Innogene and Info Kinetics Sign Agreement for BA/BE studies in Indonesia

Singapore-based drug development company Innogene Kalbiotech has signed a Memorandum of Understanding (MoU) with Malaysian clinical research organisation (CRO), Info Kinetics to provide accredited bioavailability and bioequivalence (BA/BE) studies in Indonesia. Innogene was acting on behalf of the biopharma unit of PT Kalbe Farma.

With the signing of the MoU, the two companies entered into a joint venture to establish PT Pharma Kinetics, a BA/BE clinical center which will serve the domestic and Association of Southeast Asian Nations (ASEAN) clinical research markets.

PT Pharma Kinetics will be based in a hospital in Jakarta, Indonesia. Its operations will be supported by PT Pharma Metric Labs, an Indonesian-based BA/BE centre set up by Innogene in 2005. The former hopes that the results obtained from its international bioequivalence studies can assist local generic drug manufacturers in registering and exporting products to developed pharmaceutical markets in regions like Australia and Europe.

Associate Prof Dr Lee Toong Chow, MD of Info Kinetics said, ‘’There is a demand for BA/BE studies in the Indonesian market, with more than 200 pharmaceutical companies providing medicines to over 250 million people. With the expected harmonization of standards for pharmaceutical industries in ASEAN in 2010, we foresee a surge in demand for fully accredited and International Conference on Harmonization (ICH)-Good Clinical Practice compliant studies in the near future.”