European Commission revokes all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm

Decision is not due to any public health concerns regarding generic DMF products

Neuraxpharm to swiftly contest this decision at the General Court of the European Union

BARCELONA, Spain and DÜSSELDORF, Germany, Dec. 20, 2023 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, today announces that it has been notified by the European Commission of its decision to revoke all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm.

This decision is rooted in a highly disputed legal interpretation of a judgment against generic manufacturers by the Court of Justice of the European Union. This decision contradicts the European Medicines Agency's own prior scientific review, when the Commission granted an unconditional marketing permission to Neuraxpharm in 2022.

This decision is not due to any public health concerns regarding generic DMF products and there is consequently no recall of these products by the Commission. However, no further Dimethyl Fumarate Neuraxpharm will be put on the market until this situation is resolved.

Neuraxpharm will swiftly contest this decision at the General Court of the European Union, with the aim of reintroducing Dimethyl Fumarate Neuraxpharm to the European market as soon as possible.

Dr. Jörg-Thomas Dierks, Chief Executive Officer of Neuraxpharm, said, "Neuraxpharm strongly disagrees with the Commission's decision to block DMF generics as it flies in the face of the spirit of competition and denies patients much needed cost-effective treatment. This will also have a significant knock-on impact on healthcare budgets at a time when they are under significant pressure. Neuraxpharm remains committed to our mission of providing affordable, high-quality medication to patients across the European Union, including patients who depend on the more affordable generic versions of Tecfidera such as Dimethyl Fumarate Neuraxpharm."

About the Neuraxpharm Group

Neuraxpharm is the leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 35 years.

Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline, partnerships and acquisitions.

The company has more than 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, and globally via partners in more than 40 countries. Neuraxpharm is backed by funds advised by Permira.

Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratorios Lesvi) in Spain.

For more information, please visit www.neuraxpharm.com