The Mayne Pharma Group Ltd (ASX: MYX) share price is climbing today after revealing its E4/DRSP drug is one step closer to commercialisation.
At the time of writing, Mayne Pharma shares have jumped 4.6% to 38.7 cents after rallying as much as 8.1% in morning trade.
What did Mayne Pharma announce?
This morning, Mayne Pharma revealed the new drug application (NDA) for E4/DRSP to prevent pregnancy has been accepted for review by the US Food and Drug Administration (FDA).
The NDA submission includes results from two phase 3 clinical studies conducted in more than 3,725 women aged 16 to 50.
E4/DRSP is a novel combined contraceptive pill that contains 15mg of estetrol (E4) and 3mg of drospirenone (DRSP).
The drug is being developed by strategic partner Mithra Pharmaceuticals SA, a biotech based in Belgium.
Mayne signed a 20-year exclusive supply and license agreement with Mithra in October 2019 to commercialise E4/DRSP in the US. This was followed by a similar agreement for the Australian market announced in May.
What is the market opportunity for E4/DRSP?
If approved, E4/DRSP would be the first contraceptive product containing E4. It would also be the first new estrogen introduced in the US for contraceptive use in approximately 50 years.
Mayne believes the US contraceptive market is valued at US$5.4 billion. The short acting combined hormonal oral contraceptives component of the market is estimated at US$4 billion, with approximately 135 million units sold annually.
Meanwhile, Mayne states that the Australian contraceptive market is valued at $130 million, with approximately 14 million short acting combined hormonal oral contraceptives sold annually.
Commenting on today’s update, chief executive Scott Richards said:
“This is another important milestone for E4/DRSP and brings us one step closer to providing women in the US with a new contraceptive that we believe will be effective, safe and well-tolerated. We look forward to working with the FDA and Mithra during the ongoing review of our application.”
“In parallel, we continue to advance our US commercial strategy and infrastructure to ensure we are well positioned to support the potential launch of E4/DRSP in the first half of calendar 2021,” Mr Richards added.
Mayne has plans to file E4/DRSP with the Australian Therapeutic Goods Administration this calendar year.