BioWorld International Correspondent

Newron Pharmaceuticals SpA raised €30 million (US$39.6 million) in a third funding round that was led by HBM Partners AG, of Baar, Switzerland.

Newron, of Bresso, Italy, already has secured €23 million of the total, from HBM and from previous investors 3i plc, Apax Partners and Atlas Ventures. It offered additional equity worth €7 million to other interested parties, but if terms are not agreed the current investors have provided guarantees that they will take up the extra shares.

The company will use the proceeds to expand its clinical program for its candidate Parkinson's disease drug, safinamide. That is undergoing a Phase III trial in Europe, Asia and South America.

"The efficacy data will be available in the first quarter of 2006," said Newron CEO Luca Benatti. The company will, he said, initiate a second Phase III trial, involving between 200 and 300 patients, in the U.S. Design of that trial is ongoing. The company has not yet disclosed its target launch date for the product, which is not partnered.

Safinamide was originally discovered by Pharmacia & Upjohn (now part of Pfizer Inc., of New York), from which Newron was spun out in 1999. The compound has multiple mechanisms of action in the central nervous system - it inhibits dopamine uptake, it modulates the activity of both sodium and calcium channels and it selectively inhibits monoamine oxidase B activity.

The company is optimistic about its potential in Parkinson's disease, Benatti said, notwithstanding the recent high-profile failure of GDNF, which Amgen Inc., of Thousand Oaks, Calif., is developing.

"I think some of the [other] therapies were more speculative and not proven in terms of mechanism of action," Benatti said.

Safinamide also is undergoing a Phase II trial in epilepsy and restless leg syndrome, but the Parkinson's program remains the company's priority. The company's second drug candidate, ralfinamide, also is in a Phase II trial, in neuropathic pain. Data from that proof-of-concept study will be available by the year's end, Benatti said.

Newron has previously been suggested as one of Europe's likely initial public offering candidates for 2005, although Benatti said such a move is unlikely in the short term, given current market conditions.

"We're not in a rush," he said. "We are very well supported by the current investors."