Some interesting developments

Some interesting developments

This past
Friday Abbott (NYSE:ABT) announced they have submitted a 510(k) application for
new test strips to be used with their FreeStyle® and FreeStyle Lite® glucose
monitors. The new strips will use a GDH-FAD enzyme and according to the company
“will enhance the FreeStyle brand of blood glucose test strips by minimizing
the potential interference from common non-glucose sugars.”

This move by
Abbott is directly related to the statement made by the FDA back in early
August when they indicated some glucose monitors could have a problem with
false readings. Although the issue outlined by the FDA effects a miniscule
percentage of patients, the issue has taken on a life of its own as companies
whose monitors that weren’t affected by this issue have used this issue in
attempt to taint the competition. As Diabetic Investor has stated previously
the BGM market is becoming increasingly competitive and companies will use any
issue no matter how small to gain an edge.

Given the
announcement by Abbott, look for Roche and Home Diagnostics (NASDAQ:HDIX) to
make similar announcements as they too have monitors that are affected by this

To Diabetic
Investor this whole issue illustrates just how desperate BGM companies have
become. It’s about time everyone realizes that certain facts about the market
will not change. Pricing pressure and decreasing usage are here to stay and
will not go away. It is also quite clear that co-payments will continue to increase
and that the day is coming when test supplies will not be reimbursed for
non-insulin using patients. It is a complete waste of time and money for any
company to focus on non-insulin using patients.

The reality
of the situation is when it comes to BGM insulin patients are where it’s at. These
patients need and value the information provided by monitors. They use more
test strips than non-insulin patients allowing companies to more quickly recoup
their increasing cost of acquisition.

There was a
time back in the day when it was possible to increase testing frequency for non-insulin
using patients. Sadly this day has come and gone and there is nothing BGM companies
can do about it. Although Diabetic Investor disagrees with many of the studies
that have been published, the fact remains these studies have concluded that
frequent monitoring by non-insulin patients does not lead to improved outcomes.
It is also true that based on these conclusions physicians now feel quite
comfortable telling their non-insulin using patients there is no need to
monitor their glucose levels.

trying to save this segment of the market is like putting a lock on the barn
door after the animals have run away.

This same
analogy could apply to the decision made by Takeda to initiate a cardiovascular
outcomes trial for their DPP-4 Alogliptin. This trial called EXAMINE (Examination
of Cardiovascular Outcomes: Alogliptin vs. Standard Care in Patients with Type
2 Diabetes Mellitus and Acute Coronary Syndrome) is set to start next month and
be completed by December of 2014.  

Investor isn’t quite sure what the company hopes to accomplish here. Even if
the FDA approves the drug while the trial is underway, the drug faces an uphill
battle against Januvia from Merck (NYSE:MRK) and Onglyza from Bristol-Myers
(NYSE:BMS) and AstraZeneca (NYSE:AZN).

This decision
is even stranger given that the FDA is currently looking at two drugs that
could alter the competitive landscape for the lucrative type 2 market. The
agency has before them Victoza from Novo Nordisk (NYSE:NVO) and Byetta LAR from
Amylin (NASDAQ:AMLN) and Lilly (NYSE:LLY). Although Victoza remains bogged down
at the agency, LAR from all outward appearances remains on track and as
everyone knows LAR has the potential to be paradigm shifting technology.

Takeda knows something everyone else doesn’t still this is a very strange

Finally a
story coming out of the United Kingdom states that the number of people having
weight-loss operations has risen 50% in the last year. According to the story
published by the Telegragh, this surgery helped almost 80% of patients
experience “complete resolution” of their diabetes for at least two years after
the operation. These operations can cost up to $20,000 and do carry some
serious risks.

This is not
the first time a story or study showed the benefits of weight loss surgery and
diabetes. Diabetic Investor suspects it won’t be the last either and is troubled
by the increasing amount of attention surgery is getting as a method to “cure”
diabetes. As we have indicated in the past there are situations where surgery
should be considered especially in the morbidly obese. However, given the risk
and cost surgery should only be used as treatment of last resort.

Investor is also somewhat shocked that people are looking at this option with
very little long term data. As anyone who’s ever been on a diet knows losing
the weight is only half the battle and it’s just as difficult to keep the
weight from coming back. While this is data is encouraging, longer-term studies
are needed.

It is equally
disturbing that anyone would call this treatment option a “cure”, the fact is
there is no cure for diabetes and should these patient regain the weight it’s
highly probably their diabetes would return. Still this fact won’t stop the use
of surgery as a treatment option. The reality of the situation is patients are drawn
to what they believe are quick fixes, even if that supposed quick fix carries substantial
costs and risks. As Kin Hubbard once noted; “A fool and his money are soon