Neurosearch to Need More Money for Extra Trials With Huntexil
From EquityBites (March 24, 2011)
24 March 2011 - Danish biopharma company Neurosearch A/S (CPH: NEUR) will have to provide more clinical data for its Huntington’s disease drug Huntexil in the USA and this will require extra funding, according to CEO Patrik Dahlen.
Yesterday, Neurosearch announced that the US Food and Drug Administration (FDA) has required additional data to prove the effect of Huntexil in order to give the green light to a new drug application (NDA) in the USA.
The Danish company also expects feedback on the drug candidate from the European Medicines Agency (EMA) in the second quarter of 2011.
"The problem is the annual costs that we have. We have funds for the next couple of years. So if we implement it (the additional clinical trial) and if we do not get the chance to submit a marketing application in Europe, we will have to either raise funds or find alternative financial solutions," Dahlen told Danish newswire Ritzau Finans.
These alternative solutions could include sale of associated companies or sale of obesity drug candidate Tesofensine, according to the chief executive. Discussions with potential partners for Huntexil could also be considered as a last resort.
If Neurosearch does not get the go-ahead to file for regulatory approval in Europe, Huntexil may reach the market in 2014 at the earliest, according to the chief executive.
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Posted: March 2011