The Medical Products Agency in Sweden will be reference member state for Moberg Pharma's European registration application

Rhea-AI Summary

Moberg Pharma AB has received approval from the Medical Products Agency in Sweden to act as the reference member state for its registration application of MOB-015, a treatment for nail fungus. The company will initiate the registration application process in Europe via a decentralized procedure, expected to be completed by March 2022, aiming for market approval in 2023. This application could secure data exclusivity for up to 10 years post-approval, positioning MOB-015 as a potential leader in antifungal treatments.

Positive

• Secured approval from the Medical Products Agency in Sweden as the reference member state.
• Application for MOB-015 expected to submit in March 2022, targeting market approval in 2023.
• Possibility of data exclusivity for up to 10 years post-approval in Europe.

Negative

• None.

STOCKHOLM, Dec. 23, 2021 /PRNewswire/ -- The Medical Products Agency in Sweden has agreed to be reference member state for Moberg Pharma AB's registration application for MOB-015 (nail fungus treatment). The company will submit the registration application in Europe through the decentralized process, and market approval is expected in 2023.

Moberg Pharma will submit a full application, which offers the possibility of data exclusivity in Europe for up to 10 years following market approval. Moberg Pharma has been ready to submit the registration application as soon as the authority can receive it. Due to limited resources and many parallel ongoing applications, the Swedish Medical Products Agency has now announced that the application can be submitted in March 2022. The company's goal remains unchanged, to receive its first market approval and launch MOB-015 in 2023.

"We are advancing toward the company's goal to register a new and improved nail fungus drug. The need for a treatment alternative that can truly cure the nail infection is great, which means that MOB-015 can achieve a unique position through its high antifungal effect," says Anna Ljung, CEO of Moberg Pharma AB.

CONTACT:

For additional information, please contact:
Anna Ljung, CEO, telephone: +46 707 66 60 30, e-mail: anna.ljung@mobergpharma.se

About this information
This information is information that Moberg Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 8.00 a.m. CET on December 23, 2021.

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https://news.cision.com/moberg-pharma/r/the-medical-products-agency-in-sweden-will-be-reference-member-state-for-moberg-pharma-s-european-re,c3477705

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The Medical Products Agency in Sweden will be reference member state for Moberg Pharma’s European registration application

 

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SOURCE Moberg Pharma

FAQ

What is the status of Moberg Pharma's registration application for MOB-015?

Moberg Pharma's registration application for MOB-015 is set to be submitted in March 2022, with market approval expected in 2023.

Who approved Moberg Pharma's application process for MOB-015?

The Medical Products Agency in Sweden has agreed to be the reference member state for Moberg Pharma's registration application for MOB-015.

What exclusivity benefits does Moberg Pharma expect from MOB-015?

Moberg Pharma anticipates data exclusivity for up to 10 years following market approval for MOB-015 in Europe.

When does Moberg Pharma expect to launch MOB-015?

Moberg Pharma aims to launch MOB-015 in 2023 after receiving market approval.