Newron has posted positive late-stage data on its Parkinson's disease drug safinamide, a treatment former partner Merck KGaA gave up on in 2011, and signed a licensing deal with fellow Italian firm Zambon.
Top-line results from the last two Phase III studies of safinamide as an add-on treatment in both early and advanced PD patients were "consistent with the positive pattern of efficacy and safety" reported in previous Phase II/III trials, Newron notes. The drug was very well tolerated with no significant difference in, for example, the incidence of drop-outs and serious adverse events when compared with placebo.
A full analysis of the data will be presented at upcoming scientific meetings and chief medical officer Ravi Anand said the findings "indicate that safinamide will be a unique addition to the therapeutic armamentarium in the treatment of PD". The results will provide the basis for global filing for the drug, an alpha-aminoamide, in 2013.
As the results were released, the deal with Zambon was unveiled. The latter is putting in a total of 20 million euros into Newron, which includes a licence to safinamide (excluding Japan and other Asian territories where rights were recently sold to Meiji Seika Pharma) and an equity stake.
Zambon will meet the costs incurred by Newron to complete the development of safinamide and prepare the files for marketing approval in Europe and the USA. The pact also involves "significant success-based regulatory milestone payments" for Newron and double-digit royalties.
Chairman Rolf Stahel said the agreement is of "immense importance" and "the take-on of development cost by Zambon provides us with the means to broaden Newron´s strategic options".
CEO Benatti to leave
Meantime, Luca Benatti, founder and Newron´s chief executive since 1999, os to leave the company "to pursue other opportunities", having overseen the completion of the Phase III programme for safinamide and signing a new partnership. He will be replaced as CEO at the end of May by the current chief financial officer Stefan Weber.
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