Things are getting better for Amylin

Things are getting better for Amylin

Yesterday Eli Lilly (NYSE:LLY) announced they were halting development of their Alzheimer drug, semagacestat. Lilly had hoped semagacestat would provide the company with some protection from their many drugs which are about to lose patent protection. Humalog®, the company’s short-acting insulin, which generated nearly $2 billion in sales in 2009, is set to lose patent protection in May 2013.


Yesterday the Archives of Surgery published a study entitled; “Medication Utilization and Annual Health Care Costs in Patients With Type 2 Diabetes Mellitus Before and After Bariatric Surgery.” In the comment section of the study the authors write; “We observed that independence from diabetes medication was almost immediate within the initial months after surgery and did not correlate with the gradual weight loss expected. This supports the theory that the resolution of diabetes is not due to weight loss alone but is also mediated by gastric hormones with the 3 most implicated being peptide YY, glucagonlike peptide, and pancreatic polypeptide. As a known mediator of insulin regulation, glucagonlike peptide levels have been noted to increase immediately after bariatric surgery and may explain why surgeons have noted complete resolution of diabetes in some cases within days after surgery.” (Highlighting added by Diabetic Investor)


Some may be more familiar with term GLP-1, which stands for Glucagon Like Peptide.


While these two events may seem unrelated to Diabetic Investor this is just more good news for Amylin (NASDAQ:AMLN). Lilly, already in a tough spot with patent expirations, has basically become dependent on Amylin in they intend to remain a relevant player in diabetes; a situation which will only get worse when their leading diabetes product Humalog goes off patent in 2013.  Even without the Humalog situation, Lilly was in a tough spot as Novo Nordisk (NYSE:NVO) and Sanofi-Aventis (NYSE:SNY) have taken the leadership roles in diabetes, in particular in the insulin category.


The one area where Lilly holds a major edge is in the growing GLP-1 category and their relationship with Amylin. Although Byetta sales have stagnated recently, Bydureon the once-weekly formulation of Byetta is about to be approved by the FDA and give the company a huge competitive advantage over both Novo and Sanofi.


Although the study published yesterday was not intended to support the use of GLP-1 therapy it does show the important role this peptide plays in treating diabetes. Like Byetta, patients using Bydureon have seen significant improvements in glycemic control with the added benefit of weight lose. Bariatric surgery may be appropriate for those patients who are morbidly obese; Bydureon appears to be a solid fit for the millions of obese patients with Type 2 diabetes.


As if we need even more evidence that Bydureon has the potential to change the paradigm for treating Type 2 diabetes, Diabetic Investor has been reaching out to endocrinologists and primary care physicians to see if their opinion of Bydureon has changed since the last time we spoke. In our previous discussions the majority of physicians were anxious for Bydureon to come to market. Besides the benefits of solid glycemic control and weight loss, these physicians who deal with patients on a regular basis, believed the once-weekly delivery of Bydureon would enhance patient therapy compliance.


Much has changed since that time as Novo has launched Victoza® and Roche has delayed their long-acting GLP-1.  When asked how the Black Box warning that came with the approval of Victoza impacted their usage of Victoza the majority said it had no impact. They were aware of the warning but did not consider the thyroid issue to be serious. While we found greater usage of Victoza in the endo community, primary care physicians were using the drug as well.


When asked if they we’re still anxious for Bydureon to get here, the answer was a resounding yes. As we expected, when we asked if Bydureon also came with the same Black Box warning as Victoza would it change anything the answer was also a resounding no. Their biggest concern not surprisingly was what the Bydureon delivery system would look like and how much time it would take to train a patient. Unlike Diabetic Investor none of these physicians had seen the delivery system, which as we have written before is much more patient friendly than originally anticipated.


It was also interesting that a mere handful were even aware that one day Bydureon would come in a pen.  When informed Amylin was working on a pen delivery system for Bydureon you could hear the genuine excitement in their voices. The overwhelming consensus, from both groups was, when you combine once-weekly administration with a pen delivery system (assuming of course no unknown issues) sales would go through the roof.


Having followed Amylin for many years Diabetic Investor has learned not to get too far ahead of ourselves. Over the years the company has seen more than their share of ups and downs. We also know that their relationship with Lilly hasn’t been all love and kisses. Yet, as things stand today with the cards currently dealt Diabetic Investor likes what we see. There is still one more card to be dealt and experienced poker players known even when you’re holding the best hand anything can happen when the river card comes up. With the PDUFA date for Bydureon just a few weeks away, we’ll soon see if Amylin’s aces hold up.