GSK share price steady after delay to generic Advair

GSK share price steady after delay to generic Advair

GSK share price steady after delay to generic Advair

USA regulators have upheld a prior decision rejecting Hikma and Vectura's generic formulation of GlaxoSmithKline's asthma and chronic obstructive pulmonary syndrome therapy Advair Diskus.

In anticipation of this as one of the potential outcomes, Hikma said it has already finalised the planning of a new clinical study and expects to start patient enrolment in the coming weeks, with a view to submitting a response to the FDA with new clinical data as early as possible in 2019.

As of 09:36 GMT, GSK's share price had added 0.58 percent to 1,343.80p, outperforming the benchmark FTSE 100 index which now stands 0.08 percent higher at 7,229.94 points.

Hikma has worked with the US Food and Drug Administration (also known as the FDA) since the regulator delayed its VR315 treatment in May.

The FDA has now concluded the dispute process and has upheld the previous call for the extra study, further delaying the drug's potential launch date.

After Hikma and Mylan's problems in 2017, most industry analysts expected the generic threat had been pushed back until mid-2018. The latest snags mean GSK may enjoy more Advair profits for longer, although Mylan still has a chance to win a USA green light for its version of generic Advair in 2018.

The timing of the arrival of generic Advair in the United States is critical to GSK's near-term earnings outlook. The drugmaker expects its 2018 earnings, at constant exchange rates, to be flat to down 3 percent if generic Advair launches in the U.S market by mid-year. Without generics, earnings would be up 4 to 7 percent.