Amylin Reports – Clearing Hurdles
With Annual meeting and proxy fight behind them Amylin (NASDAQ:AMLN) is beginning to clear the hurdles Diabetic Investor has previously outlined. Now that LAR is awaiting FDA approval the key for Amylin remains getting LAR through the FDA and into the market. During this evening’s conference call the company announced that the letter from the FDA accepting the LAR submission provided a PDUFA date for approval sometime in first quarter of 2010. Based on this information and what’s publicly know about the status of Liraglutide, which is also awaiting approval at the FDA, it appears that another Diabetic Investor prediction is about to come true as it’s looking more likely that LAR and Liraglutide could come to market within months of each other. Should this happen this puts Novo Nordisk (NYSE:NVO) in the difficult position of selling the once-daily Liraglutide against the once-weekly Byetta LAR.
It should be noted that the company indicated that nearly 70% of Symlin patients are now using the Symlin pen delivery device. This bodes well for the company’s efforts to develop a pen delivery device for Byetta LAR. Combining once-weekly dosing with an easy to use delivery device will only enhance LAR’s broad appeal. Add in the solid data that’s coming out of the DURATION trials and Amylin should everything they need when LAR hits the market sometime in mid 2010.
Looking over the financials and the progress being made towards becoming cash flow positive it’s difficult to find much in the way of negative news. However this being Amylin, Diabetic Investor can almost guarantee that someone will find something to grip about it. Although these past few months have been difficult for the company it appears they are turning the corner. It would be premature to say the company is totally out of the woods and into the sunshine however glimmers of sunshine are on the horizon.