Ann: FDA approval of novel oral contraceptive NEXTSTELLIS, page-53

Mayne wins FDA approval for oral contraceptive

Mayne Pharma has gained approval by the powerful US Food and Drug Administration for a new application for its oral contraceptive, Nextstellis, ahead of a launch in late June.
This is only the third time in history that an Australian company has received FDA approval for a new chemical entity. Mayne’s stock jumped over 15 per cent to 53¢ each on the news.
All the past Mayne Pharma approvals have been generics or new formulations of an existing molecule.

Mayne Pharma CEO Scott Richards.

The Adelaide-based company said on Friday morning that Nextstellis, developed by its European partner Mithra Pharmaceuticals SA, 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 $US3.6 billion in sales according to IQVIA for the 12-month period ending January 2021.
The specialty pharmaceutical company chief executive Scott Richards said the approval of Nextstellis is 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,” he said.
Mr Richards has been pivoting the business away from the retail generic segment into more sustainable areas in dermatology, women’s health, infectious diseases and contract services.
Mitchell Creinin, professor and director of family planning at the University of California Davis said one of the most common concerns is side effects for patients taking contraception.
“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,” he said.
Bell Potter analyst John Hester said in a note to clients Nextstellis represents the largest single product revenue opportunity for Mayne in the company’s history.
“We expect the key selling points for Nextstellis will be safety, tolerability and avoidance of weight gain – this last point being a common side effect of currently marketed combined hormonal contraceptives (CHCs),” he said.
As a result of FDA approval, Mayne Pharma will pay Mithra $11 million in cash and issue 85.8 million ordinary shares.
Mithra will also appoint a director to the Mayne board, which will be subject to shareholder approval at the next annual meeting in November.
It has been a long road for Mayne which first lodged a US application in 2018, and hoped to get approval by June 2019. Last year the FDA questioned its application, which was resolved today.
More to come