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Livalo

Generic name: pitavastatin
Treatment for: High Cholesterol

Update: Livalo Now FDA Approved - August 3, 2009

NDA Submitted for Pitavastatin

Kowa Announces NDA Submission and MAA Filing for HMG CoA Reductase Inhibitor Pitavastatin

NAGOYA, Japan, October 27, 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. (Additional information on KPA is available on http://www.kowapharma.com ).

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).

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.

About Kowa

Kowa Company, Ltd. started operations as a cotton wholesaler in Nagoya in 1894 and has grown into a multinational Japanese company with approximately 50 affiliated companies. Kowa is engaged in developing, manufacturing and trading activities in various business fields including pharmaceutical, life science and information technology, textiles, machinery and a wide range of consumer products. During its long history, Kowa has consistently strived to meet the changing needs of the market place, and with its continuing entrepreneurial initiative, is determined to meet the needs of future generations. It is this commitment to consistency and initiative in an ever-changing world that Kowa vows to carry forward through each generation.

Global Expansion of Kowa Pharmaceutical Division

In order to extend its geographical coverage in the pharmaceutical field, Kowa has established KRI for clinical development and KPA for sales and marketing of Kowa products in the US. For Europe, Kowa Research Europe, Ltd. and Kowa Pharmaceutical Europe Co. Ltd. both headquartered in Wokingham, UK, take responsibility for clinical development and commercialisation, respectively, in the region.

Kowa has established a number of global partnerships with Livalo: Choongwae Pharma Corporation obtained commercial rights for Korea in 2005; it has successfully penetrated the market and Livalo is now ranked third in sales with a 7.2% market share. In Thailand, Biopharm Chemicals Co., Ltd. launched Livalo in January 2008. Kowa also filed an NDA with the Chinese SFDA in April 2007 and the product is expected to be launched in 2009. For Canada, Solvay Pharma Inc. will submit an NDA in 2009 and expects to launch in 2010.

Inquiry:

For US: Kowa Research Institute, Inc.
Gary Gordon, MD, Vice President, Operations
Tel.: +1-919-433-1000, Fax: +1-919-433-1620

For Europe: Kowa Pharmaceutical Europe Co. Ltd.
Bob Ireland, Vice President
Tel: +44-118-922-9000, Fax: +44-118-922-9001

For Asia: Kowa Company, Ltd.
Junichi Kawagoe, Ph.D., Director International Licensing
Tel. +81-3-3279-7296, Fax. +81-3-3279-7250

Posted: October 2008

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