I feel compelled to update Bydureon progress since I've posted about it a few times. I don't feel that I can leave you hanging in suspense.
The WSJ reports today that Amylin will send its response to the FDA this week on the agencies queries regarding Bydureon. Bydureon is Amylin's important new 1x per week drug for the treatment of type II diabetes.
The drug's success is critical to Amylin's future financial picture. When it is approved, Amylin's partner, Eli Lilly, will bestow a $40 M milestone payment on the company. The drug is also needed to fight off new competition from Novo on Amylin's current product, Byetta. Lilly is submitting Bydureon for approval in EU.
The FDA in March had asked for more information on Bydureon's label, risk management plan, and manufacturing process. No new clinical data was required. The review period that the FDA will take is unknown but can be within 60 days to 6 months depending how the resubmission is treated.
Bydureon is a new class of compound called a GLP-1 analog that is similar to a human gut hormone that induces greater insulin production to regulate blood sugar levels. Once Bydureon is approved, Amylin plans to continue work on a next version drug that can be administered only 1x per month. This is in preparation for expected competition from Roche's Taspoglutide and GSK's Syncria both in late stage trials.
Amylin expects to be showing positive operating cash flow by the end of 2010 based on Bydureon approval. Start the countdown now.