US FDA Upholds Advair Generic Issue With Hikma And Vectura

Modesto Morganelli
Marzo 13, 2018

Hikma Pharmaceuticals PLC and Vectura Group PLC said Monday they do not expect approval and launch for their USA generic version of GlaxoSmithKline PLC's Advair Diskus chronic obstructive pulmonary disease treatment until 2020 after U.S. regulators upheld their objections.

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.

Hikma's partner on the project, Vectura, said this meant a potential approval and launch of the generic inhaled medication could come in 2020 if all goes well.

The news has triggered a 1.8% decline in Hikma's share price to 882p.

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

Hikma had disputed the FDA's demand that it to conduct a fresh clinical endpoint study, but the agency upheld its original determination.

After Hikma and Mylan's problems in 2017, most industry analysts expected the generic threat had been pushed back until mid-2018. The news marks a boost for the FTSE 100 drugmaker who has signalled that its near-term earnings outlook is contingent on the arrival of generic Advair in the US. Without generics, earnings would be up 4 to 7 percent. Reuters, however, noted in its coverage of the news that generics company Mylan still had a chance to win a United States green light for its copycat Advair in the current year.

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