The GLP-1 Space Becoming Crowded

The GLP-1 Space Becoming Crowded

In spite of all the crazy rumors circulating on what the FDA will do with Bydureon, the GLP-1 space is getting more crowded by the day. While Diabetic Investor continues to believe the FDA will approve Bydureon without a black box warning, the growing data set on GLP-1’s should send a strong signal to the market of the impact GLP-1 therapy options will have on the diabetes drug market.

During this morning’s call Roche was once again touting the benefits of their GLP-1 offering, Taspoglutide. As has become standard fair for Roche little hard data was given supporting the company’s assertion that Tasoglutide is the greatest thing since sliced bread and soft soap but the company did make a point of mentioning that this outstanding data set will finally be made public at the ADA conference in June, an event Diabetic Investor won’t miss. As we have noted previously they way Roche is hyping Taspoglutide this data set better be great as the company is setting themselves up for a major embarrassment if it isn’t.

Also today Sanofi- Aventis (NYSE:SNY) released some real data for their GLP-1, Lixisenatide. According to a company issued press release; “Baseline characteristics were similar among groups in terms of mean age (53.7 ± 10.5 years), diabetes duration (2.5 ± 3.4 years) and HbA1c (8.04 ± 0.9%). HbA1c was significantly reduced in both lixisenatide titration groups versus placebo, and significantly more patients in the lixisenatide groups achieved HbA1c < 7% (46.5 to 52.2% versus 26.8%). as compared to placebo. Lixisenatide also significantly improved fasting plasma glucose and two-hour post-prandial glucose with a pronounced decrease in 2-hour post-prandial glucose excursion.

Lixisenatide was generally well tolerated. The most common adverse event was, as expected with this class of drugs, nausea occurring in 20 to 24% of lixisenatide-treated patients and 4% of placebo patients. The incidence of symptomatic hypoglycemia was low (1.7%) and similar in the lixisenatide and placebo groups.”

Looking over all this data it’s becoming fairly obvious that each player is staking out their territory and making decisions on whom and where to fight. Currently there are two approved GLP-1’s on the market, Byetta from Amylin (NASDAQ:AMLN) who is partnered with Lilly (NYSE:LLY) and Victoza from Novo Nordisk (NYSE:NVO). Amylin and Lilly are anxiously awaiting the full approval of the once weekly version of Byetta, Bydureon. Given that Lixisenatide is a once daily and Tasoglutide is a once weekly, Sanofi is going after Victoza while Roche is going after Bydureon.

Now that the GLP-1 space is becoming more crowded it’s all fair to state that all GLP-1’s share similar characteristics. All appear to do a solid job of lowering glucose with added benefit of promoting weight loss. It is also true that nausea is the most common adverse event. While we have not seen detailed data sets from either Roche or Sanofi it’s highly likely we will learn whether pancreatitis or thyroid cancer are also common adverse events.

In reality this is the $64 question. Novo from the beginning has been claiming that the thyroid cancer issue is a class effect and not unique to Victoza. Amylin has maintained that the pancreatitis issue cannot be linked directly to Byetta usage. With more data coming we should find out who’s right here which will go along ways towards determining the future of what Diabetic Investor sees a very lucrative market.

We should also get a clear picture of how the FDA feels about all this when they fully approve Bydureon. Should the FDA follow an ultra-conservative path and approve Bydureon with the same black box warning as they did with Victoza this would make Sanofi and Roche’s efforts more difficult. However, should the FDA follow a more reasonable path and approve Bydureon without this warning, Amylin and Lilly have an opportunity to own the GLP-1 space.  Looking over all the data that’s publicly available Diabetic Investor does not believe Bydureon should receive a warning but as we have seen with the FDA, it’s easier to pick the winner of the Kentucky Derby than figure what the FDA will do.

While Novo may have been their own worst enemy when it came to how they handled the thyroid cancer issue, in one respect Diabetic Investor believes the FDA was overly cautious with the black box warning. Looking at the facts there is no hard evidence that links Victoza to thyroid cancer. Diabetic Investor believes this is the reason the FDA felt it necessary to explain their decision back in February when Mary Parks, M.D. director, Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research and Curtis Rosebraugh, M.D., M.P.H. director of the FDA’s Office of Drug Evaluation published an article in the New England Journal of Medicine entitled “Weighing Risks and Benefits of Liraglutide – The FDA’s Review of a New Antidiabetic Therapy”.

One thing is certain no matter what the FDA does with Bydureon, is GLP-1 therapy is here to stay and could well change the paradigm for the treatment of type 2 diabetes. The facts are that few therapy options offer the benefits of the GLP-1 therapy. Even without the added benefit of weight loss, GLP-1’s trump almost every existing therapy options for patients with type 2 diabetes when it comes to lowering A1C and let’s not forget that is the primary function of a diabetes drug.