Now Comes The Hard Part
This morning we learned that Amylin Pharmaceuticals (NASDAQ:AMLN) has submitted their long-acting once-a-week version of Byetta, Byetta LAR to the FDA. According to a company issued press release:
“Clinical components of the NDA include the DURATION-1 study and the meta-analysis of primary cardiovascular events across the BYETTA clinical database. DURATION-1 was designed to test the superiority of exenatide once weekly, as compared to BYETTA, which is administered twice daily. In this study, exenatide once weekly treatment resulted in statistically significant reductions in A1C of 1.9 percentage points from baseline, compared to a reduction of 1.5 percentage points for BYETTA, and 77 percent of patients treated with exenatide once weekly achieved an A1C of 7 percent or less compared to 61 percent of patients treated with BYETTA. Exenatide once weekly and BYETTA were both associated with an average weight loss of 8 pounds from baseline. The most commonly reported adverse event was nausea, which was typically mild and transient and occurred less frequently in the exenatide once weekly patients. In addition, a meta-analysis across controlled clinical studies of three months or greater from the BYETTA database showed no increased risk of cardiovascular events associated with exenatide use. This analysis applied principles outlined in the FDA’s guidance for evaluating cardiovascular risk in type 2 diabetes agents.”
This is a significant step for Amylin and comes just a day after the company announced they were restructuring their sales force. In separate press release issued late yesterday the company stated;
“Amylin’s existing primary care and specialty sales forces will merge into a single organization that brings a specialty approach to endocrinologists and diabetes-focused primary care physicians. The changes are expected to be implemented in the next several weeks and will reduce the total number of Amylin sales representatives by approximately 35 percent, or 200 employees, and will result in an annualized benefit of approximately $45 million to GAAP operating results in 2010.”
With LAR now at the FDA and the changes to the sales force taking place the company can now concentrate on their proxy fight with Carl Icahn and Eastbourne Capital. Some may recall that Mr. Icahn indicated that he felt the company was allocating too much capital towards selling Byetta to primary care physicians and felt the company’s sales efforts should be realigned. It’s unknown if the reduction of 200 employees will satisfy Mr. Icahn but it seems as though Amylin is listening to his concerns.
While Diabetic Investor sees both moves as positive steps forward for the company the real test will come with how the FDA handles the LAR submission. Using the Liraglutide submission as a guide it’s almost a slam-dunk certainty that the FDA will conduct a panel meeting for LAR just as they did for Lira. As with Lira we really won’t know much about what the FDA is looking for until just days before the panel takes place. Hopefully for Amylin when the documents are released they won’t contain any surprises as they did with Lira. But it’s anyone guess what the FDA will do and we can only take a wait and see approach.
The next big event for the company is their annual meeting which will take place on May 27th and be covered by Diabetic Investor. Just days after that meeting ends it’s on to the annual ADA conference in New Orleans which is setting up to be one of the more intriguing conferences in some time and could top last year’s conference for news content.
If approved Byetta LAR will be game changing technology with the potential to generate billions in sales. Amylin and their partner Lilly (NYSE:LLY) know this which is why they have already begun to plan for enhanced delivery of LAR in a patient friend pen device. Let’s also hope the two partners have learned from their past mistakes when Byetta first came to market. LAR is the goose that lays the golden eggs not just for Amylin and Lilly but the millions of patients with type 2 diabetes who are anxiously awaiting LAR’s arrival.