* Tresiba recommended for approval by European regulator
* Novo aims to launch in several EU markets in early 2013
* U.S. verdict on drug hinges on Nov. 8 advisory panel
* Novo sees Tresiba biggest long-acting insulin in 8-9 years
By Ben Hirschler and Mette Fraende
LONDON/COPENHAGEN, Oct 19 Novo Nordisk's
ultra long-acting insulin Tresiba has been
recommended for approval by the European Medicines Agency in an
important boost for the Danish drugmaker's key new product.
The European endorsement, announced by the London-based
agency and the company on Friday, follows regulatory delays for
the diabetes treatment in the United States, where the bulk of
future sales are expected to be generated.
Tresiba, or degludec, is central to Novo's aim of ending
Sanofi's dominance of the long-acting insulin market
and the group said it expected to launch it in several European
markets early next year, subject to final approval.
Diabetes is on the rise worldwide, fuelled by increased
rates of type 2 diabetes, which is linked to obesity, making the
disease a major target for drug company investment.
The International Diabetes Federation estimates that 366
million people had diabetes in 2011 and it projects this figure
will rise to 552 million by 2030.
Mads Krogsgaard Thomsen, Novo's chief science officer, said
he expected Tresiba to win over the majority of new patients,
given its improved qualities and slow absorption rate, which
provides a long-lasting and stable effect.
"Our ambition is that this product will be the biggest
long-acting insulin in the market within the next eight to nine
years," he told Danish television.
Novo, the world's largest insulin maker, also won a green
light for Ryzodeg, which combines degludec with insulin aspart,
and this product is expected to go on sale around a year after
Recommendations for marketing approval by the European
agency's Committee for Medicinal Products for Human Use (CHMP)
are normally endorsed by the European Commission within around
"This is extremely important for Novo Nordisk," said Sydbank
analyst Soren Lontoft. "(Tresiba) is a good product, a flexible
product which will be capable of taking on rival Lantus from
Lontoft estimated peak annual sales of Tresiba at around 22
billion Danish crowns ($3.9 billion) worldwide and around 6
billion in Europe.
Ending Sanofi's 10-year dominance would be a coup for Novo,
whose long-acting insulin Levemir has failed to seriously dent
the French drugmaker's grip on the market.
Shares in Novo rose 1.3 percent by 1340 GMT, outperforming a
flat European drugs sector, although analysts cautioned
the positive decision in Europe did not provide an automatic
read-through in the all-important U.S. market.
"Although the CHMP decision - as well as September's
Japanese approval - is validation of approvability, at this
stage it is impossible to fully rule out the FDA (Food and Drug
Administration) requiring additional safety data or analyses
prior to approval," said Deutsche Bank analyst Tim Race.
The FDA said three months ago it was convening an advisory
committee meeting on Nov. 8 to assess Tresiba. It convenes such
panels when it wants independent expert advice on scientific,
technical and policy matters relating to new drugs.
Competition is heating up in the multibillion-dollar market
for long-lasting insulins. While Novo hopes Tresiba can trump
Lantus, Eli Lilly is also developing a rival drug that
is a few years behind.
Worldwide, Lantus has some 80 percent of the market for
long-acting, or basal, insulins and the product had sales of
around $5 billion last year.