Mayne Pharma signs 20-year agreement for novel oral contraceptive in the US
ADELAIDE: Mayne Pharma has entered into an exclusive license and supply agreement with Mithra Pharmaceuticals to commercialise E4/DRSP, a combined oral contraceptive, in the United States.
The product is expected to be launched in first half of calendar 2021, subject to US Food and Drug Administration (FDA) approval. On approval the product is expected to receive five-year New Chemical Entity (NCE) exclusivity from the FDA, with potential for patent protection beyond 2030.
Mayne Pharma’s CEO, Scott Richards said “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. 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”.
Under the terms of the agreement, Mayne Pharma will pay up to US$295 million comprising US$8.75 million in cash and 4.95% of Mayne Pharma’s ordinary shares at closing. Mayne Pharma will also pay US$11 million in cash and a further 4.65% of MaynePharma’s ordinary shares following FDA approval (based on issued shares at closing), plus contingent payments based on reaching cumulative net sales targets. The total consideration of US$295 million would be paid if cumulative net sales of E4/DRSP exceed US$2.25billion. In addition, there is a transfer price comprising fixed and variable component based on a percentage of net sales over the term of the license.
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 135million units sold annually.