Pitavastatin Demonstrates Promise for Low Incidence of Drug-Drug Interaction

    Study Shows Kowa's Novel Synthetic Statin is Safe and Well Tolerated in
    Combination With Warfarin

    BOSTON, June 15 /CNW/ - New data presented today showed that pitavastatin
may provide a new treatment option for patients with dyslipidemia and complex
issues, such as those on multiple medications, as evidenced by a study
supporting pitavastatin's potential for low drug-drug interaction. The data
were presented today by Kowa at the XV International Symposium on
Atherosclerosis in Boston.
    The study was conducted to evaluate the effect of pitavastatin on
warfarin, an anticoagulant often prescribed to patients with cardiovascular
disorders. Warfarin has a narrow therapeutic index and is known to have
potentially serious interactions with a wide range of medications and food
products. The results of the study demonstrated no significant drug-drug
interaction between pitavastatin and warfarin.
    "This study provides compelling evidence that pitavastatin may make
cardiovascular risk reduction simpler, especially in more clinically complex
patients taking multiple medications," said Roger E. Morgan, M.D., chief
medical officer, Kowa Research Institute. "The results presented today suggest
pitavastatin may be an effective medication to manage dyslipidemia in these
vulnerable populations."
    An open-label add-on study was conducted to determine the potential for
drug interaction following daily administration of pitavastatin 4 mg on the
steady-state pharmacodynamic (PD) and pharmacokinetic (PK) profiles of
warfarin and to assess the safety and tolerability of coadministration of
warfarin and pitavastatin in 24 healthy adult subjects. Once a target INR
(measures coagulation of sample blood against a normal measurement) of 1.2 to
2.2 was achieved for each subject with warfarin monotherapy through Day 14,
pitavastatin 4 mg was introduced and coadministered with warfarin through Day
    The results of the study demonstrated that the steady-state PD and PK
profiles of warfarin were unaffected by the coadministration of pitavastatin,
and thus no significant drug-drug interaction was observed. In addition,
pitavastatin 4 mg in combination with warfarin was safe and well tolerated by
healthy subjects when compared with warfarin administration alone.
    "The study shows that pitavastatin may fill an unmet need in the current
statin market for patients with dyslipidemia that face complex clinical issues
such as potential drug interactions," said Dr. Morgan. "We feel that
pitavastatin is a unique and effective medication for this targeted
population, and we are looking forward to bringing pitavastatin to the

    About pitavastatin

    Pitavastatin (a statin) is a fully synthetic and highly potent inhibitor
of HMG-CoA reductase used for primary hypercholesterolemia and combined
dyslipidemia. 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
has filed a New Drug Application for pitavastatin with the U.S. Food and Drug
Administration and has filed in Europe in August 2008, using the decentralized
authorization procedure. Once approved, pitavastatin will be available in
three dosage strengths (1, 2 and 4 mg).

    About Kowa

    Since its establishment in 1894, Kowa has grown into a multinational
Japanese company actively engaged in various manufacturing and trading
activities in the fields of pharmaceutical, life science and information
technology, textiles, machinery and various consumer products. Kowa focuses
its efforts on the acquisition, development, licensing and marketing of
pharmaceutical products. During its long history, Kowa has consistently
strived to meet the changing needs of the global market, and with its
continuing entrepreneurial initiative, is determined to meet the needs of
future generations. It is this commitment to consistency and initiative in an
ever-changing world that Kowa vows to carry forward through each generation.
    For more information about Kowa, please visit http://www.kowa.com.

For further information:

For further information: Carrie Fernandez, (215) 238-8500 ext. 1402,

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