Ketan Desai

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.