Avian Influenza
Roche Sub-licensed Tamiflu Production for China
By Roche
Dec 13, 2005, 15:42

12 potential partners have been identified whose addition to Roche�s Global Tamiflu Supply Network would enhance available supply. Roche also announces that it has granted a sub-license for China to Shanghai Pharmaceutical Group.

William M. Burns, CEO Roche Pharma Division, commented: �Following our open invitation to third parties we have established a short list of partners who can be ready to expand the capacity beyond 300 million treatments annually by 2007. 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. Roche and Shanghai Pharmaceutical Group have signed the first sub-licensing agreement for the overall production of oseltamivir for pandemic use in China. Roche is also in negotiations for local partnerships in other countries.

After systematic screening, Roche production experts started detailed negotiations with twelve companies who met the defined criteria in terms of quality, technical ability, capacity and the speed of bringing that capacity on stream. These companies include major pharmaceutical companies, large generic manufacturers and specialty chemical producers. Roche is now actively engaged in discussions about technology transfers and commercial terms with this shortlist of companies.

As we have surveyed the applications we have focused our attention on how our specialist production team together with each contributing company can further advance global supply,� commented Jan van Koeveringe, Head of Pharma Global Technical Operations.

Roche now shifts its emphasis and resources to technical transfer and implementation. Roche recently announced that it will have increased its own production capacity with existing partners and be in a position to produce 300 million treatments of Tamiflu annually going into 2007. To date all government orders for pandemic supplies have met their agreed delivery dates and with the further stepwise scale-up of its production network activated mid- 2006 Roche will be in a position to bring forward delivery timelines.

In specific countries, particularly in South East Asia, in light of their close proximity to the outbreaks of �bird flu� the company has been in a position to advance delivery schedules.

Taiwan, where Roche will be in a position to deliver requested quantities during 2006

Vietnam, where Roche will be providing capsules or active pharmaceutical ingredient for third parties to encapsulate locally

Korea and Malaysia where Roche are providing capsules

In India where Roche will be delivering 100,000 treatment courses of Tamiflu ordered by the Indian Government and where negotiations about a local sub-license are ongoing with local manufacturers.

In Thailand, Philippines and Indonesia, Tamiflu is not patent protected. These governments are therefore free to purchase or manufacture oseltamivir at their discretion. Roche remains willing to discuss supplying governments� orders and the quality requirements of supply.

Tamiflu exists through innovation as a result of the patent system and it is important that medical innovation continues to be encouraged through the granting of patents. Through its collaboration and sub license policy with Tamiflu Roche contributes to the defense against a potential influenza pandemic while also defending intellectual property rights - the key incentive for future innovation.

In addition, Roche offers a tiered pricing system for the sale of Tamiflu with significant reductions for pandemic use. These lower prices are further reduced for less developed countries.

Roche has also pledged to donate 3 million treatments to the WHO as a rapid response stockpile for use at the epicentre of a pandemic. �The supply chain now being put in place exceeds our current orders from World Governments. Companies we identified to take the capacity further will therefore allow Roche�s supply network to respond to future demands from world governments,� concluded David Reddy, Roche Pandemic Task Force Leader.

Tamiflu was discovered by Gilead and developed jointly by Gilead and Roche. Roche has exclusive world-wide rights for the manufacturing and marketing of Tamiflu and continues to work in partnership with Gilead.

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