GSK share price: Group files for extended indication for pulmonary drug

Written by: Alice Young
December 12, 2014

iNVEZZ.com, Friday, December 12: GlaxoSmithKline Plc (LON:GSK) has asked European regulators to extend the current therapeutic indication of the group’s pulmonary drug Volibris. The company noted that the submission was based on the results of a late-stage trial.

As of 13:49 GMT, GSK’s share price had lost 1.26 percent to 1,375.50p. The decline in the drugmaker’s shares is in line with a drop in the broader market with the benchmark FTSE 100 index currently standing 1.45 percent lower at 6,368.32p.
GSK announced yesterday in a statement that it had filed a regulatory submission to the European Medicines Agency (EMA) for a variation to the marketing authorisation for the group’s ambrisentan drug, marketed as Volibris in Europe. The company is seeking to extend the current therapeutic indication to include the drug’s use in initial combination therapy with another medicine for patients with pulmonary arterial hypertension (PAH).
PAH is a disease characterised by constriction of the blood vessels in the lungs leading to high pulmonary arterial pressures. The condition is estimated to affect about 200,000 patients worldwide.
GSK explained in the statement that the submission was based on a late-stage study, conducted in collaboration with Gilead Sciences Inc (NASDAQ:GILD). The study showed that starting an initial combination of ambrisentan and tadalafil was superior to first-line monotherapy with either medicine alone. The company noted that further regulatory submissions were planned in other countries this year as well as next year.
According to the Financial Times, as of December 9, the consensus forecast amongst 59 polled investment analysts covering GSK has it that investors should hold their position in the company. The 23 analysts offering 12-month price targets for the stock have a median target of 1,518p, with a high estimate of 1,758p and a low estimate of 1,250p.

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