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FOR IMMEDIATE RELEASE
For trade media only
Kowa announces successful EU regulatory application for pitavastatin
Statin licenced to treat patients with primary hypercholesterolaemia or mixed dyslipidemia
Wokingham, UK, 22 July 2010, 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 atorvastatin2 and simvastatin3
 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 elderly4 and patients at higher cardiovascular risk5
 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 study5
The overall safety and tolerability of pitavastatin are consistent with other commonly prescribed statins.
In pivotal Phase III studies comparing pitavastatin with atorvastatin,2 simvastatin3 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.
- Ends -
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®) 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.
Launched (or
expected)
Country/area
Current status
Distributors
Japan
Launched
September 2003
Kowa Pharmaceutical Co. Ltd.
Daiichi Sankyo Co., Ltd.*1
Korea
Launched
July 2005
Choongwae Pharma Corporation
Thailand
Launched
January 2008
Biopharm Chemicals Co., Ltd.
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/
North Africa
Preparing for
submission
2011
Algorithm SAL
Latin
America
Preparing for
submission
2011
Eli Lilly
Australia/
New Zealand
Preparing for
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® (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 €689.6 million, operating income was €144.7 million and net income was €100.4 million.
For more information about Recordati please visit www.recordati.com
For further information please contact:
Dr Rod Coombs
European Marketing Manager
Mobile: 07824 415025
Direct Line: 0118 922 9013
E Mail: [email protected]
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