FDAnews Drug Daily Bulletin


Nov. 1, 2005

In the face of growing pressure to increase production of its antiviral Tamiflu, Roche has agreed to open talks with four major generic firms to discuss allowing them to manufacture the drug.

Roche's commitment to meet with the generic companies — Teva Pharmaceutical, Barr Laboratories, Mylan Pharmaceuticals and Ranbaxy Laboratories — follows a meeting with Sens. Charles Schumer (D-N.Y.) and Lindsey Graham (R-S.C.), who have been urging Roche to find ways to boost production of Tamiflu (oseltamivir phosphate). Demand for Roche's anti-influenza drug has skyrocketed in recent months, as nations around the world look to stockpile Tamiflu to guard against a possible avian flu pandemic.

During Roche's recently completed third quarter, sales of Tamiflu more than doubled, increasing to $215.9 million from $85.1 million in the same period of 2004. For the full year, the company expects Tamiflu sales to roughly triple to between $770 million and $925 million. The drug is currently the only known treatment for avian flu.

To help meet rising demand for Tamiflu, Roche recently announced plans to open a new U.S. manufacturing plant dedicated solely to producing the drug, but lawmakers — lead by Schumer — contend that Roche can't meet Tamiflu production requirements by itself.

Under the terms of an agreement announced recently by Schumer and Graham, Roche has agreed to meet with the four generic firms to discuss potential sublicensing agreements for Tamiflu. The deal calls for Roche to "work with companies who demonstrate appropriate capabilities to manufacture Tamiflu in order to accelerate product supply." For companies eligible for a sublicense, Roche has agreed not to increase the price for sublicenses, the senators said.

In addition to negotiating sublicenses with Teva, Barr, Mylan and Ranbaxy, Roche will also begin meeting with other companies that may be qualified to manufacture Tamiflu, the senators said.