Byetta Lands a Plum as Safety Concern Remains

Alexandria, VAIn an, 'it happened on the way to the courthouse' moment, the makers of Byetta—the diabetes drug that has been associated with six deaths from Byetta acute pancreatitis—would have been overjoyed to hear this week's news that GLP-1 analogs have been added to treatment guidelines as a secondary option for patients. In spite of concerns over Byetta pancreatitis, the American Diabetes Association (ADA) together with the European Association for the Study of Diabetes (EASD) made the call. Byetta and acute pancreatitis aside, it's a godsend for Byetta.

Why? It just so happens that Byetta is the only marketed drug available in the GLP-1 analog class, according to an analyst with J.P. Morgan.

Sweet. Not only will the addition turn the tide on sluggish Byetta sales, it could help to fund research and development on a longer-lasting version of Byetta. Byetta patients are required to inject the drug twice per day. However, Byetta manufacturers Eli Lilly and Amylin are hoping that exenatide LAR, under development in concert with partner Alkermes, will only need to be injected once weekly.

One can imagine the stampede to the pharmacy if, and when exenatide LAR is approved, as diabetes patients trade their twice-daily injections for just one jab per week.

Until then, given the confidence that the ADA and EASD have shown in GLP-1 analogs, Byetta in its present form should see its fortunes improve dramatically in the short-term. While the overall diabetes market is extremely competitive, Byetta appears to have the market on GLP-1 analogs locked up for the time being, although Novo Nordisk, a manufacturer based on Denmark, is working on a once-daily injectable GLP-1 analog.

While investors and analysts are understandably happy with the news, the new exposure for Byetta only serves to heighten the concern over Byetta acute pancreatitis, which has been simmering since August when a joint report from the manufacturers and the US Food and Drug Administration (FDA) revealed six deaths among diabetics who were taking Byetta. While those deaths have not been directly attributed to Byetta, concern remains.

One must wonder, therefore, if Byetta acute pancreatitis will be seen in greater numbers now that GLP-1 analogs have been blessed by the powers as a secondary treatment option for patients. One has to wonder if more diabetics taking Byetta will result in heightened appearances of Byetta acute pancreatitis and related difficulties. As often happens when a drug reaches the larger population, the real impact of a drug is often not duplicated within the limited number of clinical trial participants when a drug is tested.

Suddenly, a small blip in the pre-approval trial morphs into something far more significant once the numbers are extrapolated across the wider, general population.

Analysts consider Byetta sales across several quarters as 'lackluster.' However, you be the judge: in the third quarter Amylin noted sales of Byetta for the quarter as $179.9 million, up by 12 percent. Wall Street, it has been reported, wasn't happy with that number.

It can be assumed that Wall Street will be much happier with regard to this most recent development on the Byetta front—if not from the context of health and safety, at least from the context of financial and performance and shareholder return on investment.

Inclusion as a secondary treatment option will only serve to improve Byetta's bottom line.

But will it improve safety? Will Byetta acute pancreatitis still be an issue? Time will tell…