Specialty pharmaceutical company Mayne Pharma Group (ASX: MYX) and women’s health drug delivery company Mithra Pharmaceuticals SA have joined forces to commercialise a next generation combined oral contraceptive in Australia.
The companies have signed an exclusive long-term licence and supply agreement to develop E4/DRSP, formulated to contain 15 milligrams of estetrol and 3mg of drospirenone.
Estetrol is a naturally-occurring estrogen produced by the human foetal liver during pregnancy.
The product will be filed with the Therapeutic Goods Administration (TGA) this year and is expected to receive five years of data exclusivity due to it being a new chemical entity.
It will be launched Australia-wide in late 2021, with Mayne retaining the option to register and launch the product in New Zealand.
The E4/DRSP Australian deal is the third transaction completed between Mayne and Mithra in recent years.
The companies have previously worked together on the launch of the generic NuvaRing intra vaginal hormonal contraceptive delivery device in 2018, as well as the preparation last month of a Food and Drug Administration application for the release of E4/DRSP in the US.
Mayne chief executive officer Scott Richards welcomed a continued partnership.
“We look forward to working closely with the Mithra team on the commercialisation of [our] key pipeline products over the next 18 months, as well as exploring further opportunities to deepen our relationship in the women’s health therapeutic category,” he said.
According to healthcare data analytics firm IQVIA, the Australian contraceptive market is valued at $130 million.
Of this, the short-acting combined (estrogen and progestin) hormonal oral contraceptives segment makes up $70 million with approximately 14 million units sold annually.
E4/DRSP is believed to have a unique mode of action with promising results from two phase 3 clinical studies conducted on 4,400 women.
Positive outcomes of the studies were seen in efficacy and safety, with good bleeding profile, cycle control and tolerability also demonstrated.