PropThink: NVO's Tresiba Recommended for Approval in Europe; FDA Panel Just Around the Corner
(Thomson Reuters ONE) -
By Jake King
Novo Nordisk (NYSE:NVO) already set a new 52-week high this week of $167.74, and
shares are poised to again break that high Friday. A European advisory panel
recommended Novo's long-acting insulin Tresiba (insulin degludec) and Ryzodeg
(insulin degludec plus insulin aspart) for approval in the E.U. Thursday,
signaling that an official decision could come within months. An FDA advisory
panel will review degludec on November 8th, and a positive vote could influence
the drug's approval domestically, which will be forthcoming following the panel.
Shares of NVO are climbing on Friday following the vote.
Tresiba has the potential to make a serious dent in Sanofi's (NYSE:SNY) Lantus
sales, the leading long-lasting insulin on the market. Lantus generated roughly
$5B in revenue globally last year, and analysts are guiding for Tresiba peak
sales between $2B and $4B. Of course, success hinges on approval in Europe and
the U.S., but analysts are optimistic that we may see both in the first quarter
of next year. Novo Nordisk has been touting Tresiba's improved ability to lower
the risk of nocturnal hypoglycaemia when compared to Lantus, and SNY is pulling
back on the news Friday, as Tresiba may present stiff competition within a year.
Although NVO should continue to pressure its new highs into the FDA advisory
panel, which is now just three weeks away, its likely the stock will pull back
beforehand, offering a better entrance point.
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Datum: 19.10.2012 - 16:14 Uhr
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News-ID 194346
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