Livazo(R) (pitavastatin), a new potent statin with beneficial effects on lipid fractions associated with heart disease, launches in Spain

By Kowa Pharmaceutical Europe, PRNE
Sunday, May 1, 2011

WOKINGHAM, England, May 3, 2011 - Kowa Pharmaceutical Europe welcomes the first European launch of its
statin, pitavastatin in Spain, where it will be marketed and distributed as
Livazo(R) by Recordati, and as Alipzadegrees by Recordati's partner
distributor, Esteve.

Spain is the first European market for Livazo, which is indicated for
patients with primary hypercholesterolemia and / or mixed dyslipidemia.[1]
Kowa Pharmaceutical Europe Co. Ltd., with Recordati, intends to launch Livazo
in further European markets later this year and into 2012.

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

- Livazo safely and effectively reduced LDL-C and achieved European
Atherosclerosis Society (EAS) guideline targets in the majority of patients
with primary hypercholesterolemia 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

- 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 risk2

- Livazo was superior to pravastatin in improving LDL-C in elderly
patients ( aged 65 years and older)[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]

"Pitavastatin is an attractive treatment option for clinically complex
patients in Europe on multiple medications, due to its distinct
pharmacological characteristics, among which the low drug-drug interaction
seen in clinical trials is particularly relevant. It has also shown strong
efficacy in metabolic syndrome patients without effect on HbA1C levels, as
well as in elderly patients," said Professor John Chapman, Director,
Dyslipidemia and Atherosclerosis Research Unit, National Institute of Health
and Medical Research, Hôpital de la Pitié-Salpêtrière Université Pierre et
Marie Curie Paris, France.

"Innovative treatments such as Livazo are key to advancing disease
management as it has shown this innovative statin not only lowers LDL-C
effectively but also addresses low residual risk, meaning associated with low
HDL-C, clearly suggesting that it has the potential to increase the
proportion of patients achieving treatment targets," added Prof Chapman.

High cholesterol levels are a major risk factor for heart disease
(cardiovascular disease), the number one cause of death globally[7] and
accounts for 33% of all deaths in Spain.[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[9] or atorvastatin.[10]

Drummond Paris, President of Kowa Research Europe, said: "The launch of
Livazo in Spain represents a great milestone for Kowa as our first European
launch. It will be the first of many launches in Europe, the Middle East and
North Africa during 2011. We are keen to offer patients across the globe
improved treatment choice and access to Livazo."


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, et al. Pitavastatin compared with
atorvastatin in primary hypercholesterolemia or combined dyslipidemia. Clin.
Lipidol. 2009;4:291-302

4. Ose L, Budinski D, Hounslow N, et al. Comparison of pitavastatin with
simvastatin in primary hypercholesterolemia 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, et al. Long-term treatment with
pitavastatin is effective and well tolerated by patients with primary
hypercholesterolemia or combined dyslipidemia. Atherosclerosis 2010; 202-208

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

8. Gomez-Huelga R, Mancera-Romero J, Bernal-Lopez M, et al. Prevalence of
cardiovascular risk factors in an urban adult population from southern Spain.
IMAP Study. Int J Clin Pract 2011; 65: 3-5

9. Data on file (study 309)

10. Data on file (study 310)

About Livazo(R)

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 novel 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 as Livazo. 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 Soyaku 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           Launched in      2011           *4
                 Spain; approved
                 in some EU
                 national phase
                 in others
    Taiwan       Submitted        2011           Tai Tien
                                                 Pharmaceuticals Co.,
    Middle East/ Launched in      2011           Algorithm SAL
    North Africa Lebanon;
                 preparing for
                 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 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 2,800, 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 around 1,400 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 2010 was EUR 728.1
, operating income was EUR 154.8 million and net income was EUR 108.6

For more information about Recordati please visit

About Esteve

Esteve is a private family-owned group of businesses headquartered in
Barcelona, Spain. Founded in 1929, Esteve has since grown into a fully
integrated pharmaceutical company with nearly 3000 employees and over $ 1B in
annual sales. The pursuit of excellence in discovery, development,
manufacturing, and marketing of innovative pharmaceuticals is Esteve's top
priority. Its international business activities extend to the animal health,
OTC, generic, and API sectors.

To find out more please visit Esteve's website at

Media enquiries: For further information please contact: Abi Dewberry, Ruder Finn UK, +44(0)7841-009-249 and +44(0)20-7462-8948

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