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.

Esperion Spin-Off: Does It Signal the Start of a New R&D Era?

Good analysis. I would go further and say that Big Pharma may change so that each company becomes a holding company. Each therapeutic area could be spun off into a separate company. There are plusses and minuses to this. The advantage is that an individual therapeutic area does not feel it is being held down by another, or is getting a step-motherly treatment. The disadvantages are that cross-functional learning and applications will be lost, as will flexibility in terms of human resources, scale, etc.