Kowa Announces Successful EU Regulatory Application for Pitavastatin

For EU Media Only

WOKINGHAM, England, July 22, 2010 - Kowa are delighted to announce that following the completion of
the decentralized regulatory procedure, that their statin, pitavastatin
has achieved a positive outcome from the UK Regulatory Authority
(MHRA) acting as the Reference Member State for 16 EU countries.
Pitavastatin is indicated for the reduction of elevated total
cholesterol (TC) and low density lipoprotein cholesterol (LDL-C), in adult
patients with primary hypercholesterolaemia, including heterozygous familial
hypercholesterolaemia, and combined (mixed) dyslipidaemia, when response to
diet and other non-pharmacological measures are inadequate.

Drummond Paris, President at Kowa Research Europe, commented "This is the
critical milestone that we needed to reach in the approval process for
pitavastatin in Europe and it is indeed a memorable achievement for the
global Kowa organization. We can now move forward into the national phase for
final approval by each of the 16 individual countries."

Pitavastatin is a fully synthetic and highly potent statin. It has a
unique cyclopropyl group on the base structure, contributing to a more
effective inhibition of the HMG-CoA reductase enzyme to inhibit cholesterol
production, and allowing for the use of a lower dose.

While few drugs, including pitavastatin, are free from drug-drug
interactions, pitavastatin may be an attractive option for physicians
treating patients taking multiple medications because its potential for
cytochrome P450-mediated drug-drug interactions is low. Pitavastatin is only
minimally metabolized by the cytochrome P450 system in the liver, which is
important because this system is involved in approximately 75 percent of all
drug metabolism.(1)

Because of its unique product attributes, pitavastatin may be a
first-line treatment option for clinically complex patient populations.
Pitavastatin will be available in three low-dose strengths (1 mg, 2 mg and 4
mg) and is anticipated that it will be used as first-line therapy with a
usual maintenance dose of 2 mg daily and a maximum dose of 4 mg daily.
Pitavastatin can be taken at any time of the day, with or without food,
allowing added flexibility for patients.

Pitavastatin's effectiveness was demonstrated by the following pivotal
Phase III trials:

    - Pitavastatin safely and effectively reduced LDL-C and achieved European
    Atherosclerosis Society (EAS) guideline targets in the vast majority of
    patients with primary hypercholesterolaemia or combined
    dyslipidaemia, similar to reductions seen with atorvastatin(2)
    and simvastatin(3)

    - Pitavastatin 2 mg and 4mg demonstrated comparable efficacy to commonly
    prescribed statins with 2mg Pitavastatin demonstrating statistically
    significantly superior efficacy compared with simvastatin 20 mg in
    lowering LDL-C, non high-density lipoprotein cholesterol (non-HDL-C) and
    total cholesterol (TC)(3).

    - Pitavastatin effectively reduced LDL-C and improved other parameters of
    lipid metabolism in special patient populations including the
    elderly(4) and patients at higher cardiovascular risk(5)

    - Pitavastatin was superior to pravastatin in improving parameters of
    lipid metabolism in elderly patients (>65 years)(4)

    - Pitavastatin demonstrated a gradual and sustained increase in high
    density lipoprotein cholesterol (HDL-C) over the long-term, supported
    by data from a 52 week extension study(5)

The overall safety and tolerability of pitavastatin are consistent with
other commonly prescribed statins. In pivotal Phase III studies comparing
pitavastatin with atorvastatin,(2) simvastatin(3) and pravastatin,(4) the
overall safety profile of pitavastatin was demonstrated, with low incidences
of adverse events (AEs). All three doses of pitavastatin (1, 2 and 4 mg)
demonstrated a comparable safety profile to 10, 20 and 40 mg of pravastatin,
(4) which is considered to be the statin least likely to cause ADRs or DDIs.
Additionally, pitavastatin has demonstrated a long-term safety profile (to 52
weeks), comparable to that of simvastatin or atorvastatin.(6)

In two 12-week pivotal Phase III studies of patients with primary
hypercholesterolaemia or combined dyslipidaemia, pitavastatin demonstrated a
similar tolerability profile to atorvastatin and simvastatin respectively, at
comparable therapeutic doses, with most AEs classed mild or moderate.(2,3)
Additionally, in a pivotal Phase III trial in the elderly population (>65
years), pitavastatin demonstrated long-term tolerability (52 weeks) with no
serious treatment-emergent adverse event (TEAEs) being attributed to
pitavastatin as well as pravastatin.

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 was launched in the U.S. in June 2010. Additionally, Kowa filed in Europe
under the decentralized procedure in August 2008. 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     Launched          Distributors
                    status        (or
                               expected)
    Japan        Launched      September  Kowa Pharmaceutical Co. Ltd.
                               2003       Daiichi Sankyo Co., Ltd.*1
    Korea        Launched      July 2005  Choongwae Pharma Corporation
    Thailand     Launched      January    Biopharm Chemicals Co., Ltd.
                               2008
    China        Launched      July 2009               *2
    USA          Launched      June 2010               *3
    EU           Registration  2011                    *4
    Canada       Submitted     2011       Abbott
    Taiwan       Submitted     2011       Tai Tien Pharmaceuticals Co.,
                                          Ltd. (Mitsubishi Tanabe
                                          Pharma Co.)
    Indonesia    Submitted     2012       Tanabe Indonesia
                                          (Mitsubishi Tanabe Pharma
                                          Co.)
    Middle East/ Preparing for 2011       Algorithm SAL
    North Africa submission
    Latin        Preparing for 2011       Eli Lilly
    America      submission
    Australia/   Preparing for 2012       Abbott
    New Zealand  submission

*1. Co-marketing by the two companies under one brand name, Livalo. 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 In the United States, Kowa Pharmaceuticals America, Inc. (Headquarters
in Alabama, US), a wholly-owned subsidiary of Kowa, sell and market
pitavastatin with a co-promotion partner, Eli Lilly (Headquarters in
Indianapolis, US).

*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 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
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 at kowa.co.uk