Despite being left at the M&A altar last fall after a key partnership deal collapsed, Newron says it has successfully completed two late-stage studies of its experimental Parkinson's drug. And the Italian biotech used the opportunity to announce that it has garnered a 20 million euro licensing deal with Zambon for the drug. At the same time, Newron's founding CEO is exiting after 13 years at the biotech.
Newron didn't release details on the data from the two Phase III studies of safinamide. But investigators assert that the drug achieved positive numbers for maintaining motor functions and improved "on" times for patients who suffer from the disease. And the news fueled a spike in Newron's shares, which soared 60% as news of the results spread.
"The positive results from these global trials provide substantial evidence for the efficacy of safinamide as an add-on treatment to the most commonly prescribed drugs in PD patients," said CMO Ravi Anand. "These results together with the previously reported positive results from Phase II and Phase III studies indicate that safinamide will be a unique addition to the therapeutic armamentarium in the treatment of PD."
Founder Luca Benatti, meanwhile, is out as CEO, replaced by CFO Stefan Weber.
Newron has been scrambling to recover since last fall, when Merck KGaA walked away from its partnership on safinamide, complaining that the commercial potential of the treatment had flagged considerably since it first signed on. That retreat in turn prompted Finland's Biotie Therapies to drop its $63 million offer to buy the company, leaving its share price in tatters. Zambon initially stepped in last April to fund the remaining R&D work and preparations to file for regulatory approval, which is slated for 2013. Meiji Seika Pharma earlier gained rights to the drug in Japan and other Asian markets.
- get the press release on Phase III results
- here's the release on the Zambon deal
- read the press release on the executive switch
- here's the story from Reuters