The powerful US drugs regulator has opened the door to a new contraceptive pill from Australian company Mayne Pharma (ASX:MYX), accepting a data pack for review ahead of drug registration.

The Food and Drug Administration (FDA) will finish a review into a new drug application (NDA) before June next year for a combination estetrol (E4) and drospirenone pill.

Mayne Pharma licensed the pill from Mithra Pharmaceuticals in October last year for a minimum of $US295m ($424.4m) in cash and scrip based on commercialisation milestones. The company believes it can make $200m a year from sales of the new pill.

If approved it would be “the first contraceptive product containing E4”, Mayne said.

The last contraceptive pill to be developed was the Qlaira in 2009, a combination pill. US sales of combined hormonal contraceptives are more than $US4bn a year. The Australian market is valued at $130m a year.

Mithra trademarked the pill under the name ‘Estelle’. It’s not to be confused with an acne drug already on the market, Diane-35, which is sold under that brand name in Australia controversially for contraception purposes as well as it has higher rates of blood clots that others.

The new Mithra pill, which uses a form of oestrogen that is produced by the human foetal liver during pregnancy, has been put through two phase-three studies in 3725 women, the final leg in the three-phase human clinical trial process.

Mayne Pharma, a pharmaceuticals distributor, is preparing to lodge a registration application with the Australian regulator later this year.

The stock rose over 6 per cent in early morning trading to 40c.

Mayne Pharma plans to set up a new women’s health sales team to market this product in the US, in addition to sales teams dedicated to its other products.


In other ASX health news:

Botanix (ASX:BOT) is resuming recruitment for its BTX 1801 phase 2a clinical study into antimicrobial action of its synthetic cannabinoids in July.

The dermatology trial for BTX 1503 has an end-of-phase-2 meeting with the FDA scheduled for July 2020, and the BTX 1702 rosacea study remains on hold until restrictions ease in Australia and New Zealand.

Anatara Lifesciences (ASX:ANR) says it won’t reach a partnering agreement by the end of FY2020 for an animal health product and is in talks with third parties over barriers to partnering.