Kowa Announces Successful EU Regulatory Application for Pitavastatin

Wokingham, England, July 22, 2010 (ots/PRNewswire) - Kowa are delightedto announce that following the completion of the decentralizedregulatory procedure, that their statin, pitavastatin has achieved apositive outcome from the UK Regulatory Authority (MHRA) acting asthe Reference Member State for 16 EU countries. Pitavastatin isindicated for the reduction of elevated total cholesterol (TC) andlow density lipoprotein cholesterol (LDL-C), in adult patients withprimary hypercholesterolaemia, including heterozygous familialhypercholesterolaemia, and combined (mixed) dyslipidaemia, whenresponse to diet and other non-pharmacological measures areinadequate.

Drummond Paris, President at Kowa Research Europe, commented"This is the critical milestone that we needed to reach in theapproval process for pitavastatin in Europe and it is indeed amemorable achievement for the global Kowa organization. We can nowmove forward into the national phase for final approval by each ofthe 16 individual countries."

Pitavastatin is a fully synthetic and highly potent statin. Ithas a unique cyclopropyl group on the base structure, contributing toa more effective inhibition of the HMG-CoA reductase enzyme toinhibit cholesterol production, and allowing for the use of a lowerdose.

While few drugs, including pitavastatin, are free from drug-druginteractions, pitavastatin may be an attractive option for physicianstreating patients taking multiple medications because its potentialfor cytochrome P450-mediated drug-drug interactions is low.Pitavastatin is only minimally metabolized by the cytochrome P450system in the liver, which is important because this system isinvolved in approximately 75 percent of all drug metabolism.(1)

Because of its unique product attributes, pitavastatin may be afirst-line treatment option for clinically complex patientpopulations. Pitavastatin will be available in three low-dosestrengths (1 mg, 2 mg and 4 mg) and is anticipated that it will beused as first-line therapy with a usual maintenance dose of 2 mgdaily and a maximum dose of 4 mg daily. Pitavastatin can be taken atany time of the day, with or without food, allowing added flexibilityfor patients.

Pitavastatin's effectiveness was demonstrated by the followingpivotal 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 areconsistent with other commonly prescribed statins. In pivotal PhaseIII studies comparing pitavastatin with atorvastatin,(2)simvastatin(3) and pravastatin,(4) the overall safety profile ofpitavastatin was demonstrated, with low incidences of adverse events(AEs). All three doses of pitavastatin (1, 2 and 4 mg) demonstrated acomparable safety profile to 10, 20 and 40 mg of pravastatin, (4)which is considered to be the statin least likely to cause ADRs orDDIs. Additionally, pitavastatin has demonstrated a long-term safetyprofile (to 52 weeks), comparable to that of simvastatin oratorvastatin.(6)

In two 12-week pivotal Phase III studies of patients with primaryhypercholesterolaemia or combined dyslipidaemia, pitavastatindemonstrated a similar tolerability profile to atorvastatin andsimvastatin respectively, at comparable therapeutic doses, with mostAEs classed mild or moderate.(2,3) Additionally, in a pivotal PhaseIII trial in the elderly population (>65 years), pitavastatindemonstrated long-term tolerability (52 weeks) with no serioustreatment-emergent adverse event (TEAEs) being attributed topitavastatin as well as pravastatin.

About pitavastatin

Pitavastatin (a statin) is a fully synthetic and highly potentinhibitor of HMG-CoA reductase used for primary hypercholesterolaemiaand combined dyslipidaemia. Pitavastatin has a unique cyclopropylgroup on the base structure common to the statin class. Since its2003 launch in Japan, pitavastatin has accumulated millions ofpatient-years of exposure. Many of these patients have comorbiditiesand are taking multiple medications. Kowa received FDA approval ofpitavastatin (LIVALO(R)) for the treatment of primaryhypercholesterolaemia and combined dyslipidaemia in August 2009 andit was launched in the U.S. in June 2010. Additionally, Kowa filed inEurope under the decentralized procedure in August 2008. In much ofEurope, pitavastatin will be marketed by Recordati. Pitavastatin willbe 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 andcommercialization of pharmaceutical products including pitavastatinas 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 41billion yen in 2009.

*2 Kowa (Shanghai) Pharma Consulting. Co., Ltd., a wholly-ownedsubsidiary of Kowa, is obtaining and providing information tophysicians and hospitals in China to ensure proper use ofpitavastatin.

*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 KowaPharmaceutical Europe Co., Ltd. (Headquarters in Wokingham, UK), awholly-owned subsidiary of Kowa, and Recordati (Headquarters inMilan, Italy), a partner distributor.

About Kowa

Kowa Company, Ltd. (KCL) is a privately held multinationalcompany headquartered in Nagoya, Japan. Established in 1894, KCL isactively engaged in various manufacturing and commercial activitiesin the fields of pharmaceutical, life science, informationtechnology, textiles, machinery and various consumer products. KCL'spharmaceutical division was founded in 1947, and is focused oncardiovascular therapeutics, with sales of the company's flagshipproduct, LIVALO, totaling US$430 million (12% market share) in Japanduring the last fiscal year and expected to exceed US$600 million inthe near future.

Kowa Pharmaceuticals America, Inc. (KPA) is a specialtypharmaceutical company focused primarily in the area ofcardiometabolic therapeutics. The company, started in 2001 asProEthic Pharmaceuticals, Inc., was acquired by KCL in September of2008. A privately held company, KPA focuses its efforts on theacquisition, development, licensing and marketing of pharmaceuticalproducts. Its lead product, LIPOFEN(R) (fenofibrate capsules), isindicated as adjunctive therapy to diet to reduce elevated TG and toincrease HDL-C in adult patients with primary hypercholesterolemia ormixed dyslipidemia.

Kowa Research Europe, Ltd. (KRE), established in 1999 in theUnited Kingdom, is responsible for European clinical trials forKowa's strategic global pharmaceutical development.

About Recordati

Recordati, established in 1926, is a European pharmaceuticalgroup, listed on the Italian Stock Exchange (Reuters RECI.MI,Bloomberg REC IM, ISIN IT 0003828271),with a total staff of over2,950, dedicated to the research, development, manufacturing andmarketing of pharmaceuticals. It has headquarters in Milan, Italy,operations in the main European countries, and a growing presence inthe new markets of Central and Eastern Europe. A European field forceof over 1,450 medical representatives promotes a wide range ofinnovative pharmaceuticals, both proprietary and under license, in anumber of therapeutic areas including a specialized businessdedicated to treatments for rare diseases. Recordati's current andgrowing coverage of the European pharmaceutical market makes it apartner of choice for new product licenses from companies which donot have European marketing organizations.

Recordati is committed to the research and development of newdrug entities within the cardiovascular and urogenital therapeuticareas and of treatments for rare diseases. Consolidated revenue for2008 was EUR689.6 million, operating income was EUR144.7 million andnet income was EUR100.4 million.

For more information about Recordati please visithttp://www.recordati.com


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

Kowa Company, Ltd.

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Kowa Announces Successful EU Regulatory Application for Pitavastatin