Lexicillin QD

EU approves the Norvartis DPP-4 inhibitor vildagliptin (Galvus)

Novartis is expected to re-submit the once-daily oral drug to the FDA some time before 2009, and to answer concerns about the skin lesions seen in monkeys during a clinical trial. It received an approvable letter for the drug last year.

Although it's forecasted that this drug could achieve more than $1 billion in annual sales, there are about a year behind Merck's sitagliptin (Januvia) which is currently on the market in the US.



Bloomberg.com: Health Care

Technorati Tags: Galvus, vildagliptin, Januvia, sitagliptin, Novartis, Merck,

Novartis CEO cites diabetes as biggest problem

But, for Novartis their next gen diabetes drug, Galvus, won't be resubmitted for approval until mid 2009.

A Drug Maker’s Views of What Ails Health Care - New York Times

Technorati Tags: Novartis, diabetes, Galvus

Pioglitazone, sitagliptin, and exenatide may benefit from rosiglitazone CV risks

The WSJ's health blog has an article "Pharma Box Office: Diabetes Drugs" which speculates that other recently developed non-insuline therapies for type 2 diabetes, the incretin mimetic exenatide, and the incretin enhancer sitagliptin, may take a higher profile considering the meta-analysis suggesting increased CV risks associated with rosiglitazone.

Merck’s push behind diabetes pill Januvia [sitagliptin] and Janumet (a combination [of sitagliptin] with generic diabetes medicine metformin) accounted from 36% of the contacts, or details in industry parlance, that sales reps made with primary care doctors who write the most prescriptions in April, ImpactRx data show. Merck’s U.S. sales of the medicines for the four months ending in April were $115 million, according to data from Wolters Kluwer Health.

Lilly and Amylin's exenatide, lauched 2 years ago, has had sales of $221 million through the end of April.

Takeda Pharmaceuticals’ Actos drugs [pioglitazone, along or in combination with metformin], the closest chemical competitors to Avandia, got 23% of details in the month. U.S. sales of the Actos franchise were $988 million through the end of April, Wolters Kluwer’s data show.

Novartis is still working on resolving an FDA approvable letter regarding vildagliptin and additional studies needed to resolve possible renal dosing issues.

Technorati Tags: diabetes, pioglitazone, sitagliptin, exenatide, metformin

Rab10 protein important in insulin-dependent glucose uptake

Rab10 is now believed to work downstream of GLUT4 , the glucose transporter in the cell membranes of muscle and fat tissue.

"Rab10, a Target of the AS160 Rab GAP, Is Required for Insulin-Stimulated Translocation of GLUT4 to the Adipocyte Plasma Membrane," is published in the latest issue of Cell Metabolism. By using knock-out models, Rab10 appears to be an important component in the insulin-signaling pathway that regulates GLUT4.

It is hope that this understanding this mechanism might help in developing a therapy for patients who become increasingly insulin resistant, a prediabetes condition.

Technorati views diabetes as a "hot topic"

I agree that this topic is worthy of coverage on the blogs, but I'd prefer to see a more quantitative estimate, rather than the report of "massive increases in diagnosed cases."

The CDC gives the specifics:

In 2004, about 1.4 million adults between 18 and 79 years of age were diagnosed with diabetes. From 1997 through 2004, the number of new cases of diagnosed diabetes increased by 54%.

Soprano’s Star Aida Turturro talks about her diabetes

This comes by way of dLife.com (The video will play at their Web site when you click on the image.)

She mentions that while she was diagnosed some 5 years ago, she didn't seek therapy for 2.5 years. She also talks about the difficulties of maintaining a good diet, especially when the cast and crew are eating mega portions of pasta.

FDA approves Merck's sitagliptin (Januvia)/metformin combination therapy for type 2 diabetes

From PharmaLive:

PharmaLive: FDA Approves Janumet for Type 2 Diabetes, Offering Powerful Glucose Control of a DPP-4 Inhibitor and Metformin in a Single Tablet

Sitagliptin (Januvia), a dipeptidyl peptidase-4 inhibitor, was approved late last year.




Technorati Tags: diabetes, metformin, janumet, sitagliptin

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IncretineForum: extrapancreatic effects of incretins

With the recent FDA approval of Merck's sitagliptin (Januvia), and the expected approval next month of Novartis' (vildagliptin), both oral therapies for type 2 diabetes, interest is building in the pharmacodynamics of these incretin enhancers.

INCRETIN eForum has produce a CME piece, Extrapancreatic Effects Of Incretins: An Overview. Dr. Basu writes:

Glucose tolerance is heavily dependant not only on the quantity and pattern of postprandial pancreatic insulin and glucagon secretion but also on the sensitivities of the various tissues (liver, muscle, fat depots) to these hormones for utilization of glucose. While hepatic and peripheral insulin sensitivity has been shown to be significantly impaired in type 2 diabetes, other studies have shown normal hepatic responses to glucagon in these individuals. Furthermore, glucose effectiveness — defined as the ability of glucose per se (in the absence of dynamic changes in insulin concentrations) to influence its own uptake by liver and muscle and suppress its own release by the liver and to a lesser extent the kidney — plays a significant role in postprandial glucose homeostasis, especially in people with impaired insulin sensitivity, i.e., type 2 diabetes. Indeed, the minimal model, as well as other model-independent techniques, have shown impaired glucose effectiveness in type 2 diabetes.

This piece attempts to address the "whole-body glucose physiology" that more simplified explanations miss. Also, the issues of glucotoxicity and lipotoxicity should be included.