DGAP-News

Newron announces Paragraph IV ANDA filings for Xadago(R) (safinamide) in the USA

DGAP-News: Newron Pharmaceuticals S.p.A. / Key word(s): Miscellaneous Newron announces Paragraph IV ANDA filings for Xadago(R) (safinamide) in the USA 20.05.2021 / 07:00 The issuer is solely responsible for the content of this announcement. Newron announces Paragraph IV ANDA filings for Xadago(R) (safinamide) in the USA

Milan, Italy - May 20, 2021 - Newron Pharmaceuticals S.p.A. ("Newron") (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that with reference to its media release of May 4, 2021, it received further Paragraph IV Notice Letters regarding the submission by a generic manufacturer of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA), seeking approval to engage in the commercial manufacture, use or sale of safinamide mesylate drug product in the U.S. before expiration of certain US patents. Such further Paragraph IV Notice Letters are not unusual and additional similar notices from other generic manufacturers may follow.

Newron is reviewing the details of these Notice Letters and will respond as appropriate to protect its intellectual property rights relating to Xadago^(R) (safinamide) tablets.

Xadago^(R) (safinamide) tablets are currently protected by three patents listed in the FDA's Approved Drugs Product List (Orange Book) that expire no earlier than 2027.

About Newron Pharmaceuticals
Newron (SIX: NWRN, XETRA: NP5) 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^(R)/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. For more information, please visit: www.newron.com