Friday January 13th 2023

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Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are pleased to announce the launch of HALOETTE® (etonogestrel and ethinyl estradiol) a vaginal hormonal contraceptive ring into the US market.

HALOETTE® contraceptive is a generic version of NUVARING® , a combined hormonal contraceptive flexible ring indicated for the prevention of pregnancy. According to IQVIA, NUVARING® US brand and generic sales were approximately USD 564 million for the 12 months ended November 2022.

Under the terms of the long-term license and supply agreement, Mayne Pharma will pay Mithra a milestone of EUR 1.6 million.

Mayne Pharma’s CEO Mr Shawn O’Brien said: “We are pleased to announce the launch of HALOETTE® in the US. This is another example of our commitment to providing women with more contraceptive choice. Mayne Pharma continues to expand its women’s health portfolio with the recent launch of NEXTSTELLIS® (estetrol/drospirenone) in the US and Australia, and our new license agreement for ANNOVERA®, IMVEXXY® and BIJUVA® from TherapeuticsMD.”

Mithra’s CEO Mr Leon Van Rompay said: “We are pleased to start the year with the commercial launch of our affordable contraceptive alternative in the US, the world's largest pharmaceutical market. This key milestone has been reached thanks to the support of our Mithra CDMO, highlighting its unique expertise in developing and manufacturing complex pharmaceutical devices.”