TIDMLEL
Date: May 31, 2012
Refer to: Eliza Merves
Makovsky + Company Inc. for Kowa Pharmaceuticals America, Inc.
Office (212) 508-9631
Mobile (908) 256-1243
emerves@makovsky.com
Lisa Garman
Kowa Pharmaceuticals America, Inc.
Mobile (404) 291-4772
lgarman@kowapharma.com
Christina Gaines, APR
Eli Lilly and Company
Office (317) 276-3845
Mobile (317) 366-2568
Gaines_Christina_Diane@Lilly.com
New Data Showed LIVALO® (pitavastatin) Met Primary Endpoint of LDL-C Reduction
When Compared with Pravastatin
PREVAIL U.S. primary and secondary lipid endpoints and lipoprotein particle
analysis presented at the National Lipid Association Scientific Sessions
Scottsdale, AZ, May 31, 2012 -- Kowa Pharmaceuticals America, Inc. and Eli
Lilly and Company (NYSE:LLY) today announced results of the PREVAIL U.S. study
(Pitavastatin compaREd with praVAstatin In Lowering LDL-C in the U.S.) which
evaluated the efficacy of LIVALO® (pitavastatin) 4 mg compared with pravastatin
40 mg in reducing low-density lipoprotein cholesterol (LDL-C), the primary
endpoint, as well as effects on other lipid parameters and lipoprotein
particles in adult patients with primary hyperlipidemia or mixed dyslipidemia.
Study results were presented during two poster sessions at the National Lipid
Association's (NLA) Scientific Sessions in Scottsdale, Arizona.
PREVAIL U.S. was designed as a superiority trial for the primary endpoint,
LDL-C reduction, and evaluated the adult population age 18-80 with primary
hyperlipidemia or mixed dyslipidemia. LIVALO 4 mg showed superior LDL-C
reduction compared with pravastatin 40 mg after 12 weeks of therapy. The study
did not compare LIVALO 4 mg with pravastatin 80 mg.1
Data for secondary endpoints showed LIVALO 4 mg reduced apolipoprotein B
(Apo-B), non-HDL-C, and total cholesterol compared with pravastatin 40 mg and
improved high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG).1
In addition, the effect of LIVALO and pravastatin on individual lipoprotein
particles was evaluated as a pre-specified exploratory analysis using nuclear
magnetic resonance (NMR) spectroscopy. LIVALO showed significantly greater
reductions in total LDL particle (LDL-P) concentration and increases in HDL
particle (HDL-P) concentration and size.
"We are very pleased with the results of PREVAIL U.S., which are consistent
with previous trials evaluating LIVALO's effect on LDL-C reduction," said Dr.
Craig Sponseller, Vice President of Medical Affairs at Kowa Pharmaceuticals
America, Inc. "Although the clinical relevance of these data require further
study, these data are important as they represent the first of such particle
analysis with LIVALO."
PREVAIL U.S. study investigator, Dr. Kari Uusinarkaus, Fellow of the National
Lipid Association, and Associate Medical Director, Adult Primary Care and
Disease Management Departments, Colorado Springs Health Partners, explains, "We
continue to research and pursue a greater understanding on the effect of
lipid-modifying agents, particularly statins, on lipoprotein particles and the
use of direct measures of particle number and size in advancing our clinical
assessment of dyslipidemia and its treatment."
About the Study
In the 12-week, Phase 4, multicenter, randomized, double-blind study, 328
adults meeting the established profile for inclusion were randomly assigned to
receive once-daily morning doses of LIVALO 4 mg or pravastatin 40 mg.1 Full
lipid panels and lipoprotein particle assessments using nuclear magnetic
resonance (NMR) were performed on blood samples drawn on Day 1 and following
the final dose at 12 weeks.2
The data were presented in two posters at the NLA meeting. In the first poster,
"Pitavastatin 4 mg is Superior to Pravastatin 40 mg in LDL-C Reduction: Results
from PREVAIL U.S. Trial in Primary Hyperlipidemia or Mixed Dyslipidemia,"
subjects treated with LIVALO 4 mg experienced a median percent reduction in
LDL-C of 38.1% over the treatment period compared to a 26.4% median percent
reduction in patients randomized to pravastatin 40 mg. LIVALO reduced total
cholesterol by 25.8%, with pravastatin showing a total cholesterol reduction of
18.3%. LIVALO treated patients experienced a significant 26.9% reduction in Apo
B compared with a 17.7% reduction associated with pravastatin.1
In the second poster, "Pitavastatin 4 mg Significantly Reduces LDL-P and
Increases HDL Size Compared with Pravastatin 40 mg: Results from PREVAIL U.S.,"
the pre-specified, exploratory objective was to evaluate LIVALO 4 mg vs.
pravastatin 40 mg on lipoprotein particle concentrations and size. LIVALO 4 mg
significantly reduced the concentration of LDL-P by 517.0 nanomoles per liter
(nmol/L) compared with 396.0 nmol/L for pravastatin 40 mg (p<0.001). Both
LIVALO and pravastatin increased HDL-P with a mean percent change in HDL-P of
9.59% versus 7.03%, respectively (p=0.045). Significant increases in HDL size,
and small HDL, as well as significant decreases in VLDL-P and IDL-P were also
noted for LIVALO compared with pravastatin over the 12-week study period.
Improvement was observed in Apo A1, medium and large HDL for both agents, but
were not statistically different between treatment arms. Additional studies are
needed to better understand the
clinical impact.2
No clinically important differences in the safety profiles were observed
between LIVALO and pravastatin in PREVAIL U.S. The overall incidence of
treatment-emergent adverse events (TEAEs) was similar between treatment groups
(47.6% for LIVALO and 44.5% for pravastatin), and most events were mild or
moderate in severity. The most frequently reported drug-related TEAEs were
muscle spasms and myalgia (each of which occurred at an incidence of 1.8% for
LIVALO and 1.2% for pravastatin).1
About LIVALO
LIVALO is a HMG-CoA reductase inhibitor indicated for patients with primary
hyperlipidemia and mixed dyslipidemia as an adjunctive therapy to diet to
reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol
(LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase
high-density lipoprotein cholesterol (HDL-C).
Limitations of Use:
* Doses of LIVALO greater than 4 mg once daily were associated with an
increased risk for severe myopathy in premarketing clinical studies. Do not
exceed 4 mg once daily dosing of LIVALO.
* The effect of LIVALO on cardiovascular morbidity and mortality has not been
determined.
* LIVALO has not been studied in Fredrickson Type I, III, and V dyslipidemias.
In addition to being launched in the U.S. in June 2010, LIVALO is also approved
in Japan (2003), South Korea (2005), Thailand (2007), China (2008), European
Union (2010), Taiwan (2011), Mexico (2009) and Australia (2010).
About Primary Hyperlipidemia and Mixed Dyslipidemia
Primary Hyperlipidemia is defined as an elevation of cholesterol, particularly
"bad" cholesterol (LDL-C), triglycerides (TG), or both. Mixed dyslipidemia is
usually characterized by an elevation of LDL-C, TG, and a decrease in the
"good" cholesterol (HDL-C) in the blood.
Important Safety Information for LIVALO® (pitavastatin) Tablets
CONTRAINDICATIONS
LIVALO is contraindicated in patients with a known hypersensitivity to product
components, in patients with active liver disease (which may include
unexplained persistent elevations in hepatic transaminase levels), in women who
are pregnant or may become pregnant, in nursing mothers, or in coadministration
with cyclosporine.
WARNINGS AND PRECAUTIONS
Skeletal Muscle Effects
Cases of myopathy and rhabdomyolysis with acute renal failure secondary to
myoglobinuria have been reported with HMG-CoA reductase inhibitors, including
LIVALO.
* The risk of skeletal muscle effects (e.g., myopathy and rhabdomyolysis)
increases in a dose-dependent manner with advanced age (>65 years), renal
impairment, inadequately treated hypothyroidism, and in combination use with
fibrates or lipid-modifying doses of niacin (=1 g/day).
* Concomitant administration of LIVALO with gemfibrozil should be avoided.
* LIVALO therapy should be discontinued if markedly elevated CK levels occur or
myopathy is diagnosed or suspected. LIVALO therapy should also be temporarily
withheld in any patient with an acute, serious condition suggestive of myopathy
or predisposing to the development of renal failure secondary to rhabdomyolysis
(e.g., sepsis; hypotension; dehydration; major surgery; trauma; severe
metabolic, endocrine, and electrolyte disorders; or uncontrolled seizures).
* Advise patients to promptly report unexplained muscle pain, tenderness, or
weakness, particularly if accompanied by malaise or fever, and to discontinue
LIVALO if these signs or symptoms appear.
Liver Enzyme Abnormalities
Increases in serum transaminases have been reported with HMG-CoA reductase
inhibitors, including LIVALO.
* It is recommended that liver enzyme tests be performed before the initiation
of LIVALO and if signs or symptoms of liver injury occur.
* There have been rare postmarketing reports of fatal and non-fatal hepatic
failure in patients taking statins, including pitavastatin. If serious liver
injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs
during treatment with LIVALO, promptly interrupt therapy. If an alternate
etiology is not found do not restart LIVALO.
* Advise patients to promptly report any symptoms that may indicate liver
injury, including fatigue, anorexia, right upper abdominal discomfort, dark
urine or jaundice.
* LIVALO should be used with caution in patients who consume substantial
quantities of alcohol and/or have a history of chronic liver disease.
Endocrine Function
Increases in HbA1c and fasting serum glucose levels have been reported with
HMG-CoA reductase inhibitors, including LIVALO.
ADVERSE REACTIONS
In short-term controlled studies, the most frequent adverse reactions reported
by =2% of patients treated with LIVALO 1 mg, 2 mg, and 4 mg, respectively, and
at a rate = placebo were back pain (3.9%, 1.8%, 1.4% vs 2.9%), constipation
(3.6%, 1.5%, 2.2% vs 1.9%), diarrhea (2.6%, 1.5%, 1.9% vs 1.9%), myalgia (1.9%,
2.8%, 3.1% vs 1.4%), and pain in extremity (2.3%, 0.6%, 0.9% vs 1.9%). This is
not a complete listing of all reported adverse events.
For additional information please visit http://www.kowapharma.com/documents/
LIVALO_PI_CURRENT.pdf
About Kowa Company, Ltd. and Kowa Pharmaceuticals America, Inc.
Kowa Company, Ltd. (KCL) is a privately held multinational company
headquartered in Nagoya, Japan. Established in 1894, KCL is actively engaged in
various manufacturing and commercial activities in the fields of
pharmaceutical, life science, information technology, textiles, machinery and
various consumer products. KCL's pharmaceutical division is focused on
cardiovascular therapeutics, with sales of the company's flagship product
LIVALO, totaling $530 million (14.6% market share) in Japan in the 2010 fiscal
year, and was launched in the United States in June 2010.
Kowa Pharmaceuticals America, Inc. (KPA) is a pharmaceutical company
specializing primarily in the area of cardiometabolic diseases. The company,
started in 2001 as ProEthic Pharmaceuticals, Inc., was acquired by KCL in
September of 2008. A privately held company, KPA directs its efforts towards
the acquisition, licensing and marketing of pharmaceutical products.
exchange rate used $1=85JPY
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -
through medicines and information - for some of the world's most urgent medical
needs. Additional information about Lilly is available at www.lilly.com. P-LLY
LIVALO is a registered trademark of the Kowa group of companies.
P-LLY
Data on File: Morgan R, Campbell S, et al, "Pitavastatin 4 mg is Superior to
Pravastatin 40 mg in LDL-C Reduction: Results from PREVAIL US Trial in Primary
Hyperlipidemia or Mixes Dyslipidemia," Poster presented at the National Lipid
Association Annual Scientific Sessions 2012, May 31-June 3, 2012; Scottsdale,
AZ.
Data on File: Sponseller C, Morgan R, et al, "Pitavastatin 4 mg Significantly
Reduces LDL-P and Increases HDL Size Compared with Pravastatin 40 mg: Results
from PREVAIL US," Poster presented at the National Lipid Association Annual
Scientific Sessions 2012, May 31-June 3, 2012; Scottsdale, AZ.
END
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