Research & Development
Newron Announces Paragraph IV ANDA Filing for Xadago in the USA
4 May 2021 - - Italy-based biopharmaceutical company Newron Pharmaceuticals S.p.A. (SIX: NWRN) (XETRA: NP5) has received a Paragraph IV Notice Letter regarding the submission by a generic manufacturer of an Abbreviated New Drug Application to the US Food and Drug Administration, seeking approval to engage in the commercial manufacture, use or sale of safinamide mesylate drug product in the US before expiration of certain US patents, the company said.

Newron said it is reviewing the details of this Notice Letter and will respond as appropriate to protect its intellectual property rights relating to Xadago (safinamide) tablets.

Xadago (safinamide) tablets are currently protected by three patents listed in the FDA's Approved Drugs Product List (Orange Book) that expire no earlier than 2026.

Newron is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system.

The company is headquartered in Bresso near Milan, Italy. Xadago/safinamide has received marketing authorization for the treatment of Parkinson's disease in the European Union, Switzerland, the USA, Australia, Canada, Brazil, Colombia, Israel, the United Arab Emirates, Japan and South Korea, and is commercialized by Newron's Partner Zambon.

Supernus Pharmaceuticals holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories.

Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia.
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