Lilly Responds

As a follow-up to yesterday's post, I am pleased that J. Scott MacGregor who handles public relations for the Humalog brand at Eli Lilly and Company, actually contacted me to share the company's official perspective on the question I posed, and I felt it was worthy of sharing that response with my readers, so here it is:


The development of Memoir spanned 7 years and cost millions of dollars to bring to market here in the U.S. The task of developing the sophisticated electronics -- and then determining how to fit the chip into a pen device that would be both accurate and reliable, dose after dose, and then manufacturing it on a broad scale -- was a daunting hurdle overcome by top-flight device engineers and scientists, both at Lilly and our partner in development, Battelle Medical Device Solutions in Columbus, OH. This was no standard task, and Memoir is no standard pen. Its electronics and memory feature are unlike any pen on the market for the delivery of insulin.

Developing a pen with a memory feature was the direct result of feedback from patient research. Patients told us they wanted an insulin delivery device that would deliver simple and accurate dosing and could help them simplify the daily management of diabetes by easing the burden with a memory feature. Our engineers then set out to deliver on those patient needs, and we're pleased that patients who use Humalog here in the U.S. can now benefit from this innovation.

Could these same engineers design a device with memory that could dose in half-unit increments? Possibly, yes, in the future. But that will require additional years of development, and we didn't want to delay the introduction Memoir to patients here in the U.S.

Clearly, there are some people using insulin who may benefit from half-unit dosing -- in particular, we believe a half-unit pen may be attractive to people who don't need large amounts of insulin or parents of some children with diabetes. HumaPen Luxura HD was developed to fill this need. We're very pleased to be launching Luxura HD in April, and recognize that some people may benefit from a half-unit pen and others from a device with memory such as Memoir.

In the end, the answer is simple: we listen to patients and try to develop new devices that will meet their needs. But the story of the development of these two pens is not nearly as simple as it may seem.

One additional clarification -- Memoir is manufactured in Clinton, MA. The Luxura HD is manufactured in Wisconsin by a different manufacturer.



First, I would like to extend my sincere appreciation to Scott MacGregor for sharing that with us. It certainly clarifies the company's thought process and what led to the two pen delivery device products that Lilly is now introducing. However, I would like to call attention to a few elements.

If Lilly began development of the HumaPen Memoir 7 years ago, yet researched the wants and needs of patients in January 2007, there is something of a disconnect unless other research was done during the product development phase. It would appear that the research was done to prove there was a need for the product and its features, rather than investigating what patients actually wanted or needed. In other words, the horse was put before the cart.

To be sure, the Memoir was a great idea, and there is no doubt that Lilly spent considerable time and resources developing it in order to better meet the needs of patients, but it seems painfully evident that the needs of patients with type 1 diabetes, most of whom remain sensitive to small changes in dosage, have fallen behind the massive type 2 market in the eyes of company management. The real question is whether this is the wisest choice for the management of the Humalog franchise?

In terms of overall patients, type 1 patients remain a key constituency for the insulin franchise, and one I would argue that the company can no longer afford to ignore or consider as secondary to the massive type 2 market. Why? There is no doubt that insulin-using type 2 patients buy much more insulin -- some type 2 patients are so insulin resistant that they require U-500 insulin vs. the standard U-100 -- but their purchase volume does not align quite so well with the overall number of buyers. There are an estimated 4 million insulin users in the U.S., and we know that all 1.1 million type 1 patients are included among them. That means that while the type 1 market consumes less insulin volume overall, they still account for 27.5% of all the people who actually buy insulin. It is already well documented that most type 2 insulin users have far less risk of hypoglycemia than patients with type 1, therefore a half-unit difference in dosage is unlikely to have a material impact. But for many type 1 patients (including many adults), a half unit can literally mean the difference between hyperglycemia and hypoglycemia.

Clearly, many type 1 patients choose an insulin pump because it delivers insulin with a level of precision that they cannot obtain in any other way. Pen devices are clearly aimed at patients who do not pump insulin, whether by choice or due to economics, or because they are recently diagnosed. But the number of new users with type 1 is increasing almost as quickly as the type 2 market. Why? For the type 2 market, many endocrinologists see the hyperinsulinemia which is a symptom of many type 2 patients as part of the problem, rather than the solution. After all, excessive insulin contributes to inflammation as well as elevated lipids and blood fats and other co-morbidities associated with the metabolic syndrome. Among type 2 patients, insulin sensitizer drugs such as metaformin will always be a first-line treatment because they are effective yet inexpensive. As more modern treatments including incretin based treatments like exenatide (Byetta) which Lilly co-markets with partner Amylin Pharmaceuticals emerge, insulin will decrease in relative importance for treatment among the type 2 market. Lilly has been a key beneficiary of this trend (as the marketer of Byetta), but it also suggests that the ever-expanding treatment options for the type 2 market will further erode the need for insulin among this group except among patients with long-standing type 2 diabetes.

While the HumaPen Luxura HD does put Lilly on a more competitive footing with rival Novo Nordisk (and they've lost a LOT of market share to Novo Nordisk in the last 5 years), it really does little to differentiate Humalog or to make prospective users say "I really want to use Humalog because Lilly's pen device helps me in a way that Novolog cannot". And then there is Sanofi Aventis' Apidra, the newest rapid-acting insulin analog. Apidra will clearly continue growing from its tiny sliver of the insulin market, but the real question is where the growth will come from. Although Sanofi's OptiClick pen is not much of a threat today, that could be modified fairly easily. Its painfully evident that more precise dosages were obviously an afterthought for the product developers, not something that was incorporated right from the very beginning. Yet in spite of the Lilly's research, which included both type 1 and type 2 patients, which revealed that 84% said a memory feature would be valuable, and fully 94% said its important to know if they missed an insulin dose, the HumaPen Luxura HD fails to address these needs -- a lost opportunity at establishing customer loyalty.

The most important take away is that while the type 1 market may be smaller in terms of purchase volume for insulin, insulin manufacturers simply cannot afford to overlook the fact that they remain very large in terms of number of overall users. That's something that a company selling insulin cannot afford to overlook.