ASX-LISTED Mayne Pharma has executed a 20-year license and supply agreement with Mithra Pharmaceuticals to commercialise a novel oral contraceptive in Australia.
The pact relates to E4/DRSP, a next generation oral contraceptive containing Estetrol (E4) 15mg and drospirenon (DRSP) 3mg.
E4 is a naturally occuring oestrogen which is produced by the human foetal liver during pregnancy.
The product is expected to be filed with the Therapeutic Goods Administration (TGA) this year, with a potential commercial launch in the second half of 2021.
"On approval, the product is expected to receive five years of data exclusivity from the TGA as it is a new chemical entity," Mayne Pharma said.
The company also has the option to obtain a license to register and launch E4/DRSP in New Zealand.
Mayne CEO, Scott Richards, said the product has a unique mode of action that has shown promising results in two phase 3 clinical studies conducted in 4,400 women, positive outcomes in efficacy & safety.
It's Mayne's third transaction with Mithra, with which Mayne alsp partners for generic Nuvaring and E4/DRSP oral contraceptive in the US.
Mithra CEO, Francois Fornieri, said he was delighted to strengthen the company's strategic partnership with Mayne which has "extensive commercial capabilities and infrastructure to support the launch in Australia".
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