Novo Says Their GLP-1 Tops Byetta- The Real Story

Novo Says Their GLP-1 Tops Byetta- The Real Story

This morning Novo Nordisk (NYSE:NVO) announced results from their LEAD™ 6 comparing the effects of liraglutide, a once-daily human GLP-1 analogue, with Byetta, a twice-daily GLP-1 analogue. The 26-week study, the first study to provide a direct comparison between the two GLP-1 analogues, included 464 people with type 2 diabetes who were randomized to treatment with either liraglutide once daily or Byetta twice daily, as add-on to their existing treatment consisting of metformin, sulfonylurea, or a combination of both.

Here is a summary of results;

HbA1c – Patients treated with liraglutide achieved a reduction in HbA1c of more than 1.1 percentage points, compared to a reduction in HbA1c of less than 0.8 percentage points in the
Byetta group, a difference which was statistically significant.

Weight Loss- Both patients treated with liraglutide and patients treated with Byetta lost on average around 3 kg during the course of the study, with a trend towards more weight loss in the liraglutide group.

Side Effects – The most frequently reported adverse event for both liraglutide and Byetta was nausea at a level of around 25% (percent of all study participants reporting nausea at least once). In the liraglutide group, the percentage of patients reporting nausea in each week fell to low single-digit numbers after 8–10 weeks, similar to the level observed in a background
population. In the Byetta group, the level after 8-10 weeks of treatment remained at the level of 10%.

Based on news shares of Amylin (NASDAQ:AMLN) are getting hammered down almost 9%. Before everyone jumps onto the Novo bandwagon and off the Amylin train, it’s important to keep this news in the proper perspective. First and foremost, Diabetic Investor is not surprised by the results and we see a market for both drugs. Second, it’s obvious that Novo is trying to establish liraglutide as more patient friendly GLP-1 due to its once daily administration compared to twice daily administration of Byetta. Third, Novo realizes that they will have a limited window of opportunity to establish liraglutide in the market as they know that the long acting once a week version of Byetta is coming.

Diabetic Investor believes this sell off in Amylin shares is overblown although it does create a buying opportunity before Amylin releases their data on Byetta LAR, which Diabetic Investor believes will be very good. The fact of the matter is liraglutide was just submitted to the FDA and even if approved quickly has several hurdles to overcome. Diabetic Investor remains firm in our belief that Byetta LAR will be a mega-blockbuster drug and Amylin will eventually be acquired by their Byetta partner Lilly (NYSE:LLY).

This is not to say Novo won’t be competitive in the growing GLP-1 market, rather just as they had to play catch up in the long acting insulin market, they will once again be playing catch up in the GLP-1 market.

David Kliff
Diabetic Investor
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