Kowa Announces Successful EU Regulatory Application for Pitavastatin

Wokingham, England, July 22, 2010 (ots/PRNewswire) - 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
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

ots Originaltext: Kowa Company, Ltd.
Im Internet recherchierbar: http://www.presseportal.de

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