Roche Plans New US Manufacturing Facility for Tamiflu while Cipla Prepares to Market Generic

October 20, 2005
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Roche Plans New US Manufacturing Facility for Tamiflu while Cipla Prepares to Market Generic

Despite acknowledging possible patent infringement battles, Cipla Ltd. (Bombay, India, www.cipla.com) this week announced that it will make and commercialize its generic version of "Tamiflu" (oseltamivir phosphate), a neuraminidase inhibitor patented by Roche (Basel, Switzerland, www.roche.com).

At a US selling price of $60 per treatment, Tamiflu is currently in high demand and in critically short supply amidst growing concerns of worldwide shortages of flu vaccines and growing fears of an influenza pandemic.

Roche has been under increasing pressure to license generic versions of the antiviral, which was designed to fight a multitude of influenza viruses and has demonstrated, in animal models, effectiveness against the H5N1 strain believed to cause avian flu.

Legally, generic manufacturers cannot sell the patented drug in Western nations. Nonetheless, all national patent laws, including those of the United States, allow governments to cancel patents during emergencies and either buy generics or force innovators to license their formulations to competing companies.

Meanwhile, this week Roche reiterated that it has been working with many governments over the past few months to determine their needs for stockpiling Tamiflu and that it is willing to enter discussions with governments and private companies on the production of Tamiflu for emergency pandemic use.

In an Oct. 18 company release, Roche CEO William M. Burns said, “In support of the global effort to fight a potential pandemic, we would be prepared to discuss such sub-licenses to increase the manufacturing of Tamiflu, provided such groups can realistically produce substantial amounts of the medicine for emergency pandemic use in accordance with appropriate quality specifications, safety, and regulatory guidelines."

In the release, Roche also announced that it had received approval from the US Food and Drug Administration to provide an additional capsule manufacturing site in the United States for Tamiflu. As the company reports, “this facility is part of a network of more than a dozen production sites for Tamiflu worldwide, more than half of which are with third-party manufacturers.”