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  • Mayne Pharma Group (MYX) has signed a 20-year licence and supply agreement with Mithra Pharmaceuticals to commercialise a new oral contraceptive in Australia
  • The product is expected to be filed with the Therapeutic Goods Administration (TGA) in 2020 and is expected to launch in the second half of the 2021 calendar year
  • The Australian contraceptive market is valued at $130 million
  • Mayne Pharma is down 2.25 per cent on the market close today, trading for 43.5 cents each

Mayne Pharma Group (MYX) has signed a 20-year licence and supply agreement with Mithra Pharmaceuticals to commercialise an oral contraceptive in Australia.

E4/DRSP is a novel, next-generation oral contraceptive containing Estetrol (E4) and drospirenone. E4 is a naturally occurring oestrogen that is produced by the human foetal liver during pregnancy.

The product is expected to be filed with the Therapeutic Goods Administration (TGA) some time this year, with an expectation to launch in the second half of the 2021 calendar year.

Once approved, the contraceptive is expected to receive five years of data exclusivity from the TGA as it is a new chemical entity.

CEO Scott Richards is pleased to have extended the license to the Australian market.

“E4/DRSP has a unique mode of action that has shown promising results in two phase 3 clinical studies conducted in 4400 women with positive outcomes in efficacy and safety and also showed good bleeding profile, cycle control and tolerability,” he said.

Mithra Pharmaceuticals focuses on providing innovation and choice in women’s health, specialising on contraception and menopause.

This is the third transaction the company has completed with Mithra.

“We look forward to working closely with the Mithra team on the commercialisation of these 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,” Scott said.

The Australian contraceptive market is valued at $130 million.

Mithra’s CEO Francois Fornieri is pleased to be able to bring the contraceptive to the Australian market.

“Mayne Pharma has extensive commercial capabilities and infrastructure to support the launch in Australia and will be able to leverage from launching the product in the U.S., the world’s largest pharmaceutical market, which is targeted for the first half of calendar 2021,” he said.

Mayne Pharma is down 2.25 per cent on the market close today, with shares trading for 43.5 cents each.

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