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 The Swiss drugmaker said in an emailed statement on Thursday it had
received a so-called complete response letter from the U.S. Food and
Drug Administration (FDA) and a generic Advair launch this year was
now "highly unlikely".
Such letters typically outline concerns and conditions that must be
addressed to gain U.S. approval.
The setback follows similar delays last year for rival copies of
GSK's inhaled drug developed by Mylan and Hikma, which has been
working with Vectura.
After Mylan and Hikma's problems, most industry analysts expected
the generic threat had been pushed back until mid-2018, providing
Britain's biggest drugmaker with a short-term profit boost. But the
Sandoz news may cause a rethink.
"It now looks like the can has been kicked down the road," Berenberg
analysts said in a note.
Advair is particularly difficult for generic drugmakers to copy
because they must develop an inhaler device that delivers the
medicine correctly into patients' lungs.
The fact that Sandoz, one of the world's most experienced generics
firms, has also stumbled highlights the challenges of making a
generic that is acceptable to the FDA, although such Advair copies
are already available in Europe.
The timing of the arrival of generic Advair in the United States is
critical to GSK's near-term earnings outlook. The drugmaker said on
Wednesday that earnings, at constant exchange rates, would be flat
to down 3 percent in 2018 if generic Advair launches in the U.S
market by mid-year. Without generics, earnings would be up 4 to 7
percent.
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A GSK spokesman had no immediate comment on the latest Sandoz news.
Dealing with the threat to Advair, which has generated more than $1
billion in annual sales since 2001, is a key challenge facing GSK's
core pharmaceuticals division.
Another is the competitive pressure in its big HIV medicines
division, where Gilead Sciences on Wednesday won a FDA green light
for a once-daily, triple-combination tablet containing a new
integrase inhibitor bictegravir.
GSK's majority-owned ViiV Healthcare unit hit back by filing a
lawsuit alleging that Gilead was infringing patents on ViiV's rival
integrase inhibitor dolutegravir.
ViiV is not looking to have Gilead's product removed from the market
but it wants compensation, which analysts said could result in
royalties being paid to ViiV by Gilead, if the legal action is
successful.
GSK shares were 2.7 percent higher by 0910 GMT.
(Reporting by Ben Hirschler; Editing by Edmund Blair and Mark
Potter)
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