Italy’s Newron Pharmaceuticals says it has received approval from US regulators to carry out clinical trials of ralfinamide, the firm’s compound for chronic pain.
The Milan-based firm said that its investigational New Drug Application has been granted by the US Food and Drug Administration to conduct trials of ralfinamide, following a review by the agency of all preclinical and clinical data generated by Newron. The company noted that it expected to start further trials by the fourth quarter of 2007, having carried out previous Phase II studies in Europe and India.
Dispute settled with Purdue
The news was announced just after Newron said it had reached “a commercial settlement” with Purdue Neuroscience Co with regard to patents relating to certain compounds, including ralfinamide.
The agreement gives Newron the option to acquire ownership of a number of worldwide patents and applications related to use of certain compounds for treating pain, “including but not only ralfinamide”. The Italian group has paid an undisclosed sum to Purdue, and said that additional payments would be made, including royalties, if ralfinamide is approved for marketing.
For its part, Purdue will forgo any judicial review in the USA of a January 2007 ruling by that country’s Patent and Trademark Office, which held that it was unable to contest ‘priority of invention’ in a case brought against Newron. The latter’s chief executive, Luca Benatti, said the settlement was achieved “on terms that appropriately reflect the removal of any future uncertainty” surrounding the PTO’s judgement “and potential future litigation costs.”
Newron’s lead compound is safinamide, which is being developed with Merck Serono, and the companies recently presented promising late-stage data which suggest that the drug has an effect on cognitive performance in patients with early Parkinson’s disease. Safinamide is also being investigated as a treatment for Alzheimer’s disease, restless leg syndrome and other cognitive disorders.