Januvia, Acomplia and Byetta
This morning Merck (NYSE:MRK) announced that the European Commission has granted a license for Januvia™, which opens the door for the company to begin marketing the drug across the European Union (EU).
Also today we learned that the FDA will conduct a panel meeting for Acomplia from Sanofi-Aventis (NYSE:SNY). The meeting will be held on June 13th, just a few days before the American Diabetes Association annual meeting.
Finally, based on recent prescription data it appears Byetta from Amylin (NASDAQ:AMLN) has regained some sales momentum although sales appears to be tracking slightly below analysts estimates.
The missing piece of information which should come later this week is what the FDA plans to do with Janumet™, which is awaiting FDA approval.
While Diabetic Investor does not believe these three drugs are joined at the hip, there is a relationship between the three. Januvia continues to perform well and with the EU approval appears well on its way to reaching blockbuster status. Should the panel meeting for Acomplia prove negative this would continue Merck’s good fortune by potentially eliminating a competitor in the type 2 drug category. Even if the meeting goes well and the panel gives thumbs up for Acomplia without restrictions, it will be some time before the drug receives full FDA approval. Amylin is also watching the developments for Acomplia closely as many analysts see the drug as a greater threat to Byetta sales than Januvia.
Some might suspect with the EU’s approval of Januvia that FDA will approve Janumet, which is merely the combination of Januvia and metformin into one pill. Diabetic Investor does not see one event tied to the other. It is not unusual for the EU to approve a drug after the FDA has already done so. Things will become very interesting should there be any delays or changes coming from the FDA on Janumet. The real question yet to be answered is; Is there an issue with all DPPIV’s or are the issues seen with Galvus from Novartis (NYSE:NVS) unique to that particular DPPIV? The FDA’s decision on Janumet will have wide ranging consequences for the entire type 2 market and several compounds under development. Merck officials have publicly stated that a decision should come in late March and with just 5 days left in month we should the answer soon.
While it would be an overstatement to say the future of Januvia sales hinges on the decision, it would be a fair to say that the FDA’s decision will send a message- hopefully it will be a clear message.