Livazo(R) (Pitavastatin), a Statin With Beneficial Effects on Lipid Fractions Associated With Heart Disease, Launches in Lebanon

By Kowa Pharmaceutical Europe, PRNE
Tuesday, March 22, 2011

WOKINGHAM, England, March 23, 2011 - Kowa Pharmaceutical Europe welcomes the first regional launch of its
statin, Livazo (pitavastatin) in Lebanon, where it will be marketed by
Beirut-based Algorithm, under an exclusive license.

Aimed at patients with primary hyperlipidemia and / or mixed
dyslipidemia,(1) Lebanon will be the first market for Livazo outside the Far
East and the USA. Algorithm will launch Livazo in the rest of the Middle East
and North Africa from 2012 onwards.

Livazo is a potent statin that combines effective control on
LDL-cholesterol (LDL-C) and triglycerides (TG), long-term incremental
HDL-cholesterol (HDL-C) increase and, due to its novel structure, is less
likely to have drug-drug interactions.(2) Its effectiveness has been
demonstrated in several Phase III clinical studies:

    - Livazo safely and effectively reduced LDL-C and achieved European
      Atherosclerosis Society (EAS) guideline targets in the majority of
      patients with primary hyperlipidemia or mixed dyslipidemia, similar
      to reductions seen with atorvastatin(3) and simvastatin(4)

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

    - Livazo effectively reduced LDL-C in the elderly(5) and also improved
      LDL-C and other parameters of lipid metabolism in patients at higher
      cardiovascular risk(2)

    - Livazo was superior to pravastatin in improving LDL-C in elderly
      patients (65 years)(5)

    - Livazo demonstrated a gradual and sustained increase in HDL-C over the
      long-term, supported by data from a 52 week extension study(6)

"We welcome innovative treatments such as Livazo, which not only lowers
LDL-C effectively but also addresses HDL residual risk and so has the
potential to increase the proportion of patients achieving treatment
targets," said Professor Ibrahim Salti, Professor of Medicine and Head of the
Division of Endocrinology and Metabolism at the American University of Beirut
in Lebanon. "Pitavastatin has shown good efficacy in metabolic syndrome
patients without effect on HbA1C levels, as well as in elderly patients. The
low drug-drug interaction makes it an attractive option for clinically
complex patients on multiple medications."

High cholesterol levels are a major risk factor for heart disease, the
number one cause of death globally.(7) In Lebanon, about one sixth of all
adults has high blood cholesterol, but only two fifths of these receive
medical treatment for it.(8)

The overall safety and tolerability of pitavastatin are consistent with
other commonly prescribed statins. In Phase III studies comparing
pitavastatin with atorvastatin(3), simvastatin(4) and pravastatin(5), the
overall safety profile of pitavastatin was demonstrated, with low incidences
of adverse events. All three doses of pitavastatin (1, 2 and 4 mg)
demonstrated a comparable safety profile to 10, 20 and 40 mg of
pravastatin(5), which is considered to be the statin least likely to cause
adverse drug reactions or drug-drug interactions. Additionally, pitavastatin
has demonstrated a long-term safety profile (to 52 weeks),(6) comparable to
that of simvastatin or atorvastatin.(9,10)

Drummond Paris, President of Kowa Research Europe, said: "The launch of
Livazo in Lebanon represents a milestone for Kowa as our first product in
this region. It will be the first of many launches in Europe, the Middle East
and North Africa during 2011. We are keen to offer the benefits of Livazo to
patients across the globe."


    1.  Livazo Summary of Product Characteristics

    2.  Ose L. Pitavastatin: finding its place in therapy. Ther Adv Chronic
        Dis. 2011. Published online before print. January 26, 2011, doi:

    3.  Budinski D, Arneson V, Hounslow N, Gratsiansky N. Pitavastatin
        compared with atorvastatin in primary hypercholesterolemia or
        combined dyslipidemia. Clin. Lipidol. 2009;4:291-302

    4.  Ose L, Budinski D, Hounslow N, Arneson V. Comparison of pitavastatin
        with simvastatin in primary hypercholesterolaemia or combined
        dyslipidaemia. Curr Med Res Opin 2009;25: 2755-64

    5.  Stender S, Hounslow N. Robust efficacy of pitavastatin and comparable
        safety to pravastatin. Atherosclerosis Suppl. 2009; 10:e945

    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;

    7.  World Health Organization. Cardiovascular diseases fact sheet.
        Accessed on 14 February, 2011.

    8.  Rady, A. Is lifestyle affecting the risk of non-communicable diseases
        in Lebanon? Human & Health 2010;13:15-17

    9.  Data on file (study 309)

    10. Data on file (study 310)

About Livazo

Pitavastatin (a statin) is a fully synthetic and highly potent inhibitor
of HMG-CoA reductase used for primary hypercholesterolemia and combined
dyslipidemia. 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 co-morbidities and are taking multiple medications. Kowa
received FDA approval of pitavastatin (Livalo(R)) for the treatment of
primary hyperlipidemia or mixed dyslipidemia in August 2009 and it was
launched in the U.S. in June 2010. Additionally, Kowa filed in Europe in
August 2008 using the decentralised authorisation procedure and received
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).

    Country/area  Current status     Launched (or      Distributors

    Japan        Launched           September 2003   Kowa Pharmaceutical Co.
                                                     Daiichi Sankyo Co.,

    Korea        Launched           July 2005        Choongwae Pharma

    Thailand     Launched           January 2008     BioPharma Chemical

    China        Launched           July 2009                 *2

    USA          Launched           June 2010                 *3

    EU           Approved in some
                 EU countries,
                 undergoing         2011                      *4
                 national phase
                 in others

    Taiwan       Submitted          2011             Tai Tien Pharmaceuticals
                                                     Co., Ltd.

    Middle East/ Launched in
    North Africa Lebanon;
                 preparing for      2011             Algorithm SAL
                 other launches
                 in 2012-2015

    Latin        Submitted in       2011             Eli Lilly
    America      part

    Indonesia    Submitted          2012             PT. Tanabe Indonesia

    Australia/   Submitted in       2012             Abbott
    New Zealand  part

*1. Co-marketing by the two companies under one brand name, Livalo. The
annual sales of Livalo tablets in Japan reached $520 million in 2010.

*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 Indiana,

*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, totalling $520 million (14.3% market share) in
Japan during 2010 and expected to exceed $700 million in the near future.

Kowa Research Europe, Ltd. (KRE), established in 1999 in the United
, is responsible for European clinical trials for Kowa's strategic
global pharmaceutical development.

Kowa Pharmaceutical Europe Co. Ltd, established in 2000, is a
specialty pharmaceutical company located in Wokingham, UK, focused primarily
on cardiometabolic therapeutics. Working in harmony with KRE, these European
pharmaceutical divisions of Japanese Kowa Company, Ltd. are committed to
ground-breaking research, development and marketing to ensure quality
products are made available to people around the world, enabling them to
enjoy a better standard of health and a more comfortable life.

About Algorithm

Algorithm, pharmaceutical manufacturer based in Lebanon, aims
at being the trusted regional partner to medical and patient communities and
is committed to delivering quality care in pharmaceutical therapies. It
operates in the Middle East and North Africa region with a product portfolio
consisting of innovative products as well as differentiated generics,
focusing mainly on the following therapeutic areas: cardiology,
endocrinology, neurology, gynaecology and urology. Algorithm has built
partnerships with many international companies, amongst which is Kowa.

Media enquiries: For further information please contact: Maya Anaokar - Ruder Finn UK, +44(0)20-7462-8960 / +44(0)7894-095-429

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