(Recasts, adds analyst comment and details)
By Edwina Gibbs
TOKYO Oct 29 Takeda Pharmaceutical Co Ltd
(4502.T) said on Monday that U.S. health authorities had
recommended that it stop some clinical trials of its
cholesterol-lowering TAK-475, a key drug candidate for the
TAK-475 is one of three drugs in late-stage development that
Japan's biggest drugmaker had hoped would become a big earner to
offset expected profit declines after its mainstay diabetes drug
Actos loses U.S. patent protection in 2011.
The U.S. Food and Drug Administration recommended that
Takeda halt trials with higher doses of the drug after elevated
levels of an enzyme that may indicate liver damage were more
often found than in control groups. This included severe cases
of the complication.
It has also requested additional clinical data before the
company submits a new drug application.
"In a best case scenario, this is going to tack on another
two years before Takeda can submit the drug for approval," said
Kenji Masuzoe, drugs analyst at Deutsche Securities.
"But this involves a liver enzyme that Takeda had not
reported problems with before, which raises red flags and puts a
huge question mark over the drug itself," he added.
He said Takeda's shares, which ended trade at 8,060 yen
prior to the announcement, could fall by 400-500 points on
Takeda had planned to submit its new drug application for
TAK-475 in the April-June quarter next year.
TAK-475 is a "squalene synthase inhibitor", a type of
cholesterol-lowering drug that has not yet been brought to
market. Analysts believe that Takeda is the only drugmaker
currently working on the development of such a drug.
Takeda said in a statement it would immediately study future
plans for TAK-475 in the United States, Europe and Japan.
It also said the greater frequency of patients found with
elevated liver enzyme levels had so far not been observed with
lower doses of the drug.
If it were to reach the market, TAK-475 would be up against
Merck & Co. Inc's (MRK.N) and Schering-Plough Corp's SGP.N
Zetia and Vytorin.
Sales of Zetia and Vytorin, which combines Zetia and Merck's
slightly less potent statin Zocor, rose 26 percent to $1.3
billion in the latest quarter.
Takeda's two other key drug candidates, both also in phase
III development, are SYR-322, which belongs to a new class of
diabetes treatments, and TAK-390MR, a successor to heartburn and
ulcer drug Prevacid.
Takeda has said it hopes to file new drug applications in
the United States for these two by mid-2008.