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Bioxel looks to contractors for scale-up

By Gregory Roumeliotis , 06-Jun-2006

Bioxel, a company which manufactures and markets taxane active pharmaceutical ingredients (APIs) used in chemotherapeutic drugs, has turned to two contract manufacturing companies to scale up production.

Taxane-based drugs accounted for worldwide sales of approximately $5bn in 2005, driven by a demand for the treatment of cancer and other diseases, including psoriasis, rheumatoid arthritis, Alzheimer's disease and cardiovascular disease.

One of these taxanes is paclitaxel, a second-generation drug now in advanced stages of clinical development and in generic drug products currently marketed in North America and Europe.

Bioxel has manufactured and distributed natural paclitaxel for international pharmaceutical companies since 2004 and is now responding to demand by ramping up production.

It also scaling up production of another taxane, docetaxel, derived from a species of Canada yew, Taxus baccata, and also used in the treatment of cancer.

Details of the deals were not disclosed but it is understood the outsourcing companies will carry out the commercial scale-up of specific steps of Bioxel's manufacturing process for semi-synthetic taxanes.

"These agreements represent a key milestone in the industrial scale-up of our technologies and the commercialization of our new taxane products," said Bioxel CEO Pascal Delmas.

"We have aligned ourselves with industry leaders that have the facilities and pharmaceutical expertise to accelerate our development and bring our next products on stream."

In 2005 Bioxel filed two patents covering the synthetic conversion of 9-DHB to paclitaxel and docetaxel.

9-DHB is a side stream taxane that the company produced during the isolation and purification of natural paclitaxel, a product the company presently markets.

These technologies allow for synthetic production of both paclitaxel and docetaxel, two of the world's most widely used cancer therapy ingredients.

Taxanes contained in Canada yew biomass are extracted, concentrated and separated using initial chromatographic purification process.

This stage isolates two intermediate products: 9-DHB and crude paclitaxel, which is the starting material for the current good manufacturing practice (cGMP) manufacturing of pure paclitaxel.

Bioxel can also convert 9-DHB into paclitaxel or docetaxel API using a patented high-yielding process.

The company has built a large inventory of 9-DHB from which it intends to produce its new semi-synthetic taxanes and is looking forward to the opening up of docetaxel to generic competition starting in 2008.

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