Mithra And Lotus Announce Approval Of ALYSSA , An Innovative Oral Contraceptive, In Both Taiwan And Hong Kong

• ALYSSA, developed by Mithra, is the first and only oral contraceptive drug containing estetrol, a native estrogen (E4) and drospirenone (DRSP), which features strong efficacy, safety and tolerability with excellent cycle control
• Under the partnership with Mithra, Lotus will be exclusively marketing ALYSSA in both Taiwan and Hong Kong to pursue overall contraceptive market worth US$25M, growing at a 3-year CAGR of 11% since 2019
• Lotus anticipates the commercial launch of ALYSSA contraceptive pill by the first quarter 2023 in Taiwan, followed by Hong Kong later in the year

Lotus Pharmaceutical Co., Ltd. and Mithra Pharmaceuticals, SA today are pleased to announce that Estelle, the first-of-its-kind oral contraceptive with a novel estrogen developed by Mithra, has been approved by both Taiwan Food and Drug Administration (TFDA) and Hong Kong Drug Office, Department of Health, under the trademark ALYSSA. Through this partnership with Mithra, Lotus will be exclusively marketing the product in Taiwan and Hong Kong.

Already commercialized globally, including major markets such as the US, Canada, Australia and several European countries, ALYSSA is the first ever oral contraceptive pill to combine the native and selective estrogen, estetrol (E4) with drospirenone (DRSP). E4 is a naturally occurring estrogen produced by the human body during pregnancy, and, in ALYSSA, E4 is derived from a plant source. Thanks to E4’s unique pharmacologic profile and mechanism of action, ALYSSA has been specifically designed to help overcome the issues associated with synthetic or modified estrogen-based COCs.

Upon launch, ALYSSA will compete in the Taiwanese oral contraceptive market which was valued at US$14M¹ in 2021 and currently mainly dominated in Taiwan by ethinyl estradiolbased estrogen solutions. Lotus will also market the product in Hong Kong to capture the market potential of approximately US$112M as of 2021.

Petar Vazharov, Chief Executive Officer of Lotus, commented: “We are very excited about our partnership with Mithra to introduce a novel oral contraceptive in Taiwan and Hong Kong markets. Within our existing women healthcare portfolio, the approval of ALYSSA represents an important milestone in providing women with new generation options for their reproductive health. ALYSSA offers an effective, safe, and well-tolerated contraceptive pill with predictable cycle control and has demonstrated low impact on certain parts of the body.”

• ¹ MAT Q1 2022, Oral contraception market
• ² MAT Q1 2022, Oral contraception market

Leon Van Rompay, CEO Mithra Women’s Health, commented: “We are pleased to share the approval received by our partner Lotus for our Estelle contraceptive in both Taiwan and Hong Kong, which marks our first authorization on the Asian continent. After successfully launching Estelle in the United States, Canada, Australia and in Europe, these upcoming launches in these two markets further demonstrate Mithra’s ability to pursue Estelle 's business development with best-in-class partners in core territories. Therefore, we are proud to, jointly with Lotus, continue revolutionizing the contraceptive landscape by offering Taiwanese and Hong Kongese women an alternative solution with an optimal benefit/risk.”​