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* Green light generic copy of GSK's $8-billion drug Advair
* Danish approval is first for product in Europe
* Inhaled medicine developed by Vectura and Sandoz
* News overshadows U.S. approval for new GSK drug Anoro
* GSK shares fall 1.1 percent, Vectura up 13.4 percent
By Ben Hirschler and Paul Sandle
LONDON, Dec 18 Denmark has approved the sale of
a generic copy of GlaxoSmithKline's $8 billion-a-year
inhaled lung drug Advair, threatening future sales of the
British firm's biggest product.
Sandoz, the generics division of Swiss drugmaker Novartis
, and Vectura, another British company, said on
Wednesday they had received approval from Danish regulators for
AirFluSal Forspiro, which was previously known as VR315.
The green light marks the first approval of the product in
Europe and analysts said more European approvals were likely to
follow, with other Nordic countries and Germany seen among
Sandoz has completed authorisation procedures in a further
seven European countries but the group said the timing of final
approvals in these markets would depend on national health
Investors in GSK, Britain's biggest drugmaker, have been
bracing for generic competition to Advair, which is also is also
known as Seretide and Viani, but exactly when generics would
reach the market has been uncertain.
Much attention has been focused on development of the
Sandoz/Vectura product, which analysts have long thought was a
generic version of Advair. Sandoz confirmed on Wednesday that
its medicine did, indeed, contain the two active ingredients in
Advair - salmeterol and fluticasone.
Inhaled drugs such as Advair are difficult to copy because
of the complexity of making a device that works effectively to
deliver the medicine directly into the lungs.
"The regulatory pathway to generic respiratory medicine is
quite complicated, so it's certainly an important milestone for
Vectura to have this one approved," said analyst Charles Weston
The approval poses a threat to GSK but Weston said generic
cannibalisation was likely to be fairly slow.
Alistair Campbell of Berenberg Bank also said the generic
product would not be directly substitutable at pharmacies for
Berenberg had been assuming a 40 percent chance of approval
in Europe and 2017 sales of around $250 million, or roughly 10
percent of Advair's current European sales.
"VR315 in Europe, with a 40 percent chance of approval,
makes up 19 pence of our Vectura valuation. On an un-risked
basis, this climbs to 46 pence," Campbell said in a research
The new Sandoz/Vectura drug uses an advanced inhaler and is
designed for patients with asthma and chronic obstructive
pulmonary disease (COPD). It has been approved in Denmark in
both mid- and high-strength dosage forms.
Shares in GSK ended down 1.1 percent at 1,548.5 pence,
underperforming a 0.8 percent advance in the Stoxx 600 Europe
healthcare sector index, while Vectura was up 13.4
percent at 137.25 pence. Novartis was up 1 percent at 68.45
A spokesman for GSK said it was waiting to see more details
before commenting on developments.
GSK has for many years been a market leader in respiratory
medicine and the company hopes to maintain its leading position
with the introduction of a new generation of products for asthma
That strategy received a boost on Wednesday when the U.S.
Food and Drug Administration (FDA) approved GSK's Anoro for
COPD, following a green light earlier in the year for another
lung drug known as Breo or Relvar.
There are currently no generic versions of Advair in the
United States but the prospect of copies reaching the world's
biggest market were increased in September by a draft guidance
document from the FDA setting out requirements for such copies.
(Editing by Kate Kelland and Greg Mahlich)