Serono says it won global rights to Newron's Parkinson's Disease treatment
The Associated Press

Published: October 16, 2006

GENEVA, Switzerland Swiss drugmaker Serono SA said Monday it won worldwide rights to develop Newron Pharmaceuticals SpA's safinamide Parkinson's disease treatment.

Serono will become responsible for future development and manufacturing costs and will make upfront and additional payments of as much as US$200 million (€159.9 million), the company said in a statement. The company will also pay Newron undisclosed royalties on worldwide net sales.

Other details of the financial terms were not disclosed.

Newron recently reported positive results with safinamide from an early Phase III study in Parkinson's disease, Serono said in a statement.

"This partnership enables us to expand our neurology portfolio by investing in innovative products to meet significant unmet medical needs, such as Parkinson's and Alzheimer's disease," said Franck Latrille, Serono's senior executive vice president for global product development.

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Newron’s lead product, safinamide, is currently in Phase III trials for the treatment of Parkinson’s disease and in Phase II for Restless Leg Syndrome.

Safinamide is a unique molecule with multiple mechanisms of action and a very high therapeutic index. It combines inhibition of dopamine uptake and potent, selective and reversible inhibition of monoamine oxidase (MAO) B, without a MAO-A effect, with potent sodium (Na+) channel blocking activity and calcium (Ca2+) channel modulation.

The Na+ channel blockade selectively affects those neurons with abnormal firing patterns and leaves normal activity unaltered.

Safinamide and its use is protected worldwide by several patents assigned to Newron.

Safinamide in Parkinson’s disease

Safinamide has also shown strong activity in clinical trials. In a multinational Phase II placebo controlled trial in early Parkinson’s disease , safinamide has improved motor disability by an average 30%.

Maximal beneficial effect was observed in those patients under stable treatment with one single dopamine agonist. Safinamide was tolerated as well as placebo. The drug has also demonstrated excellent bioavailability, linear kinetics and is suitable for once-a-day administration.



Benefits of safinamide treatment in Parkinson’s disease include:

•dopamine uptake inhibition
•potential neuroprotective activity due to multiple mechanisms of action
•reversible MAO-B inhibition leading to a favorable side effect profile
•absence of MAO-A activity in humans therefore no cheese effect

Symptom relief in Parkinson disease by safinamide: Biochemical and clinical evidence of efficacy beyond MAO-B inhibition.

Stocchi F, Vacca L, Grassini P, De Pandis MF, Battaglia G, Cattaneo C, Fariello RG.

IRCCS San Raffaele Pisana, Rome, Italy.

In an open pilot study, doses of safinamide (100, 150, and 200 mg once a day, higher than previously tested) were administered to 13 parkinsonian patients along with a stable dose of dopamine (DA) agonist, causing a significant progressive improvement in motor performance as evaluated by the Unified Parkinson Disease Rating Scale (UPDRS) part III over an 8-week period (4.2 points; P < 0.001). In association with levodopa, the same doses of safinamide in another group of patients (N = 11) induced a significant decrease in motor fluctuations (UPDRS part IV, 2.1 points; P < 0.001), accompanied by a dose-proportional increase of the levodopa AUC, up to 77% from baseline. Because MAO-B was fully inhibited (95%) at all doses tested, we suggest that these biochemical and symptomatic dose-dependent effects must be related to additional mechanisms of action, such as inhibition of glutamate release, increased dopamine release, or inhibition of dopamine re-uptake. These hypotheses are under investigation and will pursue confirmation in controlled clinical trials.

PMID: 17030737 [PubMed - in process]