Milan, Italy – March 3, 2008 - Newron Pharmaceuticals S.p.A. (“Newron”, SWX: NWRN), a research and development company focused on novel CNS and pain therapies, and Hunter-Fleming Ltd., a private UK bio-pharmaceutical company developing new medicines to treat neurodegenerative and inflammatory disorders, today announced that Hunter-Fleming has received a recommendation from the independent Data Safety Monitoring Board (DSMB) to continue a Phase II safety and tolerability study with HF0220 in patients with Alzheimer’s disease (AD). The recommendation is based on the results of an interim review of the study being undertaken by Hunter-Fleming. On February 9, 2008, Newron signed an agreement to acquire 100% of the issued share capital of Hunter-Fleming.
The Phase IIa multi-centre, double blind placebo controlled, biomarker trial includes 40 patients in study centres in the UK and Sweden, who are treated for 28 days at different doses of HF0220.
An independent data monitoring committee has now completed their review of the data from the first phase of the trial. They have concluded that the data collected to date justify the initiation of a second one month treatment phase which will, in addition to safety and tolerability, assess the biological markers that may be used in future efficacy trials in AD.
Mike Capaldi, Hunter-Fleming’s CEO, commented: “We are very encouraged by the report of the data monitoring committee. The interim results confirm that HF0220 is safe and well tolerated. We look forward to gaining more information on the properties of HF0220 in patients with Alzheimer’s disease in the second part of the study.”
Luca Benatti, Newron’s CEO, added: “The results of this review support our belief in the Hunter-Fleming pipeline and in particular the potential of HF0220 to treat this major debilitating 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 conducting phase II trials with ralfinamide for the treatment of neuropathic and post surgical (dental) pain. A phase II placebo controlled study in patients with peripheral neuropathic pain demonstrated the efficacy of ralfinamide in reducing the severity of pain, as well as demonstrating an improvement in sleep and the ability to perform daily activities. The drug was well tolerated, with no change in the incidence of adverse events compared to placebo. A phase II study with ralfinamide is ongoing in post surgical (dental) pain.
On February 9, 2008, Newron signed an agreement providing for the acquisition of 100% of the issued share capital of Hunter-Fleming, a private UK bio-pharmaceutical company developing new medicines to treat neurodegenerative and inflammatory disorders. The transaction enlarges Newron’s pipeline particularly in the area of neuro-inflammation. Hunter-Fleming provides a pipeline of three compounds in various phases of clinical development and one in discovery. The most advanced compound is in an ongoing phase II safety and tolerability study in Alzheimer’s disease patients. The agreement is conditional to shareholders’ approval, expected for April.
Newron’s clinical pipeline is also supported by a portfolio of early-stage proprietary compounds generated by its ion channel drug discovery platform. Newron is headquartered in Bresso, near, Milan, Italy. The company is listed at SWX Swiss Exchange, trading symbol NWRN.
For more information, contact:
Media Investors and analysts
Italy
Luca Benatti - CEO Phone: +39 02 6103 4 626 UK/Global media Julia Phillips Financial Dynamics Phone: +44 (0) 20 7269 7187
Switzerland Martin Meier-Pfister The Investor Relations Firm AG Phone: +41 43 244 81 40 Stefan Weber - CFO Phone: +39 02 6103 46 30
