Delivery Systems Matter

Delivery Systems Matter

Yesterday Sanofi-Aventis (NYSE:SNY) released second quarter earnings and there were no surprises with their number one selling insulin Lantus®. Sales growth was strong and the company continues to make inroads in the type 2 market. According to the company they continue to gain share with newly insulinized patients. While other forms of insulin appear to have held steady within this group Lantus has gained 10% over the past year. The company specifically pointed to their SoloStar® insulin pen as the driver for growth.

Sanofi has a rather ambitious plan for Lantus stating they would like move the drug from being the number insulin to number one anti-diabetic. Considering the pending competition Sanofi will have tough task. Novo Nordisk (NYSE:NVO) should have a decision from the FDA on Liraglutide, their once daily GLP-1. Amylin (NASDAQ:AMLN) already has Byetta on the market and looks to submit Byetta LAR to the FDA late this year or early next year. Roche has their own version of a once-weekly GLP-1 under development and Lilly (NYSE:LLY) appears to be on their way to reinvigorating their insulin franchise.

Looking at the competition Diabetic Investor sees both opportunities and obstacles if Sanofi is to achieve their goal. On the plus side Lantus is firmly established in the market and has proven to be effective. Physicians are comfortable with the drug and patients favor it’s once daily administration. On the negative side of the ledger studies have shown that patients using Lantus tend to gain weight compared to those using a GLP-1 like Byetta. Although Lantus has fewer adverse events then Byetta, the weight lose benefits of all GLP-1’s cannot be ignored.

It will be interesting to see how Novo positions Liraglutide when it gains FDA approval. Will they take on Byetta directly or will they position the drug as an alternative to Lantus. Given the body of data the company has accumulated on the drug they could fight on both fronts. Like Lantus, Liraglutide is delivered via injection once daily. The company has also indicated Liraglutide will come with a pen delivery system and use conventional insulin needles. Looked at side by side Novo reps will stress that both Lantus and Liraglutide offer solid glucose control yet Liraglutide offers the added benefit of weight loss. Given Novo’s well known proficiency for designing pen delivery systems Diabetic Investor suspects the Liraglutide delivery system will be very patient friendly.

Watching all this with great interest are the people at Amylin who own the most valuable asset in diabetes, the once-weekly version of Byetta. Although some people had to be hit on the side of their head with a baseball bat, most now acknowledge that Byetta LAR has the potential to change the paradigm for treating diabetes. Since the facts show that LAR is solid drug, non-believers have latched onto a new issue with the drug namely its delivery system. Based on the rumors being spread one might think the needle used with LAR is larger than a ballistic missile. While the needle will be larger than a conventional insulin needle, studies have already proven that needle size is not a factor for LAR patients.

Another “issue” is the fact that the drug requires mixing prior to administration. Diabetic Investor can understand the needle phobia but this “issue” over mixing has never made much sense. Here too if you believe the rumors one would think a patient needs an advanced degree in chemistry to properly mix the drug. We hate to keep repeating ourselves but neither needle size or mixing will stop LAR, solid glucose control, weight loss and once-weekly administration trump needle size or mixing and yes IT IS THAT SIMPLE.

Amylin has another advantage as their partner Lilly has found religion and now understands that delivery systems matter. While late to the party Lilly has introduced several new insulin pens all of which are huge improvements over their old clunky pens. It would not surprise Diabetic Investor at all if future versions of LAR comes with a convenient delivery system. Think dual chamber where the product is mixed as it is injected. Sources have also told Diabetic Investor that using a rather innovative pen design it’s quite possible to get the needle size down to 27 or 29 gauge. So much for the LAR harpoon needle.

Diabetic Investor does not believe that every patient will switch from Lantus or insulin therapy to a GLP-1. The fact is there will be patients who cannot tolerate GLP-1 therapy and it’s most frequent adverse event nausea. It’s also true that not every patient will respond to GLP-1 therapy. However it’s equally true that GLP-1 therapy has a major advantage with its weight loss capabilities. Both Novo and Amylin have already begun to tout the cardiovascular benefits of GLP-1 therapy and given the concern over adverse cardiovascular events with other diabetes drugs physicians will take notice.

When it’s all said and done this battle for diabetes drug supremacy could come down to how the drug is delivered. The success of Lantus proves that neither patients or physicians are adverse to a drug that’s delivered via injection. This swifts the battle to how and when the drug is injected. Lantus also proved that less frequent administration is a winning concept. A concept that will be taken to a new level when LAR gets here.

Looking at the history of Byetta the non-believers must be kicking themselves. At first they said patients would not use a drug that was injected twice a day. With Byetta sales approaching a billion dollars it’s fair to say that twice daily injections is not a problem. Today these same people cannot dispute the growing body of clinical evidence that shows how effective LAR is, so they have invented new concerns over needle size and mixing. Here too they will be proven wrong but that won’t stop these silly rumors. The reality is that whatever problems Amylin and Lilly have had with Byetta are largely self-inflicted. Both companies appear to have righted the wrongs of the past as they get set to do battle.

This, however, won’t stop non-believers from latching onto any rumor no matter how crazy it sounds. When it comes to the non-believers Diabetic Investor is reminded of something Laurence J Peter wrote; “You can fool some of the people all of the time and all of the people some of the time, but you can make a damn fool of yourself any old time.”

David Kliff
Diabetic Investor
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