Amylin Releases DURATION-4 Data
This morning Amylin (NASDAQ:AMLN) released data from their DURATION-4 study which compared their once-weekly GLP-1 Bydureon monotherapy to Januvia®, metformin and Actos®, and by the way Amylin shares are reacting one just might get the impression that Bydureon failed to meet expectations.
According to a company issued press release; “After 26 weeks of treatment, patients randomized to BYDUREON experienced a reduction in A1C of 1.5 percentage points from baseline, which was significantly greater than the reduction of 1.2 percentage points for Januvia. Patients randomized to metformin experienced a reduction in A1C of 1.5 percentage points, and patients receiving Actos experienced a reduction of 1.6 percentage points.”
The release also states; “Treatment with BYDUREON produced an average weight loss of 4.5 pounds, which was statistically significantly greater than the average 1.7 pounds patients lost with Januvia and the average 3.3 pounds patients gained with Actos. Patients receiving metformin experienced an average weight loss of 4.4 pounds.”
What the Street is reacting to is a couple of somewhat surprising numbers, while Bydureon produced better A1C reduction than Januvia, the reduction was equal to patients taking metformin and slightly lower than the reduction produced by patients taking Actos.
Also surprising were the weight loss numbers that patients taking metformin actually lost on average 4.4 pounds. A possible explanation for these somewhat surprising numbers is that in DURATION-4 patients were drug naïve and prior to the study used simple diet and exercise to control their diabetes. Given that the study only lasted 26 weeks it’s not that surprising that all the therapy options lowered A1C and three of the four produced weight loss. Given what we know about all the therapies used in this study Diabetic Investor suspects that had it gone on longer, the metformin patients would likely see the initial weight loss dissipate as they would likely regain the weight.
Put in perspective it really isn’t that surprising all four therapies did a solid job of lowering A1C or that other than Actos three of the four yielded some weight loss. The real key is what happens over a period longer than 26 weeks and again given what we know patients on Bydureon would see continued weight loss while patients on the other therapies would plateau and in many cases regain the weight over time.
Also lost in all this data is the fact that Bydureon is administered just once a week, while the three oral therapies are taken multiple times each day. As we have noted several times therapy compliance is critical to not only achieving A1C control but sustaining that control over time. Several studies have noted that a major factor for patients not achieving control is therapy non-compliance, and it didn’t matter if the patients where on oral meds or an injectable such as insulin. What all these studies had in common is that patients had to take their meds each and every day, usually multiple times per day.
It should also be noted that in the real world besides taking multiple medications to control their diabetes these patients are also taking other medications. According to www.healthyoutcomes.com, 40% of the patients with diabetes take 4 or more medications each day. Also according to www.healthyoutcomes.com, 74% take medications for conditions other than their diabetes. Or put another way, the less frequently a medication needs to be administered the better.
Perhaps once Bydureon is fully approved by the FDA and becomes available in the real world the Street will find religion and wake up to the fact that besides its solid A1C lowering and ability to produce sustained weight loss, once weekly administration is a huge plus for Bydureon. As Diabetic Investor has noted before Bydureon is not a wonder drug that will be used by each and every patient. However, when you look at the total package Diabetic Investor sees no reason to stray from our previously stated position that Bydureon has the potential to be a paradigm changing drug.
Anyone who has missed previous opportunities to buy Amylin shares or add to their existing holdings should consider buying when weakness occurs. The Street has rarely gotten it right when it comes to Amylin and this is one more time when they react without thinking. Take advantage of the opportunity while you can.