All that’s changing is the calendar
Since Amylin (NASDAQ:AMLN) submitted their
long-acting once-a-week version of Byetta to the FDA, the only numbers that
truly count are the days on the calendar. As each day passes the company is one
day closer to a decision that could change the competitive landscape. The
company has already cleared several of the hurdles Diabetic Investor had
previously outlined with the last, most important hurdle being the approval and
launch of Byetta LAR.
Until that hurdle is cleared we’re left
with events such as today earnings announcement, which as per usual focused less
on the numbers and more on what lies ahead. Before we jump ahead to the outlook
it’s worth noting that Byetta sales have stabilized and while not back at 2008
levels are making progress. The fact is short of Byetta sales falling dramatically,
a highly unlikely event the company is well positioned until LAR arrives in
Those who might believe that there is some type
of signal coming from the FDA as they have yet to approve Byetta as a monotherapy,
the fact is this approval, the approval of Victoza and approval of LAR are all tied
together. The fact that binds these three events together is the label language
the FDA is putting in place for all GLP-1 products. As everyone knows the FDA
issued an alert regarding Byetta and pancreatitis. It is also well known that
when Novo Nordisk (NYSE:NVO) submitted their data for Victoza to the FDA there
were also cases of pancreatitis. Although this issue was largely ignored at the
now famous FDA panel meeting for Victoza, the issue is relevant to the FDA.
Being ever cautious the FDA is looking for label language that can be used for
all GLP-1 therapies.
Once this label language is in place
Diabetic Investor sees a series of events occurring in rather quick succession.
First, Byetta will receive its approval as a monotherapy. Next, Victoza will be
approved by the FDA and finally LAR will be approved. Today’s news by Amylin
that they will be conducting a comparison study of LAR vs. Victoza should tell
everyone that Victoza will be on the market when LAR receives approval. Just
how much lead time Novo will have is difficult to gage but Diabetic Investor
suspects the gap between Victoza being approved and LAR being approved will be
just a matter of a month or two, maybe three.
Realistically this doesn’t give Novo much
time to establish a presence in the market as most physicians are aware that
LAR is coming and they prefer once weekly administration to once daily administration.
We should get a clearer picture of all this when Novo reports their results a
week from Thursday.
All in all today’s results were pretty much
as expected and that call was actually very boring. Still, after being through
a nasty proxy fight and getting LAR to the FDA, Diabetic Investor is pretty
sure the team at Amylin didn’t mind at all. They know that this boredom will
end soon enough once LAR gets here then things will get very exciting.