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Biopharmaceuticals FDA

 News Release - March 28, 2007

Daiichi Sankyo, Inc. Announces Filing For WelChol Label Change to Include Ezetimibe Efficacy Data

PARSIPPANY, N.J., March 28 (HSMN NewsFeed) -- Daiichi Sankyo, Inc. announced today that it has filed for a label change with the U.S. Food and Drug Administration to include ezetimibe efficacy data from a recent clinical study. WelChol, the number one product in the bile acid sequestrant class, is currently indicated for the reduction of LDL-C either alone or in combination with commonly prescribed statins: Lipitor® (atorvastatin calcium), Zocor® (simvastatin), Pravachol® (pravastatin sodium) and Mevacor® (lovastatin).

A study recently published in the November issue of Current Medical Research and Opinion showed that taking WelChol® (colesevelam HCI) in combination with ezetimibe (a cholesterol absorption inhibitor) reduced LDL-C by a mean 32% which reduced mean LDL-C levels by an additional 11% over ezetimibe monotherapy in patients with primary hypercholesterolemia (p< 0.0001). The, "Lipid Lowering Effects of Colesevelam HCI in Combination with Ezetimibe" (1) study was also presented in November at the American Heart Association's Scientific Sessions 2006 in Chicago.

"This data demonstrates the value of combining WelChol plus ezetimibe," said Harold E. Bays, MD, FACP, Louisville Metabolic and Atherosclerosis Research Center Inc., Louisville, KY, and lead study investigator. "This combination helps achieve even lower LDL-C levels, which is important since for every percentage point of reduction in LDL-C, there is a corresponding reduction in risk of developing coronary heart disease."

The effects of WelChol alone or in combination with a statin, fenofibrate, or ezetimibe on cardiovascular morbidity and mortality have not been determined.

According to the Center for Disease Control and Prevention, an estimated 106.9 million American adults have total blood cholesterol levels of 200 mg/dL and higher, which is above desirable. (2) For LDL-C (the "bad" cholesterol), the National Cholesterol Education Program recommends a level of less than 100 mg/dL. (3) Studies have shown that lowering cholesterol can reduce the risk for developing heart disease, including heart attacks and death related to heart disease. (4)

About WelChol

WelChol is indicated for LDL-C lowering and was approved by the U.S. Food and Drug Administration (FDA) for marketing in May 2000. WelChol is the top-selling branded drug in the bile acid sequestrants (BAS) class. WelChol is different from most other cholesterol-lowering drugs on the market because it is non-systemic, meaning that the body does not absorb it and it is eliminated without traveling to the liver or kidneys. Therefore, WelChol is not expected to have drug-drug interactions via the cytochrome P-450 pathway. Systemic medications, which include the statins, fibrates, and cholesterol absorption inhibitors, are those that are absorbed from the intestine into the bloodstream and travel throughout the body, specifically to the liver and/or kidneys.

WelChol is a prescription drug indicated alone or in combination with a statin, as an adjunct to diet and exercise for the reduction of elevated LDL cholesterol in patients with primary hypercholesterolemia (Fredrickson Type IIa) when the response to diet and exercise has been inadequate. Liver-function monitoring is not required with WelChol when used as monotherapy, and in combination with a statin, no additional liver-function monitoring is required beyond that for the prescribed statin alone.

In clinical trials with patients with primary hypercholesterolemia, when WelChol was given alone in addition to a low-fat diet and exercise, it was shown to reduce LDL cholesterol by an average of 15 to 18%.

When WelChol is given in combination with a statin, the combination can lower cholesterol levels more effectively than using either therapy alone. In pivotal studies where WelChol was taken with a statin, WelChol 3.8g provided up to an additional mean 16% (32 mg/dL) reduction in LDL cholesterol. WelChol is the only non-systemic cholesterol-lowering agent approved by the FDA for combination with a statin. WelChol can be used in combination with any dose of any statin.

WelChol is engineered for affinity and high capacity bile acid binding. It has been studied with four commonly prescribed statins -- Lipitor® (atorvastatin calcium), Zocor® (simvastatin), Pravachol® (pravastatin sodium) and Mevacor® (lovastatin). Additionally, WelChol has been studied with fenofibrate and had no effect on the bioavailability on fenofibrate. Like most prescription drugs, WelChol has not been studied in combination with all medications or supplements. Patients should always tell their doctor about all medications and supplements they are taking before starting any new therapy, including WelChol.

WelChol is not for everyone, especially those with bowel blockage. Caution should be exercised when treating patients who have trouble swallowing or severe stomach or intestinal problems. Side effects may include constipation, indigestion and gas. WelChol, either alone or in combination with a statin or fenofibrate, has not been shown to prevent heart disease or heart attacks.

WelChol is only indicated for the reduction of LDL-C either alone or in combination with a statin in patients with primary hypercholesterolemia. WelChol has also been studied in combination with fenofibrate in patients with mixed dyslipidemia (Fredrickson Type II B), and provided additional LDL-C reductions in these patients when added to a stable fenofibrate regimen. Additionally, WelChol has demonstrated beneficial effects on other lipid parameters such as HDL-C and APO-B. However, WelChol is not indicated for use in treatment of these lipid parameters or in patients with mixed dyslipidemia.

For more information on WelChol, call 877-4-DSPROD (877-431-7763), or go to the WelChol web site at

About Daiichi Sankyo, Inc.

Daiichi Sankyo, Inc. was established in April of 2006 as the U.S. subsidiary of Japanese pharmaceutical company Daiichi Sankyo Co., Ltd. The company was formed by the merger of U.S. entities Sankyo Pharma Inc., Daiichi Pharmaceutical Corporation and Daiichi Medical Research. Headquartered in Parsippany, New Jersey, the company's strategic focus is on cardiovascular diseases. Research and development of new therapies is also focused in the areas of glucose metabolic disorders, infectious diseases, cancer, immunology and bone and joint diseases. Daiichi Sankyo's portfolio includes BENICAR® (olmesartan medoxomil) and BENICAR HCT® (olmesartan medoxomil/hydrochlorothiazide), the fastest growing angiotensin receptor blocker on the market, and WelChol®, the number one branded bile acid sequestrant.(5) For more information, please visit

Trademarks not owned by Daiichi Sankyo, Inc., are the property of their respective owners.

(1) Current Medical Research and Opinion, Volume 22, Number 11, November
2006, pp. 2191-2200(10)

(2) Cholesterol Fact Sheet, last reviewed: May 12th 2006. Retrieved
February 16th from

(3) Grundy SM, Cleeman JI, Bairey Merz CN, Brewer HB, Clark LT,
Hunninghake DB, Pasternak RC, Smith SC, Stone NJ; for the Coordinating
Committee of the National Cholesterol Education Program. Implications
of Recent Clinical Trials for the National Cholesterol Education
Program Adult Treatment Panel III Guidelines. Circulation. 2004;

(4) Cholesterol Fact Sheet, last reviewed: May 12th 2006. Retrieved
February 16th from

(5) Data are representing May 2002 - February 2006 from IMS Health.
National Prescription Audit, February 2006.

Source: Daiichi Sankyo

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