Mithra Announces Estelle® Launch in Belgium

Liege, Belgium, 21 October 2021 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, is very pleased to announce that its novel combined oral contraceptive Estelle® is now available in Belgium. The product is marketed in Belgium by Richter under the brand name Drovelis® and by Ceres Pharma under the brand name Lydisilka®.

The Board of Directors confirms Leon Van Rompay as Mithra’s CEO

Liege, Belgium, 15 October 2021 – 17:45 CEST – The Board of Directors of Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, has confirmed the appointment of Mr. Leon Van Rompay as Chief Executive Officer of the company, a position he held ad interim since February 04, 2021.

Mithra Provides FDA Update on Myring®

Liege, Belgium, 6 October 2021 – 17:45 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces that its US commercial partner Mayne Pharma (ASX:MYX) has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) in relation to the abbreviated new drug application (ANDA) for Myring®, the vaginal contraceptive ring made of ethylene vinyl acetate copolymers (EVA).

In the letter, Mayne Pharma has been requested to provide additional data on compatibility. All other topics, in particular the manufacturing process by the Mithra CDMO, did not raise any supplementary questions. Mayne Pharma is working closely with Mithra and the FDA to address the few remaining questions raised in the CRL before year-end.

Mithra Announces the Appointment of its Representative to Mayne Pharma’s Board of Directors

Liege, Belgium, 4 October 2021 – 17:45 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, is pleased to announce that it has joined the Board of Mayne Pharma Group Limited, in accordance with the license and supply agreement to commercialize Nextstellis® (E4/DRSP) oral contraceptive in the United States. As Mayne Pharma’s largest shareholder (9.6% stake), Mithra has appointed Dr. Carolyn Myers as Director on the Board, as well as on the joint steering committee related to the commercialization and continued development of Nextstellis®.