Roche Disappointing Data
Last evening Roche was the last company to present data on their long-acting once-a-week GLP-1 drug candidate Taspoglutide. Just like Byetta and liraglutide, taspoglutide showed solid A1c lowering capabilities and weight loss. However, looking over the adverse event profile 52% of patients experienced nausea while 22% experienced vomiting. According to Roche this higher than usual adverse event profile was due to the fact that patients were not titrated and took the maximum dose of the drug from the beginning of the study. As the drug moves to Phase III trials the company indicated patients would begin on a lower dose for one month then move to the maximum dose for the remainder of the study. It should also be noted that taspoglutide was delivered using a 29g needle.
Compare this data to what Amylin (NASDAQ:AMLN) released yesterday in a late braking abstract for Byetta LAR. Patients taking Byetta LAR over the course of one year experienced a drop of 2.0% in A1C compared to those receiving treatment for 30 week who experienced a drop of 1.9%. Seventy-two percent of patients treated with Byetta LAR achieved an endpoint A1C of 7 percent or less, and 54 percent achieved an A1C of 6.5 percent or less. Finally, patients experienced a statistically significant and sustained average weight loss of 9.5 pounds over 52 weeks. Add it all up and Byetta LAR scores very well on the Diabetic Investor SSE scale. (Safe, Simple and Effective) This data should also put to rest concerns that liraglutide from Novo Nordisk (NYSE:NVO) will be a threat to Byetta LAR.
Quite frankly the results for LAR aren’t great their astonishing, especially given what we have learned this week about the important of solid A1C control, benefits of weight loss and avoiding hypoglycemia.
As we can see from the Roche data a company cannot simply get by in the GLP-1 market with solid A1C control and weight loss. In all honesty every GLP-1 produces these results. It should also be noted that nausea is present in all GLP-1’s. The key here is really quite simple, whoever gets their long-acting GLP-1 to market first will have a huge first mover advantage and will likely control the GLP-1 market. This situation is not unlike what happened in the long acting insulin market where Lantus from Sanofi-Aventis (NYSE:SNY) quickly gained traction after its launch. Novo Nordisk has been playing catch up with their long acting insulin Levemir® since it hit the market and still Lantus has been able to expand their lead.
The fact remains that Amylin, in spite of a rough few days here, came out on top when all the data is examined. Liraglutide is a good drug and will find its place in the market. However, Byetta LAR remains best in class. The key for Amylin and their partner Lilly (NYSE:LLY) is execution, the two companies cannot afford the same mistakes that were made when Byetta first came to market. There is no question that the demand will be there when LAR hits the market. Hopefully, Amylin and Lilly will be able to meet demand and not run into any supply issues.
In this heavyweight fight Novo throw everything they had at Amylin who was able to withstand the assault. In the end investors should thank the people at Novo for creating a great entry point into Amylin shares. While a bit bloody after tough few days, Amylin remains the most valuable property in the diabetes space.