Case Study: Specialty Chemical use for Generic Oseltamivir (Tamiflu®)

Oseltamivir, an anti-viral drug better known under the brand-name Tamiflu®, was invented by Gilead Sciences and subsequently licensed to F. Hoffman La Roche Ltd. Since the 1999 launch of Tamiflu® sales, over 33 million patients have been treated world-wide. A significant number of additional sales are due to stockpiling by governments around the world in preparation for an influenza pandemic. It is estimated that in 2006 Roche's production capacity will have reached 300 million doses per year. Oseltamivir is a compound for which there will continue to be a high demand. Shikimic acid, the starting material used to produce oseltamivir, is traditionally sourced from pods of the star anise plant, which grow only in the mountainous regions of China's southern provinces. Third-party suppliers, who work in close collaboration with Roche, are responsible for harvest and purification. Shikimic acid can also be produced by fermentation – a patented process licensed by Roche through which they eventually intend to produce a majority of their shikimic acid. As a result of Roche's two sourcing strategies, shikimic acid is not readily available to other drug manufacturers.

US and Canadian patent protection for oseltamivir expires in 2016. It is generally accepted that in Canada generic drugs will very quickly capture approximately 80% of the market due to the “forced subsitution” required by drug insurance plans. However, generic manufacturers will be unable to produce a generic equivalent to Tamiflu® if they cannot obtain shikimic acid. As a licensee of the same fermentation technology used by Roche to produce shikimic acid, Upcycled Aromatics would be ideally positioned as an alternate supplier of high quality shikimic acid. Agreements established with generic drug manufactures would allow us to capture a share of the lucrative shikimic acid market while reducing or eliminating the associated uncertainty.