Asahi Kasei Pharma signs distribution agreement with Stanbio Laboratory for the marketing of Lucica® Glycated Albumin-L in the US
Asahi Kasei Pharma Corp.
Asahi Kasei Pharma has entered into an exclusive distribution agreement with Stanbio Laboratory, L.P., a wholly owned subsidiary of EKF Diagnostics Holdings plc., for the marketing of Lucica® Glycated Albumin-L (“Lucica® GA”) in the US.
Developed by Asahi Kasei Pharma, Lucica® GA is an in vitro diagnostic assay kit for glycated albumin for use with biochemical auto-analyzer. Lucica® GA has been approved and launched in Japan (2002), China (2005), Korea (2013), Indonesia (2013), Taiwan (2015), and Europe (2015), and Asahi Kasei Pharma has received 510(k) clearance for Lucica® GA from the US Food and Drug Administration (FDA) on October 12, 2017. Under the distribution agreement announced today, Stanbio will perform marketing, promotion, and distribution, and Asahi Kasei Pharma will perform manufacturing of Lucica® GA.
The number of people with diabetes continues to increase, and diabetes is known to raise the risks of heart disease, cancer, and dementia. According to the US Centers for Disease Control and Prevention (CDC), there are 30.3 million people in the US (9% of the population) with diabetes and 84.1 million (34% of the adult population aged 18 years or older) who are considered to have prediabetes. There is wide recognition of the urgent necessity of effective preventive measures.
Among the various measurements used for glycemic control required for the treatment of diabetes, measurement of glycated albumin provides an indication of the glycemic level of the preceding two to three weeks, a shorter term than is indicated by HbA1c, the most commonly used measurement, which indicates the glycemic level during the preceding two to three months. By providing an intermediate-term indicator, glycated albumin measurement is considered to be especially useful for the confirmation of shorter-term therapeutic efficacy when treatment is newly initiated and when there is a change in the treatment regimen. Glycated albumin measurement is furthermore regarded as useful in the case of pregnant women, patients with dialysis, patients with diseases that reduce the lifespan of erythrocytes (such as hemolytic anemia and renal anemia), and hemoglobin variants, for whom HbA1c may provide insufficient indication of glycemic level. The clinical utility of Lucica® GA has been corroborated by various research reports.
Asahi Kasei Pharma and Stanbio will work together to further contribute to patients and healthcare professionals in the US by providing a new option for glycemic control via this agreement.
About Stanbio Laboratory, L.P.
Stanbio Laboratory, L.P. is a wholly owned subsidiary of EKF Diagnostics Holdings plc. located in Texas, USA. Stanbio takes pride in manufacturing products that contribute to quality healthcare by focusing into the specialty reagents for diabetes care that are used on open channel chemistry systems in many prestigious and respected medical facilities in the United States.
Please visit the company’s website (www.ekfusa.com) for more information on Stanbio.
About EKF Diagnostics Holdings plc.
EKF Diagnostics Holdings plc. is a global, integrated medical diagnostics business, head quartered in Cardiff, UK and has sites in five other countries. EKF designs and manufactures diagnostic equipment for use within Point-of-Care settings. The company's product portfolio includes small blood analyzers and associated consumables used in testing patients for conditions including diabetes and anemia. EKF is also a manufacturer of liquid reagents, enzymes and fermentation products used in the Central Laboratory market.
Please visit the company’s website (www.ekfdiagnostics.com) for more information on EKF.