You’ve got to be kidding
Bristol Myers Squibb (NYSE:BMY) issued a press release with the headline; “Study Finds That ONGLYZA™ (saxagliptin) When Added To Metformin
Was Non-Inferior To JANUVIA (SITAGLIPTIN) When Added To Metformin In Reducing
Hemoglobin (HbA1c) In Adults With Type 2 Diabetes Mellitus”
And just what did this ground breaking
study find, again according to the press release; “In the primary analysis of
individuals who completed the study and complied with study procedures, ONGLYZA
5 mg per day achieved an adjusted mean change from baseline in HbA1c of –0.52
percent, compared to –0.62 percent for subjects taking JANUVIA 100 mg per day.
Results of the study demonstrated that therapy with ONGLYZA 5 mg was
non-inferior to JANUVIA 100 mg when added to metformin (difference in adjusted
mean change from baseline vs. JANUVIA plus metformin 0.09 percent, 95 percent
CI -0.01 to 0.20). Non-inferiority of ONGLYZA to JANUVIA was also demonstrated
in a confirmatory analysis of all individuals receiving study treatment for
whom a change from baseline in HbA1c could be calculated.”
Other than patients taking a lower of dose of Onglyza just
what benefit, if any, would a patient receive from taking Onglyza over Januvia?
Put another way, just what piece of information from this study would compel a physician
to switch a patient from Januvia to Onglyza?
While Diabetic Investor has never been overly impressed with
Januvia, we are even less impressed with Onglyza. The fact is Onglyza is a
me-too drug if there ever was one and this study just proves what everyone
already knows; we don’t need two DPP-4’s on the market let alone one. This
study also confirms something Diabetic Investor has been saying since the say
Onglyza was approved by the FDA, about the only weapon BMY has to gain market
share is price.
The fact is Merck (NYSE:MRK), the makers of Januvia, have
turned a rather lackluster drug into a blockbuster mostly by promoting that the
drug carries few adverse events or side effects. A claim that now may be in
danger that the drug has been linked to pancreatitis. This is somewhat ironic
given that Merck sales reps have been calling Januvia an oral version of
Byetta, which has also been hurt by pancreatitis concerns. While Diabetic
Investor does not believe either drug causes pancreatitis, we have long been
concerned that Januvia was rushed to market without being fully investigated.
Frankly no one needs another diabetes drug coming under
scrutiny after it has been on the market and used by millions of patients. The
fallout from the Avandia controversy continues to slow the drug development and
approval process. However if there is anything that should have been learned by
now is that no drug is completely safe and it could take years until the full
impact of a drug is truly known. What makes Januvia and the entire class of
DPP-4’s just a little scary is the number of researchers who have concerns.
The reality is neither Januvia nor Onglyza add much value to
the patient already taking metformin. The incremental improvements in HbA1c
hardly justify the cost of either medication. Add in the uncertainty about the
long term effects of any DPP-4 and one has to wonder how Januvia became a
blockbuster. The truth is had there been no Avandia controversy Januvia would
have had a much tougher hill to climb.
The fact is Januvia continues to be the luckiest drug ever.
It came to market at the right time. Its primary competitor was delayed at the
FDA. Other possible competitors had their own share of problems basically
opening the door for Januvia to become the primary replacement for Avandia.
Today the drug has reached blockbuster status and has solidified itself as THE
With today’s news from Bristol the lucky streak continues as
the study offers nothing of value and merely confirms what everyone already knows.
It also confirms something Diabetic Investor has seen too many times in the
diabetes market; no matter how hard you try you just can’t fix stupid.