Novo Reports – A battle is brewing
While Novo Nordisk (NYSE:NVO) continues to deliver impressive performance , the real news coming out of today’s earnings call was Liraglutide, their once daily GLP-1, will be submitted to the FDA before the end of the second quarter. Although there are no guarantees with the FDA, Diabetic Investor sees an approval before the end of 2008. This is when the real battle begins.
As we reported earlier today Liraglutide has been proven to be very effective at lowering A1c, but lacked the weight loss capabilities seen with Byetta. Still Liraglutide does have some advantages over Byetta, most notably its once daily administration compared to Byetta twice daily. More importantly Novo has a huge sales force which will be aggressively promoting the product. The company will also be the beneficiary of all the heavy lifting done by Amylin (NASDAQ:AMLN) and Lilly (NYSE:LLY) educating physicians and patients on the benefits of GLP-1 therapy.
This news also increases the pressure on Amylin to get the once-a-week version of Byetta to the FDA as quickly as possible. Amylin has publicly stated Byetta LAR will be submitted to the FDA during the first half of 2009, with an outside shot of submission late in 2008. While Diabetic Investor does not anticipate any delay with LAR, Amylin and their partner Lilly are well aware that the stakes are high.
Based on physician interviews there is high level of awareness about Byetta LAR and it is not an understatement to say that physicians are anxiously awaiting the drugs submission. Physicians understand what once weekly dosing means for patient compliance and they are equally impressed by the data seen from LAR.
The unanswered question is will physicians wait for LAR or will they switch patients to Liraglutide due to the once a day administration and then switch patients to LAR when it becomes available. This is why it is so important that there be no delays in getting LAR to the FDA.
A battle is brewing and the stakes are high. Byetta is already approaching blockbuster status and LAR has the potential to be a paradigm shifting technology. While Novo is late to the party they have the experience, money and sales force to compete and compete effectively. Game on!