Newron Is Exploring All Options for Safinamide
From Tensid Regulatory (October 28, 2011)
Newron is exploring all options for safinamide
Biotie acquisition discussions terminated
Milan, Italy, 28 October 2011 - Newron Pharmaceuticals S.p.A. ("Newron"), a research and development company focused on novel CNS and pain therapies, today announces that the ongoing talks with Biotie Therapeutics Corp. on the planned acquisition of Newron by Biotie have been terminated.
Newron believes that regaining global commercial rights to safinamide, Newron's lead treatment for Parkinson's disease currently in late phase III worldwide development, opens to the company substantial opportunities to create value for its shareholders. JSB Partners has been mandated to support Newron in this endeavour.
Based on the previously reported completion of enrolment of the Phase III MOTION and SETTLE trials, these studies are scheduled to report results in first half of next year. These two trials were designed to complete the planned Phase III development of safinamide as adjunctive treatment at any stage of Parkinson's disease, that was the basis for the registration programme agreed upon with health authorities in key world markets.
Luca Benatti, Newron's CEO, stated: "Regaining the global commercial rights to safinamide provides Newron the opportunity to pursue all strategic options. We estimate that the registration dossier will be ready for submission to health authorities in key world markets by the end of 2012. To companies with commercial capabilities this offers an extremely attractive opportunity in a focused specialist market".
As a result, the EGM planned for Monday 31 October 2011 will no longer vote on the proposed acquisition of Newron by Biotie. Attending Newron shareholders will be informed accordingly. Biotie will be entitled to receive a break-up fee of ?¬1.5m.
About Newron Pharmaceuticals
Newron Pharmaceuticals S.p.A. (www.newron.com) is a biopharmaceutical company focused on novel therapies for diseases of the Central Nervous System and pain. Phase III trials of safinamide are currently ongoing for the treatment of Parkinson's disease (PD). Newron is currently evaluating the clinical development of ralfinamide for pain and psychiatric diseases. Newron's additional projects are at various stages of preclinical and clinical development, including HF0220 for neuroprotection, NW-3509 for the treatment of schizophrenia, as well as pruvanserin and sarizotan for treatment of CNS diseases. Newron is headquartered in Bresso, near Milan, Italy. The company is listed at SIX Swiss Exchange, trading symbol NWRN.
For more information, contact:
Investors and analysts
Luca Benatti - CEO
Phone: +39 02 6103 4 626
Phone: +44 (0) 20 7269 7187
Phone: +41 43 244 81 40
Stefan Weber - CFO
Phone: +39 02 6103 46 30
Phone: +49 177 723 0152
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 and current and future collaborations for the development and commercialisation of its product candidates and reduce costs (including staff costs), (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron's anticipated future revenues, capital expenditures and 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 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 programmes, development activities, commercialisation 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.
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Posted: October 2011