February 18, 1998 Press release
(Reprinted from www.About.com):
http://pharmacology.miningco.com/health/pharmacology/library/newdr98/bl0218a.htm
Press Release: West Haven, Connecticut and Philadelphia,
Pennsylvania,
February 18, 1998 -- Bayer Corporation Pharmaceutical
Division and
SmithKline Beecham (SB) announced today the launch of Baycol™
(cerivastatin sodium tablets), a new cholesterol-lowering agent of
the statin class of drugs.
Baycol, an HMG-CoA reductase inhibitor, is indicated as an
adjunct to diet for the reduction of elevated total and low-density
lipoprotein cholesterol (LDL-C) levels in patients with primary
hypercholesterolemia and mixed dyslipidemia (Fredrickson types IIa
and IIb) when response to dietary restriction of saturated fat and
cholesterol and other non-pharmacological measures alone have been
inadequate.
"Baycol continues Bayer’s proud heritage in cardiovascular
medicine," said David Ebsworth, Ph.D., President of the
Pharmaceutical Division at Bayer Corporation. "We’re bringing
to the rapidly-expanding statin marketplace a new
competitively-priced drug which offers physicians and their patients
a safe and effective alternative that in addition to diet helps
achieve target cholesterol levels at a good value."
A 24-week, randomized, double-blind, placebo-controlled U.S.
clinical trial using Baycol in 934 patients with primary
hypercholesterolemia has shown that once-daily dosing with the
recommended dose of 0.3 mg produced a mean 28 percent reduction in
LDL-C, a 13 percent reduction in triglycerides and a 10 percent
increase in high-density lipoprotein cholesterol (HDL-C). The
recommended daily dose (0.3 mg), with an average wholesale price (AWP)
of $1.32 (bottles of 100), provides particular value for patients.1*
Baycol, used as an adjunct to diet, may help patients reach the
cholesterol goals recommended by the National Cholesterol Education
Program (NCEP).** NCEP, established in 1985 by the National Heart,
Lung and Blood Institute (NHLBI), provides nationally-recognized
guidelines for target cholesterol levels in an effort to reduce
illness and death from cardiovascular disease and reduce the percent
of Americans with high blood cholesterol. The effect of Baycol on
cardiovascular morbidity and mortality has not been determined.
"For patients to effectively reduce cholesterol, it is
essential that they comply with therapy. Yet a high price for
treatment can be challenging to patients and is often one of the
barriers to compliance. Thus, a cholesterol-lowering medicine that
is competitively priced can help patients get the treatment they
need at a cost that is affordable," said Edgar Gonzalez, PharmD,
FASHP, FASCP, associate professor of medicine and pharmacy, Medical
College of Virginia, and director, Research Services, Managed Care
Resources, Chesapeake, Virginia.
By comparison to the AWP of $1.32 for the 0.3 mg daily dose for
Baycol, the daily price based on AWP for the most commonly
prescribed doses of other statin drugs are: Lipitor®(10 mg), $1.82;
Lescol® (20 mg), $1.25; Pravachol® (20 mg), $2.06, Mevacor® (20
mg), $2.33, and Zocor® (10 mg), $2.10, (20 mg), $3.66. 1* Price
comparisons do not imply that the products being compared are
equally effective.
Patients with hypercholesterolemia should be placed on a standard
cholesterol-lowering diet. If the response to dietary restrictions
of saturated fat and cholesterol and other non-pharmacological
measures are inadequate, patients should continue on their diet,
then treatment with Baycol can begin. The recommended dosing for
Baycol is 0.3 mg once-daily, in the evening, with or without food.
The recommended starting dose in patients with moderate or severe
renal impairment is 0.2 mg once-daily, in the evening. No dosing
adjustment is required in the elderly, with the exception of those
patients with moderate or severe renal impairment.
Baycol is contraindicated in patients with hypersensitivity to
any component of this medication, in patients with active liver
disease or unexplained persistent elevations of serum transaminases,
in women during pregnancy, and in nursing mothers.
Baycol should be temporarily withheld from any patient
experiencing an acute or serious condition predisposing to the
development of renal failure secondary to rhabdomyolysis (acute
serious muscle disease), e.g., sepsis; hypotension; major surgery;
trauma; severe metabolic, endocrine or electrolyte disorders or
uncontrolled epilepsy.
Myopathy (a disorder of muscle tissues or muscle) should be
considered in any patient with diffuse myalgias, muscle tenderness
or weakness, and/or marked elevation of plasma creatine kinase (CK).
Patients should be advised to report promptly unexplained muscle
pain, tenderness, or weakness, particularly if accompanied by
malaise or fever. Baycol therapy should be discontinued if markedly
elevated CK levels occur or myopathy is diagnosed or suspected. The
risk of myopathy is increased with concurrent administration of
cyclosporine, fibric acid derivatives, erythromycin, azole
antifungals or lipid-lowering doses of niacin.
As with all statins, it is recommended that liver function tests
be performed before the initiation of treatment, at 6 and 12 weeks
after initiation of therapy or elevation in dose, and periodically
thereafter.
Studies have confirmed that Baycol has no drug to drug
interactions with commonly used drugs such as warfarin, digoxin,
cimetidine and antacids.
Baycol is generally well-tolerated. In clinical trials with over
3,000 patients, the most common adverse events regardless of
causality were rhinitis, pharyngitis, headache, dyspepsia, diarrhea,
arthralgia and myalgia. In the U.S. placebo-controlled clinical
studies, discontinuations due to adverse events occurred in 3 % of
cerivastatin sodium tablet-treated patients and in 3 % of patients
treated with placebo.
Baycol was cleared for marketing by the Food and Drug
Administration on June 26, 1997. Bayer Corporation and SmithKline
Beecham jointly announced a co-promotion agreement for the product
in July 1997. Under the terms of the agreement, SB will provide
marketing and sales support for Baycol. Bayer and SB will also work
together toward the development of new dosage formulations.
Baycol is the most recent addition to Bayer’s cardiovascular
portfolio, which also includes Adalat® (nifedipine) capsules and
Adalat CC® (nifedipine) extended release tablets, as well as Bayer
Aspirin and Trasylol® (aprotinin injection).
Cerivastatin is currently marketed in the United Kingdom and
Germany. Bayer anticipates regulatory clearances for cerivastatin in
several other major markets of the world.
The most recent addition to SB’s cardiovascular portfolio is
Coreg® (carvedilol), an agent with beta-blocking and vasodilating
properties, which was introduced in the United States in June 1997
for the treatment of hypertension and congestive heart failure.
Teveten™ (eprosartan), SB’s angiotensin II receptor
antagonist, was approved by the U.S. Food and Drug Administration in
December 1997.
Bayer Corporation is a research-based company with major
businesses in healthcare and life sciences, chemicals and imaging
technologies. The company had 1996 sales of $9 billion and employs
24,000 people. Bayer Corporation is investing approximately $9
billion in capital expenditures and research and development in the
U.S. operations from 1995 through the year 2000. Capital
expenditures for 1996 totaled $632 million, and $621 million was
spent for research and development. Bayer Corporation, with
headquarters in Pittsburgh, is a member of the worldwide Bayer
group, a $32.4 billion chemical and pharmaceutical company based in
Leverkusen, Germany.
SmithKline Beecham -- one of the world’s leading healthcare
companies -- discovers, develops, manufactures, and markets
pharmaceuticals, vaccines, over-the-counter medicines, and
health-related consumer products, and provides healthcare services
including clinical-laboratory testing, disease management, and
pharmaceutical-benefit management.
For company information, visit SmithKline Beecham on the World
Wide Web at www.sb.com.
Prescribing information for Baycol™ Adalat®, Adalat CC®
, and Trasylol® is available via fax-on-demand by calling
1-800-753-0352, ext. 703.
__________________
1. Red Book® Update. January 1998. In press.
* Average Wholesale Price (AWP) is from a published price list
and may or may not represent actual price to pharmacists or
consumers. Retail pricing may vary from community to community and
may affect cost savings to the patient.
**LDL-C reductions may vary from patient to patient.
Lipitor (atorvastatin calcium) is a registered trademark of Parke-Davis;
Lescol (fluvastatin sodium) is a registered trademark of Sandoz
Pharmaceuticals Corporation; Pravachol (pravastatin sodium) Tablets
is a registered trademark of Bristol-Myers Squibb Company; Mevacor (lovastatin),
U.S.P. and Zocor (simvastatin) are registered trademarks of Merck
& Co., Inc.