EQS Group-Ad-hoc: Newron Pharmaceuticals SpA / Key word(s): Miscellaneous 
Newron announces Paragraph IV ANDA filings for Xadago(R) (safinamide) in the USA 
20-May-2021 / 07:00 CET/CEST 
Release of an ad hoc announcement pursuant to Art. 53 KR 
The issuer is solely responsible for the content of this announcement. 
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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 
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End of ad hoc announcement 
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Language:     English 
Company:      Newron Pharmaceuticals SpA 
              Via Antonio Meucci 3 
              20091 Bresso 
              Italy 
E-mail:       info@newron.com 
Internet:     www.newron.com 
ISIN:         IT0004147952 
Listed:       SIX Swiss Exchange 
EQS News ID:  1198586 
 
End of Announcement EQS Group News Service 
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1198586 20-May-2021 CET/CEST


 
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(END) Dow Jones Newswires

May 20, 2021 01:02 ET (05:02 GMT)