Docetaxel head to head

Canadian firms BioVectra and Bioxel both announced moves in their taxane portfolio last week, with the two companies aiming to complement their paclitaxel offering with the potentially lucrative addition of docetaxel to their catalogues. Bioxel announced the availability of its version of the active pharmaceutical ingredient (API), with drug master files (DMFs) already filed with the US Food and Drug Administration (FDA) and Health Canada. The launch at CPhI was proving very successful when In-PharmaTechnologist caught up with the company's head of operation, Paul Metz, at the show. "Everything we've made up until now has been sold, and we're pre-selling material from our validation campaign,"​ he said. "About half of that is already committed now…It's going to be a big product." ​ Bioxel uses the Canadian and US manufacturing facilities of CMO Ampac to produce its taxane products. The company has patented a semi-synthetic route to docetaxel starting from a side stream taxane captured during its natural paclitaxel process. Since the process was brought on-stream in 2004, the company has accumulated over 150Kg of an intermediate taxane called 9-DHB - the starting material for the semi-synthetic route to paclitaxel and docetaxel. According to Bioxel, this is enough material to secure the full development and commercial launch of several formulated products. Meanwhile, fellow Canadian firm BioVectra has announced a partnership with Taxolog to commercialise proprietary technologies for taxane semi-synthesis and the submission of an abbreviated new drug application (ANDA) for formulated docetaxel. The partnership provides BioVectra with technology developed by Robert Holton of Florida State University, based on 10-deacetylbaccatin III (for the synthetic conversion of paclitaxel to docetaxel) and an innovative route of side-chain synthesis that avoids expensive side chain starting materials or taxanes with limited availability. BioVectra's docetaxel will also be manufactured in Canada, with enough capacity to serve the world market, according to CEO Dale Zajicek. Both companies cite their unique technologies as the selling point of their products, with efficiency and non-IP infringing features particularly emphasised. The products garnered much interest during the CPhI trade show, with manufacturers keen to get involved when patent expiries open the way for the generic docetaxel market. Docetaxel is the active ingredient in Sanofi-Aventis' blockbuster cancer drug, Taxotere. The drug generated sales of €923m over the first half of this year alone, but is due to start losing patent protection from the end of this year. Taxotere is currently approved for five different cancer types in the EU and US, and only a week or so ago Sanofi announced US approval of the drug for the treatment of locally advanced head and neck cancer prior to chemoradiotherapy and surgery. Although the patent expiries that are looming will no doubt dent Sanofi's Taxotere derived income, the company also has other taxane derivatives in development, some of which appear to be showing greater efficacy and safety than Taxotere in clinical studies.