* GlaxoSmithKline could benefit
* N. American EpiPen sales fall
* Shares fall in afternoon trading
(Adds analyst comment, updates shares)
By Michael Erman and Natalie Grover
May 10 Generic drug maker Mylan NV on
Wednesday said it disagrees with the reasoning behind the U.S.
Food and Drug Administration's decision not to approve its
generic for GlaxoSmithKline Plc's blockbuster Advair in
Mylan President Rajiv Malik said the FDA was asking it to
comply with standards set out in draft guidance the agency
issued, but that it believes it is not required to do so. An FDA
spokeswoman declined to comment, saying she was prohibited by
law from discussing a pending application.
Mylan made the comments while reporting first-quarter
earnings, in which it flagged declining sales for emergency
allergy treatment EpiPen but said it will still meet previously
announced earnings targets for the year.
Malik said the company could not comment further on the
length of the delay for approval until it meets with the FDA to
discuss their disagreement, but that the FDA had designated it
as requiring a "major" amendment to its application.
A "major" amendment means a delay of 10-months for an FDA
response, according to agency guidelines.
Hikma Pharmaceuticals also has a generic version of
Advair which is awaiting an FDA decision by May 10. Analysts on
Wednesday said they were now expecting the FDA to question that
application as well.
Mylan shares fell 0.8 percent to $37.73 in afternoon
The company still backed its full year profit and revenue
forecast, despite the delay for generic Advair.
The company said earlier this year that its projections
always account for possible delays and rejections.
"It's sort of a 'Trust me, we have other stuff that will
make up for it,'" said Wells Fargo analyst David Maris. "This is
a really big product so I don't know what that could be, but
they did mention Copaxone, and that would be an upside
Mylan had originally targeted a 2013 launch for its generic
version of Teva's multiple sclerosis drug Copaxone, but it was
delayed. It now expects to hear from the FDA next month.
Mylan reported a first-quarter profit that edged past
expectations, helped by demand for products it gained through
the acquisition of Swedish drugmaker Meda.
Mylan has come under fire for sharply increasing the price
of EpiPen and classifying the life-saving treatment as a generic
rather than a branded product, which led to much smaller rebates
to state Medicaid programs.
The company said first-quarter sales of EpiPen in North
America declined due to increased competition and the launch of
its authorized generic, which costs $300.
Mylan posted net income of $66.4 million, or 12 cents per
share in the first quarter, up from $13.9 million, or 3 cents
per share, last year.
Excluding one-time items, Mylan earned 93 cents per share,
beating analysts' average estimate by 1 cent, according to
Thomson Reuters I/B/E/S.
(Reporting by Michael Erman in New York and Natalie Grover in
Bengaluru and Toni Clarke in Washington D.C.; Editing by Sai
Sachin Ravikumar and Nick Zieminski)