May 29th, 2007

A GREEN LIGHT TO START PRODUCTION OF SEMISYNTHETIC PACLITAXEL: A brand new facility for the manufacture of high power cytotoxic active principles
The FDA awards "full marks" to the Settala plant

Milan, May 29th, 2007 - A brand new facility which will produce Paclitaxel by semisynthesis has been inaugurated by Indena at its main factory in Settala, near Milan. The semisynthetic active principle will be marketed alongside the natural Paclitaxel and is further testimony to the leadership of Indena, already the world's major producer of this most widely sold active principle, a well-known anti-tumour agent.

Commercial Director Daniele Giavini declared that "this new high-containment plant would help Indena strengthen its position as world leader in the production and semisynthesis of taxanes.  The aim was to capture an increasing share in a market where finished products have exceeded an annual global turnover of some 2.5 billion euro".

Semisynthetic Paclitaxel is obtained using a specific process patented by Indena based on the 10-Deacetylbaccatin, a molecule extracted from yew trees (Taxus baccata) cultivated in the company's-own plantations. The 10-Deacetylbaccatin acts as an intermediate for the production of various anti-tumour molecules such as Paclitaxel, Docetaxel and others on which the company is still experimenting.

"The aim of the company - Daniele Giavini explained - is to respond to market demands, by moving over to a more competitive semisynthetic active principle; as per all company products we have direct control over the entire supply chain from initial plantation to the end product".

The processes used in the production of natural Paclitaxel as well as all the other active principles which Indena exports to the United States underwent an inspection last March by the American Food and Drug Administration, the body which governs the sale of pharmaceuticals in the US.  The FDA inspectors reported total conformance with their exacting standards for Good Manufacturing Practices (GMP) and renewed the company's "permit" to continue to export active principles to the US, without requiring any kind of corrective measure. 

According to Ernesto Martinelli, Group Quality Assurance Director: "the properties of a product derive, not only from the quality of raw materials and the successful implementation of advanced production methods, but from a tried and tested Quality Assurance System. As has been the case for the last ten years, we have emerged with flying colours from an inspection conducted by one of the world's most stringent bodies. This is further confirmation of how quality in Indena is a concept which embraces all stage of production from start to finish".

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