Amylin R&D Day
This morning Amylin (NASDAQ:AMLN) conducted their annual research and development presentation. Based on the data presented Diabetic Investor is more firmly convinced that Amylin is the most valuable property in diabetes and at present levels is an outstanding buy.
First let’s take a look at the data for their once-weekly version of Byetta, Byetta LAR. In a study with 295 subjects comparing LAR to Byetta, while subjects on Byetta experienced a reduction in A1c of 1.5%, subjects on LAR did even better lowering their A1c by 1.9% – in fact 3 of 4 patients using LAR the A1c fall below 7%, 2 of 4 fell below 6.5%. Patients on LAR also lost on average 8 pounds and there was approximately 30% LESS nausea for LAR subjects.
Even better was the company providing some additional information on the LAR regulatory path. The company restated that based on current conditions LAR will be submitted to the FDA late in the first half of 2009. However, this date could be accelerated to early 2009 or even late 2008 depending on what the FDA may or may not require. Diabetic Investor suspects the company would not have made such a statement if they did not have confidence in the possibility of submission earlier than late 2009.
This confidence was reinforced as the company announced new studies that will compare LAR to TZD’s/DPP-4, LAR vs. Lantus and as a monotherapy vs. metformin. It appears the company is gearing up for an aggressive launch of LAR once approved. Given the high level of interest in LAR by physicians these additional studies will only reinforce their belief in LAR. While LAR will not be for everyone, its powerful profile combined with simple dosing has the potential to change the paradigm for treating type 2 diabetes.
Not resting on LAR the company also provided additional information on their extensive work in obesity, another (excuse the expression) huge market. Although not as advanced as their diabetes products the company appears to have several exciting compounds in their pipeline. The fact that there is no major obesity drug on the market, the growing problem of obesity and Amylin’s impressive portfolio of compounds only adds value to the company.
Perhaps the most the important fact that wasn’t even mentioned today was that nearly two-thirds of patients with diabetes are not achieving control. Control being defined as by the American Diabetes Association (ADA) as an A1c of 7% or less, the European Association for the Study of Diabetes (EASD) defines control as an A1c of 6.5% or less. Given the data for both Byetta and LAR it’s obvious that both drugs have a substantial positive impact. While there are those who will do their best to concentrate on possible negatives, just as they did when Byetta first came to market, LAR is a paradigm changing treatment option. And yes it is that simple.