Kowa Announces First EU Marketing Authorisation for Pitavastatin Granted in the UK (1)

WOKINGHAM, England, August 17, 2010 /PRNewswire/ --

-- Statin Licenced to Treat Patients With Primary Hypercholesterolaemia or Combined Dyslipidemia

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.

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