Japanese approval for first drug using Elan Drug Technologies'
13 January 2010
Elan Drug Technologies has announced Japanese government
approval of the first drug using its NanoCrystal technology.
The drug, Emend (aprepitant), is used for the treatment of cancer
chemotherapy-induced nausea and vomiting. It 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.
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
“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.