TechMARK movers: Skyepharma down on US delay

1st Sep 2009 13:04

Skyepharma is leading the fallers on news that the US launch of the drug developer's asthma treatment Flutiform will be delayed for two years at least after the US Food and Drug Administration insisted on more data on dosing. The result is a blow for Skyepharma, which originally had expected approval in the first quarter of this year after the drug passed a phase three trial. As a result it is unlikely Flutiform will be approved in the US before the second half of 2011, Skyepharma added. Under its current license agreement, US partner Abbott is responsible for paying for additional clinical or other trials required by the FDA. The potential review issues are not expected to have an impact upon the development of Flutiform for Europe or Japan, which remain on track, Skyepharma said.Drug developer AstraZeneca is to press ahead with plans to submit its ticagrelor drug, Brilinta, for regulatory approval in the fourth quarter of 2009 after positive results from a major trial. The company hailed results from a trial which showed ticagrelor reduced cardiovascular death and heart attacks over clopidogrel in acute coronary syndromes (ACS) patients. Astra said that results from the phase III head to head trial PLATO (a study of Platelet Inhibition and Patient Outcomes), showed that ticagrelor achieved greater efficacy in the primary endpoint, reduction of cardiovascular events (CV death, MI, stroke) over clopidogrel without an increase in major bleeding.FTSE TechMARK - FallersSkyepharma (SKP) 101.00p -10.62%Parity Group (PTY) 19.50p -8.24%Renovo Group (RNVO) 28.50p -5.00%Dialight (DIA) 167.50p -4.29%Ark Therapeutics (AKT) 41.50p -4.05%Morse (MOR) 28.00p -3.45%Filtronic (FTC) 35.75p -3.38%Imagination Technologies (IMG) 157.50p -3.37%Wolfson Microelectronics (WLF) 135.50p -3.21%Alphameric (ALM) 31.00p -3.12%FTSE TechMARK - RisersOxford Biomedica (OXB) 12.00p +6.67%Biocompatibles International (BII) 190.00p +2.70%Optos (OPTS) 80.00p +2.56%Sinclair Pharma (SPH) 27.50p +1.85%XP Power (XPP) 320.00p +1.59%Puricore (PURI) 17.50p +1.45%GB Group (GBG) 20.00p +1.27%Sepura (SEPU) 45.50p +1.11%Kofax (KFX) 145.00p +1.05%Asterand (ATD) 25.25p +1.00%