- Mayne Pharma (MYX) and Mithra Pharmaceuticals have received approval for its combined oral contraceptive Nextstellis from the U.S. Food and Drug Administration (FDA)
- Mayne has a 20-year licence agreement for Nextstellis, which is the first and only contraceptive pill to contain a native estrogen called estetrol, which is produced from a plant source
- Previous studies showed Nextstellis is safe, effective and meets its primary efficacy endpoint of pregnancy prevention, while also delivering excellent results in cycle and bleeding control and tolerability
- As a result of receiving FDA approval, Mayne Pharma will pay Mithra U.S. $11 million (around A$14.19 million) in cash and issue 85.8 million ordinary shares
- Mayne Pharma Group is up 1.10 per cent, trading at 46 cents
Mayne Pharma (MYX) and Mithra Pharmaceuticals have received approval for its combined oral contraceptive Nextstellis from the U.S. Food and Drug Administration (FDA).
Nextstellis is a tablet containing three milligrams drospirenone and 14.2 milligrams of estetrol (E4), which the company plans to commercially launch by the end of June.
Developed by Mithra, Nextstellis is the first and only contraceptive pill containing a native estrogen called estetrol, which is produced from a plant source. This is also the first new estrogen introduced in the U.S. in more than 50 years.
Two phase three clinical studies conducted on 3725 women showed Nextstellis was safe, effective and met its primary efficacy endpoint of pregnancy prevention. The drug also delivered excellent results on a variety of secondary endpoints, like cycle control, bleeding control, safety, and tolerability.
“We believe the approval of Nextstellis represents a new era in contraception and demonstrates the potential of our E4 portfolio,” said Mithra CEO Leon Van Rompay.
As a result of receiving FDA approval, Mayne Pharma will pay Mithra US$11 million (around A$14.19 million) in cash and issue 85.8 million ordinary shares. Mithra is also entitled to a Mayne Pharma board position, which will be determined at an annual meeting in November 2021.
The company says nearly 10 million American women use short-acting combination contraceptives that use estrogen and progestin, with the U.S. market generating US$3.6 billion (roughly A$4.64 billion) in sales over 2020.
“The approval of Nextstellis represents an important milestone, providing women with a new choice for their reproductive health,” said Mayne Pharma CEO, Scott Richards.
“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.”
Mayne Pharma has a 20-year exclusive licence and supply agreement in the U.S. and Australia for Nextstellis.
Mayne Pharma Group is up 1.10 per cent, trading at 46 cents at 9:30 am AEST.