Intercept Pharmaceuticals is gearing up for a potential launch in the up-and-coming NASH field—and it’s not taking the opportunity lightly.
Intercept COO Jerry Durso said last week that the company has already made “significant progress” toward rolling out obeticholic acid to treat nonalcoholic steatohepatitis, also known as NASH. Approved as Ocaliva to treat primary biliary cholangitis, the drug could be up for an FDA decision in the first half of next year.
In NASH, Durso said his company has initiated payer talks and hired an internal sales force to support the rollout. It’s also working with a contract sales team “to give us additional reach and flexibility,” he said on a recent conference call.
The NASH approval would be focused on patients who've developed fibrosis in their livers. Patients suffering from advanced fibrosis have no treatment options, Durso said, and their doctors are “eager" to treat them and prevent their progression to cirrhosis. Progression to cirrhosis can occur in 14 months for some patients, he added.
“These patients are critically ill and the urgency to treat is paramount,” Durso said. The company has already launched its unbranded disease education push NASH Truth.
Payers recognize the need for treatment as well, Durso said. With the FDA's support, the company has started “proactive discussions” with payers based on its phase 3 data, and Intercept believes the drug's "strong value proposition … resonates with payers and we'll continue to make the communication of this benefit a top priority."
For the rollout, Intercept plans to target 15,000 hepatologists and GI specialists in the U.S. Already, it’s worked with about 5,000 of those doctors in promoting Ocaliva’s original indication, with 55 territory business managers heading that effort.
The company is planning to bump that number up to 150 for the new rollout by launch time. On top of that 150-strong sales team, the company is working with contract sales reps, and it has already trained the “first wave” of those experts, Durso said. They’re already working with specialists.
Intercept filed its FDA application for the new obeticholic acid indication in September. At the time, the company requested a priority review because the drug had previously scored a breakthrough therapy designation. If granted, the shorter review would give the drug a 6-month review time, setting up a potential approval in the first half of 2020.
As Intercept gears up for the rollout, the company recently released a phase 3 data analysis that found treatment with the drug “resulted in early and consistent improvements” in their conditions that could be detected with noninvasive tests. The results suggest that the tests could be used to monitor how patients respond to treatment, offering advantages over liver biopsies.