Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA has received US Food and Drug Administration (FDA) approval for the New Drug Application (NDA) for the novel combined oral contraceptive NEXTSTELLIS(3 mg drospirenone (DRSP) and 14.2 mg of estetrol (E4) tablets).
Mayne Pharma anticipates the commercial launch of NEXTSTELLIS by the end of June 2021.
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. The new appointment will be subject to shareholder approval at the next Annual General Meeting in November 2021.
We are very proud that our teams achieved this important milestone for the commercialisation of NEXTSTELLIS in the world’s largest pharmaceutical market,”Mithra’s CEO, Leon Van Rompay, said.
“We look forward to working closely with our partner Mayne Pharma to make this commercial launch a success. The approval of NEXTSTELLIS 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 NEXTSTELLIS represents a new era in contraception and demonstrates the potential of our E4 portfolio.”
Developed by Mithra, NEXTSTELLIS is a novel, patent protected combined oral contraceptive pill containing 3 mg drospirenone (DRSP) and 14.2 mg estetrol (E4). E4 is a naturally produced estrogen during pregnancy, which can now be made from a plant source.
In two phase 3 clinical studies conducted in 3,725 women, NEXTSTELLIS was shown to be both safe and effective and met its primary efficacy endpoint of pregnancy prevention. It also delivered excellent results on a variety of secondary endpoints that demonstrated outstanding cycle control, bleeding control, safety, and tolerability.
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 (TGA).