Takeda Chemical Files New-Drug Application for Diabetes Pill
Bloomberg News
January 18, 1999, 3:34 p.m. ET
Takeda Chemical Files New-Drug Application for Diabetes Pill
Washington, Jan. 18 (Bloomberg) -- Japan's Takeda Chemical
Industries Ltd. filed a new-drug application with the U.S. Food
and Drug Administration to market its Actos oral diabetes
treatment.
Actos, or pioglitazone hydrochloride, allows some diabetics
to avoid insulin injections. Takeda said Actos may be used on its
own or in conjunction with other treatments and has been studied
in more than 2,500 patients in the U.S., the company said.
If the drug is approved by the FDA, Osaka-based Takeda will
market Actos with Eli Lilly & Co. as part of an agreement signed
last year.
Lilly and Takeda have asked the FDA for an expedited review
of the drug, which could have a market of $755 million and be
available later this year, said Don Hannaford, a spokesman for
Takeda.
Actos is one of a new group of compounds called
thiazolidindiones. They work by reducing the body's resistance to
insulin rather than simply increasing the supply as do many other
treatments.
''Because the drug attacks one of the basic causes of the
disease, Actos offers a more logical approach to treatment than
many other therapies,'' Roberta Schneider, vice president of drug
development at Takeda America, said in a statement.
Hannaford said that about 30 percent of the U.S. Medicaid
budget goes towards treating diabetes and its complications.
Medicaid is the government's health insurance program for the
elderly.
The application comes at a time of heightened competition
in the $2.5 billion world market for treating type-2 diabetes, a
common, chronic condition that usually occurs in people over
age 45. Diabetes affects an estimated 135 million people
worldwide and can lead to serious health complications, including
blindness and kidney failure.
Last week, stock of Lilly rival Warner-Lambert Co. fell in
part over concern about the safety of its Rezulin diabetes pill,
which has been linked to liver damage and 33 deaths. Rezulin is
undergoing a new safety review in light of the problems.
Indianapolis-based Lilly said in October that year-to-date
sales of insulin products increased 9 percent to $816.4
million, its third biggest-selling product group after the
antidepressant Prozac and Zyprexa, a schizophrenia drug.
--Jennifer Farley in the Princeton newsroom (609) 279-4104 mos
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