GLP-1 therapy the new frontier

GLP-1 therapy the new frontier

This morning Sanofi-Aventis (NYSE:SNY) announced results from their GetGoal clinical program for Lyxumia® (lixisenatide) their once-daily GLP-1 currently in phase III trials.  Like other drugs in the category and Lyxumia is no different, patients experienced reductions in HbA1c, low incidence of hypoglycemia and weight loss.

Considering that Lyxumia isn’t scheduled to be submitted to the FDA until the late 2012 and it will be the fourth GLP-1 on the market, this of course assumes Bydureon will be approved, it’s not surprising that Sanofi is taking a page from the Novo Nordisk (NYSE:NVO) playbook and is studying Lyxumia six ways from Sunday. The GetGoal clinical program consists of nine different studies that will yield tons of data but won’t change the fundamental course of the drug.

The simple fact is any drug, no matter how good it is, that comes to market in the number four position stands little chance of gaining much traction. Lyxumia will have the additional hurdle of coming to market after Bydureon which as everyone knows is administered just once a week. It will also have to compete with Victoza® which is already on the market and is also a once-daily administration.

On the flip side this news should send yet another signal as to just how important GLP-1 therapy has become. Sanofi in particular understands that with Lantus going off patent in 2014, they need to do whatever they can to strengthen their diabetes drug portfolio. However, Diabetic Investor suspects the company understands that Lyxumia, while a promising drug, will never be able to replace the revenue stream generated by Lantus. We further suspect that company is paying close attention to the legal battle between Lilly (NYSE:LLY) and Amylin (NASDAQ:AMLN) and could well be developing a strategy to step in as Amylin’s knight in shining armor.

While Novo, Amylin and now Sanofi have built an impressive dataset on how GLP-1’s perform this category is no longer about whether GLP-1 therapy is safe or effective, this category will come down who offers the fewest injections and here Bydureon is clearly the winner. Just as Victoza trumps Byetta, one injection per day compared to two injections per day, Bydureon trumps both Victoza and Lyxumia with just one injection per week; something that will take on even greater significance when Bydureon comes with a pen delivery system.

Anyone who doubts how this market will develop should take a look at what’s currently going on in the DPP-4 market which is dominated by Januvia. Firmly established as the number one drug in this category we have yet to see any competing DPP-4 even come close to establishing a toe-hold in this market.  Like the GLP-1 market, while there are some minor differences between the players, all the drugs do basically the same thing, the same way.  All anyone needs to do is to lay the clinical data from all drugs side by side, and this can be done for DPP-4’s or GLP-1’s, and it’s fairly obvious that there are no major differences in results or adverse event profiles.

This is one reason Diabetic Investor believes Bydureon has the potential to become a mega-blockbuster, not because it is necessarily a better GLP-1, rather more because its once-weekly administration offers a compelling benefit over its competitors. The simple fact is Bydureon does not have to produce better results as long as those results match the results of drugs in the same category which require more injections. The reality is physicians will have a fairly easy time convincing patients to take a drug which only requires one injection per week.  The fact that Bydureon is a very effective drug is just a bonus, as these physicians know better than anyone else, medication adherence, or lack thereof, for diabetes patients is the difference between good or poor outcomes.

The bottom line here for Sanofi is they know all this. They also are fully committed to the diabetes market and has stated on many occasions they want to become the dominate global diabetes company. The company is pursuing an aggressive strategy of complete diabetes management, selling the patient not only the drugs and devices they need but also providing disease management services. However, with Lantus set to hit the patent cliff, Apidra® having difficulty establishing itself and Lyxumia coming late to the GLP-1 market, the company just might make a bold move and go after Bydureon.  A fact that surly brings a smile to the folks at Amylin.