22.07.2010 – 08:02
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.
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.
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.
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
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
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