership with Mithra Pharmaceuticals SA with a binding Head of Terms (HoT) agreement for the development and commercialization of the first estetrolbased combined oral contraceptive (15 mg estetrol (E4) / 3 mg drospirenone) and the mono estetrol (E4) investigational product for the treatment of the symptoms of menopause in China.
Upon the finalization of the license agreements, Richter will have the exclusive commercialization rights for both products in China. Richter will perform and fund the clinical studies required to obtain marketing approvals in China.
Upon the finalization of the license agreements Richter will pay to Mithra a down payment of EUR 4.5 million. The deal also foresees a total of EUR 1.2 million in payments for the achievement of regulatory milestones for both products, and EUR 8.5 million in sales-related milestones, as well as a low-double-digit share of cumulative net sales (royalties) after launch.
China is a major Asian market and pivotal for Richter to enable it to better serve women’s needs in the Asia Pacific region. According to recent data, the 2023 addressable market for contraceptives in China stands at EUR 104 million annually with an annual CAGR of 15% over five years while the addressable market for menopause is valued at EUR 87 million with a CAGR of 10% during the next five years.
Erik Bogsch, Chairman of the Board of Richter, commented that “we strongly believe that Richter will address Chinese women's increasing health needs and meet a growing demand for innovative therapies with both E4 containing products. We look forward to working together with Mithra throughout our market entry process. With Mithra’s innovation engine and Richter's commercialization capabilities, we will be able to offer this market a next generation solution that will have a positive impact on millions of women’s lives across this vast market.”
David Horn Solomon, CEO of Mithra stated that “we are excited to sign this agreement with our valued partner Gedeon Richter. Both ESTELLE® and DONESTA® will enable us to offer differentiated efficacy, safety, and convenience to millions of women across China. Oral contraceptives are commonly used by Chinese women and there is a major demand for menopause medication in this growing market, which counts an impressive 660 million women across all ages. We are convinced that our offering will make an active difference to their lives. We look forward to working closely with our partner to support their drive for success there.”


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