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Kowa Company, Ltd. grants Abbott

exclusive rights to market pitavastatin calcium,

a lipid-lowering drug, in Australia and New Zealand

Wokingham, UK, 28th June 2010, following an enthusiastic expansion programme into new markets, Kowa Company, Ltd. President: Yoshihiro Miwa, headquartered in Nagoya, Japan, has granted Abbott, headquartered in Illinois, USA the exclusive license to distribute and market pitavastatin calcium (brand name Livalo), a lipid-lowering drug, in Australia and New Zealand. This agreement means that pitavastatin will now be marketed in five continents.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. Abbott will apply for regulatory approvals to market pitavastatin in Australia and New Zealand and will exclusively distribute the drug in these countries.
Kowa has been granted exclusive rights by Nissan Chemical Industries, Ltd. to develop and distribute pitavastatin around the world except in Japan and Korea. Through Kowa’s expansion programme partnerships in a number of regions, have been formed with a companies such as Eli Lilly and Recordati.
Bob Ireland, Vice President of Kowa in the EU comments, “This exciting expansion is being made possible through the relationships developed with our partners that now reach five continents. In Europe working with Recordati has proven a great strategy for expanding our EU presence.”
- Ends -
About pitavastatin

Pitavastatin (a statin) is a fully synthetic and highly potent inhibitor of HMG-CoA reductase used for primary hypercholesterolaemia and combined dyslipidaemia. Pitavastatin has a unique cyclopropyl group on the base structure common to the statin class. Since its 2003 launch in Japan, pitavastatin has accumulated millions of patient-years of exposure. Many of these patients have comorbidities and are taking multiple medications. Kowa received FDA approval of pitavastatin (LIVALO®) for the treatment of primary hypercholesterolaemia and combined dyslipidaemia in August 2009 and it will be launched in the U.S. in June 2010. Additionally, Kowa filed in Europe in August 2008 using the decentralised authorisation procedure and is due to receive a regulatory approval in mid 2010. In much of Europe, pitavastatin will be marketed by Recordati. Pitavastatin will be available in three dosage strengths (1 mg, 2 mg and 4 mg).


Global business in pitavastatin

Kowa has dedicated itself enthusiastically to the R&D and commercialization of pharmaceutical products including pitavastatin as a global corporation.




Country/area

Current status

Launched (or expected)

Distributors

Japan

Launched

September 2003

Kowa Soyaku Co., Ltd,
Daiichi Sankyo Co., Ltd.*1

Korea

Launched

July 2005

Choongwae Pharma Corporation

Thailand

Launched

January 2008

BioPharma Chemical

China

Launched

July 2009

*2

USA

Approved

2010 2Q

*3

EU

Submitted

2010

*4

Canada

Submitted

2011

Abbott

Taiwan

Submitted

2011

Tai Tien Pharmaceuticals Co., Ltd. (Tanabe Mitsubishi Pharma Co.)

Middle East/
North Africa

Preparing for submission

2011

Algorithm SAL

Latin America

Preparing for submission

2011

Eli Lilly

Indonesia

Preparing for submission

2012

Tanabe Indonesia
(Tanabe Mitsubishi Pharma Co.)

Australia/
New Zealand

Preparing for submission

2012

Abbott

*1. The annual sales of Livalo tablets in Japan reached 41 billion yen in 2009.

*2 Kowa (Shanghai) Pharma Consulting. Co., Ltd., a wholly-owned subsidiary of Kowa, is obtaining and providing information to physicians and hospitals in China to ensure proper use of pitavastatin.

*3 Co-promotional activities in the United States will be conducted by Kowa. Pharmaceutical America, Inc. (headquarters in Alabama), a distributor owned by Kowa, and Eli Lilly.

*4 In Europe, pitavastatin will be distributed by Kowa Pharmaceutical Europe Co., Ltd. (Headquarters in Wokingham, UK), a wholly-owned subsidiary of Kowa, and Recordati (Headquarters in Milan, Italy), a partner distributor.
About Kowa

Kowa Company, Ltd. (KCL) is a privately held multinational company headquartered in Nagoya, Japan. Established in 1894, KCL is actively engaged in various manufacturing and commercial activities in the fields of pharmaceutical, life science, information technology, textiles, machinery and various consumer products. KCL’s pharmaceutical division was founded in 1946, and is focused on cardiovascular therapeutics, with sales of the company's flagship product, LIVALO, totaling $440 million (14% market share) in Japan during the last fiscal year and expected to exceed $600 million in the near future.


Kowa Pharmaceuticals America, Inc. (KPA) is a specialty pharmaceutical company focused primarily in the area of cardiometabolic therapeutics. The company, started in 2001 as ProEthic Pharmaceuticals, Inc., was acquired by KCL in September of 2008. A privately held company, KPA focuses its efforts on the acquisition, development, licensing and marketing of pharmaceutical products. Its lead product, LIPOFEN® (fenofibrate capsules), is indicated as adjunctive therapy to diet to reduce elevated TG and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
Kowa Research Europe, Ltd. (KRE), established in 1999 in the United Kingdom, is responsible for European clinical trials for Kowa's strategic global pharmaceutical development.

About Abbott


Company name

Abbott

Established in

1888

Chairman and CEO

Miles D. White

Headquarters

Abbott Park, Illinois

Employees

About 83,000 worldwide

2009 Revenue

$30.8 billion USD

Abbott products marketed in

More than 130 countries



About Recordati
Recordati, established in 1926, is a European pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271),with a total staff of over 2,950, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. It has headquarters in Milan, Italy, operations in the main European countries, and a growing presence in the new markets of Central and Eastern Europe.  A European field force of over 1,450 medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati’s current and growing coverage of the European pharmaceutical market makes it a partner of choice for new product licenses from companies which do not have European marketing organizations. 
Recordati is committed to the research and development of new drug entities within the cardiovascular and urogenital therapeutic areas and of treatments for rare diseases.  Consolidated revenue for 2008 was €689.6 million, operating income was €144.7 million and net income was €100.4 million.
For more information about Recordati please visit www.recordati.com

For further information please contact:
Bob Ireland

bireland@kowa.co.uk

Office Tel: +44 (0) 118 944 3804



Mobile: +44 (0) 7796 952845



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