Careful what you wish for

Careful what you wish for

This morning Amylin (NASDAQ:AMLN), Lilly (NYSE:LLY) and Alkermes (NASDAQ:ALKS) announced results from the DURATION-6 study which was a head to head comparison between their once weekly GLP-1 Bydueron™ and Novo Nordisk (NYSE:NVO) once daily GLP-1 Victoza®. According to a press release issued by the companies this morning:

“Results showed that patients receiving BYDUREON experienced a reduction in A1C of 1.3 percentage points from baseline, compared to a reduction of 1.5 percentage points for Victoza. BYDUREON did not meet the pre-specified primary endpoint of non-inferiority to Victoza. “

Obviously this was not the result the companies had hoped for and many in the investment community will use these results to dump shares. As always as it seems to be the case with Amylin the investment community continually looks for reasons to take a negative view of the company.  The reality is while it would have been nice had Bydueron beat Victoza when it came to lowering A1C, the fact remains that Victoza is injected once daily while Bydueron is injected just once weekly and when it comes to therapy compliance once weekly beats once daily.

Look for Novo to jump on the news as they too realize that once-weekly beats once daily. Yet at the moment Novo has the advantage as Victoza is one the market while the Bydueron remains at the FDA. Novo correctly understands that they need to establish a solid base for Victoza before Bydueron gets here as they know that physicians are reluctant to change therapy options that work and there is no question that Victoza works.

This news also places a greater burden on Amylin to get the pen delivery system for Bydueron on the market quickly after the drug receives full approval. While the initial Bydueron delivery system is not terrible it requires more work than the simple Victoza pen. As we have noted on several occasions Novo excels at developing very patient friendly delivery systems and ease of delivery cannot be underestimated when it comes to an injectable therapy option.

The real battle for GLP-1 market supremacy will likely be fought not with delivery systems but with formulary placement and pricing.  Novo could make life very difficult for Amylin should they try and pursue a win at all cost pricing strategy for Victoza. Novo attempted a similar move with Levemir their long acting insulin in hopes they could steal share away from market leader Lantus.

As Diabetic Investor has noted previously the GLP-1 market is growing and becoming an important battleground. We have also noted this market is not for the faint of heart and the competition will be fierce. With Bydueron still awaiting FDA approval and Novo’s aggressive Victoza push, Novo for the moment has the upper hand as Byetta sales have stagnated.

Diabetic Investor still believes Bydueron has the potential to be a paradigm shifting technology. However, the stakes have gotten higher with this news putting even greater pressure on Amylin, Lilly and Alkermes to execute when full approval comes.