23:28:07 EDT Thu 16 May 2024
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Cipher Pharmaceuticals Inc
Symbol CPH
Shares Issued 25,335,620
Close 2023-07-04 C$ 3.57
Market Cap C$ 90,448,163
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Cipher Pharma partner receives EU approval of MOB-015

2023-07-05 09:55 ET - News Release

Mr. Craig Mull reports

CIPHER PARTNER, MOBERG PHARMA ANNOUNCES APPROVAL FOR MOB-015 IN THE EUROPEAN UNION

Cipher Pharmaceuticals Inc.'s partner, Moberg Pharma AB, has obtained European Union approval for MOB-015 (nail fungus treatment) as a result of demonstrating superior levels of mycological cure (76 per cent versus 42 per cent for comparators) and a significantly better complete cure rate.

MOB-015 has been recommended for national approval in 13 European countries, which will be commercialized through partners such as Bayer and Allderma, and is expected to be launched in Nordic countries such as Sweden during 2023.

Cipher holds the exclusive Canadian rights to MOB-015, a new topical treatment of onychomycosis (nail fungus) based on Moberg's patented proprietary formulation of terbinafine. In Canada, according to IQVIA, the total prescription market for Onychomycosis was greater than $82-million at Dec. 31, 2022, with a single product having over 90-per-cent market share.

Craig Mull, interim chief executive officer of Cipher, commented: "This is a fantastic achievement whereby the European Union has recognized MOB-015 as delivering quick visible improvements to patients living with nail fungus. We are excited about our partnership with Moberg Pharma, who have a strong track record developing and commercializing nail fungus products previously in both Europe and North America. This approval is a tremendous step in the right direction towards ultimately receiving market approval in Canada and the United States. We will continue to work closely with Moberg in making this clinically proven effective treatment available to Canadians as soon as possible."

Moberg Pharma continues to invest and advance MOB-015 through an additional phase 3 trial of a total of 350 patients with sites across the United States and Canada. The purpose of this study is to facilitate market approval in North America as well as further strengthen the product's clinical evidence beyond the mycological and complete cure rates already demonstrated to the European Union. Patient enrolment in the clinical trial is progressing according to plan with full enrolment expected in 2023.

About Cipher Pharmaceuticals Inc.

Cipher Pharmaceuticals is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early- to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and currently markets those products either directly in Canada or indirectly through partners in Canada, the U.S. and South America.

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