Newron hopes to partner would-be schizophrenia blockbuster this year

Funds from an evenamide licensing deal would help Newron to accelerate development of rare disease drug sarizotan.

Phase 2a data for Newron's schizophrenia drug evenamide due in March should help the company sign a development partner later this year, according to CEO Stefan Weber.

The Italian biotech published preliminary safety and efficacy data from the trial earlier this month which suggested evenamide—a sodium channel blocker—could improve management of psychotic symptoms in schizophrenia whilst avoiding side effects seen with existing drugs that block dopamine.

Weber told Bloomberg in an interview that there is "a good chance of a licensing deal in the second half of the year" for evenamide (also known as NW- 3509), which he believes could become a blockbuster.

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Evenamide is thought to work by reducing the release of the neurotransmitter glutamate, a novel mechanism in schizophrenia. Adding it to other drugs in patients showing a worsening of their symptoms showed "a pattern of benefit on all efficacy measures assessed" in the trial, according to the biotech.

Weber said funds from an evenamide licensing deal would allow it to accelerate development of sarizotan, a drug for the rare disease Rett syndrome that he sees as particularly promising.

Rett syndrome results in severe mental and physical disability and affects around 36,000 patients in the U.S. and Europe. Newron recently started the pivotal STARS trial of sarizotan to see if the drug can treat the abnormal breathing patterns associated with the disease. Children with Rett syndrome sometimes exhibit symptoms of rapid or slow breathing, as well as breath-holding, and are known to swallow air which can lead to abdominal bloating.

Analysts at Edison said in a recent research note that sarizotan could potentially see a first approval and launch in 2018 and bring in peak sales of €260 million (around $280 million). Given the size of the indication, the biotech could commercialize the drug on its own with a small salesforce.

Sarizotan was originated by Merck KGaA to reduce side effects from Parkinson's disease treatment but was dropped in 2006, with Newron licensing it five years later.

March is shaping up to be a critical month for Newron, as its only marketed drug—Xadago (safinamide) for Parkinson's disease—is finally back on track in the U.S. after the FDA sent the firm a complete response letter in March.

Since then the agency has confirmed to Newron's commercial partners Zambon and US WorldMeds that no further clinical trials will be required on its potential for abuse or dependence, and it is due to deliver a verdict on the revised application by 21 March.

Edison is now predicting a launch for Xadago in the US before the end of the year, as partner Zambon continues to roll the drug out across Europe. At last count it was available in 11 E.U. countries.

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