Mayne Pharma shares jumped nearly 19% yesterday a near five-month high after the company revealed an exclusive long-term deal to sell a new contraceptive drug in the USA.
Mayne said in a statement to the ASX that it had signed a 20-year supply and licence agreement with Belgium-based Mithra Pharmaceuticals to commercialise a “next-generation” contraceptive pill.
Mayne Pharma will pay up to $US295 million ($A440 million) in cash and shares if net sales of the drug exceed $US2.25 billion ($A3.36 billion). The sector is said to be worth $US5.4 billion annually with short term contraceptives accounting for nearly 80% of that figure, or around $US4 billion a year. Around 135 million units a year are sold in the US.
Mayne said if approved the new drug could generate annual sales of up to $US200 million at its peak.
Mayne shares surged at the opening and ended the day up 18.87% to 63 cents.
Mayne said in the statement the drug called E4/DRSP, contains 15mg estetrol (E4) and 3mg drospirenone and could see improved patient outcomes among America’s 10 million women who use short-acting hormonal contraceptives.
Mithra has developed a method to produce E4, a native estrogen created by the human foetal liver during pregnancy, at scale through a plant-based process after more than 20 years of research and development, according to the statement.
The new pill is expected to be rolled out in the first half of 2021, subject to US regulatory approval.
“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,” Mayne chief executive Scott Richards said.
Mr. Richards expects E4/DRSP to be a “foundation asset” in women’s health for years to come.
“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,” he said.
It also strengthens ties between Mayne and Mithra, as they simultaneously target approval for a generic contraceptive ring next year.
