Newron Pharmaceuticals' U.S. headache continues as its once-failed drug that was delayed by the FDA last year has now been stiff-armed by the FDA, which handed out a complete response letter to the developer.
The Italian biotech has been told that if it wants the drug to be approved in the key U.S. market it will need to undertake clinical evaluation of the potential effect of Xadago (safinamide) on behaviors relating to abuse liability and dependence/withdrawal effects as required by the Controlled Substance Staff in the Center for Drug Evaluation and Research at the FDA.
Dr. Ravi Anand, CMO of Newron, said: "The complete response letter does not require submission of any additional new data/studies/analyses for efficacy or safety in patients with Parkinson's disease. Newron is requesting a meeting with the representatives of the Controlled Substance Staff and Division of Neurological Products to finalize plans for the additional experiments."
The CRL comes just two weeks after its fellow Italian biopharma and drug partner Zambon announced a strategic agreement with St. Matthews, KY-based US WorldMeds to commercialize Newron's Xadago (safinamide).
The drug, to be marketed as Xadago, is designed to serve as an add-on therapy to dopamine therapies or levodopa in patients with Parkinson's. Safinamide failed back in 2010--souring Newron's relationship with then-partner German Merck--leading to its new partnership with Zambon.
The company has endured a tough time, and 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.
Newron said in a statement that it would provide an update on the potential timelines for approval of safinamide "in the near future."
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. The drug launched in Germany through Zambon--the EU's biggest pharma market--in May, followed by launches in Switzerland, Spain and Italy.
In its full-year results released at the start of March, Newron said it had received a €1.8 million ($2 million) milestone payment from Zambon for the drug, as well as €500,000 in royalties based on net sales.
Newron estimates that peak annual sales could reach as much as $500 million--although much will depend on the FDA's final decision on the drug.
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