WOKINGHAM, England, June 28, 2010 /PRNewswire/ -- 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."
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(R)) 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 Distributors
expected)
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/ Preparing for 2011
North Africa submission Algorithm SAL
Latin Preparing for 2011
America submission Eli Lilly
Indonesia Preparing for 2012 Tanabe Indonesia
submission (Tanabe Mitsubishi Pharma Co.)
Australia/ Preparing for 2012
New Zealand submission 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(R) (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 More than 130
in 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.
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