If the drug can control dyskinesia, it might generate $1.5 billion in annual revenue. (NIH image)

(Bloomberg) — Newron Pharmaceuticals SpA, which last week won European approval for the first innovative drug for Parkinson’s disease in a decade, expects partner Zambon SpA to seal a deal soon to help sell the medicine in the United States.

Zambon, which has global rights outside of Asia to safinamide, is in advanced talks for a sub-licensing deal in the U.S. that will probably be agreed upon by the end of next quarter, Newron Chief Executive Officer Stefan Weber said in an interview in London on Thursday. A sub-licensing partner would help Newron market the drug in the United States and possibly expand its sales potential in treating another condition related to Parkinson’s, he said.

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Safinamide affects the way the body releases and processes substances such as monoamine oxidase B, dopamine and glutamate. One recent study showed that the drug protected against brain cell loss and behavioral impairment in rodent models of Parkinson’s disease. Some researchers have suggested that the drug might also be a treatment for epilepsy, and one 2007 journal article indicated that researchers might study whether the drug could be helpful to people’s Alzheimer’s disease.

The U.S. Food and Drug Administration (FDA) accepted Newron’s submission for safinamide and will probably complete its review by Dec. 29, the Bresso, Italy-based company said this week. A U.S. licensing deal could include an agreement to conduct late-stage trials on safinamide’s effect on dyskinesia, the involuntary muscle movements common in Parkinson’s patients, said Samir Devani, an analyst at Rx Securities in London who recommends buying the company’s shares.

“That’s the real joker card,” Devani said by phone. While safinamide peak sales may reach $450 million in six years, adding dyskinesia to the approved label could yield an additional $1 billion, he said.

Newron’s shares climbed 0.8 percent to 30.81 Swiss francs at 12:45 p.m. in Zurich after falling as much as 5.4 percent earlier in the day. The stock has advanced 73 percent in a year, giving the company a market value of 406 million francs ($416 million).

The drug’s effect on reducing the involuntary movements was observed in a sub-population of patients in trials, Weber said.

Potential takeover

Safinamide, also known as Xadago, is an oral, once daily add-on therapy to existing drugs for Parkinson’s disease. Meiji Seika Pharma Co. holds rights to the medicine in Asia.

Newron is developing five additional medicines, including three for rare diseases.

Given the sure bet with safinamide and the pipeline of drugs, a takeover by a mid-cap company that specializes in neurological diseases is possible, Devani said.

“It’s not unreasonable to assume that whoever licenses the drug is going to see the attraction of capturing more of safinamide’s value by acquiring Newron,” he said.

Weber declined to say whether any companies have approached Newron with a takeover offer.

While Newron suffered a setback when Merck KGaA terminated a partnership on safinamide in 2011 in a reorganization of research and development, the European approval is a vindication for the drug, Weber said.

“We always believed in it,” Weber said. “And we’ve been able to prove it step by step to the science and investor world. That is the reason we are back from the situation of that time.”

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