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28.06.2010 – 09:06

Kowa Company, Ltd.

Kowa Company, Ltd. Grants Abbott Exclusive Rights to Market Pitavastatin Calcium, a Lipid-lowering Drug, in Australia and New Zealand

Wokingham, England, June 28, 2010 (ots/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.
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 EUR689.6 million, operating income was EUR144.7 million and
net income was EUR100.4 million.
For more information about Recordati please visit
http://www.recordati.com

Contact:

CONTACT: For further information please contact: Bob
Ireland,bireland@kowa.co.uk, Office Tel: +44(0)118-944-3804,
Mobile:+44(0)7796-952845