* Novo Nordisk says 2 patients on Victoza died in Japan
* Says deaths due to inappropriate stopping of insulin
* Says fatalities not related to Victoza
* Shares little changed
(Adds details, quotes, share price)
COPENHAGEN, Oct 8 Danish drugmaker Novo Nordisk
(NOVOb.CO) said two patients in Japan who were being treated
with its Victoza type-2 diabetes drug died from the
discontinuation of their insulin treatment and not by Victoza.
Novo Nordisk's chief science officer said on Friday the
patients, who had type 1 diabetes and required insulin, died
from a condition called ketoacidosis, in which sugar in the body
is burnt into acid, which can induce a coma in patients who go
off insulin suddenly.
"These unfortunate fatalities are not related to Victoza,"
Novo Nordisk Chief Mads Krogsgaard Thomsen told Reuters.
"Because insulin was inappropriately discontinued, they
developed ketoacidosis and died from it," he said.
"Both (patients) were insulin-dependent, both had been
receiving insulin treatment for a long time, and for some reason
the treating Japanese physicians completely discontinued insulin
treatment and gave them a low dose of Victoza instead," he said.
Victoza is not approved as a substitute for insulin. It and
rival GLP-1 drugs stimulate cells to release natural insulin in
the body when blood sugar levels are high and are used to treat
patients that can control their blood sugar levels without
insulin injections. Rivals include Eli Lilly's (LLY.N) Byetta.
"Victoza is for type 2 diabetes patients who are not
dependent on insulin, and that is reflected in the label,"
Shares in Novo Nordisk, the world's biggest insulin
producer, were little affected, closing down 0.2 percent at 537
crowns and holding up better than a 0.7 percent drop in the
Copenhagen bourse blue chip index .OMXC20.
Novo began rolling out Victoza, which it hopes will become a
blockbuster with sales of more than $1 billion -- in Europe last
year, in the all-important U.S. market in February, and recently
in Japan and Canada.
Thomsen said that Novo Nordisk is working on getting
approval for use of Victoza in combination with insulin.
"But that is a different story from patients who have been
using insulin for long and then having insulin discontinued," he
He said that Novo Nordisk reported the deaths to Japanese
medical regulators as required.
Thomsen said he expected Japanese regulators would explain
to physicians Victoza was not a substitute for insulin in
insulin-dependent patients and was not approved for treatment of
patients with type-1 diabetes. Type 1 diabetes is fatal unless
treated with insulin.
"Our view is that the Japanese authorities will ... ensure
that this does not happen again by making sure that it is not
used in insulin-dependent patients," he said.
(Reporting by John Acher; Editing by Karen Foster)