By Ben Hirschler
LONDON (Reuters) - GlaxoSmithKline looks unlikely to face competition from a substitutable copy of its blockbuster lung drug Advair in the United States this year, after a second generic application was turned down by U.S. regulators.
Hikma Pharmaceuticals (LON:HIK) said on Thursday the Food and Drug Administration (FDA) had decided not to approve its version of the inhaled medicine for asthma and chronic lung disease at this time, due to "major" issues with the application.
The company said there was now a low likelihood of approval this year.
Hikma and its partner Vectura are in a race with Mylan to launch the first U.S. generic copy of Advair that can be substituted for the original product in pharmacies. The FDA has already delayed approval of Mylan's version.
Both Hikma and Mylan have received so-called complete response letters from the FDA that were categorised as major. Dealing with a major amendment to a generic drug application means a delay of 10 months for an FDA response, according to agency guidelines.
Shares in Hikma and Vectura fell 8 and 9 percent respectively in early trading.
Hikma said it was in the process of reviewing its response, adding that it appeared no material issues were raised regarding the substitutability of its proposed inhaler device used to deliver the medicine.
Mylan, whose application for a rival generic was turned down in March, disclosed for the first time on Wednesday that the FDA had designated its application as requiring a major amendment.
The delays offer a short-term reprieve for GSK, which has been bracing for the arrival of U.S. generic Advair, without knowing exactly when copies will arrive.
Without substitutable generic Advair in the all-important U.S. market this year, GSK expects adjusted 2017 earnings per share (EPS) to rise by between 5 and 7 percent, in constant currencies. If they had launched by mid-year, it had forecast EPS would be flat to slightly lower.
GSK shares were little changed in early trade.