WOKINGHAM, England, April 28, 2010 /PRNewswire/ -- New long-term phase III data published today in Atherosclerosis demonstrates that, of patients with primary hypercholesterolaemia or combined dyslipidaemia who received 4mg of pitavastatin, 74% and 73.5% achieved NCEP* and EAS* low-density lipoprotein cholesterol (LDL-C) targets at 52 weeks, respectively. At the end of this open-label one-year extension study, reductions in LDL-C observed during previous 12-week double-blind phase III studies were maintained (104.3 mg/dL at week 52 compared with 105.6 mg/dL at the end of the double-blind phase). Furthermore, high-density lipoprotein cholesterol (HDL-C) levels rose continually over 52 weeks, with an overall increase of 14.3% from initial baseline, while changes in other efficacy parameters and ratios** were sustained during 52 weeks treatment compared with the end of the double-blind studies. These data demonstrate sustained efficacy of pitavastatin over the long-term.

Statins are considered the mainstay of dyslipidaemia treatment, however many patients do not reach clinically optimal lipid targets.(1-4) Previous studies have demonstrated that around half of patients failed to reach LDL-C targets with the initially prescribed dose of statin, and that of these, 86% had still not reached LDL-C target after six months, despite dose adjustment and use of the clinician's statin of choice.(5) Furthermore, 68.2% of patients in UK general practice failed to reach optimal clinical levels of HDL-C within a year of starting statin therapy;(6) these studies suggest there is an unmet clinical need in the management of dyslipidaemia.

This study confirms that pitavastatin is an effective and well tolerated long-term treatment option for patients with hypercholesterolaemia or combined dyslipidaemia, commented Dr. Leiv Ose, MD PhD, Rikshospitalet, Oslo University Hospital, Norway, and Study Investigator. Many patients do not reach LDL-C targets on their current treatment regimen, and this can be said for other important lipid parameters including HDL-C. A statin which has the potential to help healthcare professionals and patients alike achieve lipid targets represents a welcome treatment option for the future.

Prior to this extension study, all patients had previously taken part in one of two double-blind studies, and had received pitavastatin (2mg or 4mg QD), atorvastatin (10mg or 20mg QD) or simvastatin (20mg or 40mg QD) for 12 weeks. On completion of the two studies, 1353 patients (42.5% males / 57.5% females; mean age 58.6 years) took part in this open-label extension study to assess the long-term safety and tolerability of pitavastatin 4mg QD for up to 52 weeks; secondary objectives were to assess NCEP and EAS LDL-C target attainment, other lipid and lipoprotein fractions.

*National Cholesterol Education Program (NCEP) and European Atherosclerosis Society (EAS) **Efficacy parameters (Triglycerides, total cholesterol, non-HDL-C, Apo-A1 and Apo-B, high sensitivity C-reactive protein, oxidized LDL ) and ratios (total cholesterol: HDL-C, non-HDL-C:HDL-C and Apo-B:Apo-A1)

Pitavastatin was well tolerated to 52 weeks; no serious treatment-emergent adverse event (TEAE) was related to pitavastatin, with the most commonly reported TEAEs being increased blood creatinine kinase (5.8%), nasopharyngitis (5.4%) and myalgia (4.1%). Additionally, there were no clinically significant abnormalities in routine laboratory variables, urinalysis, vital signs or 12-lead ECG. Pitavastatin also demonstrated a favourable safety and tolerability profile throughout the extension study, exemplified by a low rate of discontinuations due to adverse events.

Data from this pivotal, phase III study demonstrates pitavastatin's sustained and robust efficacy, safety and tolerability profile said Dr Neil Hounslow, Vice President of scientific affairs, Kowa Research Europe. With sustained efficacy, low rates of discontinuations due to adverse events and continued increases in HDL-C observed over 52 weeks, pitavastatin could provide clinicians with a new option in the long-term treatment of patients with hypercholesterolaemia or combined dyslipidaemia.

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 will be launched in the U.S. in June 2010. Additionally, Kowa filed in Europe in August 2008 using the decentralised authorisation procedure and is due to receive a regulatory approval in mid 2010. 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).

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 1946, and is focused on cardiovascular therapeutics, with sales of the company's flagship product, LIVALO, totaling $440 million (14% market share) in Japan during the last fiscal year and expected to exceed $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 dyslipidaemia.

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.


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2. Ferrières J et al Arch Cardiovasc Dis 2008;101:557-63

3. García Ruiz FJ et al Pharmacoeconomics 2004;22 Suppl 3:1-12

4. Hermans MP et al Acta Cardiol 2009;64:177-85

5. Foley KA, Simpson RJ Jr, Crouse JR III, et al., Effectiveness of statin titration on low-density lipoprotein cholesterol goal attainment in patients at high risk of atherogenic events Am J Cardiol. 2003;92:79-81

6. Phatak H, Wentworth C, Sazonov V, et al., Prevalence and predictors of lipid abnormalities in patients treated with statins in the UK general practice Atherosclerosis 2009;202:225-33


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