Hep C Discussion Forum

Julie M. Donnelly

Reporter- Boston Business Journal

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The U.S. Food and Drug Administration has issued a letter to Vertex Pharmaceuticals (Nasdaq: VRTX) saying the company published a misleading branded story promoting its drug for hepatitis C, Incivek. The FDA is demanding that the Cambridge, Mass.-based company, which won FDA approval for the drug in May of 2011, stop disseminating the materials in question.

The letter reads in part, The branded story is misleading because it overstates the efficacy, omits material facts and minimizes important risk information about the drug product.

Vertex spokeswoman Erin Emlock said that the branded story had not yet been used as the basis for a patient presentation, which was its intent. "We are re-evaluating it," Emlock said. "we take the FDA's feedback seriously and will address the concerns raised."

The branded Incivek story described the experience of a patient named James, who had stage 3 cirrhosis due to hepatitis C and failed to have a response on another drug regimen. He found the drug combination including Incivek to be effective.

The story included statements such as:

And six months after treatment ended, I found out Id cleared the virus. That made me feel so good. I was so happy to know Id be around a little longer to see my son grow up. [page 5]

. . .Im cleared, I can take my son to the batting cage. We go sailing on my boat and take nice vacations. I even retired from the railroad and started a successful cab business, which I really enjoy. Im loving life. [page 5]

The FDA found that while these statements might reflect this patients experience, it is misleading because it implies that all such patients will successfully achieve a Sustained Virologic Response (SVR).

The FDA says that in fact, only 14 percent of patients like James, with cirrhosis who failed to respond on other drugs, achieved an SVR with the Incivek regimen.

The FDA asked Vertex to respond to the letter by June 11, detailing whether the company plans to comply with the agencys request, listing all promotional materials that include violations, and providing a plan for discontinuing their use.

On Tuesday, Vertex revised data it had previously reported on the effects of another drug, Kalydeco, when used in combination with a potential treatment, VX-809, with cystic fibrosis (CF) patients. By Wednesday afternoon, the company's stock had substantially recovered from a drop of more than 20 percent, triggered by that news.