Eli Lilly and Company
November 09 2002 - 3:30AM
UK Regulatory
BW20021109002005 20021109T093011Z UTC
( BW)(ELI-LILLY-&-CO)(BC43) Eli Lilly and Company: Head-to-Head
Study Showed Teriparatide -- rDNA origin -- Injection Increased Bone
Formation
Business Editors
UK REGULATORY NEWS
BARCELONA, Spain--(BUSINESS WIRE)--Nov. 09, 2002--
3-Dimensional Bone Imaging Shows Lilly's Teriparatide Increased Spine
Bone Mineral Density Five-Fold Compared With Alendronate
Promising data from a head-to-head trial to compare teriparatide
(rDNA origin) injection (recombinant human PTH (1-34)) and alendronate
were presented today at the World Health Organization's Third
International Symposium on Clinical and Economic Aspects of
Osteoporosis and Osteoarthritis. The trial known as FACT (Forteo
Alendronate Comparison Trial) utilized Qualitative Computerized
Tomography (QCT) that allows for a 3-Dimensional image of bone mass,
along with the conventional, 2-Dimensional bone scan. After six
months, the patients treated with Lilly's anabolic bone formation
agent teriparatide showed a five-times greater QCT bone mineral
density (BMD) in the lumbar spine, compared to the bisphosphonate
drug, alendronate.
Forteo is the proposed global brand name for Lilly's teriparatide
for severe osteoporosis, with Forsteo being the considered name in the
European Union. Teriparatide is currently under review by the European
Medical Evaluation Agency and the United States Food and Drug
Administration.
"This is the first time these two drugs have been compared using
the potential marketed dose of teriparatide and the marketed dose of
alendronate." said, Michael R. McClung, MD, Oregon Osteoporosis
Center, Portland. "While teriparatide and alendronate both have been
shown to increase BMD and decrease fractures in previous
studies(1),(2), we were most intrigued by the different mechanisms by
which this occurs. We utilized the QCT scan because it is the only
bone mass measurement method that provides volumetric measurements.
Most interesting is the change in the significant volume of bone
(14.6 percent), created by teriparatide therapy compared to
(2.9 percent), increase with alendronate therapy. The five fold
increase in bone formation with teriparatide therapy is consistent
with the increase in bone volume reported in recent studies that
included bone biopsies."(3)
Bone formation agents
Current osteoporosis treatments work to slow or stop bone loss,
primarily by inhibiting osteoclast mediated bone resorption. Bone
formation agents work in a unique way, by activating bone-forming
cells called osteoblasts and promoting the growth of new bone. The
FACT interim results add to recent research published in the Journal
of Clinical Endocrinology and Metabolism showing that from baseline to
endpoint, teriparatide increased lumbar spine BMD 2.7 percent greater
than alendronate at three months. The BMD difference between the
teriparatide treated group increased to 5.4 percent at six months and
8.3 percent at twelve months over the alendronate group.(4)
The FACT study: background and results
Six-month interim FACT results showed that treatment with
teriparatide increased markers of bone mass by five-fold from
baseline, (217 percent with teriparatide), while treatment with
alendronate resulted in a decrease in markers of bone formation of
67 percent from baseline.
FACT is an 18-month, pivotal, Phase IV, double-blind,
double-placebo-controlled, trial that included 206 postmenopausal
women with osteoporosis. Women were randomized to either a once-daily
subcutaneous injection of a 20 ug (microgram) dose of teriparatide
plus a placebo pill or alendronate 10 mg plus placebo injection. The
mean age of study participants was 65 and all had similar baseline
characteristics.
Other important, six-month FACT results were:
-- Percentage change in lumbar spine BMD measured by dual X-ray
absorptiometry (conventional 2-D bone scans)
The change from baseline in areal lumbar spine BMD was greater
in the teriparatide group (n=84) than in the alendronate group
(n=87), 4.7 percent vs 3.2 percent respectively (P less than
0.01).
-- Changes in two important markers of bone turnover (PINP and
NTX) Teriparatide increased markers of bone turnover (PINP) by
217 percent (P less than 0.01; n=85) and increased markers of
bone resorption (NTX) by 59 percent (P less than 0.01; n=84).
Alendronate decreased markers of bone turnover (PINP) by 67
percent (P less than 0.01; n=76) and decreased markers of bone
resorption (NTX) by 72 percent (P less than 0.01; n=73).
A critical need
Osteoporosis is a global problem, affecting more than 150 million
people worldwide. It affects up to 50 percent of postmenopausal
women(5), and as the population of the world both grows and ages it is
becoming an increasingly significant cause of mortality and
morbidity.(6) Each year there are 2.3 million osteoporotic fractures
in Europe and the US costing an estimated EUR 30 million to treat.(7)
Studies suggest that osteoporosis may be a quickly progressing disease
once a fracture occurs. The accumulation of multiple spinal fractures
may result in pain, height loss, deformity, functional limitations,
and diminished quality of life.(8)
Side effect profile
In studies with teriparatide, the most frequent treatment-related
adverse events were generally mild to moderate and dose-related. At
the 20 ug dose, dizziness or leg cramps were reported in 9 percent and
3 percent of women, respectively; compared with 6 percent and
1 percent on placebo. At the 40 ug dose, nausea or headache occurred
in 18 percent and 13 percent, respectively, compared with 8 percent
and 8 percent on placebo.
Development of teriparatide was suspended by Lilly in 1998 to
evaluate carcinogenicity findings in a rodent study. In the study,
rats given teriparatide starting early in their lifetimes and treated
with the drug for nearly their entire lifetimes developed bone tumors,
including osteosarcomas. No bone tumors occurred in human patients in
the clinical trials. A comprehensive assessment by external oncology
experts and company researchers concluded that the finding in rats was
unlikely to predict an increased risk of osteosarcoma for humans
receiving teriparatide for the intended clinical use. This conclusion
was based, in part, on several important differences between rat and
human bone biology and responses to teriparatide.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of best-in-class pharmaceutical products by applying
the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Indiana, Lilly provides answers - through medicines and
information - for some of the world's most urgent medical needs.
References:
(1) Black DM, et al., Lancet. 1996:348: 1535-1541
(2) Neer R, et al. Effect of Parathyroid Hormone (1-34) on
Fractures and Bone Mineral Density in Postmenopausal Women
with Osteoporosis. N Engl J Med. 2001; 344: 1434-1441
(3) Jiang, ASBMR 2002: Dempster 20014.
(4) Body JJ, Gaich GA, Scheele WH et al. A randomized double-blind
trial to compare the efficacy of teriparatide (recombinant human
parathyroid hormone (1-34)) with alendronate in postmenopausal women
with osteoporosis. J Clin Endocrinol Metab. 2002 Oct;87(10):4528-35
(5) Hall M. Target Osteoporosis. ABPI, London, 1996
(6) International Osteoporosis Foundation Annual Report 1998
(7) International Osteoporosis Foundation
(8) Boning Up on Osteoporosis: A Guide to Prevention and Treatment.
National Osteoporosis Foundation; 2000.
FORTEO(TM)(teriparatide (rDNA origin)] injection)
Short Name: Lilly (Eli) & Co.
Category Code: MSC
Sequence Number: 00001180
Time of Receipt (offset from UTC): 20021107T174955+0000
--30--djl/cl* ne/uk
CONTACT: Lilly
Sondra McQueary, 317/985-4045
Lisa Swingler, +44 1276 484886
KEYWORD: INDIANA SPAIN UNITED KINGDOM INTERNATIONAL EUROPE
INDUSTRY KEYWORD: MEDICAL BIOTECHNOLOGY PHARMACEUTICAL PRODUCT
SOURCE: Eli Lilly and Company
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