Pitavastatin Demonstrates Promise for Low Incidence of Drug-Drug Interaction

June 15, 2009

Study shows Kowa’s novel synthetic statin is safe and well tolerated in combination with warfarin

BOSTON, June 15 /PRNewswire/ — 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 21.

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 market in the U.S.”

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 expects a response from the agency in Q3 of 2009. Once approved, pitavastatin will be available in the United States in three dosage strengths (1, 2 and 4 mg).

About Kowa Company Ltd. and Kowa Pharmaceuticals America, Inc.

Kowa Company, Ltd. is a privately held multinational company headquartered in Nagoya, Japan. Established in 1894, Kowa is actively engaged in various manufacturing and trading activities in the fields of pharmaceutical, life science, information technology, textiles, machinery and various consumer products. Kowa’s pharmaceutical division is focused on cardiovascular therapeutics, with fiscal year 2008 sales of the company’s flagship product, LIVALO(R) (pitavastatin) totaling $340 million in Japan.

Kowa Pharmaceuticals America, Inc. is a specialty pharmaceutical company focused primarily in the area of cardiology. The company, started in 2001 as ProEthic Pharmaceuticals, Inc., was acquired by Kowa Company, Ltd. 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 triglycerides and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia.

For more information about KPA, please visit www.kowapharma.com.

SOURCE Kowa Company Ltd.; Kowa Pharmaceuticals America, Inc.

Source: newswire

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