* Novo Nordisk wants degludec to challenge Sanofi's Lantus
* FDA sets Nov. 8 advisory panel meeting on degludec
* FDA has set no new date for approval
* Decision had earlier been expected in late October
* Novo Nordisk shares fall 0.9 pct, rival Sanofi's up
By John Acher and Ben Hirschler
COPENHAGEN, July 18 Novo Nordisk's
bid to challenge Sanofi's dominance of the
long-lasting insulin market hit another snag after U.S.
regulators delayed approval of the Danish drugmaker's degludec
until after an expert review.
Novo has said degludec could become a blockbuster - defined
by the industry as a treatment that generates more than $1
billion in sales within five years of its launch. But some
analysts see the drug with peak sales potential as high as the
current $5 billion for Sanofi's top-selling Lantus.
The delay by the U.S. Food and Drug Administration follows
an earlier extension of the review process in June and could
push the launch of the drug into next year. This is a blow to
the world's biggest maker of insulin since degludec is a pivotal
new product with which it hopes to consolidate its position in
the fast-growing diabetes market.
The FDA said in June it would decide on new drug
applications for degludec on its own and in combination with
insulin aspart on Oct. 29. But the FDA has now said a further
advisory committee meeting will be held on Nov. 8, Novo said on
The FDA convenes advisory committees when it wants
independent expert advice on scientific, technical and policy
matters relating to new drugs.
Analysts said that the delay was likely to push the U.S.
approval of the drug into early 2013, but Novo spokesman Mike
Rulis declined to predict when the product would be launched.
"The FDA has not informed us about when they expect to make
an approval decision," Rulis said. "Since we don't know that for
sure, we cannot say anything about an expected launch date."
"It is hard to say what kind of a delay we are talking
about," Rulis added. "There are examples of when the FDA has
made decisions just five or six weeks after advisory committee
meetings have been held, and sometimes it takes months."
Rulis said the FDA had not informed the company what it
wanted the advisory committee to discuss.
The FDA's extension of its review in June to late October
had already been a setback as investors had expected it to
render a decision on the experimental drug by July 29.
Bank of America Merrill Lynch analysts said in a note that
the timing of the advisory committee meeting suggested a three
to four month delay in the approval.
DNB Markets analyst Rune Dahl said in a note to clients the
delay would likely postpone U.S. approval until early 2013, but
that degludec, known also by its brand name Tresiba, could be
approved in the Europe Union and Japan before then.
Novo submitted the new drug applications to the FDA on Sept.
SANOFI SHARES HIGHER
Shares in Novo, which have outperformed the market by
gaining 34 percent this year, fell 0.9 percent to 885 crowns by
1320 GMT on a flat Copenhagen bourse. Sanofi shares
traded up more than 2 percent at 62.25 in Paris.
"The question now is if some analysts will have to take down
their 2013 estimates," DNB's Dahl said. "If so, it's going to be
Dahl said it was hard to quantify the benefit to Sanofi from
the degludec delay, but Sanofi's shares were getting a lift from
Competition is heating up in the multibillion-dollar market
for long-lasting insulins. Novo hopes degludec can trump Lantus,
while 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. Dahl said he still expected global
peak sales of degludec to reach that figure.
Ending Sanofi's 10-year dominance would be a coup for Novo,
whose long-acting insulin Levemir has failed to dent seriously
the French drugmaker's grip on the market.
Type 2 diabetes, which is linked to obesity, is growing
rapidly around the world, making the sector a major target for
drug company investment, as highlighted most recently by a deal
between Bristol-Myers Squibb and AstraZeneca to
share the $7 billion cost of buying U.S. diabetes specialist