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GLG News by this Author

Is the End of the Beginning of Diabetes Coming?

October 11, 2009

Analysis of:Andromeda Biotech Consummates Deal with Teva for the Commercialization of DiaPep277, its Late Stage Development Drug for Type 1 Diabetes | www.pipelinereview.com

Teva's global operations and recognition in association with many generic drugs of different classes and for different indications across many speciaties will be immensely helpful in marketing DiaPep277 worldwide.

Third to market but any advantages?

October 11, 2009

Analysis of:ONGLYZA™ (saxagliptin) Receives Marketing Authorisation In Europe For The Treatment Of Type 2 Diabetes | www.pipelinereview.com

With sitagliptin (Januvia, MRK) and vildagliptin (Galvus, NVS) already well established in the European market and the additional availability of the combination of these drugs with metformin, it seems unlikely that saxagliptin (Onglyza, BMS/AZ) will grab much of the market.

Metagliptin too?

September 21, 2009

Analysis of:Glenmark’s novel molecule for Diabetes, Melogliptin to enter phase III trials | www.pipelinereview.com

Yet another gliptin drug for diabetes is to start phse 3 trials.

Lantus Wins, Mannkind Loses

September 21, 2009

Analysis of:Sanofi-aventis to purchase Diabel manufacturing facility in Frankfurt to strengthen Insulin Production Capacities | www.pipelinereview.com

Sanofi-aventis has scored a coup in getting the Diabel manufacturing plant in Frankfurt-Höchst, Germany, one of the largest state-of-the-art insulin manufacturing plants in the world. Since Pfizer had intended that facility to manufacture insulin for the ill-fated Exubera, it should be happy to have had competition for its purchase. Mannkind had expected to buy it to manufacture Afresa, its inhaled insulin product that is expected to make it to market. But since Sanofi-aventis was the original Exubera developer, they had the step-in right .

Tardy with their own combo!!

September 21, 2009

Analysis of:Takeda Submits a New Drug Application for a Fixed-Dose Combination Tablet of Actos ® with sulfonylurea in Japan | www.pipelinereview.com

Japan may soon have Actos/sulfonlurea combination tablets available such as those that have been selling in the US and Europe for several years. Ironic, in that Takeda, a Japanese company, was the developer of Actos, an insulin sensitizing drug, years ago, and has sold it in the USA for several years.

Why a third ME TOO drug?

September 21, 2009

Analysis of:ONGLYZA™ (Saxagliptin) Receives Positive Opinion in Europe for the Treatment of Type 2 Diabetes | www.pipelinereview.com

Both Januvia (sitagliptin, Merck) and Vildagliptin (and Vildagliptin plus metformin, a single pill dosed twice daily combination drug, Novartis) are already available in Europe. Onglyza (saxagliptin, AstraZeneca and BMS) offers no apparent clinical advantage over them.

Byetta Preventing Mortality? Even IF True, Wrong Formulation?

August 11, 2008

Analysis of:Lilly Diabetes Drug Shows a Life-Extending Promise | www.nytimes.com

The recent finding that Byetta therapy decreased mortality in the ACCORD study needs to be replicated in studies designed to address that point.  Even if it is replicated and statistically significant, it probably will not be true for the widely anticipated once weekly extended formulation of the drug.

Race to Market, with Competition Hot on Heels

June 19, 2008

Analysis of:After One Year, Type 2 Diabetes Patients Taking Exenatide Once Weekly Sustained Improvements in Glycemic Control and Weight; DURATION-1 Presented at ADA 2008 | newsroom.lilly.com

As exciting as the DURATION I study results have been, Roche's GLP-1 agonist is also looking good in earlier phase trials, and there are MANY competitors in this GLP-1 realm, as well as the gliptins (oral, with similar efficacy on glucose and A1c but without the dramatic weight loss), chomping at the bit to get a piece of the action.

AGI-1067 May Address More than the Blood Sugar

May 30, 2008

Analysis of:AtheroGenics Announces Encouraging Interim Results From Phase 3 Clinical Trial of AGI-1067 in Type 2 Diabetes | www.fiercebiotech.com

This compound may have additiional benefit in type 2 diabetic patients, especially those with the cardiometabolic syndrome. 

PERISCOPE Makes Sense

April 9, 2008

Analysis of:New Data Showed Actos (pioglitazone HCl) Prevented Progression of Atherosclerotic Plaque Volume in Patients With Type 2 Diabetes | pharmalive.com

The recent findings regarding pioglitazone in a large, randomized, intravascular cardiac ultrasound study finally begin to show some indication of the expected efficacy for which many physicians chose to use the drug, i.e., to decrease cardiovascular disease or its progression.  From pioglitazone's mechanism of action leading to changes in endothelial function, cytokine generation, and decreasing inflammation, it was expected to abort progression of cardiovascular disease, with the exception of congestive heart failure.  Though it's effects on osteopontin and osteoprotegin, which were thought to be positive in decresing likelihood of vascular dysfunction and calcification,  were also found to suppress the osteoblasts and lead to increased fractures of the distal extremities (hands and feet), the risk:benefit ratio has yet to be determined in long phase clinical trials.

Slim Chance?!

April 9, 2008

Analysis of:Taranabant looks promising | www.taranabant-health.com

Merck's endocannabinoid inverse agonist (CB1R )recently completed a 52 wk trial in which 2000 subjects were randomized to placebo, 2, 4, or 6 mg of taranabant.  Before the trial ended, the 6 mg dosed subjects had to be rerandomized to placebo or 4 mg due to toxicity.  The most common side effects were  gastrointestinal.   At study end, 40% of those on the 4 mg dose had had psychiatric side effects, compared to 28% on 2mg and 20% of those on placebo.  Only those on 4 mg lost 5% of their initial wt.(the minimum amount to be considered metabolically significantly important).  Wt. loss for placebo, 2, and 4 mg were 2.6, 6.6, and 8.1 Kg from a baseline weight of about 100 KG.  It seems that the 4 mg dose is the one that should be taken to market for efficacy but, with the fear of suicidal ideation turning up as a possible side effect, the company may choose to go with a lower dose that is less effective.

Right data, wrong interpretation?

February 11, 2008

Analysis of:Diabetes Study Partially Halted After Deaths | www.nytimes.com

That more people died in the "tight" control group is true, but was it tight control that was responsible or could it have been the means by which it was controlled?  It was not rosigitazone (Avandia) or hypoglycemia responsible for the deaths, according to the articles (the scientific article has not yet been published).  But any treatment to get the glucose down was allowed and probably the most common sulfonylurea used was glyburide, known in Europe as glibenclamide.  This drug, and some meglitinides, are known to impair ischemic preconditioning, a powerful endogenous protective mechanism of the myocardium to limit damage when repeated episodes of ischemia (inadequate blood suppply) to the heart occur.  If subjects were having "silent ischemia" (no symptoms), which is known to be most common in diabetics, then the use of these drugs could lead to more heart attacks, many of which would manifest as sudden death. These 2 were responsible for the differences in deaths in the 2 groups.

Stay Alert for Registration Trial Results

February 4, 2008

Analysis of:Denosumab Osteoporosis Study Met Primary and All Secondary Bone Mineral Density Endpoints in a Head-to-Head Comparison with Weekly Alendronate (FOSAMAX(R)) | www.pipelinereview.com

After the many false hopes raised using surrogate markers, we certainly want to wait for definitive end-point trial results involving fracture rate and possible long-term side effects.  However the 40% greater increase in BMD compared to the standard of bisphosphonate therapy is quite exciting.  Its potential utility in metastatic bone disease alone, where cost/benefit and risk/benefit ratios would be much more favorable, might be worthwhile and probably cost effective. I'll certainly eagerly await results of the registration trials.

Major Boon for Diabetes Companies, if only...

January 14, 2008

Analysis of:Diabetes legislation proposed | www.bizjournals.com

Diabesity is pandemic, too late diagnosed, too little treated.  ADA recommendations for screening with fasting blood sugars result in relatively late diagnoses since the FBS doesn't usually rise until the disease has been present for several years. 

WHICH IS MORE EXCITING?

September 25, 2006

Analysis of:SemBioSys Achieves Major Insulin Milestone | www.pipelinereview.com

SymBioSys has developed a relatively less expensive way of mass producing insulin at a time when worldwide needs for insulin are expected to climb dramatically.

Meanwhile they have developed a way to supply a non-FDA regulated nutraceutical (DHA) which is expected to become in greater demand, which could help fund the clinical trials of insulin and apoA1.

Low apoA1 is very difficult to treat clinically.  In a small trial exogenous apoA1 has been found to be beneficial in reducing atherosclerosis.

Metabolic Marvel or Vanity Vanquished?

September 25, 2006

Analysis of:Acomplia (Rimonabant) - Investigational Agent for the Management of Obesity | www.drugdevelopment-technology.com

There is a growing epidemic of obesity worldwide, followed by the epidemic of type 2 diabetes.
More people in the world now die as a result of overnutrition than undernutrition.
Metabolically significant improvements were seen along with weight loss with rimonabant therapy.
Improvements were durable with continued therapy for 2 years and reversed when therapy discontinued.

Long term therapy can be anticipated if the ongoing clinical trials show a marked decrease in morbidity/mortality, potentially leading to a huge chronic market.

Two great classes--why not?

September 25, 2006

Analysis of:Start of Phase 3 Clinical Program in the U.S. | www.pipelinereview.com

Takeda is thinking ahead and planning for marketing of the combination of pioglitazone and TAK-536, which will likely stand them in good stead and able to grab increased market share when/if the combo is approved.

 

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