Elan Drug Technologies Announces First Japanese Approval Of Product Using Its NanoCrystal(R) Technology

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 14 Dec 2009 - 5:00 PDT

email to a friend   printer friendly   opinions  

Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE: ELN) announces the approval by the Japanese Ministry of Health, Labour and Welfare of EMEND® (aprepitant) for the treatment of cancer chemotherapy-induced nausea and vomiting. EMEND®, which was developed by a subsidiary of Merck & Co Inc., Whitehouse Station, N.J., USA and licensed to Ono Pharmaceuticals Co., Ltd. for the Japanese market, is the first licensed product approved in Japan that incorporates Elan Drug Technologies' NanoCrystal® technology.

NanoCrystal® technology, enables formulation of poorly water soluble compounds for all routes of administration. For EMEND®, this technology advance eliminates a food requirement and improves bioavailability by 600%. EMEND® was confirmed to be effective for both acute and delayed phases of nausea and vomiting in Japanese clinical trials, and becomes the first therapy approved for treatment of delayed phase nausea and vomiting (24 hours or later after start of cancer chemotherapy) in Japan.

"The approval of EMEND® is a significant achievement for our NanoCrystal® technology, as it marks the first Japanese approval of a product incorporating this technology in this very important market," said Shane Cooke, Executive Vice President and Head of Elan Drug Technologies. "We hope this is the first of many products using our NanoCrystal® technology to be launched in Japan."

NanoCrystal® technology is a proprietary technology developed by Elan Drug Technologies through Elan Pharma International Limited and other Elan affiliates. Five licensed products have now been approved using the NanoCrystal® technology by various health authorities including the US Food and Drug Administration (FDA). Products incorporating the NanoCrystal® technology are sold in markets worldwide.

Source
Elan Drug Technologies and NanoCrystal® Technology

• Additional
• References
• Citations