Pitavastatin- a potent statin which inhibits HMG-CoA reductase and decreases LDL-cholesterol levels even at low dosages.

In Japan, Pitavastatin was approved in July 2003 and launched under the brand name Livalo in September of the same year. In Japan, Livalo is categorized as a potent statin which inhibits HMG-CoA reductase and decreases LDL-cholesterol levels even at low dosages. Kowa estimates that Livalo sales in Japan will achieve USD 300M in fiscal 2008.

Kowa Company, Ltd. (Kowa), headquartered in Nagoya, Japan, today announced that Kowa has submitted a New Drug Application dated October 1 to the US Food and Drug Administration (FDA) for Pitavastatin Calcium tablets (Pitavastatin) for the treatment of primary hyperlipidemia and mixed dyslipidemia, through its US subsidiary, Kowa Research Institute, Inc. (KRI), located in North Carolina.
Once approved, the novel compound will be launched under the brand name Livalo (name subject to approval by the FDA) by Kowa through Kowa Pharmaceuticals America, Inc. (KPA), a recently acquired US subsidiary located in Montgomery, Alabama. KPA, formerly known as ProEthic Pharmaceuticals Inc., and acquired by Kowa in July 2008, changed its name effective September 1, 2008. A Marketing Authorization Application for Pitavastatin was also filed in 16 EU countries on August 29, 2008 with their respective regulatory agencies including the United Kingdom's Medicines & Healthcare Products Regulatory Agency (MHRA) who is acting as Reference Member State (RMS).

(Additional information available on http://www.kowapharma.com ).