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Newron reports positive Phase III data for safinamide as treatment for PD; regulatory filings planned for 2013

Wednesday, May 16 2012 | Comments
Evidence Grade 0 What's This?
Newron Pharmaceuticals SpA's safinamide demonstrated efficacy as an add-on therapy for patients with Parkinson's disease (PD) in the final two Phase III trials of the drug's development program.

With these positive findings, the firm said it expects filings for regulatory approvals of the drug to begin in markets worldwide next year.

The MOTION and SETTLE trials were both six-month, double-blind, placebo-controlled trials.

The MOTION trial included 679 patients with early idiopathic PD who had been treated with a stable dose of a single dopamine agonist for at least four weeks before being randomized to receive once-daily treatment with safinamide 50 mg, safinamide 100 mg or placebo as adjunctive therapy. The primary endpoint was the change in motor symptoms, as assessed by the change in the Unified Parkinson's Disease Rating Scale, from baseline to week 24.

The SETTLE trial included 549 patients with mid- to late-stage idiopathic PD who had been treated with a stable dose of levodopa for at least four weeks and who experienced motor fluctuations with more than 1.5 hours of "off" time during the day. The participants in this trial could also receive stable doses of other treatments, including a dopamine agonist, a catechol-O-methyltransferase inhibitor, an anticholinergic drug and/or amantadine hydrochloride. Following a four-week levodopa stabilization phase, the participants were randomized to receive safinamide or placebo as adjunctive therapy. The primary endpoint was the change in daily "on" time, as assessed by patient recordings on diary cards, from baseline to week 24.

According to Newron, benefits of safinamide were observed in analyses of both primary and secondary outcome measures. In addition, the firm said the drug was "very well-tolerated," with no significant difference between safinamide and placebo in rates of dropouts, serious adverse events, treatment-emergent adverse events, laboratory abnormalities or ophthalmologic findings.

Newron said the results from these trials "were consistent with the positive pattern of efficacy and safety reported in previous Phase II/III studies," including studies 009 and 015, which evaluated safinamide in early PD, and study 016, which evaluated the drug in advanced PD.

The firm added that full analyses of the data from these trials will be presented at upcoming scientific meetings.

The MOTION and SETTLE trials are part of a clinical development program in which safinamide is being evaluated as add-on therapy to treatment with a dopamine agonist in early PD and as add-on therapy to treatment with levodopa in advanced PD. Other placebo-controlled trials in the program include studies 009, 015, 016, 017 and 018.

Separately, Newron announced that it executed a strategic collaboration and license agreement for safinamide with Zambon Co. SpA.

The two firms signed a strategic collaboration and license option agreement last month. At the time, Zambon made an equity investment in Newron and committed to increase its stake in Newron in a future share capital increase. In addition, Zambon said it would pay an undisclosed sum for the exclusive option to a license for safinamide covering the drug's research, development, manufacture and marketing in all territories other than Japan and key Asian territories covered by a license agreement established earlier this year between Newron and Meiji Seika Pharma Co. Ltd.

With the execution of this license option agreement, Zambon will make a total investment in Newron of approximately $25.5 million, at the current exchange rate, an amount that covers the completion of safinamide's clinical development and the preparation of applications for marketing approval in the United States and Europe. Under this agreement, Newron will also be eligible to receive regulatory milestone payments as well as double-digit royalties on future sales of safinamide in the licensed territories.

Merck Serono SA, a division of Merck KGaA, returned the global rights to safinamide to Newron last month after making the decision to reprioritize its pipeline. When Merck announced these plans last October, the firm said that it believed safinamide had "a more limited market potential than originally anticipated."

This information concerns a use that has not been approved by the Food and Drug Administration.

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