It's a little early to call it, but it looks like
Bristol-Myers Squibb (NYSE: BMY) and
AstraZeneca (NYSE: AZN) have a potential
blockbuster on their hands.
Their new diabetes drug, dapagliflozin, seems to work
pretty well when combined with metformin, a standard of care
for type 2 diabetics. In a six-month trial, at all the doses
tested, the drug was able to lower HbA1c levels -- a measure
of long-term glucose levels -- better than placebo.
Dapagliflozin is in a new class of diabetes medications
that inhibits the kidneys from moving glucose back into the
bloodstream, and thereby lowers the glucose levels in
diabetics. With a new mechanism of action, there's always
concern that side effects might crop up, but so far
everything looks OK.
If dapagliflozin has another successful clinical trial and
wins approval, it'll enter a pretty crowded market. But I
think there's room, especially if it can be used as an add-on
therapy with a popular drug such as
Merck 's (NYSE: MRK) Januvia. The companies
could also be bold and combine the new drug with their
recently approved diabetes drug, Onglyza, which might help
the latecomer compete against Januvia.
If new oral medications are developed that can help slow
the progression of the disease, the clear losers will be
companies making insulin and other injectable drugs, like
Amylin Pharmaceuticals ' (Nasdaq: AMLN) and
Eli Lilly 's (NYSE: LLY) Byetta and
Novo Nordisk 's (NYSE: NVO) Victoza. These
treatments are typically used later in the disease's
progression, after oral drugs are no longer capable of
keeping glucose levels down.
It'll probably be another year before the companies file
for marketing approval, putting a potential approval in 2011.
The drug's still worth keeping an eye on, though, whether
you're invested in Bristol-Myers, AstraZeneca, or one of the
makers of rival diabetes treatments.
This article was originally published as
Warning: Potential Blockbuster Aheadon
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