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.

*********************************


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