Mayne Pharma and Mithra announce FDA approval of HALOETTE®, a generic version of NUVARING®
Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are pleased to announce that the US Food and Drug Administration (FDA) has granted approval of the Abbreviated New Drug Application (ANDA) for HALOETTE® (etonogestrel and ethinyl estradiol) vaginal hormonal contraceptive ring. Mayne Pharma anticipates the commercial launch of HALOETTE® ring by early calendar year 2023.
HALOETTE® contraceptive is a generic version of NUVARING®, a combined hormonal contraceptive flexible ring that combines etonogestrel and ethinyl estradiol, and is indicated for the prevention of pregnancy. According to IQVIA, NUVARING® US brand and generic sales were approximately USD 580 million (around EUR 570 million) for the 12 months ended June 2022 (1).
Under the terms of the long-term license and supply agreement, Mayne Pharma will pay Mithra EUR 6 million as a result of receiving FDA approval and EUR 1.6 million upon commercial launch in the U.S. Moreover, Mithra will manufacture HALOETTE® at its Contract Development and Manufacturing Organization (CDMO) facility in Belgium.
Mayne Pharma’s CEO Mr Scott Richards said: “We are very pleased to announce the approval of HALOETTE® in the US and look forward to bringing this drug-device generic to market. Mayne Pharma is proudly committed to providing women with more affordable and accessible contraceptive choices. After the approval of NEXTSTELLIS® contraceptive tablets in the US and Australia, this marks the third regulatory product approval we have received with Mithra as our development partner.”
Mithra’s CEO Mr Leon Van Rompay said: “This important milestone highlights Mithra’s world class drug development and manufacturing capabilities to develop a complex drugdevice pharmaceutical. We are thrilled to manufacture HALOETTE® ring at our Mithra CDMO and to support the launch of this affordable contraceptive alternative in the U.S., the world’s largest pharmaceutical market.”