Category Archives: Schering Boceprevir Vertex Telaprevir JNJ drug Hep C ca

Vertex Pharma: Lauded for "Tackling Toughest Hep C Non-Responders" with its Teleprevir Candidate. . . .

A new economy biz-source called Xconomy — Boston is moving a story on the exciting, and accelerating, lead Teleprevir, the Vertex next-generation Hep C drug candidate is extending over the Schering drug candidate, boceprivir — do go read it all, but here’s a salient quote:

. . . .Regulators in the U.S. and Europe allowed Vertex to recruit the hardest cases, known as “null responders” into the clinical trial. Those patients aren’t being allowed into a large trial of Schering-Plough’s competitor, boceprevir. Vertex was able to get those patients included based partly on promising data from a mid-stage study called Prove 3, which has shown that 52 percent of patients on telaprevir had no evidence of the hepatitis C virus left in the blood for at least three months after completing therapy. Standard treatments given a second time do that well for about 15 percent of patients. That kind of difference in effectiveness means big bucks for telaprevir: an estimated 6 million people in the U.S. and Europe have chronic hepatitis C infections, and about 650,000 have failed on the standard treatment. Telaprevir alone could generate $2.6 billion in U.S. sales in 2013 when factoring in patients who failed treatment and those who are new to therapy, according to Rachel McMinn, an analyst with Cowen & Co. in San Francisco.

Vertex’s telaprevir will show strong data in treatment-failure patients that significantly outshines prior data for Schering-Plough’s boceprivir,” said McMinn, in a note to clients last month, which looks ahead to presentations at the American Association for the Study of Liver Diseases annual meeting in November.

Showing a benefit among the toughest-to-treat patients is important to Vertex, partly because it would appeal to the group of patients who are most motivated to seek new treatment options, and because it could enable the company to make claims that Schering-Plough won’t be able to, says Kurt Graves, Vertex’s chief commercial officer. It also could strengthen the overall package of evidence supporting use of telaprevir, which is being tested in a pivotal study among patients new to treatment, called Advance. . . .

I would also note that Schering-Plough has still not enrolled a single Phase III patient in its boceprivir trials (still presumably negotiating trial design issues with FDA, and thus still actually remaining in Phase II with its candidate) — while
Vertex has already enrolled patients in its Phase III trial. Thus, it seems plain, Vertex is in the lead, at the moment, in this particular horse race to the US Hep C market.

Finally, remember that Schering’s candidate will likely — at best — cannibalize its own existing Hep C treatment franchise — and that is only if Schering gets to the US market first. Should Vertex win the day — it will quckly, and fundamentally shift most of Schering’s existing Hep C franchise, right out from under it — transferring that revenue, and profitability, directly to Vertex’s income statement.

How much?

North of $2 billion by 2013. Wow.

Vertex’s shares opened up $0.43 on this news, this morning, in a falling market.