April 20, 2007
Asahi Kasei Pharma Corp.
BML, Inc.

Approval for myoinositol assay kit Lucica® MI
 
Asahi Kasei Pharma (AKP) obtained approval in Japan on March 28, 2007 for Lucica® MI, an in vitro diagnostic assay for the measurement of myoinositol concentration in urinary samples. This enables easy screening of suspected diabetes cases for diagnosis using the definitive oral glucose tolerance test (OGTT). A preliminary study and a clinical trial for Lucica® MI were performed jointly with BML, a leading laboratory testing service provider, and application for regulatory approval was filed in 2005.

Generally, fasting blood glucose (FBG) tests are performed at routine physical examinations and when individuals are deemed to be at risk of diabetes. An abnormally high blood glucose concentration in an FBG test is an indicator of possible diabetes, and upon such a result an OGTT is recommended as a definitive test to enable diabetes diagnosis. In this test, an individual abstains from eating for several hours and a blood sample is taken. The individual then drinks a high-glucose solution, and further blood samples are then taken. A diagnosis for diabetes is made based on an examination of the blood glucose concentrations before and after glucose intake.

It is estimated that each year over two million people in Japan are advised to have an OGTT performed, but most decline to follow this advice due in part to the discomfort and inconvenience involved. In 2005, the most recent year for which figures have been compiled, OGTT was performed for only around four hundred thousand people in Japan.

Scientific reports have shown that among diabetic and other persons with diminished ability to metabolize glucose, a large amount of myoinositol, a sugar alcohol, is discharged to urine after a meal or intake of glucose. Measurement of urinary myoinositol concentration has thus been considered to be a potentially useful indicator of possible diabetes. Such measurement, however, conventionally requires the use of chromatography or other analytic methods that do not lend themselves to inexpensive processing of a large number of samples. The newly approved Lucica® MI assay kit works with enzyme-based reagents that can be used with common automatic analyzers, making simple and inexpensive measurement of myoinositol concentration possible for the first time.

By requiring not blood samples but only urinary samples before and after a glucose intake, Lucica® MI enables screening for the definitive OGTT to be performed with a significant reduction in the burden on both the individual subject to the test and healthcare staff. The Lucica® MI kit comprises two reagents, the first to eliminate glucose from the urinary sample prior to myoinositol measurement, and the second to perform the measurement. A single kit can be used for approximately 400 tests.

AKP will now apply for Japanese National Health Insurance (NHI) price listing, and begin a year-long program of expanded testing to study the potential for market development of Lucica® MI. BML will be commissioned to perform tests using Lucica® MI pending NHI price listing. Sales of Lucica® MI in fiscal year 2010 are targeted at ¥100 million.

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