Some interesting news in drug development

Some interesting news in drug development

This morning
Vivus (NASDAQ:VVUS) announced results from two Phase 3 studies for their weight
lose drug Qnexa™. The two studies EQUIP and CONQUER, evaluated the safety and
efficacy of Qnexa involving more than 3,750 patients. According to the company;

Average weight loss of 37 lbs was achieved
by patients treated with Qnexa for 56 weeks in the EQUIP study;

            Patients experienced improvements
in cardiovascular, metabolic and inflammatory     risk factors;

FDA efficacy benchmarks for weight loss
agents exceeded at all three doses of Qnexa tested in the clinical program

Looking at
the two studies individual the one negative that stands out is the completion
rates, according to the company-

“Completion rate for EQUIP was 47%, 57%,
59% for patients taking placebo, low-dose Qnexa and full-dose Qnexa

Completion rates for CONQUER were 57%,
69%, 64% for patients taking placebo, mid-dose Qnexa, and full-dose Qnexa,

interesting to note that in the CONQUER study which included 2,487 overweight
and obese patients with high blood pressure, high cholesterol or type 2
diabetes there was a reduction in HbA1c of 0.6% from 7.3% at baseline and the
company noted that “These improvements occurred in the presence of a
significant reduction in antidiabetic medications in Qnexa-treated patients as
compared to the placebo.”

Based on
these results the company stated they remain on track to submit Qnexa to the
FDA before the end of 2009.

At first
glance these results seem impressive however the completion rates are cause for
concern. Another significant issue, which should not be over-looked, is what
the path the FDA will follow for Qnexa when submitted. Will it be looked at as
just a weight lose drug, a far easier path, or will the FDA look at Qnexa as
weight-lose/diabetes drug, a far more rigorous path. Given the additional
scrutiny the FDA has placed on possible diabetes drugs Diabetic Investor has
previously speculated that companies would position their drugs as weight-lose
drugs that just happen to help patients with diabetes. It is a well known fact
the obesity is a major contributing factor to the epidemic growth of diabetes.

Looking over the
data from the two studies CONQUER in particular, Vivus seems to be preparing as
if the FDA will look at Qnexa as more than just a weight lose drug.

Also today
Oramed Pharmaceuticals announced they have commenced human clinical trials of
an oral GLP-1 analog. This is the same company who believes they will be the
ones who successfully develop an oral form of insulin. Currently all GLP-1’s or
insulin’s are delivered via injections.

according to study published in the most recent issue of Diabetes Care that
compared pramlintide (Symlin) or Mealtime insulin to basal insulin for patients
with type 2 diabetes the authors concluded; “ In patients taking basal insulin
and OADs, premeal fixed-dose pramlintide improved glycemic control as
effectively titrated RAIAs (rapid acting insulin analogues) . The pramlintide
regimen sometimes caused nausea but no weight gain and less hypoglycemia.”

The authors
go on to state; “With similar glycemic effects with either treatment, the
composite primary end point favored pramlintide over RAIA because of the
difference in weight.” Like other studies that have examined pramlintide
patients using the drug either showed no weight gain or weight loss while
patients on insulin therapy gained weight.

Looking over
all three events it should be becoming increasingly evident that Byetta LAR
could quickly become the dominate therapy option for patients with type 2
diabetes. LAR combines all the aspects of these other therapies options into
one nice neat little package with the added benefit of once-weekly
administration. LAR has shown the weight loss benefits of Qnexa, solid HbA1c
reduction superior to Qnexa and easy of delivery.

clinical studies tend to focus on safety and efficacy, lost in all this
clinical data is something that cannot be easily quantified the patient’s
quality of life. It’s understandable that most believe it’s no big deal to
swallow multiple pills each day. Yet in reality while there is no pain involved
when taking any oral medication it’s amazing just how many patients don’t take
their orals meds on a regular basis. It’s no secret that non-compliance with
their therapy regimen is one reason nearly two-thirds of all patients fail to
achieve adequate control.

It’s also
true that needle technology has improved dramatically over the years making any
injection therapy like insulin much easier to administer. Even with this
improvement many fail to grasp what it’s like for a patient to administer six
or more injections each day. While the injection itself may not be painful Diabetic
Investor guarantees it’s no walk in the park either. This is one reason a drug
Lantus, the world’s number one selling insulin is so popular with type 2
patients as in most cases it is injected just once a day. Once the patient
moves to multiple injections per day a while host of new issues arise.

Many believe
the ultimate situation would be an oral version of Byetta or LAR which is what
Oramed is trying to accomplish. However as we have seen with the many attempts
at making an oral version of insulin this goal is easier said than done. Even
if this goal is accomplished the pill would still be taken at least once per
day more likely multiple times per day.

This is what
makes the case for LAR so compelling. Delivered just once-a-week therapy compliance
a major issue for nearly every other form of therapy becomes a non-issue. Add
in the fact that LAR is not dose dependent and does not require that patient to
regularly monitor their glucose levels, as they would have to do with insulin
therapy, and you have a drug that enhances the lifestyle of a patient with type
2 diabetes.

Still there
are many non-believers who say the needle size or mixing will decrease LARs
appeal. It is also true that no one therapy option will work with every
patient. Diabetic Investor in no way believes that once approved it will be LAR
and nothing else. However, when looked at from the perspective of which drug
offers the most compelling set of benefits LAR has strong appeal.

LAR reminds
Diabetic Investor of a football team that excels in all aspects of the game, offense,
defense and special teams. This does not guarantee a winning season or winning
the Superbowl (even the New England Patriots who went undefeated in the regular
season and early playoff rounds eventually lost in the Superbowl.). Still just
ask any football fan and Diabetic Investor thinks you’ll find more fans wanting
a team that excels in all aspects of the game. They know it doesn’t guarantee a
good year but they also know it sure increases their chances of making it to
the big game. They way things stand today Diabetic Investor likes LARs chances.