The Mayne Pharma Group Ltd (ASX: MYX) share price is up 4.48% on Monday morning amid news the company has received US regulatory approval.
Shares of Mayne Pharma are currently trading at 35 cents each after opening at 33.5 cents a share this morning.
That's currently beating the S&P/ASX 200 Index (ASX: XJO) which is down 0.28%. Meantime, the S&P/ASX 200 Healthcare Index is 0.47% lower.
Let's check the news from Mayne this morning.
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What did Mayne Pharma announce?
Mayne Pharma Group and its Belgian partner Mithra Pharmaceuticals have been granted Food and Drug Agency (FDA) approval for a hormonal contraceptive ring for women that aims to reduce the likelihood of pregnancy.
The device, Holoette, contains the medications etonogestrel and ethinyl estradiol for its contraceptive effects.
It will be a generic alternative to Nuvaring that was approved by the FDA in October 2001.
Nuvaring and other corresponding products on the US market achieved approximately US$580 million in sales for the 12 months ended June 2022.
Mayne Pharma CEO Scott Richards said:
We are very pleased to announce the approval of Haloette in the US and look forward to bringing this drug-device generic to market. Mayne Pharma is proudly committed to providing women with more affordable and accessible contraceptive choices.
The device is the company's third regulatory product approval with its development partner Mithra.
Mithra's role is to develop and manufacture Haloette in its facility in Belgium. According to their contract, Mayne Pharma will pay six million euros to the company now the device has received FDA approval. It will pay another 1.6 million euros when the product is sold in the United States.
Mayne Pharma expects that the new contraceptive device will launch in early 2023.
Mayne Pharma share price snapshot
Mayne Pharma shares have gained 17% since the start of 2022 and 13% in the past year.
That's far outperformed the broader healthcare index. It's dropped almost 3.2% year to date and 5% since this time last year.
The company's shares have now gained 21% in just the last month, giving Mayne a current market capitalisation of $608 million.
