--> Stock should trade much higher this morning
Novo Nordisk Soars on Plans to Resubmit Rejected Insulin to FDA
2015-03-26 18:41:10.60 GMT
By Albertina Torsoli
(Bloomberg) -- Novo Nordisk A/S will resubmit its insulin
Tresiba to U.S. regulators based on an early analysis from a
study of the drug’s cardiovascular risks, putting the medicine a
step closer to approval in the the world’s biggest
pharmaceutical market.
Novo’s American depositary receipts rose 6.6 percent to
$53.60 at 2:25 p.m. in New York, the biggest intraday gain since
November 2012.
Novo plans to resubmit the long-acting insulin to the Food
and Drug Administration within the next month, the company said
in a statement. The treatment was rejected in 2013 over concerns
that it increased heart problems.
“Given Novo’s previous comments, this decision suggests
the data as it stands does not suggest a raised cardiovascular
risk,” said Sam Fazeli, an analyst with Bloomberg Intelligence.
“This means a possible launch in the U.S. in 2016.”
The FDA’s 2013 rejection was a setback to the Bagsvaerd,
Denmark-based company in its contest with Sanofi to dominate the
diabetes market. Tresiba is already sold in countries including
Denmark, the U.K., Switzerland, Sweden, Mexico and Japan. The
heart study, dubbed DEVOTE, is expected to be completed in the
second half of 2016, Novo said.
Sanofi’s American depositary receipts fell 3.2 percent to
$48.70.
“This takes out an element of uncertainty for Novo,”
Philippe Lanone, an analyst at Natixis Securities in Paris, said
in a telephone interview after the announcement. “Novo shares
will be rising on this piece of news,” which came after the
close of trading on Thursday.
Sanofi Competition
Novo needs Tresiba to wrest market share from Paris-based
Sanofi’s best-selling diabetes treatment, the Lantus insulin,
and its successor product Toujeo, soon to be introduced in the
U.S. Novo’s older product, Levemir, has trailed Lantus over the
years. The Sanofi product garnered 6.34 billion euros ($6.91
billion) in sales last year.
Long-acting insulins seek to replicate the steady stream of
the hormone that healthy people’s bodies produce over 24 hours.2
Novo’s stock has risen 29 percent this year, as of the
close in Copenhagen, for a market valuation of about 888 billion
kroner ($129 billion).
For Related News and Information:
Novo Sees U.S. Price Gains Even With New Sanofi Insulin
Sanofi Revamps Diabetes Operations to Regain Ground Against Novo
Most-read stories on the company: NOVOB DC <Equity> MCN <GO>
Top health news: HTOP <GO>
To contact the reporter on this story:
Albertina Torsoli in Geneva at +41-22-317-9202 or
atorsoli@bloomberg.net
To contact the editors responsible for this story:
Chitra Somayaji at +44-20-3525-9717 or
csomayaji@bloomberg.net
David Risser, Robert Valpuesta
2015-03-26 18:41:10.60 GMT
By Albertina Torsoli
(Bloomberg) -- Novo Nordisk A/S will resubmit its insulin
Tresiba to U.S. regulators based on an early analysis from a
study of the drug’s cardiovascular risks, putting the medicine a
step closer to approval in the the world’s biggest
pharmaceutical market.
Novo’s American depositary receipts rose 6.6 percent to
$53.60 at 2:25 p.m. in New York, the biggest intraday gain since
November 2012.
Novo plans to resubmit the long-acting insulin to the Food
and Drug Administration within the next month, the company said
in a statement. The treatment was rejected in 2013 over concerns
that it increased heart problems.
“Given Novo’s previous comments, this decision suggests
the data as it stands does not suggest a raised cardiovascular
risk,” said Sam Fazeli, an analyst with Bloomberg Intelligence.
“This means a possible launch in the U.S. in 2016.”
The FDA’s 2013 rejection was a setback to the Bagsvaerd,
Denmark-based company in its contest with Sanofi to dominate the
diabetes market. Tresiba is already sold in countries including
Denmark, the U.K., Switzerland, Sweden, Mexico and Japan. The
heart study, dubbed DEVOTE, is expected to be completed in the
second half of 2016, Novo said.
Sanofi’s American depositary receipts fell 3.2 percent to
$48.70.
“This takes out an element of uncertainty for Novo,”
Philippe Lanone, an analyst at Natixis Securities in Paris, said
in a telephone interview after the announcement. “Novo shares
will be rising on this piece of news,” which came after the
close of trading on Thursday.
Sanofi Competition
Novo needs Tresiba to wrest market share from Paris-based
Sanofi’s best-selling diabetes treatment, the Lantus insulin,
and its successor product Toujeo, soon to be introduced in the
U.S. Novo’s older product, Levemir, has trailed Lantus over the
years. The Sanofi product garnered 6.34 billion euros ($6.91
billion) in sales last year.
Long-acting insulins seek to replicate the steady stream of
the hormone that healthy people’s bodies produce over 24 hours.2
Novo’s stock has risen 29 percent this year, as of the
close in Copenhagen, for a market valuation of about 888 billion
kroner ($129 billion).
For Related News and Information:
Novo Sees U.S. Price Gains Even With New Sanofi Insulin
Sanofi Revamps Diabetes Operations to Regain Ground Against Novo
Most-read stories on the company: NOVOB DC <Equity> MCN <GO>
Top health news: HTOP <GO>
To contact the reporter on this story:
Albertina Torsoli in Geneva at +41-22-317-9202 or
atorsoli@bloomberg.net
To contact the editors responsible for this story:
Chitra Somayaji at +44-20-3525-9717 or
csomayaji@bloomberg.net
David Risser, Robert Valpuesta