Ketan Desai

Amgen Prevents Biotechs from Reaching Profitability

"E&Y acknowledges it thought 2007 was gonna be the year biotech crossed that all-important threshold".

Gonna be? Time for a remedial course in English writing.

Three Game-Changers For Big Pharma

The author is incorrect in stating that Amgen will have to conduct a fracture study (instead of simply relying on BMD) for Denosumab due to the Vytorin. Fracture studies are the standard in phase III osteoporosis studies. Look at the FDA guidance document:

www.fda.gov/CDER/GUIDA...

Also, look at Novartis' Reclast that also had fracture in its studies:

www.bio-medicine.org/m.../

Finally, Denosumab is not a me-too drug. It is an antibody - not a bisphosphonate.

Amgen: A Random Gamble?

Most of Amgen's Epo/Aranesp problems are already factored into the stock price. The future of Amgen is dependent on its pipeline, of which Denosumab (for osteoporosis) is perhaps the most prominent. The competition in the osteoporosis market is not just with Fosamax, but with many other drugs. I will be writing an analysis on this soon.