Indena Receives Green Light to Start Production of Paclitaxel by Semisynthesis
Milan, Italy -- May 29th 2007 - A brand new facility which will produce Paclitaxel by semisynthesis has been inaugurated by Indena at its main factory in Settala, Italy, 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-tumor 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 $ 3.36 billion USD”.
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. Consistent with the last ten years, Indena has emerged with an exemplary 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”.
Indena is the world's leading company dedicated to the identification, development and production of active principles derived from plants, for use in the pharmaceutical, health food and cosmetics industries. The key to Indena's success is its research, covering: the screening of medicinal plants for their pharmacological benefits; the identification of new active principles; and the development of extraction and purification systems at the cutting-edge of industrial application. Backed up by over 80 years of botanical experience, the phyto-chemical research is carried out in Indena's own Settala Research Center, near Milan. Indena also co-operates with the world's most prestigious universities and private research institutions in the biological assessment of safety and effectiveness up to clinical phase I. The company has more than 150 primary patents and has published around 700 scientific studies. Indena, with more than 700 employees, including 10% dedicated to full-time research, manages cultivation, manufacturing, and distribution operations in more than 40 countries throughout the world. The Company's experts communicate and interact constantly with the major international regulatory authorities such as WHO, EMEA, and ESCOP, and work with all the main pharmacopoeias.
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