Roche's Xofluza scores trial win in flu prevention, providing sales hope as Tamiflu craters

Xofluza
A strong clinical trial showing in flu prevention could help Roche's Xofluza pick up the slack left behind by Tamiflu's generic turn. (Roche)

With sales of Roche’s Tamiflu cratering after it went generic three years ago, the company is anxiously monitoring successor flu drug Xofluza’s chances. Now, the drug has scored new preventative data that could nudge sales upward.

A single dose of Xofluza beat placebo at preventing the onset of symptoms in patients exposed to a family member with the flu, according to a phase 3 trial released this week. Only 1.9% of Xofluza patients developed symptoms, compared with 13.7% of patients taking a placebo.

Roche plans to take those results to regulators for a potential new approval. “Preventing otherwise healthy people from developing the flu virus will reduce the overall societal burden of disease, and we look forward to sharing these data with health authorities around the world,” said Sandra Horning, R&D chief at Roche's Genentech unit.

Free Webinar

Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This webinar will discuss the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

Xofluza’s trial win could help Roche absorb the blow from Tamiflu’s continuing slide after generics hit the market in 2016. In the first quarter, Tamiflu posted a 40% sales drop from the same period the previous year, down to $180 million.

Xofluza hasn't pitched in much since its approval late last year. In the first quarter, it posted a measly $6.06 million for Roche—all in U.S. sales. But there's hope: Partner Shionogi, which owns the rights in Japan, cleared $243 million in domestic sales in fiscal 2018.

RELATED: Will mutant strains hurt prospects for Roche's flu-fighting newcomer Xofluza?

Still, Xofluza is not only fighting an uphill battle against established Tamiflu generics but also must contend with some troubling Japanese data indicating the drug’s vulnerability to mutant strains of the flu.

As of February, the National Institute of Infectious Diseases in Tokyo had already identified six resistant strains, casting a shadow over the novel drug’s future chances on the global stage. Those results backed up Shionogi’s initial clinical data, which found that 25% of children in late-stage trials had resistant strains of the flu.

Roche in February said while mutant strains had been identified, they only showed “reduced susceptibility” to Xofluza instead of full resistance, meaning they were not classified as resistant by U.S. regulators.

Xofluza also stands to lose from clinical trial data showing statistically insignificant improvement of flu symptoms over time compared with Tamiflu. In a phase 3 trial, dubbed Capstone-2, Xofluza showed improvement of symptoms in patients at 73.2 hours, topping Tamiflu’s 81 hours but still not enough to hit the trial’s primary endpoints. That result mirrored earlier Capstone-1 trial data that found little difference in symptom improvement time between the drugs.

Suggested Articles

Amgen could soon face new competition in the PCSK9 class, but an efficacy boost in treating high-risk heart attack patients could help keep it ahead.

In its quest to become the dominant SGLT2 diabetes med for heart failure, Jardiance is touting DPP-4 inhibitor-topping data to support its case.

Despite having lost some of its novelty, AZ's Brilinta is touting bleeding data over aspirin that could be a big break in acute coronary syndrome.