Newron to resubmit troubled Parkinson’s drug to FDA; abuse risks cleared

Newron Pharmaceuticals has seen a much-needed quick turnaround for its lead Parkinson’s drug as it can now resubmit its candidate in the U.S.--just four months after being blocked by the FDA.

The Italian biotech’s drug, which will be marketed as Xadago (safinamide), is designed to serve as an add-on therapy to dopamine therapies or levodopa in patients with Parkinson’s.

The drug has trodden a long and broken path, having failed back in 2010--souring Newron's relationship with then-partner German Merck, which eventually led to it creating a new partnership with fellow Italian company Zambon (as well as with St. Matthews, KY-based US WorldMeds in the U.S.).

The fallout from the 2010 failure also saw Finland’s Biotie Therapies drop its $63 million offer to buy the company, leaving its share price in tatters. It also lost its founding CEO, who departed in 2012 after 13 years at the company, and saw multiple delays from the FDA.

Then in March, after a protracted review, the U.S. regulator hit the company with a complete response letter, as it and the Controlled Substance Staff (CSS) unit had concerns about the abuse potential of the drug--specifically on its dependence and withdrawal affects.

But in a bright spot for a drug and company that has been through the mill over the past 6 years, Newron said in a statement early this morning that the FDA no longer requires Newron “to perform any studies to clinically evaluate the potential abuse liability or dependence/withdrawal effects of Xadago.”

The company’s CMO, Dr. Ravi Anand, said Newron shared that “additional preclinical abuse liability studies and additional analyses of the clinical data requested by the CSS led the FDA and CSS to conclude that no further evaluation of the abuse liability or dependence/withdrawal effects of Xadago were required.”

It will now work on resubmitting the NDA for the drug as quickly as possible, with this slated to be done by November.

The drug was something of a phoenix from the flames in Europe at least, as it was eventually approved by the EMA last year as an add-on drug with levodopa for Parkinson's disease.

It was later launched in Germany through Zambon--the EU's biggest pharma market--in May, followed by launches in Switzerland, Spain and Italy. Newron estimates that peak annual sales could reach as much as $500 million, although this is contingent upon it gaining U.S. approval.

The company’s stock, which is listed on the SIX Swiss Exchange in Europe, was up by nearly 10% this morning on the news.

- check out the release

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