Australia’s Mayne Pharma shares gain as its new birth control pill wins approval

Pharma News: Australia’s Mayne Pharma shares hit a 17-month high as the next-generation birth control pill it licensed from a Belgium company in 2019 secured approval of US regulators.

While this contraceptive pill is currently under review by the Therapeutic Goods Administration (TGA), Mayne Pharma expects to launch Nextstellis (3 mg drospirenone [DRSP] and 14.2 mg estetrol [E4] tablets) by the end of June 2021 in the United States, where the market for short-acting combined contraceptives was $US3.6 billion last year.

Developed by Mithra Pharmaceuticals, Nextstellis is a mix of drospirenone, a progestin, and esterol, a plant-derived estrogen that’s the first new estrogen introduced in the United States in more than 50 years.

It has a lower impact on liver function than similar pills like Yasmin and Yaz and doctors believe it could help with the decrease in libido some women on those pills experience.

“The approval of NEXTSTELLIS represents an important milestone in providing women with another choice for their reproductive health,” said Scott Richards, CEO of Mayne Pharma. “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.”

“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 endorcine markers,” said Mitchell Creinin, director of family planning at the University of California.

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. We believe the approval of NEXTSTELLIS represents a new era in contraception and demonstrates the potential of our E4 portfolio.”

Under the licensing agreement, Mayne will pay Mithra $US11 million in cash and 85.8 million Mayne Pharma shares.