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(Adds detail from CHMP statement, analyst comments; updatesshare movement)
By Vrinda Manocha
Jan 24 (Reuters) - PTC Therapeutics Inc said itsdrug to treat a rare muscular disorder failed to win support fora conditional approval from a panel of the European MedicinesAgency, sending its shares down as much as 17 percent in morningtrading.
The European Committee for Medicinal Products for Human Usesaid a study failed to show that patients taking the drug,ataluren, could walk a greater distance in six minutes thanpatients on placebo. (http://link.reuters.com/vew36v)
It also said the drug showed limited evidence of havingbeneficial effects on the daily activities of patients with aform of Duchenne muscular dystrophy (DMD), a genetic disorderthat causes muscle degeneration and eventual death in boys.
Analysts said conditional approval for the drug had beenconsidered unlikely, and remained positive on its potential foreventual approval by the EMA.
A conditional approval is granted to treatments that addressunmet medical needs. The drugmaker is still testing the drug ina late-stage trial.
The EMA was concerned that conditional approval would makeit difficult for the company to finish the trial, Wedbushanalyst Christopher Marai said.
PTC said it plans to request the committee for are-examination, but analysts said they expect the company would need data from its late-stage trial of the drug before it isapproved.
Marai said the drug could be approved by late 2015 or early2016 and would target about 1,500 patients in the EuropeanUnion. "The drug could generate peak sales of $350 million by2019 in the European Union," he said.
PTC joined a list of companies struggling with setbacks totheir drugs to treat DMD.
Prosensa Holding NV's partner GlaxoSmithKline Plc handed back the rights to its DMD drug less than twoweeks ago after the failure of a key trial.
Sarepta Therapeutics Inc lost almost two-thirds ofits market value in November after the U.S. FDA said the designand goals of its trial might not be sufficient to get approvalfor its muscular disorder drug.
About 15 percent of DMD cases are caused by nonsensemutations that leads to a premature end to the translation of agene into a protein, according to the U.S. National Institutesof Health.
Ataluren is designed to interact with a part of the cellknown as a ribosome, enabling it to manufacture a protein calleddystrophin, the absence of which causes muscle weakening inpatients with DMD.
The company's shares were trading down 4 percent at $24.20in morning trading on the Nasdaq. (Reporting by Vrinda Manocha in Bangalore; Editing by DonSebastian)
