I could have been a blockbuster

About the Author

Richard Meyer is a passionate Internet DTC marketer with over 15 years of progressive experience in consumer marketing who`s worked on top pharmaceutical brands like Cialis, Prozac and Sarafem, as well as two years with Medtronic Diabetes. He is currently consulting for his own company, Online Strategic Solutions, and writes a DTC column for PM 360 magazine and blogs for Eye for Pharma in addition to his own blog, World of DTC Marketing.

Has Eli Lilly demonstrated a hard lesson that the drug industry needs to learn quickly ? The faltering start of Efficient in a $6 billion market may hold broader lessons for the nation’s pharmaceutical industry about the realities of launching a drug in the new environment.

When Efficient was in development some unflattering news leaked to the media concerning the results of clinical trials. Although Mr Taurel, Lilly’s CEO at the time, tried to push back the damage was done and soon it was all over the Internet among analysts and physicians. The damage had been too substantial to repair and it seems that Efficient may not live up to Lilly’s expectations. Here are some valuable lessons that come from this product launch and development:

1. The F.D.A. from the start required a black-box warning about a heightened risk of bleeding with Effient, a risk that was highlighted by many physicians. A black-box warning by itself is not the issue here what is the issue is that the black-box warning is about heightened risk of bleeding. If your a physicians do you really want to prescribe this for a patient with that warning?

2. Medco Health Solutions, a pharmacy benefits manager for 60 million Americans, says Effient might not be any better than the market leader, Plavix, which is cheaper even now and will soon be available as a generic. In an unusual move, Medco has begun its own clinical trial to examine the effectiveness of Effient. Lesson: If your product can’t show demonstrated success against the market leader with better patient outcomes than you’re stepping the the plate with two strikes against you.

3. Effient is being squeezed by market forces. On one side, Plavix, approved in 1997, will be sold generically starting late next year. On the other side, the Swiss drug maker AstraZeneca is seeking F.D.A. approval for another blood thinner, Brilinta, which some doctors say may have an advantage over Effient in being shorter-acting and quickly reversible. That can be an advantage for patients who require surgery, reducing the risk of uncontrollable bleeding.

4. An F.D.A. panel recommended approving Effient last year only after Lilly successfully persuaded the agency to remove a cardiologist critic from the advisory panel. Lesson: Perception is the new reality and physicians took notice of this bold move which put more questions in their mind about this product.

Plavix may be expected to fall in price by as much as 90 percent when it comes off patent soon. This means that a lot of benefit managers are going to be recommending Plavix as a first line treatment option for patients. If Efficient doesn’t show better patient outcomes and Lilly can’t manage the perceptions around the drug it’s going to be nothing but a niche product.

With Zyprexa, Lilly’s biggest selling drug, due to come off patent very soon and the loss of market share in the diabetes market Lilly is a company that may soon be acquired or be forced to look at merger options. I worked at Lilly for 5 years and enjoyed my time there but most of the talented people whom I worked with have left. It was a good company to work for but not being ready for the changes in healthcare could have cost it dearly.