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Mayne Pharma receives critical FDA approval

Mayne Pharma Group surged on Friday after they announced that the US Food and Drug Administration has approved the New Drug Application for the company’s novel combined oral contraceptive Nextstellis. The critical approval puts the pharmaceutical group on track for a commercial launch of Nextstellis by the end of June 2021.

Developed by Mithra, Nextstellis is the first and only contraceptive pill containing estetrol, a native estrogen, now produced from a plant source. Estetrol is the first new estrogen introduced in the US in more than 50 years. The US market for combined hormonal contraceptives generated US$3.6 billion in sales according to IQVIA for the 12-month period ending January 2021.

In two phase 3 clinical studies Nextstellis was shown to be both safe and effective and met its primary efficacy endpoint of pregnancy prevention.

Mayne Pharma has a 20-year exclusive license and supply agreement in the US and Australia for Nextstellis. The product is under active review at the Australian Therapeutics Goods Administration.

Mitchell Creinin, Professor and Director of Family Planning at the University of California said “When speaking with patients about their contraceptive options, one of the most common concerns is side effects. Nextstellis is a new innovative contraceptive that has been shown in clinical trials to be not only safe and effective but also well tolerated with a desirable bleeding profile and minimal impact on triglycerides, cholesterol and glucose, as well as weight and endocrine markers.”

Mayne Pharma’s CEO, Scott Richards said “The approval of Nextstellis represents an important milestone, providing women with a new choice for their reproductive health. We are delighted to be introducing a new estrogen and bringing to market this novel, safe and effective option for women to consider with their healthcare providers.”

As a result of receiving FDA approval for Nextstellis, Mayne Pharma will pay Mithra US$11m in cash and issue 85.8m ordinary Mayne Pharma shares. Mithra is also entitled to a Mayne Pharma Board position.

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