Wednesday, May 22, 2013

Otsuka Pharmaceutical Factory and Fresenius Kabi Japan enter into an exclusive distribution agreement of HES products, including the newly approved Voluven 6%

Otsuka Pharmaceutical Factory, Inc.  and Fresenius Kabi Japan (FKJ) have entered into an exclusive distribution agreement in Japan, of Voluven 6%, a new to be launched HES (Hydroxyethl Starch) product, (approved on March 25, 2013) and two other existing HES products, Salinhes Fluid Solution 6% and Hespander Fluid Solution. The two products on the market are currently sold by FKJ.


Under the agreement, OPF will distribute Salinhes Fluid Solution 6%, Hespander Fluid Solution, and newly approved Voluven 6%. FKJ will continue to be the Market Authorization Holder of the Products. OPF will utilize approximately 350 Medical Representatives, specialized in the field of clinical nutrition to further promote the distribution of the HES products in Japan, and OPF will also be responsible for the collection and conveyance of safety information.

About HES (Hydroxyethl Starch) Products and Voluven 6%
The drug substance of HES (Hydroxyethl Starch) product is amylopectin, a kind of a starch derived from corn. HES products exhibit a plasma volume expansion effect by staying in the blood for a longer period of time. This is due to the slowing of metabolization by α-amylase, resulting from the hydroxylation of glucose molecules. Currently, FKJ distributes the two only HES products in Japan, Salinhes Fluid Solution 6% and Hespander fluid solution, which both have a molecular weight of 70kDa. These products are mainly used in the operating room and intensive care unit (ICU) for the treatment of hypovolemia when plasma volume expansion is required. Voluven 6% has a molecular weight of 130kDa, and the indication for the product is the maintenance of circulating plasma volume. According to dosage and administration, the maximum dosage is 50ml/kg. This makes it possible for Voluven 6% to be administered in higher dosage compared to the two existing products. Voluven 6% was initially launched in Germany in 1999