BioWorld International Correspondent

Completing one last deal before finalizing its merger with Merck KGaA, Serono SA gained exclusive rights from Newron Pharmaceuticals SpA to safinamide, a compound undergoing a Phase III trial in Parkinson's disease, for up to $200 million.

The deal comprises an undisclosed up-front payment plus development and commercial milestones. Bresso, Italy-based Newron also would receive royalties, should safinamide be approved, and the company has retained an option to co-promote the product in Italy and Spain.

Geneva-based Serono is assuming all development costs for the program, including further Phase III studies that Newron will conduct.

Obtaining a partner that was willing to commit significant resources to the project was a major priority, Newron CEO Luca Benatti said. The royalties have been structured incrementally, and Newron would receive significant money if safinamide hits it big.

"They vary according to the sales thresholds," he said.

The product is likely to attain blockbuster revenues only if it is developed in other CNS indications, such as Alzheimer's disease, as well as in Parkinson's. The compound already has been evaluated in patients with restless leg syndrome, and has potential in mild cognitive impairment as well, Benatti said.

In a double-blind, placebo-controlled Phase III trial of 270 patients with early stage Parkinson's disease, safinamide demonstrated a clinically relevant and statistically significant improvement in the Unified Parkinson's Disease Rating Scale, Part III, when administered along with a stable dose of a single dopamine agonist.

The dosing period for that study was 24 weeks, but the trial has a 12-month follow-up, which will be completed in the second quarter of 2007. In the meantime, Newron also will kick off additional Phase III studies, as will Serono. The aim, Benatti said, is to demonstrate that safinamide has positive effects on motor and cognitive symptoms in both early and late-stage Parkinson's patients and on dyskinesia in the latter category.

Safinamide is an alpha-aminoamide with multiple mechanisms of action. It is a selective inhibitor of monoamine oxidase B, an enzyme that catalyzes the breakdown of the neurotransmitter dopamine. It also inhibits reuptake of dopamine, blocks glutamate release and acts as a Na+ and Ca2+ channel blocker.

Newron obtained rights to the compound when the company was formed via a management buyout in 1999 of a Pharmacia & Upjohn (now part of New York-based Pfizer Inc.) research center in Italy. Serono's acquisition of the drug comes with an implied blessing from Darmstadt, Germany-based Merck, which unveiled plans for a CHF16.6 billion (US$13.3 billion) cash takeover of the Swiss firm last month.

In June, Merck halted development of its own Parkinson's drug, the serotonin receptor agonist Sarizotan, having failed to demonstrate efficacy in two Phase III trials in more than 1,000 patients with disabling dyskinesia.

Newron, which has raised €62 million (US$77.6 million) in funding since its formation, has a second development-stage compound, ralfinamide, undergoing a Phase II trial in neuropathic pain. That will be completed in the second quarter of 2007, Benatti said, and Newron plans to continue its development in-house.

"This is potentially a blockbuster drug. It's a huge market," he said.