The GLP-1 Space Getting Crowded

The GLP-1 Space Getting Crowded

Yesterday GlaxoSmithKline (NYSE:GSK) announced they have submitted their once-weekly GLP-1 to the FDA. According to a company issued press release; “GlaxoSmithKline (GSK) plc today announced a regulatory submission to the US Food and Drug Administration (US FDA) for albiglutide, an investigational once-weekly treatment for adult patients with type 2 diabetes.” As Diabetic Investor noted yesterday, Lilly (NYSE:LLY) also has a once-weekly GLP-1 under development and as we all know Bristol Myers Squibb (NYSE:BMY) and AstraZeneca (NYSE:AZN) have the only FDA approved once-weekly GLP-1 on the market with Bydureon.  It’s well known that Sanofi (NYSE:SNY) has a once-daily GLP-1 set to go the FDA while their arch rival Novo Nordisk already has their once-daily, Victoza on the market and is developing a longer acting version as well.

While Diabetic Investor has long believed that GLP-1 therapy could change the treatment paradigm for Type 2 diabetes, it continues to amaze us how little excitement there is over this category while other new drugs like the SGLT2’s are generating loads of excitement.  Although there are issues with many of the new oral meds, it seems that many in the investment are still holding onto the false belief that just because GLP-1’s need to injected they will never achieve blockbuster status. A falsehood that should have been disproven with the huge success of Lantus, the world’s number one selling insulin a blockbuster several times over.

Looking ahead as this space becomes more crowded our attention turns to what BMS/AZN will do with Bydureon. Back when Bydureon was still owned by Amylin Diabetic Investor noted the importance of getting this drug off to a good start and how it was imperative that BMS/AZN avoid the mistakes made by Amylin and their then partner Lilly made when Byetta was first launched. Mistakes which cost Byetta dearly and in actually contributed to the success of another blockbuster Type 2 drug Januvia from Merck (NYSE:MRK). Although early in the process Diabetic Investor isn’t quite sure that BMS/AZN actually understand the opportunity they have with Bydureon.

We base our comments solely on a series of public statements made by BMS as they seem to believe they have a broad portfolio of diabetes products and that Bydureon is just part of this portfolio not the cornerstone of the portfolio. Perhaps we are misreading these statements and that BMS understands that Onglyza will never be a major threat to Januvia and their own SGLT2 may never see the light of day.

As we always do when any new drug hits the market Diabetic Investor likes to talk with the early adapters of the therapy which in this case are endocrinologists. Typically when a new drug comes out these early adaptors pick a small segment of their patient population to try the new drug. Once they see the results the endo’s will either start prescribing this new drug to a broader segment of their Type 2 patient population or move on to the next new thing. Well based on what we’ve heard so far there is nothing to indicate that Bydureon can’t achieve blockbuster status, assuming of course BMS/AZN executes.

This is not to say in its present form Bydureon will reach blockbuster status rather when the pen delivery device for Bydureon gets here blockbuster status is well within its reach. Keep in mind that although Bydureon is taken just once a week, administration still requires a fair amount of patient interaction and the needle used to inject Bydureon is larger than the more modern needles used to inject insulin. The pen delivery device will solve both of these problems and make injecting Bydureon a much simpler process.

This is one reason why Diabetic Investor believes Bydureon’s biggest threat does not come from either GSK or Lilly but Novo Nordisk. Given that the majority of long acting GLP-1’s do the same thing the same way, how the drug is administered takes on critical importance and quite frankly no one is better at patient friendly delivery systems than Novo. Just compare the Byetta pen which is one of the worst pen designs to the Victoza pen which is pretty slick device. Based on our knowledge of the Bydureon pen Diabetic Investor would say that Novo will have their work cut out for them when their once-weekly product is ready. Still we cannot count them out of the competition given their past excellent pen designs.

The key for BMS/AZN is to build a strong case for Bydureon now and then promote the daylights out of the drug when the pen delivery system is approved. Frankly they cannot ignore any threat and assume that just because Bydureon was first to market it will by default become the standard for the category.  It would wise for BMS/AZN to learn from the mistakes Lilly made back when Novo was taking the US insulin market seriously years ago. Although it seems hard to believe today, there was time when Lilly had a stranglehold on the short-acting insulin market here in the US.  Understanding this Novo came in aggressively making deals and promoting their patient friendly delivery systems. These moves paid off handsomely for Novo and Lilly has never been the same since.

With everyone clamoring for a piece of the GLP-1 pie this will surely be a fight and if history is any guide, it won’t always be a fair fight. Be that as it may, when it comes to the GLP-1 market one thing is certain – GAME ON!