The GLP-1 Market Gaining Momentum
Yesterday two pieces of news provided further evidence that Bydureon, the once-a-week GLP-1 from Amylin (NASDAQ:AMLN), Lilly (NYSE:LLY) and Alkermes (NASDAQ:ALKS), has an opportunity to own the important GLP-1 space. The first piece came from Roche who indicated that they were halting dosing of their GLP-1 tasoglutide in final studies. According to a Bloomberg report published yesterday;
“Roche Holding AG told researchers to stop giving its experimental diabetes drug taspoglutide to patients in the final studies needed for approval after side effects such as nausea and vomiting led many to drop out of the trials.
The company, based in Basel, Switzerland, is trying to determine what caused the side effects and see if it can reformulate the medication to reduce the risk, spokeswoman Kristina Becker said in a telephone interview. More details should be available by the end of the year, she said.
The high number of patients who quit taking taspoglutide in the phase 3 trials makes it difficult to determine the drug’s long-term safety, Becker said in an e-mail. Thus, “continuing treatment with the current taspoglutide formulation is not considered to be in the best interest of patients,” she said.”
Also yesterday NICE issued draft guidance for Victoza®, the once daily GLP-1 from Novo Nordisk (NYSE:NVO). According to the guidance Victoza should only be used in Type 2 patients if:
“the person is intolerant of either metformin or a sulphonylurea, or treatment with metformin or a sulphonylurea is contraindicated, and
– the person is intolerant of thiazolidinediones and dipeptidyl peptidase-4 (DPP-4) inhibitors, or treatment with thiazolidinediones and DPP-4 inhibitors is contraindicated.”
The guidance also noted that dosing of Victoza be limited to the 1.2mg daily dose, as the agency did not see any meaningful benefit from the 1.8mg daily dose.
Given how the guidance is written this somewhat of a hallow victory for Novo who understands that Victoza will have a serious marketing problem when Bydureon is approved by the FDA in late October. This problem could be made even worse should the FDA approve Bydureon without the same black box warning given to Victoza when it received FDA approval. As Diabetic Investor has stated previously there is little in the way of scientific evidence to support a black box for Bydureon, however as we have seen before with the FDA the agency does not always use scientific evidence when making their decisions.
Even if the FDA takes the ultra conservative position with Bydureon and issues the same black box warning as they did for Victoza Diabetic Investor does not see this standing in the way of physicians prescribing the drug. The fact is Bydureon has an outstanding profile combined with weekly dosing and physicians are anxious to see this drug on the market as they understand that therapy non-compliance is a major factor in poor patient outcomes. Although Bydureon is an injectable therapy option, physicians see the once-weekly administration combined with the drugs weight loss capabilities overcoming patient’s fear of the needle.
Further evidence of just how successful Bydureon could be comes from the script data for Victoza here in the US. While the drug has had issues gaining formulary placement, physicians are prescribing the drug in ever greater numbers. Although scripts for Byetta have slowed since the launch of Victoza, the market for GLP-1 continues to expand. The fact is physicians are seeing the benefits of GLP-1 therapy and like patients prefer GLP-1 options with fewer administrations. It makes perfect sense that patients and physicians would prefer a once-daily GLP-1 like Victoza over Byetta which is injected twice a day. Lower the injection threshold to just once a week as you have with Bydureon and you’ll have a real hit on your hands, which is exactly what, will happen with Bydureon.
Diabetic Investor cautions everyone not to place too much emphasis on the early script data for Bydureon. While we see great things for the drug and the initial deliver system is not as bad as we had imagined, Bydureon scripts should skyrocket when the drug is available in a more patient friendly pen delivery system. When ready, patients using Bydureon will simply set their dose and shot with an even smaller needle than the original Bydureon delivery system.
Finally it should be noted that GLP-1 therapy although injectable is actually getting a boost from the problems experienced by Avandia and now Actos. The reality is physicians are running out of options for their poor controlled type 2 patients and GLP-1 therapy is beginning to fill that void. Unlike Avandia or Actos there does not appear to be any cardiovascular concerns with GLP-1 therapy and some see the weight loss produced by GLP-1’s as a cardiovascular benefit.
What this really comes down to is therapy compliance. It’s perfectly logical to believe that patients would prefer taking pills rather than having to inject their therapy option until you consider just how many pills these patients are taking. It’s a well known fact that patients with type 2 diabetes are not just taking pills for their diabetes and it’s not all that uncommon for these patients to be taking even more pills for related conditions such as cholesterol, hypertension, etc.
Simply put the fewer times any drug has to be taken the better and what could be simpler than patients with type 2 diabetes taking their diabetes medication just once-a-week.