Mayne Enters 20-Year Agreement with Mithra for Oral Contraceptive Commercialization

October 3, 2019
Pharmaceutical Technology Editors

The contraceptive is expected to receive new chemical entity designation from FDA, giving it patent protection beyond 2030. It will be launched in early 2021, pending FDA approval.

Mayne Pharma, an Australia-based pharmaceutical company that specializes in drug delivery, announced a 20-year license and supply agreement with Mithra, a women’s health company in Belgium, for the commercialization of E4/DRSP, a combined oral contraceptive made up of 15 mg estetrol (E4) and 3 mg drospirenone (DRSP), in the United States. 

According to an Oct. 2, 2019 press release, the oral contraceptive is a native estrogen produced by the human fetal liver during pregnancy. Two Phase III clinical trials of the drug were conducted in over 3000 women and showed positive results against primary efficacy and safety endpoints and positive secondary endpoints for bleeding profile, cycle control, and tolerability. 

Mayne previously teamed up with Mithra for the development of the generic Nuvaring, an intra vaginal hormonal contraceptive delivery service. 

“If approved, [e]stetrol (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,” said Scott Richards, CEO, Mayne, in the press release. “E4/DRSP is an innovative contraceptive with a unique mode of action that [P]hase II and [P]hase III studies suggest could result in improved patient outcomes. 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.”

“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 US. 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 US,” added Francois Fornieri, CEO, Mithra, in the press release. 

The contraceptive is expected to receive new chemical entity designation from FDA, giving it patent protection beyond 2030. It will be launched in early 2021, pending FDA approval. 

Source: Mayne Pharma