ScinoPharm’s easy-filter irinotecan gets US patent

Taiwanese API maker ScinoPharm has been granted a US patent for new crystalline forms of irinotecan which are designed to allow for easier filtration during production processing.

Improved filtering performance offers more efficient handling and processing during manufacture, which ScinoPharm claims will help in the formulation of new pharmaceutical compositions that contain irinotecan hydrochloride.

The patent, number 7,435,818 entitled "Novel Crystal Forms of Irinotecan Hydrochloride," covers preparation methods and use of the novel molecules in the treatment metastatic colon cancer.

This is the ninth US patent granted to ScinoPharm to date and the second relating to irinotecan hydrochloride after number 7,157,179 which covers a proprietary process for the preparation of a key intermediate.

Hardy Chan, ScinoPharm’s chief scientific officer (CSO), said that the firm had been "awarded a US patent while other patent applications for the same polymorph are still pending in many other countries,” adding that this “demonstrates our competence in the development and manufacture of oncological drug substances."

"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.

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 $556M in 2007, according to IMS Health.

ScinoPharm has registered a Drug Master File (DMF) for irinotecan hydrochloride in 40 countries, including the United States and most European countries.