Compare and Contrast
Basically there are two ways to release data
from a recently completed study; there is the right way and then there is the
Roche way. As Diabetic Investor has been reporting Roche seems to believe it’s
perfectly fine to announce to the world that their GLP-1 drug candidate is “superior”
to the competition without providing any concrete data to back up this claim.
The company has explained to Diabetic Investor that there is no need to provide
any “real” data as this would some prevent this data from being presented at
future conferences.
Compare that to Amylin (NASDAQ:AMLN) who just
this morning announced the results from the recently completed DURATION-5
study. According to press release; “Amylin Pharmaceuticals, Inc. (Nasdaq:
AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS)
today announced positive results from a head-to-head study comparing exenatide
once weekly, an investigational diabetes therapy, to BYETTA® (exenatide) injection taken twice daily, in patients with type 2 diabetes. After 24
weeks of treatment, patients taking exenatide once weekly experienced a statistically
superior reduction in A1C, a measure of average blood sugar over three months,
of 1.6 percentage points from baseline, compared to a reduction of 0.9
percentage points for BYETTA. Patients treated with exenatide once weekly
achieved a mean A1C of 7.1 percent compared with a mean A1C of 7.7 percent in
those treated with BYETTA. Both treatment groups achieved statistically
significant weight loss by the end of the study, with an average loss of 5.1
pounds for patients taking exenatide once weekly and 3.0 pounds for patients
taking BYETTA.”
Notice that the press release actually states
that Byetta LAR lowered A1C by 1.6%, produced a mean A1C of 7.1% and patients
on the drug lost 5.1 pounds. The release also provides more hard numbers;
numbers which we’re sure will be covered in greater detail at upcoming
conferences, perhaps the annual JP Morgan Healthcare Conference at the start of
the New Year. Obviously the folks at Amylin, Lilly and Alkermes thought it was prudent
to actually back up their claim that Byetta LAR was superior to Byetta. Unlike Roche who apparently believes that
their word should be good enough.
Now there are some who may argue that it’s not
fair to compare what Amylin, Lilly and Alkermes did to what Roche did as LAR is
awaiting approval at the FDA and the Roche compound remains in clinical trials.
This argument really doesn’t hold much weight as Diabetic Investor can site
hundreds of examples of companies who release detailed data from their clinical
trials and still present this data at future conferences.
This lack of transparency by Roche makes
Diabetic Investor wonder just what the company is hiding. If the drug is really
as good as they say it is why not give at least a small glimpse of the data. We
don’t think it’s too much to ask to see something, anything that actually backs
up this assertion.
The reality here is that as everyone can
plainly see by the real data provided by Amylin, Lilly and Alkermes is that Byetta
LAR will be tough to beat. Roche is holding out hope that by creating some
mystery surrounding their GLP-1 compound this will somehow slow what Diabetic
Investor expects to be a mega-blockbuster with LAR.
The facts are Victoza is still awaiting
approval at the FDA; LAR is moving through the FDA and will not face any
serious competition for at least two years, most likely longer. As Diabetic Investor has said all along Byetta
LAR has the potential to be a paradigm changing drug. A drug, that once
approved, could well change the competitive landscape for the treatment of type
2 diabetes. There really is no mystery here no matter how hard Roche tries to
create one.
