Mayne Pharma has entered into an exclusive license and supply agreement with Mithra Pharmaceuticals SA to commercialize E4/DRSP, a combined oral contraceptive, in the U.S. The product is expected to be launched in first half of calendar 2021, subject to U.S. 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.
 
E4/DRSP is a novel, next generation combined oral contraceptive composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP). Estetrol (E4) is a native estrogen produced by the human foetal liver during pregnancy. Following more than 20 years of research and development, Mithra can now produce Estetrol (E4) at scale through a complex plant-based production process.
 
“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,” said Scott Richards, chief executive officer, Mayne Pharma. “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 U.S.”
 
If approved, Estetrol (E4) will be the first native estrogen approved in a contraceptive product in the U.S. and the first new estrogen introduced in the U.S. in approximately 50 years. E4/DRSP is an innovative contraceptive with a unique mode of action that phase II and phase III studies suggest could result in improved patient outcomes.
 
Mr. Richards, said, “This product is expected to be a foundation asset in Women’s Health for many years to come and has a strong and synergistic fit with Mayne Pharma’s currently marketed portfolio of more than 20 branded generic contraceptives and existing pipeline products such as generic Nuvaring for which we are targeting approval in calendar 2020.
 
“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. We are attracted to the underlying fundamentals of the US short-acting combination contraceptive market (estrogen + progestin) in terms of its stability and scale with more than 10 million American women using combination oral contraceptives, patches or vaginal rings every day.”
 
Francois Fornieri, chief executive officer, Mithra, said, “We are delighted to sign this landmark agreement and believe Mayne Pharma is the best possible partner for the commercialization of E4/DRSP in the U.S. Mithra and Mayne Pharma have been partners since 2017 and we look forward to helping Mayne Pharma maximize the potential of its Women’s Health franchise in the U.S.”