ScinoPharm, an active pharmaceutical ingredient (API) specialist, has been granted US Patent No. 7,435,818 entitled "Novel Crystal Forms of Irinotecan Hydrochloride." The new patent provides for novel crystalline forms of irinotecan hydrochloride and processes for their preparation as well as pharmaceutical compositions containing the new forms and methods of treating metastatic carcinoma of the colon or rectum using these new forms.
This patent is the ninth US patent granted to ScinoPharm and the second patent for one of the company's high demand oncology products, irinotecan hydrochloride. ScinoPharm has already been granted a US Patent No. 7,157,179 covering the proprietary process for the preparation of a key intermediate of irinotecan hydrochloride.
The present invention provides crystalline forms of irinotecan hydrochloride that are more easily filtered from solution as compared to the existing forms of irinotecan hydrochloride. This increased ease of filtering promotes more efficient handling and processing of irinotecan hydrochloride during the manufacturing process, thus facilitating the formulation of new and improved pharmaceutical compositions which contain irinotecan hydrochloride.
That we were awarded a US patent while other patent applications for the same polymorph are still pending in many other countries demonstrates our competence in the development and manufacture of oncological drug substances," stated Dr. Hardy Chan, CSO and executive vice president of ScinoPharm.
"And yet again we solidify our position as the world's leading supplier of irinotecan hydrochloride to the generic industry with adequate patent protection and continuous commitment to innovation," Dr. Chan added.
The latest patent adds to ScinoPharm's growing patent portfolio which now consists of 11 granted patents and more than 24 patent applications in the United States and abroad for a wide range of products.
Irinotecan hydrochloride, a cancer drug most commonly used to treat patients with metastatic carcinoma of the colon or rectum, became generic in the US in February 2008. Annual sales of the drug in the US market alone were approximately US$556 million in 2007, according to IMS Health data.
To provide broad access to markets worldwide, ScinoPharm has registered a Drug Master File (DMF) for irinotecan hydrochloride in 40 countries, including the United States and most European countries.
Specializing in the development and manufacture of highly potent compounds with proprietary processes, ScinoPharm is among the leading companies supplying oncological API. In addition to irinotecan hydrochloride, ScinoPharm offers 20 other products in its oncological line, including paclitaxel and docetaxel.
ScinoPharm Taiwan, Ltd. is a leading high quality API supplier to the global pharmaceutical and biotechnology industry. We provide a full range of API services from process development, and production of early phase clinical trial material to large-scale manufacturing for commercial launches.