DGAP-News

Newron announces half-year 2020 results

DGAP-News: Newron Pharmaceuticals S.p.A. / Key word(s): Half Year Results Newron announces half-year 2020 results 15.09.2020 / 07:00 The issuer is solely responsible for the content of this announcement. Newron announces half-year 2020 results

Milan, Italy, September 15, 2020 - 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 its financial results and operational progress for the half-year ended June 30, 2020.

Highlights:

Evenamide (Schizophrenia)

• All evenamide pre-clinical studies requested by the US Food and Drug Administration (FDA) completed with no toxicity concerns identified
• First clinical safety study initiated despite industry wide delays caused by COVID-19
• Newron on track to initiate its pivotal Phase III program in 2021
• Newron currently evaluating potential options for partnering/co-developing evenamide

Xadago(R)/safinamide (Parkinson's disease)

• Newron noted Supernus Pharmaceuticals' acquisition of US WorldMeds' CNS portfolio, including the US rights to Xadago(R)/safinamide, effective June 2020
• Progress made in plans to perform the levodopa-induced dyskinesia (PD LID) study with Xadago
  • Zambon previously held discussions with the FDA on the design of a potentially pivotal efficacy study to evaluate the effects of Xadago(R)/safinamide in patients with PD LID
  • Intention is to perform the study in the US, Europe and Asia/Australia
  • Zambon acknowledges Newron's experience in the development of Xadago in patients with Parkinson's disease; discussions to have Newron as the party responsible for conducting the study; Zambon will remain associated with the study
  • Financial terms to stay unchanged

Sarizotan (Rett syndrome)