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Newbury Pharmaceuticals

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Teriflunomide Newbury approved by the Norwegian Health Authorities

Newbury Pharmaceuticals is pleased to announce the Marketing Authorization (MA) of Teriflunomide Newbury 14 mg film-coated divisible tablets in Norway as the first country in a Scandinavian registration procedure. Approvals in Sweden and Denmark are expected to follow upon finalized national reviews.

“Our product is a fully bioequivalent version of Aubagio 14mg film-coated tablets. Moreover, being a divisible tablet with one product, we can cover the 7 mg strength needed for the treatment of the pediatric population. Based on this positive progress, we will proceed to launch this product when regulatory exclusivities and patents allow us.” Says Mr. Lars Minor, CEO of Newbury.

Teriflunomide is a prescription drug indicated for treatment of relapsing forms of multiple sclerosis. Multiple sclerosis is characterized by immune-mediated inflammation and neurodegeneration. It is a disease of unknown etiology. Although the exact mechanism of action of teriflunomide in MS is not fully clear, it is thought to reduce the number of lymphocytes, thereby reducing inflammation and controlling the symptoms of the disease.

For more information, contact:

Lars Minor, CEO
lars.minor@newburypharma.com
Mobile: +46 72-377 3005

www.newburypharma.com

About Newbury Pharmaceuticals

Newbury Pharmaceuticals is building a pipeline of proprietary and licensed products with focus on specialty and branded products in the Nordics. Newbury aims to make a difference by offering treatment solutions within areas like oncology, rare diseases and neurology. The portfolio is built by leveraging experience and extensive international network. Newbury offers strategic partnerships of innovation for the benefit of the Nordic healthcare market.

Västra Hamnen Corporate Finance is the Company's Certified Adviser on Nasdaq First North and can be reached at ca@vhcorp.se or +46 (0) 40 200 250.

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Teriflunomide Newbury approved by the Norwegian Health Authorities

Datum 2022-11-01, kl 08:30
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Teriflunomide Newbury approved by the Norwegian Health Authorities
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