New terbinafine supplier secured
Moberg Pharma AB (OMX: MOB) today announces that a new terbinafine supplier has been secured for MOB-015 (drug for nail fungus). As a result, terbinafine availability is no longer a limiting factor for the company's launch plans.
Over the past year, Moberg Pharma qualified a new terbinafine manufacturer with an authorized EU Certificate of Suitability (CEP) now available for MOB-015. Three product batches have been produced using terbinafine from the new supplier where available stability data confirm the shelf-life profile of MOB-015.
The status is unchanged for the previously communicated approval process regarding the first additional terbinafine supplier, submitted in April. Moberg Pharma has earlier responded to all questions received from the Medical Products Agency and awaits the agency´s decision.
As a result, Moberg Pharma expects to have several alternate terbinafine suppliers secured in the near future. Each of these suppliers has the capacity to meet the company's global terbinafine demand.
“Securing a new terbinafine manufacturer for MOB-015 represents a key milestone that enables future launches. It means that the timeline for the company's launch rollout can be maintained, and that access to terbinafine is no longer a limiting factor for MOB-015. MOB-015 is already available to Swedish patients under the brand name Terclara® and we look forward to reaching patients in all 13 approved countries in the future, as there is a great need for a topical treatment that truly cures the nail infection", says Anna Ljung, CEO of Moberg Pharma AB.
For additional information, please contact:
Anna Ljung, CEO, telephone: +46 70 766 60 30, e-mail: anna.ljung@mobergpharma.se
About this information
This information is information that Moberg Pharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication at 8.00 am CET on December 18th, 2024, through the contact person above.
About Moberg Pharma, www.mobergpharma.com
Moberg Pharma AB (publ) is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The company’s drug MOB-015 is a novel topical treatment for onychomycosis (nail fungus) with market approval in 13 EU countries. MOB-015 is sold in Sweden under the brand name Terclara® and is available at all pharmacy chains. Phase 3 clinical trials for MOB-015 involving more than 800 patients indicate that the product has the potential to become the future market leader in onychomycosis. Moberg Pharma has agreements with commercial partners in place in various regions including Europe and Canada. Moberg Pharma is headquartered in Stockholm and the company's shares are listed under Small Cap on Nasdaq Stockholm (OMX: MOB).
