Semi-synthetic paclitaxel production starts in Italy

Semi-synthetic paclitaxel will be produced in Settala, near Milan, and the semi-synthetic version will be marketed alongside the natural paclitaxel. Indena commercial director Daniele Giavini said: "This new high-containment plant [will] help Indena strengthen its position as world leader in the production and semi-synthesis of taxanes." "The aim was to capture an increasing share in a market where finished products have exceeded an annual global turnover of some €2.5bn. The aim of the company is to respond to market demands, by moving over to a more competitive semi-synthetic active principle,"​ Giavini said. The main advantage to moving to semi-synthetic prduction would be the increase in production efficieny in the competitive industry, Indena marketing director Christian Artaria told in-PharmaTechnologist.com. "The main reason of this move is to respond to market demands. Indena is by far the largest producer of paclitaxel worldwide. The target of Indena is to maintain this leadership."​ Semi-synthetic paclitaxel would be built using a specific patented semi-synthetic process based on using 10-Deacetylbaccatin, a molecule extracted from European yew trees (Taxus baccata​), which are cultivated in the company's own North Italy plantation. The technique differs from obtaining natural paclitaxel, which can be extracted directly from the raw material. The 10-Deacetylbaccatin acts as an intermediate for the production of various antitumour molecules, of which the most common is paclitaxel. Paclitaxel, the active pharmaceutical ingredient (API) in Bristol Myers Squibb's anti-cancer drug Taxol, belongs to the taxane family of cytotoxic molecules. The family also includes docetaxel, which is the API in Sanofi-Aventis' Taxotere for breast, non-small cell lung, prostate, gastric, and head and neck cancers. A novel second-generation taxane, ortataxel, has been found to be 20 to 30 times more potent that either paclitaxel or docetaxel, and is still in ongoing trials, though Indena has developed a semi-synthetic pathway for it. The market for taxane-based drugs is massive, driven by a demand for cancer treatment. In 2006, the taxane drug market was estimated at $4bn (€2.98bn) and paclitaxel API's represent a global market of around $150m. Indena, which specialises in the identification, development and production of active principles derived from plants, was one of the first companies to move into this niche market and exports products to the US. Fellow taxane-producing company Bioxel Pharma is also looking to offer semi-synthetic paclitaxel by 2008.