WelChol(R), in combination with Lipitor(R), cuts LDL cholesterol levels by 48%

December 27, 2001

Parsippany, N.J. (December 27, 2001) -- WelChol® (colesevelam HCl) and Lipitor® (atorvastatin calcium), taken in combination, can lower LDL cholesterol levels by 48% in patients with moderately high cholesterol -- a reduction statistically superior to either therapy alone -- according to a new study published in the October 2001 issue of Atherosclerosis. The study demonstrated that patients receiving this combination (3.8 g WelChol plus 10 mg Lipitor) experienced additive reductions in LDL cholesterol that were not significantly different from the maximum recommended dose of Lipitor alone (80 mg). This is welcome information for the new National Cholesterol Education Program (NCEP) guidelines. Issued this past May, the guidelines specify that patients at high risk for coronary heart disease must be treated more aggressively. They go on to note that combination therapy is a safe and effective way of lowering LDL cholesterol and reaching goal. "The results of WelChol/Lipitor coadministration suggest that this combination may be beneficial in lowering LDL cholesterol to NCEP recommended target levels for patients with or at risk of developing CHD," said Donald Hunninghake, MD, principal study investigator and professor of medicine and pharmacology at the University of Minnesota. This is the third such combination study with WelChol plus a leading statin demonstrating the two work better than either alone. The prior studies were conducted with simvastatin (Zocor®) and lovastatin (Mevacor®).

According to a study published in the April 1st issue of American Journal of Medicine , WelChol, taken in combination with Zocor, lowered LDL cholesterol levels by 42% in patients with moderately high cholesterol, a reduction more dramatic than either therapy alone. A study published in the June 2001 issue of Clinical Cardiology demonstrated that WelChol combined with Mevacor was efficacious and well tolerated, resulting in an additive 34% reduction in LDL cholesterol. WelChol, available by prescription only, effectively lowers LDL cholesterol (or "bad" cholesterol) and is the only lipid-lowering agent that is FDA-approved for combination use with a statin. Administered alone or in combination with a statin, WelChol is indicated as adjunctive therapy to diet and exercise for the reduction of elevated cholesterol in patients with primary hypercholesterolemia when diet and exercise alone are not adequate.

About the WelChol/Lipitor Study

In this four-week multicenter, double-blind, placebo-controlled study, 94 men and women with moderate hypercholesterolemia (LDL cholesterol = 160 mg/dl, triglycerides = 300 mg/dl) were monitored to determine the efficacy and safety of WelChol when co-administered with starting doses of Lipitor.

After 4 weeks on the American Heart Association Step I diet, the patients were randomly assigned to one of five treatment groups: placebo, WelChol 3.8 g/day, Lipitor 10 mg/day, WelChol 3.8 g/day plus Lipitor 10 mg/day, or Lipitor 80 mg/day. Fasting lipids were measured at screening, baseline and at two and four weeks. At the end of the trial, the combination appeared to be additive as compared to either constituent alone, with a 48% reduction in mean LDL cholesterol levels.

Because WelChol is not absorbed into the blood stream, it has few side effects. The most common side effects (>5%) versus placebo (sugar pill) are gas (12% vs. 14%), constipation (11% vs. 7%), infection (10% vs. 13%), upset stomach (8% vs. 3%), and headache (6% vs. 8%). WelChol should not be taken by patients who have bowel obstruction. There is no change in the adverse event profile with the coadministration of atorvastatin (Lipitor), simvastatin (Zocor) or lovastatin (Mevacor®). As with all medications, patients should always let their healthcare provider know about the medications and supplements they are taking. Also, liver-function monitoring is not required with WelChol, and in combination with a statin, no additional liver-function monitoring is required beyond that which is required for the prescribed statin alone. For more information on WelChol, call 877-4-SANKYO (877-472-6596), or go to the WelChol web site at www.welchol.com.
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About Sankyo

Sankyo Pharma is dedicated to developing and marketing innovative pharmaceuticals for the U.S. market. Sankyo Pharma has operations in New York and New Jersey with a Research Institute in California. A sales force of more than 500 professionals, including a dedicated managed care sales force, promotes Sankyo Pharma products. Sankyo Pharma's parent company, Sankyo Co. Ltd. of Tokyo, is the second-largest pharmaceutical company in Japan and one of the leading pharmaceutical companies in the world. Sankyo is a global innovator and a primary source of new therapeutic agents including drugs for hypertension and cardiovascular disease. Sankyo played an important role in establishing the HMG-CoA reductase inhibitor (or "statin") class of lipid-lowering agents. Sankyo originated the statin class in 1971 with the discovery of mevastatin, although mevastatin was not commercialized. Sankyo also co-discovered lovastatin (Mevacor), the first statin therapy to be marketed.

It discovered, co-developed and manufactures pravastatin. Sankyo independently markets pravastatin throughout the world and through its licensee, Bristol-Myers Squibb. Pravastatin is marketed as Pravachol® in the United States.

*Please see package insert for full prescribing information.

Mevacor® and Zocor® are registered trademarks of Merck & Co., Inc.; Lipitor® is a registered trademark of Pfizer Inc.; Pravachol® is a registered trademark of Bristol-Myers Squibb Co.

References
Hunninghake, Donald, Insull, William, Toth, Phillip, Davidson, David, Donovan, Joanne, Burke, Steven. Coadministration of Colesevelam Hydrochloride with Atorvastatin Lowers LDL Cholesterol Additively. Atherosclerosis. April 1, 2001; 110:352-360. Knapp, H et al. Efficacy and Safety of Combination Simvastatin and Colesevelam in Patients with Primary Hypercholesterolemia. American Journal of Medicine. April 1, 2001; 110::352-360 Davidson, Michael, Toth, Phillip, Weiss, Stuart, McKenney, James, Hunninghake, Donald, Isaacsohn, Jonathan, Donovan, Joanne, Burke, Steven. Low-Dose Combination therapy with Colesevelam Hydrochloride and Lovastatin Effectively Decreases Low-Densitiy Lipoprotein Cholesterol in Patients with Primary Hypercholesterolemia. Clinical Cardiology. June, 2001; 24:467-474.

Hill and Knowlton

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