Mayne Pharma setback over generic version of Nuvaring approval hits stock

Shares in the drug developer fell almost 20 per cent after a hiccup in its bid to win FDA approval for a generic version of contraception device Nuvaring.

Shares in drug developer Mayne Pharma fell almost 20 per cent after it experienced a hiccup in its years-long progress to win approval for a generic version of contraception device Nuvaring from the US Food and Drug Administration.

It marks the second Australian company in a week to face a roadblock, or at the very least a “please explain” from the FDA, with Mesoblast failing to progress to the next stage of approval for one of its medical treatments that saw its shares collapse almost 50 per cent.

On Tuesday Mayne Pharma, whose chairman is former Woolworths boss Roger Corbett and major shareholder is pokies and hotels king Bruce Mathieson, updated the market to its pipeline for women’s health products. Mayne Pharma said it had received a complete response letter (CRL) from the FDA in relation to its abbreviated new drug application for a generic version of Nuvaring.

The questions raised in the letter and further information required was not detailed by Mayne Pharma, but the news that its progress on the generic contraception device could be slowed or perhaps even halted by the FDA forced heavy selling by investors.

Shares in Mayne Pharma fell almost 20 per cent on Tuesday and later closed down 6c at 32c.

Mayne Pharma said in a statement to the ASX it was working closely with its development partner, Mithra Pharmaceuticals, and the FDA to address the questions raised in the CRL.

“Following submission of the response to the CRL, Mayne Pharma will then receive a new target action date from the FDA,’’ it said.

Mayne Pharma chief executive Scott Richards said the drug developer was confident it could address the issues raised.

“Pleasingly, the FDA has indicated that Mayne Pharma and its development partner Mithra have an acceptable manufacturing process for generic Nuvaring. Furthermore, the market opportunity continues to be highly attractive with only one indepen­dent generic approved and an addressable market of $US920m [$1.28bn],” he said.

Mayne Pharma had presented its latest application for the generic product to the FDA in December and was awaiting its next milestone but instead was handed a letter asking for more information. The company also said it recently participated in a mid-cycle review meeting with the FDA regarding the new drug application for Nextstellis to prevent pregnancy.

“The FDA did not raise any substantive issues at the meeting and indicated that no major safety concerns have been noted at this point in their review,’’ Mayne Pharma said.