Amylin Pharmaceuticals (Nasdaq: AMLN) got a
triple dose of good news over the weekend. Individually, each
might not have amounted to much, but together they were good
for a 10% pop in the company's shares yesterday.
Amylin and marketing partner
Eli Lilly (NYSE: LLY) have been dealing with
potential pancreatitis issuesfor their diabetes drug
Byetta for more than two years now. The Food and Drug
Administration has finally gotten around to changing the
label, and it won't contain a "dreaded" black-box warning.
I'm not sure the lack of a strong warning is going to help
sales much, but the
temperedwarning isn't likely to hurt sales any more than
the reported cases already have.
In other Byetta news, the drug was approved for use as a
monotherapy; it had been approved only for use in combination
with other diabetes drugs. The CEO claims that it'll
potentially add 3 to 4 million patients, but the key word
there is potentially. I have a hard time seeing very many
doctors recommend and patients accept a twice-daily injected
drug as a first-line treatment because so many oral diabetes
medications from
Merck (NYSE: MRK),
Bristol-Myers Squibb (NYSE: BMY),
AstraZeneca (NYSE: AZN), and others are
available. Byetta is a good drug, arguably better than its
oral counterparts, but most doctors are still going to try
the oral medications first and only use an injected drug if
the oral drugs can't control glucose levels.
The monotherapy indication isn't a complete waste of time,
though. It should carry over to the extended-release version
of Byetta that is under review with the FDA. The once-weekly
drug, made possible through
Alkermes ' (Nasdaq: ALKS) extended-release
technology, should have a fighting chance against oral
medications at grabbing diabetics early in their disease
progression.
The third bit of good news came from Amylin's obesity
pipeline. The company partnered the drugs out to Takea
Pharmaceutical for a measly $75 million upfront, but the deal
could be worth more than $1 billion more in milestone
payments as the drugs progress through the regulatory and
commercialization process. Amylin would also
get double-digit royalties -- that is, at least
10%Â of sales -- on drugs that eventually make it
to market.
The structure of the deal is good for Amylin. The company
is taking on more risk than if it had taken a larger upfront
payment and lower milestone and royalty payments, but it's
not struggling for cash and can afford to take the risk.
The hat trick was excellent for investors, but an
investment in Amylin still remains a play on once-weekly
Byetta. Even if an approval comes next year all by itself,
it'll have
more bangthan the trio did on Monday.
This article was originally published as
Amylin Scores a Hat Trickon
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