Kowa Announces Successful EU Regulatory Application for Pitavastatin (1)

WOKINGHAM, England, July 22, 2010 /PRNewswire/ --

-- For EU Media Only

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

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.

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 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

(CONTINUA)