A bet made by Mayne Pharma (ASX: MYX) in 2019 has paid off today after the US Food and Drug Administration (FDA) approved an application for the oral contraceptive NEXTSTELLIS, containing the first new estrogen to be introduced to the US market in more than 50 years.
In October 2019 Mayne entered a 20-year exclusive licence agreement with the drug's Belgian developer Mithra Pharmaceuticals (Euronext Brussels: MITRA) to commercialise the tablets, which contain the plant-based estrogen estetrol derived from soybeans through research that took decades.
This is in contrast to existing products on the market that are based on synthetic estrogen, leading Mithra's CEO Leon Van Rompay to describe the breakthrough as hailing in a "new era in contraception".
MYX shares opened 19.5 per cent higher at $0.055 today.
Adelaide-based Mayne Pharma is giving up close to 10 per cent of its shares - worth around $39 million at yesterday's closing price - to Mithra as part of the deal, as well as US$10 million (AUD$12.9 million) in cash.
Mithra is also entitled to a Mayne Pharma board position, with a new appointment to be voted on by shareholders at the next annual general meeting in November this year.
Mayne now anticipates the commercial launch of NEXTSTELLIS by the end of June 2021, tapping into the US market where 10 million women currently use short-acting combination (estrogen and progestin) contraceptives.
The US market for combined hormonal contraceptives generated US$3.6 billion in sales according to IQVIA for the 12-month period ending January 2021.
The new contraceptive is also already approved in Canada, received a positive opinion from European authorities recently, and Mayne Pharma is hoping for Australian approval by the end of this calendar year.
"The approval of NEXTSTELLIS represents an important milestone, providing women with a new choice for their reproductive health," says 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."
Van Rompay says Mithra is very proud that its team has achieved this important milestone for the commercialisation of NEXTSTELLIS 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," Van Rompay says.
"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."
Mitchell Creinin, a professor and the director of family planning at the University of California describes a few advantages working in favour of NEXTSTELLIS.
"When speaking with patients about their contraceptive options, one of the most common concerns is side effects," says Creinin.
"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."Never miss a news update, subscribe here. Follow us on LinkedIn, Instagram and Twitter.
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