FDA, New Products, Regulatory

All revved up and ready to roll, Roche is handed the keys to a multibillion-dollar hemophilia market

Roche has a green light to greatly expand its sales effort behind Hemlibra, the landmark hemophilia drug that is making marketing life miserable at Shire.

The FDA has rolled out an approval for the global heavyweight to start selling their drug — a breakthrough that has nevertheless stirred some uneasiness on the safety side — to patients who have yet to develop factor VIII inhibitors. That market is several times larger than the initial group Roche gained access to last year.

The news was widely expected. Roche’s efficacy data — 96% and 97% reduction in bleeds based on treatments delivered either weekly or every two weeks — had already inspired analysts to mark this drug down as a potential $5 billion a year blockbuster. Roche has also been fine tuning its game plan for the marketing team, which has roiled rivals at Shire and other factor VIII players.

That headache will soon belong to Christophe Weber, the CEO at Takeda. Weber, though, had plenty of time to run the numbers on the impact on the franchise, which they’ll control once the Shire buyout is complete.

Michael Callaghan

Hemlibra is one of the stars of a new cast of drug players for Roche, which needs new money to replace some of the older revenue streams from its aging, unprotected mainstays like Avastin. Roche execs recorded revenue of 23 million Swiss francs for the drug in Q1, saying they were pleased by the early traction they were gaining.

The drug, though, has a potentially dangerous side. Back in the spring Roche alerted patient groups to a case involving one person who developed an anti-drug antibody to Hemlibra, forcing them off therapy. It’s not nearly enough to prevent regulators from getting the breakthrough drug to patients, but it does create risk that has to be factored into the equation.

“(W)e now have a new class of medicine for the first time in nearly 20 years,” said Michael Callaghan, hematologist, Children’s Hospital of Michigan, Detroit. “Hemlibra can reduce bleeds, and it offers a new subcutaneous administration once weekly, every two weeks or every four weeks.” 


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Molecular Templates Jersey City, NJ
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