Pitavastatin Consistently Demonstrates Sustained Increases in HDL-C and Offers Atheroprotective Benefits

WOKINGHAM, England, June 27, 2011 -

Today, at the European Atherosclerosis Society (EAS) congress,
Kowa Pharmaceutical Europe announced results from a post marketing
surveillance study showing pitavastatin provides consistent
long-term increases in high-density lipoprotein cholesterol (HDL-C)
in a broad range of patients with
hypercholesterolaemia.^[1]

The data from the Livalo Effectiveness and
Safety (LIVES) Study Extension showed a relationship between
on-treatment serum HDL-C levels and cardiovascular risk, and that
pitavastatin consistently provided clinically relevant elevations
in HDL-C that continued to increase over five years.
^[1]

“The results of the LIVES Study Extension highlight the benefits
of pitavastatin in patients at risk of cardiovascular disease
(CVD). Not only does pitavastatin consistently increase HDL-C
levels, but it also has additional patient benefits that help to
reduce CVD. We very much look forward to seeing the full results
anticipated at a later date,” said Professor Tamio Teramoto, Dean
and Chairman of Internal Medicine, Teikyo University School of
Medicine, Japan.

Recently published guidance from the EAS recommends that
physicians target elevated LDL-C and decreased HDL-C, both of which
are recognised as risk factors for CVD.  Study results have
shown that pitavastatin could be beneficial to patients as it
reduces LDL-C and consistently raises HDL-C over long-term
treatment. ^[1]  

In addition, further Kowa data is being announced at EAS, which
demonstrates that pitavastatin has beneficial anti-oxidative and
anti-inflammatory effects, in addition to its direct effects on
cholesterol levels. The additional benefits of pitavastatin include
consistently decreasing levels of oxidized low-density lipoprotein
(Ox-LDL) and high sensitivity C-reactive protein (hs-CRP) in
at-risk patients during long-term treatment. Both of these are
associated with atherosclerosis.^[2]

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
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®) 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).

Pitavastatin launched in Lebanon and Spain in 2011; other
European and Middle Eastern launches are planned for 2011 and 2012.
 For more information about the geographical availability of
pitavastatin and marketing companies please visit the Kowa
Pharmaceutical Europe website www.kowapharmaceuticals.eu

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 Kingdom, is responsible for European clinical trials for
Kowa’s strategic global pharmaceutical development.

Kowa Pharmaceutical Europe (KPE) 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.

1. Hounslow, N. Pitavastatin provides long-term improvements in
HDL-cholesterol in a range of patients with dyslipidaemia:results
from a phase III study programme. Abstract presented at EAS. June,
2011

2. Hounslow, N. Pitavastatin has pleiotropic antioxidative and
anti-inflammatory benefits in patients with dyslipidaemia:results
from a phase III study programme. Abstract presented at EAS. June,
2011

Media enquiries: For further information please contact: Abi Dewberry, Ruder Finn UK, +447841009249 and +44(0)2074628948, adewberry at ruderfinn.co.uk