DMF for ScinoPharm's docetaxel
been assigned a drug master file (DMF) number for its anti-cancer
ingredient docetaxel, the first such designation for the API in the
US.
Docetaxel is used to treat a broad range of cancers and is the active ingredient in Sanofi-Aventis' drug treatment, Taxotere (docetaxel).
"Early US DMF filings help securing potential customers," said ScinoPharm president and CEO, Dr Jo Shen.
"We are working hard to become the first DMF filer for the APIs that we are currently developing."
DMFs, while not expressly required by the US Food and Drug Administration (FDA) which issues the DMF allocations, could offer added value to the product for ScinoPharm customers.
As the DMF holder, ScinoPharm can authorise the FDA to release the information to support customers' investigational new drug applications (INDs), new drug applications (NDA)s, or an abbreviated new drug application (ANDA).
Although ScinoPharm may be the first to obtain a DMF number for docetaxel, others may not be far behind.
Canadian firm Bioxel Pharma, for example, plans to submit drug master files for docetaxel to regulatory agencies in North America and Europe during 2007, following its successful production of docetaxel at pre-industrial scale towards the end of last year.
Sanofi's Taxotere was first approved in 1995 and is currently marketed in over 100 countries in eight indications for four forms of cancer.
In March last year the company also received additional approval for the use of Taxomere in the treatment of metastatic gastric cancer.
The drug generated net sales of €1.8bn for the Sanofi in 2006, but is due to start losing patent protection at the end of this year, opening up the market for generic competitors and expanding the potential customer base for ScinoPharm's docetaxel product.
Sanofi does, however, have several other taxane derivatives in development - some of which appear to be showing greater efficacy and safety than Taxotere in clinical studies.
ScinoPharm currently has 170 DMF registrations worldwide, with 22 in the US, and intends to register docetaxel in all other key markets.
The API will be manufactured at the company's GMP certified plant in Taiwan, which has capacity to produce over 100kg a year.
The company is looking to cash in on the rapidly growing oncology market, which it predicts to expand becoming the second largest market in the pharmaceutical industry by 2010.
