Roche Announces Major Delay for GLP-1

Roche Announces Major Delay for GLP-1

We all know that drug development is a tricky business, a business made even more difficult by the increasingly conservative nature of the FDA. Today we learned that taspoglutide, the once-weekly GLP-1, under development by Roche has been delayed for 12 to 18 months, possibly longer. According to a company issued press release:

“In the Phase III studies, the incidence of hypersensitivity reactions reported as related to taspoglutide is higher than expected for the study population, although it remains uncommon (i.e. incidence < 1%). The most frequently reported symptoms in patients who developed hypersensitivity reactions were skin reactions and gastrointestinal symptoms, while cardiovascular and respiratory symptoms were less frequent. All patients recovered without complications.

Roche has identified a potential association between hypersensitivity reactions and anti-drug antibodies (ADAs). In consultation with the FDA, Roche has decided to implement a risk mitigation plan which has been communicated to Health Authorities globally. The plan is designed to identify patients at potential risk of these reactions. As such, ADA levels will be routinely monitored and patients that develop pre-specified ADA levels will discontinue treatment and continue to be monitored in the trials.”

Now Diabetic Investor hates to gloat but some may recall that we have been critical of Roche for their lack of information regarding taspoglutide. Each time the company issued a press release on the drug all we got was the drug meet the primary endpoint of the study but no actual data to backup their claim that taspoglutide was the greatest drug to come along since penicillin. Diabetic Investor stated we were anxious to see some real data and would hold Roche accountable for their previous statements. As this news makes clear there’s a good reason why the company didn’t want anyone to see the real data.

Obviously this is very good news for Amylin (NASDAQ:AMLN), Lilly (NYSE:LLY) and Alkermes (NASDAQ:ALKS), who are anxiously awaiting FDA approval for their once-weekly GLP-1 Bydureon. Diabetic Investor continues to believe that Bydureon will receive full approval without any black box warnings.  It’s important to note that Bydureon is basically a line extension of Byetta which has been on the market for several years and is being used by over one million patients. While there is no way to accurately predict what the FDA will do however, based on the scientific evidence there is no justification for a black box warning; but as we have seen before with the FDA decisions are not always made using scientific evidence.

This news is just another blow to Roche, who has already seen their diabetes device business fall into disarray. The company had hoped that taspoglutide would reinvigorate their struggling diabetes franchise and keep them as relevant player. While the company appears committed to taspoglutide, one has to wonder how serious this commitment is as it gives Bydureon clear ownership of the once-weekly GLP-1 space for at least two years, most likely longer.

This news is also poetic justice and perhaps will teach the company a valuable lesson. As Diabetic Investor stated from the beginning if the data really was that great release it for all to see and analyze. As an alternative the company could have said nothing at all rather than having egg on their face, again. As the old saying goes; “Better to be thought a fool than to open your mouth and remove all doubt.”

Diabetic Investor is hardly surprised for when it comes to diabetes, devices and now drugs, Roche has proven they couldn’t get wet standing in a rain shower.