Newron Pharmaceuticals Reports Half-Year Results 2014
Milan, Italy – 16 September 2014 – Newron Pharmaceuticals S.p.A. (“Newron”, SIX: NWRN), a research and development company focused on the development of therapies for patients with Central Nervous System (CNS) and pain disorders, today announces its financial results for the half year ended June 30, 2014.
Half-Year 2014 Highlights
• Application for Authorization of safinamide submitted to Swissmedic by Zambon as the Authorization holder
• New results with NW-3509, demonstrating potential of unique mechanism to benefit poor responders to antipsychotics in patients with schizophrenia, presented at the 4th Biennial Schizophrenia International Research Society (SIRS) Conference
• CHF 22.2 million raised in private placements to existing and new institutional shareholders in Europe and the US
• Safinamide New Drug Application (NDA) submitted to the US Food and Drug Administration (FDA)
In May, Newron achieved a key milestone by submitting safinamide to the US FDA for the indications “safinamide as add-on therapy to a stable dose of a single dopamine agonist” in early Parkinson’s disease patients and “safinamide as add-on therapy to levodopa alone or in combination with other Parkinson’s disease treatments” in mid-to late stage Parkinson’s disease patients. Upon preliminary review, the FDA identified some organization and navigation problems, relating to the hyperlinking of tables, folders and the organization of the table of contents in the submission, as well as the conformation of the Package Insert to FDA guidelines. The Refusal to File (RTF) letter received on July 28, 2014, does not relate to the acceptability of the clinical data, and no judgment is made on the efficacy or safety of safinamide.
Following on from the submission in December 2013 of the Marketing Authorization Application (MAA) for safinamide to the European Medicines Agency, in April Newron reported Zambon’s submission to Swissmedic for approval in Switzerland. These submissions cover the indications “safinamide as add-on therapy to a stable dose of a single dopamine agonist” in early Parkinson’s disease patients and “safinamide as add-on therapy to levodopa alone or in combination with other Parkinson’s disease treatments” in mid-to late stage Parkinson’s disease patients.
Progress in R&D pipeline – with new funding
New mechanistic and behavioral studies with Newron’s compound NW-3509 confirmed its potential for use in patients with schizophrenia. These studies, together with preliminary results from an ongoing US Phase I study were presented at the 4th Biennial Schizophrenia International Research Society (SIRS) Conference in April in Florence, Italy. The results confirmed NW-3509’s selectivity to block voltage gated sodium channels (VGSCs) based on the evaluation of over 130 targets including receptors, channels, transporters and enzymes. By end of the current year, Newron plans to initiate a placebo-controlled safety and efficacy trial in schizophrenic patients who are poor responders to current treatment.
In April, Newron completed a capital increase resulting in gross proceeds of CHF 18.6 million, following the subscription by institutional investors of 1,183,597 newly issued shares.
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