• Mayne Pharma had hoped to have its generic version of NuvaRing approved in the US by June 2019
  • United States regulators have questions about Mayne Pharma’s application that Mayne says it is confident it will be able to resolve
  • Mayne said that the FDA raised no significant issues or major safety concerns about its novel contraceptive pill candidate, NEXTSTELLIS

Mayne Pharma (ASX:MYX) says the US Food and Drug Administration (FDA) has kicked back its abbreviated new drug application for a generic version of the vaginal contraceptive ring, NuvaRing, but the Adelaide and North Carolina-based company believes it can resolve the issues raised by the regulator.

Mayne first submitted its application for a generic version of NuvaRing back in March 2018, saying at the time it hoped to commercialise a generic version of Merck’s contraceptive in FY2019. That is to say, by June 2019.

A generic version of the NuvaRing did get approved in the United States in December 2019 — but it wasn’t Mayne’s version. It was NYSE-listed Amneal Pharmaceutical’s EluRyng.

It’s still not clear when Mayne’s product might be approved. Once Mayne and its development partner, Mithra Pharmaceuticals, submit a response to the FDA they’ll receive a new target action date.

“We are confident we can address the issues raised in the letter in a timely manner,” said Mayne Pharma chief executive Scott Richards, adding that the FDA had no issues with the manufacturing process for the drug.

Vaginal contraceptive rings are expected to reach $US920m ($1.3bn) in US sales this year.

Mayne also said it had met with the FDA regarding its NEXTSTELLIS novel oral contraceptive pill application that it submitted in June. The company licensed the pill from Mithra in October 2019 for a minimum of $US295m in cash and scrip, and if approved it would be the first new contraceptive pill released in the US in over a decade.

Richards said the FDA raised no significant issues or major safety concerns during the mid-cycle review. The regulator is scheduled to act on the application in about six months.

Shortly before noon on Tuesday, Mayne shares had slipped 16 per cent to 32c, down from 45c at the start of the year.