More than three years after Merck KGaA decided to dump its partnership with Milan-based Newron Pharmaceuticals, which in turn iced a planned buyout by Biotie, the Italian biotech has persevered to win European approval to market safinamide as an add-on drug for Parkinson's disease.
Newron soldiered on to wrap a follow-up Phase III study of safinamide--to be sold as Xadago--to back up its use in combination with the standard, levodopa. And while there have been plenty of doubts raised about the drug's market potential, Newron itself has bullishly projected peak annual sales at $500 million, with a retry at the FDA being readied for later this year.
The drug is intended to help fluctuating Parkinson's patients deal with motor symptoms that can occur.
Last summer the FDA refused to accept the new drug application from Newron and its partner Zambon, citing organization and navigation problems with the filing that set them back yet again.
That was just one of the latest events in a long and painful haul for Newron, which had to acknowledge back in 2010 that the drug had failed a Phase III study for controlling the involuntary movements associated with Parkinson's. But after Merck KGaA stepped out in 2011, Italian drugmaker Zambon stepped in, paying $26.2 million at the time to fund the rest of the clinical work as well as the regulatory filings.
"Levodopa, still the gold standard of symptomatic efficacy in the treatment of Parkinson's disease, in its long-term use is associated with motor complications which still constitute a major unmet medical need in PD therapy," says Werner Loewe of Innsbruck Medical University and University Hospital in a statement. "Targeting non-dopaminergic systems might be an alternative approach to improve and control such motor complications, enhancing efficacy and removing the need for further increases in levodopa dose, that has been shown to worsen motor fluctuations."
- here's the release