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Newbury Pharmaceuticals

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Dimethyl Fumarate Newbury approved by the Swedish Health Authorities

Newbury Pharmaceuticals is pleased to announce the Marketing Authorization (MA) of Dimethyl Fumarate Newbury 120 & 240 mg hard capsule in Sweden as the first country in a Scandinavian registration procedure. Approvals in Norway and Denmark are expected to follow upon finalized national reviews.

“The approval of Dimethyl Fumarate Newbury is the 3rd product approved for the treatment of multiple sclerosis following the approval of Teriflunomide Newbury and Fampridine Newbury during the last quarter of 2022 and it further shows our commitment within the field of Neurology. Multiple sclerosis is a serious life changing disease where the company aim to provide cost efficient alternatives to current treatments. Based on this positive progress, we will proceed to launch this product, within respective markets as soon as regulatory exclusivities and patents allow us.” Says Mr. Lars Minor, CEO of Newbury.

Dimethyl Fumarate Newbury is indicated for the treatment of relapsing remitting multiple sclerosis. Our product has been developed based on the reference brand Tecfidera.

MS is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves. Multiple sclerosis is characterized by immune-mediated inflammation and neurodegeneration. It is a disease of unknown etiology.

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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Dimethyl Fumarate Newbury approved by the Swedish Health Authorities

Datum 2023-03-06, kl 14:30
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