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Newron Finds New Safinamide Partner in Zambon Agreement

By Nuala Moran
Staff Writer

LONDON – Newron Pharmaceuticals SpA has found a new partner for its Phase III drug safinamide, securing a €20 million (US$26.1 million) opening payment, with milestones and royalties to come, from the Italian pharma company Zambon SpA.

Safinamide became available for partnering after Merck KgaA said in October 2011 it was handing back rights to the alpha-aminoamide, an add-on therapy to dopamine agonists or levodopa in treating Parkinson's disease. That sparked the eleventh-hour collapse of a deal under which Milan, Italy-based Newron was to be acquired by Biotie Therapies Oyj, of Turku, Finland. (See BioWorld International, Nov. 2, 2011.)

Stefan Weber, Newron's chief financial officer, said the company had not analyzed whether signing up with Zambon was better than being acquired by Biotie since the latter deal "is history." But he told BioWorld International the new deal is preferable in the sense that Zambon is a midsized pharma with a sales and marketing infrastructure in place in 15 countries and is ready to distribute safinamide.

"They are looking for an extension into a new field, which is CNS [central nervous system diseases]. We have the experience, having taken safinamide to two Phase III trials. We do the [development] work. It's a perfect combination," Weber said. Biotie, on the other hand, was planning to buy Newron to acquire the safinamide royalty stream due from Merck. "Biotie is a good company, but it's a biotech with no sales and marketing operation. So this deal is better because Zambon will invest substantially," Weber added.

Under the terms of the deal, Zambon is making an initial payment of €20 million, consisting of an option fee, a down payment on the license, costs to complete development of safinamide and an equity investment, under which Zambon is acquiring 9.1 percent of Newron.

Merck Serono, part of Merck KgaA, of Darmstadt, Germany, is due to formally give back the global rights to safinamide on April 17, and Weber said the handover process is progressing well.

Zambon has until the end of April to confirm it will take up its option on the drug. If it does so, the Milan-based pharma company will make a further undisclosed up-front payment and Newron will be eligible for regulatory milestones upon FDA and European Medicines Agency filings and approvals, plus double-digit royalties on sales.

Zambon will commit itself in advance of the release of results from the two Phase III trials – due sometime before the end of June – testing safinamide as an adjunct to dopamine agonist therapy in early stage Parkinson's and as an adjunct to levodopa therapy in mid- to late-stage Parkinson's.

"The deal is a pre-results deal, and the terms are fixed even if the trials aren't positive; Zambon is taking the risk," Weber said.

Roberto Consonni, CEO of Zambon, said the company sees a significant opportunity in safinamide as an add-on therapy to dopamine. "We trust Newron's CNS expertise to take safinamide forward."

Shares in Newron, which is quoted on the SIX market in Switzerland, rose by 15.2 percent April 5 to CHF4. 18 (US$4.54) on the announcement of the Zambon deal. The news that Merck was pulling out of the safinamide license and Biotie's subsequent decision not to go ahead with the acquisition had forced Newron's shares to a low of CHF1.68 on Nov. 22, 2011.

Things began to look up in January when Newron announced a licensing agreement with Meiji Seika Pharma Co. Ltd. of Tokyo, covering the research, development, manufacturing and marketing of safinamide in Japan and key Asian territories. That deal, which became binding in February, will become effective upon the return of the global rights to safinamide from Merck Serono on April 17.

Newron received an up-front payment of €5 million from Meiji, but other financial terms of the agreement were not disclosed.

"Everyone's first reaction to the news Merck was handing over the safinamide license was 'You can't make me believe there is a good reason why.' But when Meiji signed the deal, that helped dramatically, and there was a lot more interest from pharma," Weber said.

"We now have everything we need to take safinamide through to file, and Zambon will be prepared for its launch," he added.