Twice daily, once daily, once-weekly, needle size?

Twice daily, once daily, once-weekly, needle size?

This morning AstraZeneca (NYSE:AZN) made it official as they finally launched the long-awaited Bydureon® pen.  The question now becomes will the arrival of a pen delivery system help push Bydureon sales higher or is this too little too late. Too fully gauge, yes the choice of words here is intentional, the potential impact of the pen a little history.

From the beginning Diabetic Investor has maintained that the GLP-1 category has the potential to change the treatment of Type 2 diabetes. This class of drugs has several notable advantages; simple dosing, solid glucose control, low risk of hypoglycemia plus weight loss. Perhaps best of all it’s not insulin which isn’t a swipe at insulin rather a reality as physicians and Type 2 patients see the move towards insulin as an admission of failure. This may sound crazy but patients seem to be more comfortable adding an injectable GLP-1 rather than insulin.

Since Byetta was first approved we have seen several advancements in GLP-1 options, we have gone from Byetta injected twice-daily to Victoza® from Novo Nordisk (NYSE:NVO) injected once-daily to Bydureon® and Tanzeum™ from GlaxoSmithKline (NYSE:GSK) taken just once-weekly. Lilly (NYSE:LLY) also has an extended release GLP-1 under review at the FDA which could see approval soon.

The general thought process was that with each improvement in dosing, GLP-1 usage would become more prevalent. Basically Victoza would do better than Byetta, and Bydureon and Tanzeum would do better than Victoza based on the fact that patients would inject less frequently. To some extent Diabetic Investor has been correct here as Victoza has exceeded expectations however Bydureon has underperformed. Diabetic Investor sees this underperformance due to several reasons, the drug has had more owners than a NBA franchise, until the pen became available administration wasn’t exactly patient friendly and the fears of pancreatic issues associated with the class. Recent research has indicated these fears over pancreatic issues are somewhat overblown, however these fears persist.

With the launch of the Bydureon pen the next question, now that Tanzeum is here, could well be will needle size determine market share. The Bydureon pen uses a 23 gauge 9/32 needle while the Tanzeum pen uses a 29 gauge 5mm thin wall needle. Just as an FYI when it comes to patient comfort the higher the needle gauge the better. Given this fact, one has to wonder how Bydureon with its larger needle will compete with Tanzeum and Lilly’s offering which also comes with a smaller needle. As with most diabetes drugs these days there isn’t a huge performance difference between extend release GLP-1’s. One could and probably should argue that a drugs delivery system, especially with an injectable therapy, could be deciding the factor.

Granted this does not take into account formulary position and the patient’s out-of pocket costs, still this could force Astra to be more aggressive when pricing Bydureon. Initial reports from the field indicate that Glaxo has been very aggressive with Tanzeum offering payors a 30% discount compared to Bydureon.  Considering that Lilly is likely to be as aggressive as Glaxo, the extended release GLP-1 market is setting up for a nice little price war.

This is also the reason Novo is trying to reposition Victoza as a treatment for obesity. Novo correctly senses that the GLP-1 market is becoming just as problematic as the short-acting insulin market. By repositioning Victoza as a treatment for obesity it’s possible the franchise could continue to grow with higher margins thrown in as an added benefit.

Although items such as delivery system and needle size may not seem important, they become enormously important as companies look to find any advantage over the competition no matter how small it may seem. Something that will play out quickly once Lilly’s extend release GLP-1 is approved. This is what happens when you have multiple drugs in one category all of which perform pretty much the same. Yes there are some minor differences between them but not anything earth shattering. Priced the same payors could well decide for extended release GLP-1’s good things come with smaller needles.