Roche Says Mircera Filing in U.S. and EU Proceeding as Planned

Roche's pending applications for investigational erythropoiesis-stimulating agent (ESA) Mircera in the U.S. and Europe are proceeding according to plan, William Burns, CEO of Roche's pharma division, said.

Safety concerns with ESAs prompted recent congressional scrutiny following an FDA announcement warning physicians about use of the ESAs for both oncology and end-stage renal disease. Roche has previously halted a Phase II dose-finding trial of Mircera in non-small-cell lung cancer patients with chemotherapy-induced anemia.

"All the significant issues are behind us. We're now talking labeling and some of the fine tuning," Burns said. "There's a very clear understanding that the renal anemia is a different segment than the cancer area and we see no influence at the moment with our interactions with the regulators coming from that."

Roche also reported strong sales for anti-influenza drug Tamiflu (oseltamivir), which were up 47 percent to $581 million. However, Burns noted that the firm was sticking to the previous forecast of $660 million to $1 billion.

The FDA recently approved the first vaccine for H5N1 influenza virus, manufactured by sanofi-aventis. When asked how the firm viewed the approval with respect to future Tamiflu sales, Burns said: "Frankly, I don't think of the vaccine in any way as our competitor."

"If there's a major outbreak, it will not be H5N1. That's been around now for a couple of years. It's not showing strong signs of man-to-man transmission." Burns said. "So I think there is still a role for both."