Hikma faces further delays in launching generic version of GlaxoSmithKline blockbuster drug

GSK share price steady after delay to generic Advair

GSK share price steady after delay to generic Advair

GlaxoSmithKline has won a further reprieve for its blockbuster Advair lung drug after USA regulators insisted Hikma Pharmaceuticals conduct a further clinical study evaluating its generic version of the drug.

Hikma announced in a statement this morning that the US Food and Drug Administration (FDA) had requested the completion of an additional clinical endpoint study for the pharmco's generic version of GSK's Advair Diskus treatment.

In a bid to accelerate progress, Hikma now expects to start patient enrolment in the next few weeks and anticipates new clinical data will be submitted 'as early as possible in 2019'.

"Whilst the outcome of the dispute resolution process is disappointing, we now have a clear pathway forwards, and we and our partner Hikma remain confident in, and committed to the approval of VR315", said Vectura's chief executive James Ward-Lilley. "Assuming the successful execution of the new study and a standard regulatory review, we now expect a potential approval and launch during 2020".

Opioid prescription makes more money for the Doctors
That study revealed that more than 68,000 doctors received payouts from the drug industry which totaled $46 million. Doctors who recommended especially large measures of the medications were the well on the way to get paid.

Vectura was 7.1% lower at 75.55 pence early Monday, the worst performer in the FTSE 250, while shares in Hikma were down 2.8% at 873.00p.

The setback marks good news for GSK, which said in its full-year results last month that it expects its earnings to be flat to down three percent this year, if generic copies of its Advair inhaler hit the United States market by mid-year.

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.

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