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OFFON

NEWRON PHARMACEUTICALS S.P.A.

(NWRN)
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PRESS RELEASE: Newron announces Paragraph IV ANDA filing for Xadago(R) (safinamide) in the USA

05/04/2021 | 01:01am EDT
DGAP-News: Newron Pharmaceuticals S.p.A. / Key word(s): Miscellaneous 
Newron announces Paragraph IV ANDA filing for Xadago(R) (safinamide) in the USA 
2021-05-04 / 07:00 
The issuer is solely responsible for the content of this announcement. 
=---------------------------------------------------------------------------------------------------------------------- 
Newron announces Paragraph IV ANDA filing for Xadago^(R) (safinamide) in the USA 
Milan, Italy - May 4, 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 it received a Paragraph IV Notice Letter 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. 
Newron is reviewing the details of this Notice Letter 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 2026. 
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 
For more information 
Newron 
Stefan Weber - CEO 
+39 02 6103 46 26 
pr@newron.com 
UK/Europe 
Simon Conway/ Natalie Garland-Collins, FTI Consulting 
SCnewron@fticonsulting.com 
Switzerland 
Valentin Handschin, IRF Reputation 
+41 43 244 81 54 
handschin@irf-reputation.ch 
Germany/Europe 
Anne Hennecke/Caroline Bergmann, MC Services 
+49 211 52925220 
newron@mc-services.eu 
USA 
Paul Sagan, LaVoieHealthScience 
+1 617 374 8800, Ext. 112 
psagan@lavoiehealthscience.com 
Important Notices 
This document contains forward-looking statements, including (without limitation) about (1) Newron's ability to develop 
and expand its business, successfully complete development of its current product candidates, the timing of 
commencement of various clinical trials and receipt of data and current and future collaborations for the development 
and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, 
(3) Newron's financial resources, and (4) assumptions underlying any such statements. In some cases, these statements 
and assumptions can be identified by the fact that they use words such as "will", "anticipate", "estimate", "expect", 
"project", "intend", "plan", "believe", "target", and other words and terms of similar meaning. All statements, other 
than historical facts, contained herein regarding Newron's strategy, goals, plans, future financial position, projected 
revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions 
involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, 
projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual 
results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due 
to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, 
development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative 
results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining 
regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability 
to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of 
existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or 
other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial 
developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, 
intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may 
prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results 
of Newron's research programs, development activities, commercialization plans, collaborations and operations will not 
differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron 
does not undertake any obligation to publicly up-date or revise forward looking statements except as may be required by 
applicable regulations of the SIX Swiss Exchange where the shares of Newron are listed. This document does not contain 
or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form 
the basis of or be relied upon in connection with any contract or commitment whatsoever. 
=---------------------------------------------------------------------------------------------------------------------- 
2021-05-04 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. 
The issuer is solely responsible for the content of this announcement. 
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. 
Archive at www.dgap.de 
=---------------------------------------------------------------------------------------------------------------------- 

1191998 2021-05-04

 
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https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=show_t_gif&application_id=1191998&application_name=news 
 

(END) Dow Jones Newswires

May 04, 2021 01:00 ET (05:00 GMT)

Stocks mentioned in the article
ChangeLast1st jan.
DJ INDUSTRIAL 1.06% 34382.13 Delayed Quote.9.74%
EURO / BRAZILIAN REAL (EUR/BRL) -0.12% 6.404 Delayed Quote.1.05%
FTI CONSULTING, INC. -0.41% 142.37 Delayed Quote.27.43%
NEWRON PHARMACEUTICALS S.P.A. 0.48% 2.11 Delayed Quote.-2.33%
SEIKA CORPORATION 0.06% 1702 End-of-day quote.23.87%
SUPERNUS PHARMACEUTICALS, INC. 2.38% 30.54 Delayed Quote.21.38%
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Financials
Sales 2021 6,46 M 7,84 M 7,84 M
Net income 2021 -19,3 M -23,5 M -23,5 M
Net Debt 2021 12,0 M 14,5 M 14,5 M
P/E ratio 2021 -1,77x
Yield 2021 -
Capitalization 34,4 M 41,7 M 41,7 M
EV / Sales 2021 7,17x
EV / Sales 2022 4,81x
Nbr of Employees 23
Free-Float 93,8%
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Mean consensus UNDERPERFORM
Number of Analysts 3
Average target price 7,14 €
Last Close Price 1,93 €
Spread / Highest target 407%
Spread / Average Target 271%
Spread / Lowest Target 135%
EPS Revisions
Managers and Directors
NameTitle
Stefan Weber Chief Executive Officer & Director
Roberto Galli Vice President-Finance
Ulrich Köstlin Non-Executive Chairman
Ravi Anand Chief Medical Officer
Luca Benatti Independent Non-Executive Director
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