Hikma Pharmaceuticals PLC and Vectura Group PLC said Monday they do not expect approval and launch for their United States generic version of GlaxoSmithKline PLC's Advair Diskus chronic obstructive pulmonary disease treatment until 2020 after U.S. regulators upheld their objections.
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'.
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.
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 already faced a delay in USA approval for its Advair generic in 2017, as did rival generics company Mylan, and last month a third Advair copy from Novartis's Sandoz division also got knocked back by the FDA.
Hikma had disputed the FDA's demand that it to conduct a fresh clinical endpoint study, but the agency upheld its original determination. 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 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 are expected to grow between four and seven percent.