Join our daily newsletter At The Bell to receive exclusive market insights
- Mayne Pharma (MYX) has received feedback from the U.S. Food and Drug Administration (FDA) on some of its new drug applications
- First, the FDA sent a complete response letter (CRL) with some questions on Mayne’s oral contraceptive, known as NUVARING
- Mayne believes it can quickly address the issues raised by the FDA, and noted the regulatory body had approved the company’s manufacturing process
- The company also received a CRL on its potential first-to-market women’s health generic product
- During its assessment, the FDA concluded the product was adequate, but Mayne’s packaging facility needed some work
- In addition, Mayne completed a mid-cycle review meeting with the FDA regarding its oral contraceptive pill, NEXTSTELLIS
- Positively, the FDA did not raise any substantive issues or major safety concerns about the pill during the meeting
- On the market today, Mayne is down 17. 1 per cent and is trading for 31.5 cents per share
Mayne Pharma (MYX) has received feedback from the U.S. Food and Drug Administration (FDA) on some of its new drug applications.
NUVARING
First, the FDA sent a complete response letter (CRL) with some questions on Mayne’s oral contraceptive, known as NUVARING.
Now, Mayne and its development partner, Mithra Pharmaceuticals, are working closely with the FDA to address the questions raised in the CRL.
The company didn’t provide details on the questions posed by the FDA, but Mayne said it’s able to quickly address the issues.
Mayne CEO, Scott Richards, is confident the company can target the queries in a timely manner.
“Pleasingly, the FDA has indicated that Mayne Pharma and its development partner Mithra have an acceptable manufacturing process for generic NUVARING,” he said.
“Furthermore, the market opportunity continues to be highly attractive with only one independent generic approved and an addressable market of US$920 million (around A$1.2 billion),” he added.
Following the submission of the response to the CRL, Mayne will then receive a new target action date for its NUVARING application.
Women’s Health Generic Product
The company also received a CRL on its potential first-to-market women’s health generic product.
During its assessment, the FDA concluded the product was adequate, but Mayne’s packaging facility needed some work. However, Mayne also noted the facility was assessed by a desktop audit rather than in-person due to COVID-19.
“Mayne Pharma is working closely with the FDA and its development partner to close out this application as soon as possible,” the company said.
NEXTSTELLIS
Mayne has also completed a mid-cycle review meeting with the FDA regarding its oral contraceptive pill, NEXTSTELLIS.
Positively, the FDA did not raise any substantive issues at the meeting and said there were no major safety concerns on the product at this time of the review.
“The NEXTSTELLIS mid-cycle review meeting with the FDA provided us with some insights into the review process so far, and we are pleased that no significant issues and no major safety concerns were raised,” Scott told the market.
Mayne is aiming to have this contraceptive launched in the first half of 2021.
On the market today, Mayne is down 17. 1 per cent and is trading for 31.5 cents per share at 11:30 am AEDT.
