Kowa Announces First EU Marketing Authorisation for Pitavastatin Granted in the UK

Wokingham, England, August 17, 2010 (ots/PRNewswire) - Kowa are
delighted to announce that the Medicines and Healthcare products
Regulatory Agency (MHRA) has granted a UK licence for their statin,
Livazo(R) (pitavastatin). This follows the completion of the
decentralized regulatory procedure, in which the MHRA delivered a
positive outcome for pitavastatin whilst acting as the Reference
Member State for 16 EU countries. The UK licence represents the first
national approval in the EU. Pitavastatin is indicated for adults as
an adjunctive therapy to diet for the treatment of primary
hypercholesterolaemia or combined dyslipidemia. It is available in
doses of 1 mg, 2 mg and 4 mg.

Drummond Paris, President at Kowa Research Europe, commented
"pitavastatin has been the leading product in our cardiovascular
portfolio in Asia since 2003, we are therefore thrilled to reach this
European milestone and look forward to achieving the ongoing national
marketing authorisations (MA) within the EU."

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)

"Since many patients treated for elevated cholesterol may be on
multiple medications, it is important that physicians caring for
these patients understand how treatment with a cholesterol
medication, such as a statin, may potentially interact with the other
drugs the patient may be taking," said Professor John Betteridge,
Department of Diabetes and Endocrinology, UCLH, London.

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.

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 it 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.

The overall safety and tolerability of pitavastatin are
consistent with other commonly prescribed statins. In 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 Drug-drug
interactions. Additionally, pitavastatin has demonstrated a
long-term safety profile (to 52 weeks), comparable to that of
simvastatin or atorvastatin.(5)

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 co-morbidities
and are taking multiple medications. Kowa received FDA approval of
pitavastatin (LIVALO(R)) for the treatment of primary
hypercholesterolaemia and mixed 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
North Africa submission 2011 Algorithm SAL
Latin Preparing for
America submission 2011 Eli Lilly
Australia/ Preparing for
New Zealand submission 2012 Abbott

*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, Gratsiansky N. Pitavastatin
compared with atorvastatin in primary hypercholesterolemia or
combined dyslipidemia Clinical Lipidology 2009; 4(3): 291-302

3) Ose L, Budinski D, Hounslow N, Arneson V.. 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; 10(2):
e945

5) 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; 210 (1): 202-208

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

Contact:
CONTACT: For further information please contact: Dr Rod Coombs,
EuropeanMarketing Manager, Mobile: +44(0)7824-415025, Direct
Line:+44(0)118-922-9013, E Mail: rcoombs@kowa.co.uk