Bioxel files new patent for taxane manufacturing processes
second international patent application to secure the synthesis of
paclitaxel and decetaxel - two taxane-based drugs effective against
cancer.
The Quebec-based company, which specialises in the manufacturing of taxane active pharmaceutical ingredients (APIs), said this is the second of two key patents that describe the full synthesis of paclitaxel and docetaxel from common starting material isolated during Bioxel's current natural paclitaxel manufacturing process.
This new patent is aimed at protecting the company's unique synthesis processes and intermediates leading to these two taxane ingredients.
Since docetaxel and decetaxel can only be manufactured through a semi-synthetic route, it represents a challenge for generic drugmakers because the route of synthesis and the corresponding intermediates are well protected by the originator.
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.
"The patents give Bioxel a proprietary pathway to the promising docetaxel market, while increasing the overall productivity of its taxane manufacturing platform, thereby enhancing its competitive edge," said the company.
The firm is currently carrying out the scale-up of its taxane production and expects to have a first pilot lot of docetaxel - which is derived from a compound extracted from the needles of yew trees - ready before the end of the year, in an attempt to meet the market opportunity for generic versions of Taxotere, a chemotherapeutic drug marketed by Sanofi-Aventis, which generated $2.2bn in global sales last year.
The first patents on docetaxel will begin to expire at the end of 2007.
In addition, Bioxel currently manufactures and sells naturally-sourced paclitaxel to drug companies focusing on anti-cancer therapies and to generic manufacturers. Its current good manufacturing practice (cGMP) unit is located at its US site.
The company currently holds US, Canadian and European Drug Master Files (DMF) for paclitaxel and has submitted these for use in registered products to regulators in 15 countries.
