CHMP recommends Approval of Xadago^TM (safinamide) to treat Parkinson´s disease in the EU

• First New Chemical Entity (NCE) in 10 years to receive a positive opinion from CHMP for the treatment of Parkinson’s disease (PD) patients
• Positive Opinion for Use of Safinamide as Add-on to L-dopa alone or in combination with other Parkinson’s disease medications in mid-late stage PD patients with motor fluctuations
• Decision based on the results of two international Phase III placebo-controlled studies in over 1,100 patients 
• Safinamide’s profile is differentiated from “standard of care” demonstrating su-stained efficacy in the long term (more than two years)

Milan, Italy, 7th January, 2015 – Newron Pharmaceuticals S.p.A. (“Newron”), a research and development company focused on novel CNS and pain therapies, and its partner Zambon S.p.A., an international pharmaceutical company strongly committed to the CNS therapeutic area, announced today that the EU Committee for Medicinal Pro-ducts for Human Use (CHMP) recommended that the European Commission approve the use of Xadago™ (safinamide) as add-on to L-dopa alone or in combination with dopamine agonists, entacapone, amantadine, and/or anticholinergics, for the treatment of patients with mid-late stage Parkinson’s disease experiencing motor fluctuations despite being stabilized on ‘Standard of Care’.

C. Warren Olanow, M.D., FRCPC, Henry P. and Georgette Goldschmidt Professor and Chairman Emeritus of the Department of Neurology and Professor of Neuroscience at the Mount Sinai School of Medicine, stated: “Safinamide is the first NCE to be approved for the treatment of Parkinson’s disease in the past 10 years. In a two year double blind study, the product demonstrated rapid onset of efficacy (within two weeks) and benefit with respect to improvements in ‘ON and OFF Time’ without an increase in dyskinesia. This was maintained for the two year duration of the trial when used as an add-on treatment to PD patients with L-dopa-induced motor fluctuations, compared with ‘Standard of Care’. No other agent has demonstrated this duration of benefit in a double blind trial. Safinamide’s effects are dependent upon pharmacological mechanisms that are not shared with other PD drugs. These effects include its dual mechanism of highly selective, reversible inhibition of MAO-B, and state and use-dependent blockade of sodium channels that inhibit glutamate release, implicated in causing dyskinesia. Preclinical experiments and data from a large number of dyskinetic patients enrolled in a placebo controlled clinical study indicate that safinamide also has the potential to improve L-dopa induced dyskinesia in PD patients.”

Fabrizio Stocchi, M.D., Professor of Neurology, Director of the Parkinson’s Disease and Movement Disorders Research Centre, and Institute for Research and Medical Care IRCCS San Raffaele, Rome, who has been involved with safinamide trials from the beginning, said: “The benefits of safinamide were demonstrated as adjunctive treatment for fluctuating patients on top of L-dopa alone or in combination with other PD medications.Safinamide demonstrated significantly improved motor fluctuations, Parkinsonism, Quality of Life and Activities of Daily Living without any increase in ‘ON Time with troublesome dyskinesia’. My experience in treating PD patients with safinamide in Rome over the last 10 years, as well as my review of all the data indicate that safinamide is extremely well tolerated even over long periods of time. Safinamide does not require any specific medical monitoring, dietary restrictions, or particular precautions because the risk of drug interactions is very low”.

Ravi Anand, M.D., Newron’s CMO, said, “The CHMP decision on safinamide is a great result for PD patients and physicians, providing them with a therapeutic alternative that is an improvement over “standard of care” in patients with mid-late stage Parkinson’s di-sease patients on L-dopa, who constitute a major proportion (over 75%) of those that are experiencing this progressive debilitating disease. Safinamide’s unique profile of rapid onset and long lasting efficacy, significant even at two years, in a randomized placebo-controlled trial, has not been demonstrated with any other PD medication. In addition, safinamide improved patient and care giver rated Quality of Life measures, including PDQ39 and EQ-5D, as well as depressed mood. We thank the CHMP and EMA staff for their scientific advice during the development of safinamide and performing a timely review of the MAA”.

Maurizio Castorina, CEO of Zambon, said, “We are very excited by the decision of the CHMP that recognizes the therapeutic benefits of Xadago™. We now eagerly await the EU Marketing Authorization from the European Commission, so this product can be launched and its benefits made available to Parkinson’s disease patients starting in the first half of 2015. Zambon will make its best effort for the expeditious availability of Xadago™ and its success in the marketplace”.

The CHMP’s positive opinion on Xadago™ will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. The final decision will be applicable to all 28 European Union member countries, as well as Iceland, Liechtenstein and Norway.