BioWorld Today Correspondent

LONDON – Neurosearch A/S announced a major restructuring and cost reduction plan that will see a 20 percent cut in staff numbers and the spinout of its discovery research into a separate unit, as it marshals resources for the final push to go it alone on commercializing its Huntington's disease treatment, Huntexil.

"Neurosearch will continue to sharpen its strategic focus on becoming a speciality central nervous system biopharmaceutical company," CEO Patrick Dahlen told a teleconference held to discuss the moves.

This will involve spinning off all its ion channel discovery expertise and associated partnerships into a new independent unit, NsDiscovery; the appointment of new executives to boost the medical and sales and marketing effort behind Huntexil; and cost-cutting to reduce expenditure by DKK100 million (US$17.4 million) from 2012.

The basis of the restructuring is to ensure "optimal resources" are placed behind Huntexil. "We want to get to file as soon as possible," Dahlen said. "We feel it shows great potential as a new drug for treating Huntington's disease." Meetings with the FDA and the European Medicines Agency are due to take place to, "explore the best and most efficient regulatory pathway," he added.

Last month, Neurosearch announced results of a meta-analysis of two Phase III trials of Huntexil, showing that although the studies each individually failed to meet the primary endpoint of improvement in modified motor score at 12 weeks, they did show significance at week 26. Both trials demonstrated a significant impact on the secondary endpoint of total motor score, a measure of all motor symptoms. In addition, there was a statistically significant dose-response relationship and the safety and tolerability profiles were favorable.

The product has support from physicians specializing in Huntington's and from patients' groups, with many patients moving into open-label extensions of the two trials. But it remains to be seen if regulators will call for another Phase III trial.

Coming up behind Huntexil are ordopidine and seridopidine, two more compounds in the same class of dopidines, discovered by Neurosearch, which have dopaminergic stabilizing properties. Both are ready to enter Phase II as treatments for Parkinson's disease. "We will go into Phase II with at least one of them this year, regardless of FDA feedback on Huntexil. It's our duty and our job to move these compounds forward in the best possible way," Dahlen said.

The move to focus on these clinical-stage CNS programs will see one of Neurosearch's long-touted assets, the obesity treatment tesofensine, hived off to NsDiscovery. Dahlen said Ballerup, Denmark-based Neurosearch will not put any more resources into the Phase II drug until it is partnered. NsDiscovery will also be responsible for existing relationships with Eli Lilly, Janssen and Abbott.

Dahlen said the formation of NsDiscovery will create a best-in-class CNS-focused drug discovery operation with 20 years experience in ion channels. It will be funded through collaboration deals.