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Merck KGaA (MKGAF.PK) to Return Safinamide Rights to Newron Pharmaceuticals (NWRN), Citing "Limited Market Potential"


10/21/2011 6:52:27 AM

October 21, 2011 -- Milan, Italy, October 21, 2011 – Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel CNS and pain therapies, announced today that Merck Serono, a division of Merck KGaA, Darmstadt Germany, is returning global rights to safinamide to Newron effective in 180 days. The decision by Merck Serono is due to strategic considerations and re-prioritization of its R&D pipeline, and is not based on any new efficacy or safety findings with safinamide.

Based on the agreement signed in 2006, Merck Serono has confirmed that it will meet its contractual and ethical commitments regarding the ongoing clinical development program for safinamide until April 2012.

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 have been set up to complete the planned Phase III development of safinamide as an adjunctive treatment for Parkinson’s disease that was the basis for the registration programme agreed upon with health authorities in key world markets. Merck Serono will work with Newron to execute an appropriate transfer of the program to Newron.

The collaboration of Merck Serono and Newron on pruvanserin and sarizotan continues.

Newron will now re-assess all the opportunities for safinamide including re-partnering the compound at some stage. Ownership of global commercial rights for safinamide could provide Newron the option to pursue marketing of this new chemical entity for Parkinson's disease in selected territories, as well.

On 27 September Newron announced its intention to merge with Biotie Thera- peutics. Both companies will evaluate this new opportunity.

Further announcements will be made in due course.

About safinamide

Safinamide is an alpha-aminoamide that is currently being developed by Merck Serono and Newron as an add-on therapy to dopamine agonists or levodopa in patients with early or late- stage Parkinson’s disease. It is believed to have both dopaminergic and non-dopaminergic activities, including selective and reversible inhibition of monoamine oxidase B (MAO-B), activity-dependent sodium channel antagonism and inhibition of glutamate release in vitro. Studies are ongoing to better understand safinamide’s actions in patients with Parkinson’s disease.

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. Newron is undertaking phase III trials with safinamide for the treatment of Parkinson’s disease (PD) in conjunction with its partner, Merck Serono, which has exclusive worldwide rights to develop, manufacture and commercialize the compound in PD, Alzheimer’s disease, and other therapeutic applications. Newron is currently evaluating the further 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 and NW-3509 for the treatment of schizophrenia. Newron is headquartered in Bresso, near Milan, Italy. The company is listed at SIX Swiss Exchange, trading symbol NWRN.

For more information, contact:

Media

Italy

Luca Benatti - CEO

Phone: +39 02 6103 4 626

E-mail: pr@newron.com

UK/Global media

Julia Phillips

FTI Consulting

Phone: +44 (0) 20 7269 7187

Switzerland

Martin Meier-Pfister

IRF Communications

Phone: +41 43 244 81 40

Investors and analysts

Stefan Weber - CFO

Phone: +39 02 6103 46 30

E-mail: ir@newron.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 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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