Amylin Pharmaceuticals
- The company is waiting to hear about its second attempt to get diabetes drug Bydureon approved by the Food and Drug Administration.
- Most of the patient switches from the company's twice-daily Byetta to Novo Nordisk's
(NYSE: NVO) new once-daily Victoza have already occurred. - Prescriptions of Byetta increased 4.2% from May to June.
- The GLP-1 drugs, Byetta and Victoza, are growing fast -- perhaps faster than other classes of diabetes drugs that medications like Merck's
(NYSE: MRK) Januvia, Takeda's Actos, and Onglyza from Bristol-Myers Squibb(NYSE: BMY) and AstraZeneca(NYSE: AZN) are in -- which should be a good sign for Bydureon, which is in the same class. - The company expects to be cash flow positive by the end of the year.
Are you seeing the pattern here? There's a clear focus on the future because the most recent quarter kind of stank.
Sales of Byetta, which Amylin sells with Eli Lilly
As it is, Amylin has a fighting chance of becoming a turnaround story. Based on what the company said the FDA requested in the complete response letter, Bydureon has an excellent chance of being approved when its PUDUFA date comes up in October. And if a once-daily drug can take market share from a twice-daily one, then a once-weekly drug should certainly be able to grab it back.
Amylin is even working on a once-a-month version of the active component in Byettta/Bydureon using the technology from Alkermes