Roche Selects 12 Potential Manufacturing Partners for Tamiflu

December 15, 2005
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Roche Selects 12 Potential Manufacturing Partners for Tamiflu

Roche this week established a shortlist of 12 potential partners that met the company’s criteria for helping to enhance the global supply of its "Tamiflu" (oseltamivir), a neuraminidase inhibitor. Although the names of the companies were not released, Roche already has granted its first regional sublicense to China’s Shanghai Pharmaceutical Group (Shanghai, China, www.pharm-sh.com.cn).

Separate reports have confirmed that the list includes generics manufacturers Teva Pharmaceutical Industries (Israel, www.tevapharm.com) and Mylan Pharmaceuticals (Canonsburg, PA, www.mylanpharms.com).

Roche evaluated nearly 200 requests from manufacturers hoping to take part in the company’s Global Tamiflu Supply Network and help meet the 300 million capacity target of Tamiflu by 2007. Candidates were assessed for their ability to increase the global availability for pandemic use without negatively affecting Roche’s own production capability. Criteria included the ability to contribute to critical manufacturing steps (e.g., bio fermentation, azide chemistry, and combined alcohol granulation and capsule filling) or the ability to fully produce Tamiflu in substantial quantities through contract manufacturing using approved Roche processes and technology transfer and by means of issued sublicenses or deblocking licenses.

The 12 potential partners will now be invited for further “in depth negotiations,” according to the company.

In a company statement, William M. Burns, CEO Roche Pharma Division, explained, “As yet we have not identified anyone who could significantly speed up the agreed delivery timelines for the first half of 2006, but we have been able to identify partners to insure against breakdowns in supply and partners to broaden geographic coverage. Based on the current orders we have received from governments around the world, our capacity to produce 300 million treatments by 2007 is significantly ahead of demand.”

Meanwhile, Roche is negotiating with local partnerships in Asian countries, especially Taiwan, Vietnam, Korea, Malaysia, and India, and emphasized its willingness to discuss supplying government orders in Thailand, Philippines, and Indonesia, where Tamiflu is not patent protected.

Tamiflu is designed to be active against all clinically relevant influenza viruses by blocking the action of the neuraminidase (NAI) enzyme on the surface of the virus. When neuraminidase is inhibited, the virus cannot spread to and infect other cells in the body. In studies involving animal models, Tamiflu was shown to be effective against the currently circulating avian H5N1 strain.

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