Mayne Pharma (ASX: MYX) has entered into an exclusive license and supply agreement with Europe-based women’s health specialist Mithra to commercialise E4/DRSP, a combined oral contraceptive, in the United States.
Mayne Pharma’s CEO, Scott Richards said the product is expected to be launched in first half of calendar 2021, subject to US Food and Drug Administration (FDA) approval.
E4/DRSP is a novel, next generation combined oral contraceptive composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP). Estetrol (E4) is a native estrogen produced by the human foetal liver during pregnancy.
Mr Richards said that following more than 20 years of research and development, Mithra can now produce Estetrol (E4) at scale through a complex plant-based production process.
“I am excited to announce the addition of E4/DRSP, a next generation oral contraceptive, to our specialty brand portfolio and further strengthen our relationship with Mithra, who is also our partner for generic NUVARING,” Mr Richards said.
“This transaction transforms Mayne Pharma and is highly consistent with our stated strategy to build our specialty business with durable, high growth novel products in core therapeutic categories leveraging our commercial capability and associated know-how in the US.
“If approved, Estetrol (E4) will be the first native estrogen approved in a contraceptive product in the US and the first new estrogen introduced in the US in approximately 50 years. E4/DRSP is an innovative contraceptive with a unique mode of action that phase II and phase III studies suggest could result in improved patient outcomes.
“This product is expected to be a foundation asset in Women’s Health for many years to come and has a strong and synergistic fit with Mayne Pharma’s currently marketed portfolio of more than 20 branded generic contraceptives and existing pipeline products such as generic NUVARING for which we are targeting approval in calendar 2020.
“Women’s Health is a core therapeutic area for the company and this deal enables Mayne Pharma to accelerate and extend its position in this specialty. We are attracted to the underlying fundamentals of the US short-acting combination contraceptive market (estrogen + progestin) in terms of its stability and scale with more than 10 million American women using combination oral contraceptives, patches or vaginal rings every day.”
Mithra’s CEO, Mr Francois Fornieri said his company believes Mayne Pharma is the best possible partner for the commercialisation of E4/DRSP in the US.
Mithra and Mayne Pharma have been partners since 2017 and we look forward to helping Mayne Pharma maximise the potential of its Women’s Health franchise in the US.”
In two phase III clinical studies conducted in 3,725 women, E4/DRSP showed positive top-line results against primary efficacy and safety endpoints and achieved positive secondary endpoints including good bleeding profile, cycle control, and tolerability.
The US contraceptive market is valued at US$5.4 billion according to IQVIA with the short acting combined hormonal contraceptives (CHCs) component estimated at US$4.0 billion and approximately 135 million units sold annually.