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Production partners benefit from Roche's Tamiflu boost

By Gregory Roumeliotis , 23-Mar-2006

Responding to surging demand for its flu drug Tamiflu, Roche has announced it is expanding its external contractors to fifteen in nine different countries, as its needs for intermediates and finished product increase.

This week the US Department of Health and Human Services ordered 3.8m more doses of Tamiflu, and as governments prepare for a potential avian influenza pandemic, Roche has vowed to secure supply by ramping up capacity by 100m treatments to 400m annually.

Albemarle, Ampac, API Corporation, Clariant, DSM, FIS, Martek Biosciences, Novasep/Dynamit Nobel, PHT International, PPG Industries, Sanofi-Aventis, Shaanxi Jiahe Phytochem and Siegfried are among the companies that will be involved in contributing to the overall production of Tamiflu.

 

In addition to deals for the complete production of Tamiflu with India's Hetero and China's Shanghai Pharmaceuticals, Roche has also granted a production sub-licence to another Chinese company, HEC Group.

 

Roche is also looking at sharing know-how to initiate production in Africa, a move that was welcomed last week by the World Health Organisation.

 

The Swiss drug firm has predicted sales this year for Tamiflu will reach 1.1bn to 1.2bn Swiss francs (€7bn-€7.5bn), excluding sales as a treatment for regular influenza.

 

"We are now ahead of demand in meeting the manufacturing challenge, but as a research based company, our role goes beyond this," said William M.Burns, CEO of Roche's Pharma Division.

 

"We are committed to further expanding the knowledge base regarding Tamiflu and the H5N1 virus but we cannot do this alone and we need to collaborate with third parties moving forward."

 

The company is keen to point out that for H5N1 to be the next pandemic strain it must change again, so the effectiveness of Tamiflu against an outbreak of bird flu in humans is far from certain.

 

What is more, the manufacturing of the drug poses many challenges, since the process, which has many complicated steps, takes approximately six to eight months once all the raw materials have been sourced.

 

The starting material of the Tamiflu production process, shikimic acid, is extracted from the pods of the star anise in four mountain provinces in the south west of China, though Roche claims it is substantially increasing its fermentation capacities with the use of special e-coli bacteria which, when overfed glucose, produce shikimic acid.

 

Martek and Sanofi both say they will produce shikimic acid via fermentation; Martek in South Carolina and Sanofi in France.

 

Morover, Clariant has announced it will produce a shikimic acid derivative known as epoxide at a US plant and Novasep will produce a downstream azide intermediate in Germany.

 

Tamiflu, a neuraminidase inhibitor, was invented by Gilead Sciences and licensed to Roche in 1996.

 

To date Roche has accepted pandemic orders for Tamiflu from more than 65 countries worldwide, with several nations ordering enough of the drug to cover 20 percent to 40 per cent of their populations.

 

Another neuraminidase inhibitor, GlaxoSmithKline's inhalable Relenza, is also proving popular at the moment.

 

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