Another Boost for the GLP-1 Market

Another Boost for the GLP-1 Market

According to a report by the Brookings Institution released yesterday obesity costs the US economy $215 billion per year in direct and indirect impact including medical expenses and lost productivity.


Researchers writing in Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy noted; “Medical costs appear to have increased dramatically over the last decade and may continue to grow with future increases in rates of overweight and obesity in US adults and children, perhaps substantially.”


Ironically this report was released on the same day the FDA released a report citing safety issues with lorcaserin an obesity drug from Arena Pharmaceuticals (NASDAQ:ARNA) which faces a difficult an FDA advisory panel on Thursday. Not surprisingly Arena shares fell 40% yesterday and continue to sell off today.

This leaves Orexigen (NASDAQ:OREX), who has a weight loss drug of their own, Contrave® which is set to face an FDA advisory panel in early December, as the last hope for what was once a three horse race between Orexigen, Arena and Vivus (NASDAQ:VVUS). Vivus already had their panel which didn’t go well as the panel recommended against approving Qnexa, their weight loss drug.

At least one company Takeda seems to believe Contrave® will survive what has been a rigorous FDA approval process as they entered into an exclusive partnership with Orexigen to develop and commercialize Contrave®, in the United States, Canada and Mexico. According to an Orexigen issued press release back when the deal was announced back on September 2, “Under the terms of the agreement, Orexigen will receive an upfront cash payment of $50 million from Takeda, and Takeda will obtain an exclusive marketing right from Orexigen in the United States, Mexico and Canada while Orexigen retains the right to co-promote with Takeda in the United States. Orexigen will be eligible to receive payments of over $1 billion upon achieving certain regulatory and sales-based milestones. Assuming Contrave is commercialized, Takeda will pay tiered double-digit royalty payments on net sales in the Territory.”


Considering how the panel ruled on Qnexa and the damning report issued yesterday on lorcaserin, Diabetic Investor is not overly optimistic that Contrave® will experience a different outcome.  Should Contrave® meet the same fate as Qnexa and the likely fate of lorcaserin that would leave the huge obesity drug space void of any promising options, that is until you consider the proven weight loss capabilities of two already approved diabetes drugs, Byetta from Amylin (NASDAQ:AMLN), Lilly (NYSE:LLY), Alkermes (NASDAQ:ALKS) and Victoza® from Novo Nordisk (NYSE:NVO).  Bydureon, the once a week version of Byetta, will soon join this group as the drug’s PUDFA date is set for late October.


Although Byetta, Bydureon and Victoza are diabetes drugs, it would be naïve to believe that physicians will only prescribe these drugs which have proven weight loss capabilities to their patients with diabetes.  This is especially true for Bydureon which has the added benefit of being administered just once a week.


It would be equally naïve to believe that just because these drugs are delivered via injection that patients will all of a sudden find religion and begin exercising and eating properly in the never ending battle of the bulge. The fact is physicians now have great latitude in how they can prescribe these drugs as they can easily classify their obese patients as having pre-diabetes, if not full blown diabetes. It’s amazing how this supposed fear of injection evaporates when patients learn they can lose weight while on the drug. As Diabetic Investor noted when Byetta first hit the market, once patients learn that the drug produces significant weight loss they come in asking to be put on the drug, diabetes or no diabetes. The simple fact is vanity trumps injection fears in our weight obsessed culture.


This fact is not lost on the reps for these companies who just happen to mention that besides doing a great job controlling the patient’s diabetes there is added benefit of weight loss. It also doesn’t hurt any that none of these have shown any adverse cardiovascular or psychological events that have appeared with other weight lose drugs. Finally it should be noted the adverse events common with GLP-1 therapy, nausea and vomiting, dissipate over time and according to study data has not stopped patients from staying on the drugs.


As Diabetic Investor noted late last week the GLP-1 market continues to gain momentum and yesterday’s news just adds wind to the GLP-1 sails.  The fact is physicians are running out of option to fight diabetes as it seems with each passing day another drug is condemned by the FDA or research group. The troubles once thought limited to Avandia have now spread to Actos, and Januvia the most logical replacement, has gained traction more by default than by performance.


The reality is GLP-1 therapy offers the most compelling set of features and benefits for poorly controlled patients with type 2 diabetes. These drugs are not risk free as we have seen with the thyroid cancer concerns surrounding Victoza and the pancreatitis issues with Byetta. Having spoken with numerous physicians, both endocrinologists and primary care, the majority see the thyroid cancer issue as a non-issue and while mindful of pancreatitis there is no evidence that shows Byetta causes pancreatitis. These physicians understand that their patients with diabetes are at greater risk for several co-morbidities but must balance these risks against the complications from poorly controlled diabetes.


This has always been a delicate balancing act which has become more difficult as more drugs become tainted and less are finding their way into the marketplace. Looking over what therapy options are available or soon will be available, GLP-1 therapy is increasingly the option physicians recommend. An option that should become even more attractive when Bydureon gets here, as it’s once a week administration makes therapy non-compliance an almost non-issue. Add in simple dosing, no need to monitor blood sugars and you can see why physicians are anxious to see Bydureon on the market.


The wait is almost over and the fun will soon begin.