Kowa Announces Successful EU Regulatory Application for Pitavastatin (y 2)

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 1947, and is focused on cardiovascular therapeutics, with sales of the company's flagship product, LIVALO, totaling US$430 million (12% market share) in Japan during the last fiscal year and expected to exceed US$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 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

References

    
    1) F Peter Guengerich; Cytochrome P450 and Chemical Toxicology.
    Chem.Res.Toxicol.2008, 21, 70-83
    2) Budinski D, Arneson V, Hounslow N, et al., Pitavastatin compared
    with atorvastatin in primary hypercholesterolemia or combined
    dyslipidemia Clinical Lipidology 2009,4;3:291-302
    3) Budinski D, Arneson V, Hounslow N, et al., Comparison of
    pitavastatin with simvastatin in primary hypercholesterolaemia or
    combined dyslipidaemia Current Medical Research and Opinion
    2009,25;11:2755-2764
    4) Stender S, Hounslow N. Robust efficacy of pitavastatin and
    comparable safety to pravastatin. Atherosclerosis Suppl. 2009, Vol. 10,
    Issue 2
    5) Data on file (304,309).
    6) Ose L, Budinski D, Hounslow N, Arneson V: Long-term treatment
    with pitavastatin is effective and well tolerated by patients with
    primary hypercholesterolemia or combined dyslipidemia. Atherosclerosis
    2010; 202-208

Dr Rod Coombs, European Marketing Manager, Mobile: +44(0)7824-415025, Direct Line: +44(0)118-922-9013, E Mail: rcoombs@kowa.co.uk