Mayne Pharma Group Limited and Mithra Pharmaceuticals, SA are very pleased to announce that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for the novel combined oral contraceptive Estelle® under the trademark Nextstellis® (15 mg Estetrol (E4) / 3 mg drospirenone (DRSP)). Mayne Pharma anticipates the commercial launch of Estelle® by the end of June 2021.
Developed by Mithra, Estelle® 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.
Nearly 10 million American women use short-acting combination (estrogen and progestin) contraceptives. The US market for combined hormonal contraceptives generated US $3.6 billion (around EUR 3 billion) in sales according to IQVIA for the 12-month period ending January 2021.
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 a 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 Estelle®, Mayne Pharma will pay Mithra USD 11 million (around EUR 9.2 million) in cash and issue 85.8 million ordinary Mayne Pharma shares. Mithra is also entitled to a Mayne Pharma Board position. The new appointment will be subject to shareholder approval at the next Annual General Meeting in November 2021.
Mithra’s CEO, Leon Van Rompay said “We are very proud that our teams achieved this important milestone for the commercialisation of Estelle® in the world’s largest pharmaceutical market. We look forward to working closely with our partner Mayne Pharma to make this commercial launch a success. The approval of Estelle® represents a huge achievement for a biotech company such as Mithra and all the teams who made this ambitious project come to fruition. This is a critical step in Mithra’s journey to bring innovative medicines to the US women’s health market. We believe the approval of Estelle® represents a new era in contraception and demonstrates the potential of our Estetrol portfolio.”