Photo: Welchol(TM) (colesevelam HCl) Receives FDA Approval to Reduce Blood Glucose...

Photo: Welchol(TM) (colesevelam HCl) Receives FDA Approval to Reduce Blood
Glucose in Adults with Type 2 Diabetes
First and only medication approved to reduce both A1C and LDL cholesterol

PARSIPPANY, N.J., Jan. 22 /PRNewswire/ -- Daiichi Sankyo, Inc., announced
that the United States Food and Drug Administration (FDA) has approved
Welchol(TM) (colesevelam HCl) to improve glycemic control (measured as
hemoglobin A1C) in adults with type 2 diabetes mellitus in combination with
metformin, sulfonylureas, or insulin, either alone or in combination with
other anti-diabetic agents. Welchol is now the first and only medication
approved to reduce both glucose levels and low density lipoprotein cholesterol
levels (LDL-C). The ADA estimates that 20.8 million people in the United
States have diabetes with more than 90 percent of these people having type 2
diabetes.(1) Forty percent of patients with type 2 diabetes also have high
LDL-cholesterol.(2) Welchol is a new option that addresses both these chronic
health conditions and provides physicians with a unique therapeutic approach
for treating patients with type 2 diabetes. (Photo:
http://www.newscom.com/cgi-bin/prnh/20080122/NYTU059 )

To view the Multimedia News Release, go to:
http://www.prnewswire.com/mnr/welchol/29889/

Pivotal data presented at the American Diabetes Association's (ADA) 67TH
Annual Scientific Sessions in Chicago in June, 2007 demonstrated that Welchol
can lower both A1C and LDL-C levels in patients with type 2 diabetes who were
uncontrolled on a metformin-based regimen. Patients in the study were
randomly assigned to two groups. The addition of Welchol was compared to the
addition of placebo in patients on a metformin-based regimen. The addition of
Welchol (n=79) to pre-existing metformin monotherapy achieved a significant
mean reduction in A1C levels of 0.47 percent relative to placebo (p<0.0024).
Further, the total Welchol treatment group, when treated with either metformin
monotherapy or metformin-combination therapy, achieved significantly greater
reductions in A1C levels compared to placebo (mean reduction of 0.54%;
p<0.001). The study further demonstrated that the total Welchol treatment
group achieved significantly lower LDL-C levels compared to the placebo group
(mean reduction of 15.9%; p<0.001).
In addition, two other pivotal studies showed similar results in A1C
reductions when Welchol was added to either sulfonylurea-based therapy or
insulin-based therapy. In patients with type 2 diabetes who were inadequately
controlled on sulfonylurea-based therapy the addition of Welchol was shown to
have significant reductions in A1C (mean reduction of 0.54%; p<0.001) vs.
placebo at week 26. In patients inadequately controlled with insulin, alone
or in combination with other anti-diabetic agents, the addition of Welchol was
shown to have a significant mean reduction in A1C (mean reduction of 0.50%;
p<0.0001) vs. placebo.
"Welchol now offers physicians a treatment option that addresses two major
cardiovascular risk factors; elevated LDL cholesterol and blood glucose in
patients with type 2 diabetes," said Ronald B. Goldberg, MD, an investigator
in the insulin and metformin pivotal studies and Professor of Medicine at the
Division of Diabetes and Metabolism and Associate Director of the Diabetes
Research Institute at the University of Miami, Miller School of Medicine in
Florida. "Cardiovascular risk factors are of great concern because patients
with type 2 diabetes have a significantly increased risk of developing
cardiovascular disease. Once clinical cardiovascular disease develops, these
patients have a poorer prognosis than normoglycemic patients."
Since 2000, Welchol, a bile acid sequestrant, has been indicated, alone or
in combination with a statin, for the reduction of elevated LDL-C in patients
with primary hypercholesterolemia. It 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
interactions via the cytochrome P450 pathway. Systemic medications, which
include 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.
Additionally, Welchol has demonstrated beneficial effects on other lipid
parameters such as HDL-C and APO-B. Welchol has also been studied in
combination with fenofibrate in patients with mixed dyslipidemia (Fredrickson
Type IIb), and provided additional LDL-C reductions in these patients when
added to a stable fenofibrate regimen. Welchol is not indicated for use in
combination with fenofibrate or in the treatment of mixed dyslipidemia or
lipid parameters other than LDL-C.
"We are excited by the opportunity to help more patients with chronic
conditions reach their recommended health goals," said Joseph P. Pieroni,
President and CEO of Daiichi Sankyo, Inc. "This approval represents an
important milestone for our growing U.S. organization and underscores our
continued commitment to combating cardiovascular and metabolic diseases."
People with diabetes face significantly higher risk of developing
cardiovascular disease.(3) The ADA recommends that patients with type 2
diabetes target an A1C level of <7%.(4) A1C is a common test for persistent
hyperglycemia ("too much glucose in the blood"). Additionally, the National
Cholesterol Education Program (NCEP) recommends that patients with type 2
diabetes keep their cholesterol levels in check and target an LDL-C goal of
>100 mg/dL.(5) Despite this recommendation, nearly 40 percent of patients
with type 2 diabetes have LDL cholesterol levels greater than 130 mg/dL.(6)
It is estimated that half of all Americans have elevated blood cholesterol
levels that can negatively impact their health and quality of life.(7)
According to the National Healthcare Quality Report, nearly 40 percent of
adults with high cholesterol also have type 2 diabetes.(8)
IMPORTANT INFORMATION ABOUT WELCHOL
Welchol is indicated as an adjunct to diet and exercise to reduce elevated
low-density lipoprotein cholesterol (LDL-C) in patients with primary
hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an
hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor. Welchol is
also indicated as an adjunct to diet and exercise to improve glycemic control
in adults with type 2 diabetes mellitus.
Welchol should not be used for the treatment of type 1 diabetes or for the
treatment of diabetic ketoacidosis. It has not been studied in type 2
diabetes as monotherapy or in combination with a dipeptidyl peptidase 4
inhibitor and has not been extensively studied in combination with
thiazolidinediones. Welchol has not been studied in Fredrickson Type I, III,
IV, and V dyslipidemias. Welchol is contraindicated in individuals with bowel
obstruction, those with serum triglyceride (TG) concentrations of >500 mg/dL,
or with a history of hypertriglyceridemia-induced pancreatitis.
The effect of Welchol on cardiovascular morbidity and mortality has not
been determined.
Welchol can increase serum TG concentrations particularly when used in
combination with sulfonylureas or insulin. Caution should be exercised when
treating patients with TG levels >300 mg/dL.
Welchol may decrease the absorption of fat-soluble vitamins A, D, E, and
K. Patients on vitamin supplements should take their vitamins at least 4 hours
prior to Welchol. Caution should be exercised when treating patients with a
susceptibility to vitamin K or fat soluble vitamin deficiencies.
Caution should also be exercised when treating patients with
gastroparesis, gastrointestinal motility disorders, major gastrointestinal
tract surgery, and when treating patients with dysphagia and swallowing
disorders.
Welchol reduces gastrointestinal absorption of some drugs. Drugs with a
known interaction with colesevelam (glyburide,levothyroxine, and oral
contraceptives [ethinyl estradiol, norethindrone]) should be administered at
least 4 hours prior to Welchol. Drugs that have not been tested for
interaction with colesevelam, especially those with a narrow therapeutic
index, should also be administered at least 4 hours prior to Welchol.
Alternatively, the physician should monitor drug levels of the co-administered
drug.
Primary Hyperlipidemia: In clinical trials, the adverse reactions observed
in greater than or equal to 2% of patients -- and more commonly with Welchol
than placebo -- regardless of investigator assessment of causality were
constipation (11.0% vs. 7.0%), dyspepsia (8.3% vs. 3.5%), nausea (4.2% vs.
3.9%), accidental injury (3.7% vs. 2.7%), asthenia (3.6% vs. 1.9%),
pharyngitis (3.2% vs. 1.9%), flu syndrome (3.2% vs. 3.1%), rhinitis (3.2% vs.
3.1%) and myalgia (2.1% vs. 0.4%).
Type 2 Diabetes: In clinical trials, the adverse reactions observed in
greater than or equal to 2% of patients -- and more commonly with Welchol than
placebo -- regardless of investigator assessment of causality were
constipation (8.7% vs. 2.0%), nasopharyngitis (4.1% vs. 3.6%) dyspepsia (3.9%
vs. 1.4%), hypoglycemia (3.0% vs. 2.3%), nausea (3.0% vs. 1.4%) and
hypertension (2.8% vs. 1.6%).
Post-marketing experience: Due to the voluntary nature of these reports it
is not possible to reliably estimate frequency or establish a causal
relationship. Increased seizure activity or decreased phenytoin levels have
been reported in patients receiving phenytoin concomitantly with Welchol.
Reduced International Normalized Ratio (INR) has been reported in patients
receiving warfarin concomitantly with Welchol.
Welchol is Pregnancy Category B.
For more information on Welchol, call 877-4-DSPROD (877-431-7763), or go
to the Welchol web site at www.Welchol.com.
About Daiichi Sankyo, Inc.
Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S.
subsidiary of Daiichi Sankyo Co., Ltd., Japan's second largest pharmaceutical
company and a global leader in pharmaceutical innovation since 1899. The
company is dedicated to the discovery, development and commercialization of
innovative medicines that improve the lives of patients throughout the world.
The primary focus of Daiichi Sankyo's research and development is
cardiovascular disease, including therapies for dyslipidemia, hypertension,
diabetes, and acute coronary syndrome. The company is also pursuing the
discovery of new medicines in the areas of glucose metabolic disorders,
infectious diseases, cancer, bone and joint diseases, and immune disorders.
For more information, please visit www.dsus.com.
Please see package insert for full prescribing information.

(1) American Diabetes Association, Diabetes Statistics.
http://www.diabetes.org/diabetes-statistics/prevalence.jsp. Accessed
August 16, 2007.
(2) 2004 National Healthcare Quality Report, Agency for Healthcare,
Research and Quality. United States Department of Health and Human
Services.
(3) Rosamond W, Flegal K, Friday G, et al. Heart disease and stroke
statistics--2007 update: a report from the American Heart Association
Statistics Committee and Stroke Statistics Subcommittee. Circulation.
Feb 6, 2007;115(5):e69-171
(4) American Diabetes Association: Standards of medical care in diabetes
- 2006. Diabetes Care 29(Suppl 1):S4-S42,2006
(5) Grundy SM, Cleeman JI, Merz CN, Brewer HB, Jr., Clark LT, Hunninghake
DB, et al. Implications of recent clinical trials for the National
Cholesterol Education Program Adult Treatment Panel III guidelines.
Circulation 110: 227-239, 2004
(6) 2004 National Healthcare Quality Report, Agency for Healthcare,
Research and Quality. United States Department of Health and Human
Services.
(7) The American Heart Association, Cholesterol Statistics.
http://www.americanheart.org/presenter.jhtml?identifier=536. Accessed
August 24, 2007.
(8) 2004 National Healthcare Quality Report, Agency for Healthcare,
Research and Quality. United States Department of Health and Human
Services.

SOURCE Daiichi Sankyo, Inc.

John Radziejewski of Hill & Knowlton for Daiichi Sankyo, Inc.,
+1-212-885-0412, +1-917-238-8030, (cell),
john.radziejewski@hillandknowlton.com; or Jason Ford of Daiichi Sankyo, Inc.,
+1-973-359-2634, +1-908-868-4554, (cell), jaford@dsus.com