Microsoft word - fact sheet_ctcitra-tytonis0709.doc

Fact Sheet
Itraconazole 100mg Capsule (CTCItra)
4-[4-[4-[4-[ [2-(2,4-dichlorophenyl)- 2-(1H-1,2,4-triazol-1-ylmethyl)- 1,3-dioxolan-4-yl]methoxy]phenyl] piperazin-1-yl]phenyl]- 2-(1-methylpropyl)-2,4-dihydro-1, 2,4-triazol- 3-one 1. Product Profile
Itraconazole capsule (CTCItra), developed by CTCBIO Inc. in South Korea, is a generic version of Sporanox™ by Janssen. Although original patents of Sporanox have expired a few years ago, its generics are rare because of difficult formulation technologies and synthesis of the active ingredient. CTCBIO met the bioequivalent test in Korea and more than five companies are selling already itraconazole generics in Korea with Drug Class and Mechanism: Itraconazole is a drug used in the treatment of fungal infections, such as aspergillosis, blastomycosis, histoplasmosis, and fungal infection localized to the toenails and fingernails (onychomycosis). Generic Available: currently not in Europe, only Sandoz in the US Storage: Itraconazole should be stored at room temperature in a tight container. Prescribed For: The treatment of fungal infections which are isolated to a small area of the body (localized) or throughout the body (systemic). It is active against fungal infections such as aspergillosis, blastomycosis, histoplasmosis, and fungal infection localized to the toenails and fingernails (onychomycosis). Dosing: Should be taken with a full meal. It is important to report any signs or symptoms that may suggest liver dysfunction so that the appropriate laboratory testing can be done. These signs include unusual fatigue, poor appetite, nausea and/or vomiting, yellowing of the eyes (jaundice), dark urine or pale stool. 2. Patent & Know-how
CTCBIO filed PCT (PCT/KR2005/001991: Manufacturing method for a solid dispersion containing itraconazole) for worldwide market in 2005. And it will file a patent application claiming priority to Korean application in order to enter into selected national phases such as U.S, Europe, China, and Japan by middle of December 2006. Korean application (filed on 2004.6.24. with application number 10-2004-0047369) is English patent specification can be requested through Tytonis or BioPontis. Know-how: CTCBIO has found one additional technology to meet the standard bioequivalence profile. It will be filed as a patent and this technology will be licensed as 3. Market Information
In the U.S., there is only one generic sold by Sandoz now. There are not likely to be more than 3-4 generic competitors. U.S. licensing is under negotiation with one generic company. In Korea, by using CTCBIO technologies, more than five companies are 4. Available Documents: CMC package for EMEA is available.
3) Bioequivalent test data (in fasting condition for KFDA registration) 4) Bioequivalent test data (in fed condition for internal use)

Source: http://tytonis.net/itraconazol.pdf