Takeda Wins U.S. FDA Approval for Actos Diabetes Pill (Update3)
Bloomberg News
July 16, 1999, 10:11 a.m. ET
Takeda Wins U.S. FDA Approval for Actos Diabetes Pill (Update3)
(Adds analyst comment, details on drug label, U.S. share
activity.)
Tokyo, July 16 (Bloomberg) -- Takeda Chemical Industries
Ltd.'s Actos diabetes pill won approval of the U.S. Food and Drug
Administration, setting up a battle between Actos and SmithKline
Beecham Plc's Avandia for a market worth billions of dollars.
Actos and Avandia each are expected to generate more than $1
billion in peak annual sales, leapfrogging Warner-Lambert Co.'s
Rezulin, which has been linked to more than 30 deaths and been
dogged by FDA warnings about liver problems.
Doctors and analysts say both Actos and Avandia appear to
lack Rezulin's dangerous side effects, though analysts expect
Actos's easier dosing regimen and broader approval will give it
an edge in the growing market for adult onset, or Type II,
diabetes. Analysts expect that market to grow to $5 billion a
year.
''It gives an advantage to Actos, but I think there is a
enough market that they both can become big drugs,'' said Mehta
Partners analyst Sergio Traversa, who said he expects both drugs
to be multibillion dollar sellers. ''There is room for Avandia,
too.''
Actos, which likely will go on sale early next month, and
Avandia, which went on sale in June, are from the same class of
drugs and are licensed for use alone or with Bristol-Myers Squibb
Co.'s Glucophage, the world's best selling non-insulin diabetes
drug.
Chemically Similar
Though chemically similar, Actos may have advantages over
Avandia in a few areas. Actos doesn't appear to raise cholesterol
level, as Avandia seem to do, and Actos is a true once-a-day
pill, while Avandia may need to be taken twice a day.
In addition, Actos has been approved for use alone, with
Glucophage, with insulin and with widely used sulfonylurea drugs,
including Pfizer Inc.'s Glucotrol and Diabinese, and Pharmacia &
Upjohn Inc.'s Micronase and Orinase. Avandia lacks the insulin
and sulfonylurea uses.
''It's a big positive factor for Takeda that Actos can be
used with sulfonylurea drugs,'' said Kazuhisa Sugita, a senior
analyst at ABN Amro Securities (Japan) Ltd., who rates Takeda
''outperform.''
SmithKline, which announced the approval of Avandia May 25,
placed its drug on pharmacy shelves within weeks to secure a
headstart against Actos. Already Avandia is eating into Rezulin
prescriptions, which generated $748 million in 1998 sales.
Traversa said he expects that the availability of both Actos
and Avandia will severely limit Rezulin sales, though he said it
was unlikely that the drug's decline would be sudden.
''I think it will be a stable decline,'' he said, adding
that doctors won't necessarily move successful Rezulin patients
to another drug.
Takeda will co-market its drug with Eli Lilly & Co., which
is credited with pioneering the development of insulin in the
1920s. SmithKline has paired with Bristol-Myers to sell Avandia.
The value of the U.S. market for all diabetes drugs was
about $2 billion in 1998, said Shinji Honda, a Takeda spokesman.
Actos users will have to take liver tests every two months
in the first year, a caution prompted by the chemical similarity
of Actos and Avandia to Rezulin.
Takeda shares declined 150 yen to 6,040 in trading on the
Tokyo exchange. Lilly shares rose 5/16 to 77 3/8 in early U.S.
trading. SmithKline's American depositary receipts rose 3/4 to 65
1/8.
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