Pitavastatin Demonstrates Promise for Low Incidence of Drug-Drug Interaction

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

New data presented today showed that pitavastatin may provide a new treatment option for patients with dyslipidaemia 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 dyslipidaemia 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 dyslipidaemia 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.”

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 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 decentralised authorisation 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 www.kowa.com.

Source: Kowa

CONTACT: Laura Anderson, +44(0)207-861-3033, l.anderson at bellpottingerhealth.com