Milan, Italy – February 26, 2008 - Newron Pharmaceuticals S.p.A. (“Newron”, SWX: NWRN), a research and development company focused on novel Central Nervous System (CNS) and pain therapies, today announced that it has received a written confirmation from the European Patent Office (EPO) that they intend to grant the patent “Methods for treatment of Parkinson’s Disease”. The application was filed by Newron in Europe and in all major countries in 2004.
The patent relates to methods for treating Parkinson’s disease (PD) through the administration of Newron’s compound safinamide in combination with levodopa.
Safinamide, which is being developed by Merck Serono and Newron as an add-on therapy to dopamine agonists as well as to levodopa for patients with Parkinson’s disease, is currently in phase III clinical trials. Merck Serono, a division of Merck KGaA, has exclusive worldwide rights to develop, manufacture and commercialize safinamide in Parkinson’s disease, Alzheimer’s disease and other therapeutic applications, as per the agreement signed with Newron in 2006.
Dr. Marco Caremi, Newron’s Vice President Strategic Marketing and Head of Legal Affairs, said: “This important decision confirms Newron’s IP strategy in pursuing effective patent objectives in order to protect compounds stemming from its pipeline and to provide the best tools to extend their lifecycle.”
Dr. Luca Benatti, Newron’s CEO, said: “The EPO’s decision strengthens safinamide’s protection, as the patent will protect the use of safinamide as add-on to levodopa up to 2024.”
About Safinamide
Safinamide is an alpha-aminoamide derivative which is orally administered. Safinamide is believed to have a novel mode of action as a dopamine modulator (comprising both selective and reversible MAO-B inhibition and also blockade of dopamine reuptake) complemented by an effect on the glutamate pathway. Studies suggest that safinamide may combine the inhibition of dopamine re-uptake and MAO-B, two key mechanisms involved in the control of dopamine concentration in the brain, and inhibition of glutamate release. If regulatory approvals are obtained, Merck Serono and Newron believe that safinamide, as an adjunctive treatment to dopamine agonists and levodopa, may have a competitive advantage over current therapies for 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 conducting phase II trials with ralfinamide for the treatment of neuropathic and post surgical (dental) pain. A phase II placebo controlled study in neuropathic pain demonstrated the efficacy of ralfinamide, as well as positive effects on sleep and the ability to perform daily activities. The drug was well tolerated, with side effects comparable 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 Alzheimers’ disease patients. The agreement is conditional to shareholders’ approval, expected for April.
Newron´s clinical pipeline is 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.
