Five posters will cover new data on the need for
osteoporosis awareness as well as cost-effectiveness data on
treatment with TYMLOS
Radius Health, Inc. (Nasdaq:RDUS), a science-driven
biopharmaceutical company committed to developing and
commercializing innovative therapeutics in the areas of
osteoporosis, oncology and endocrine diseases, will present five
posters focusing on the Company’s Health Economics and Outcomes
Research (HEOR) data regarding the treatment of osteoporosis within
the U.S. healthcare system at the Academy of Managed Care Pharmacy
(AMCP) Nexus 2017 Meeting in Dallas, TX from October 16-19, 2017.
“Osteoporosis-related fractures are a serious public health
burden that could lead to excess morbidity and mortality, resulting
in high costs for post-fracture care,” said Lorraine Fitzpatrick,
MD, Chief Medical Officer, Radius Health. “We are pleased to share
data at AMCP that demonstrate the high number of osteoporotic
fractures that occur and support the need to prioritize the
management of postmenopausal osteoporosis. Cost-effectiveness is an
important consideration in the payer value assessment framework.”
Radius’ health economics data delivered at the meeting support the
need to raise patient awareness of the relationship between a
fragility fracture and increased future fracture risk, which drives
the overall cost of illness.
The following posters will be presented on Wednesday, October 18
from noon - 2:45 p.m. CST at the Gaylord Texan Hotel &
Convention Center:
- Osteoporosis-Related Fracture Events in the
U.S.
- Deane Leader Jr., Setareh A. Williams, Jeffrey R. Curtis,
Robert Gut
- Challenges in Osteoporosis Awareness and Management:
Results from a Survey of U.S. Postmenopausal Women
- E. Michael Lewiecki, Setareh A. Williams, Robert Gut
- Cost-Effectiveness of Abaloparatide vs. Teriparatide
for Prevention of Osteoporosis-Related Fracture: A U.S. Payer
Perspective
- Joel Hay, Quang Le, Yamei Wang
- Cost-Effectiveness of Abaloparatide for the Treatment
of Postmenopausal Women with Osteoporosis
- Mickael Hiligsmann, Setareh A. Williams, Jean-Yves
Reginster
- The Number-Needed-to-Treat to Prevent a Fragility
Fracture: Comparison of Abaloparatide-SC and Teriparatide
- Jean-Yves Reginster, Dennis M. Black, Gary Hattersley, Gregory
Williams, Lorraine A. Fitzpatrick, E. Michael Lewiecki
Radius has taken a responsible approach to pricing TYMLOS and
considered factors such as the unmet need, total cost of care and
affordability at the patient level.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF OSTEOSARCOMA
- Abaloparatide caused a dose-dependent increase in the
incidence of osteosarcoma (a malignant bone tumor) in male and
female rats. The effect was observed at systemic exposures to
abaloparatide ranging from 4 to 28 times the exposure in humans
receiving the 80-mcg dose. It is unknown if TYMLOS will cause
osteosarcoma in humans.
- The use of TYMLOS is not recommended in patients at
increased risk of osteosarcoma including those with Paget's disease
of bone or unexplained elevations of alkaline phosphatase, open
epiphyses, bone metastases or skeletal malignancies, hereditary
disorders predisposing to osteosarcoma, or prior external beam or
implant radiation therapy involving the skeleton.
- Cumulative use of TYMLOS and parathyroid hormone
analogs (e.g., teriparatide) for more than 2 years during a
patient's lifetime is not recommended.
Orthostatic Hypotension: Orthostatic
hypotension may occur with TYMLOS, typically within 4 hours of
injection. Associated symptoms may include dizziness, palpitations,
tachycardia or nausea, and may resolve by having the patient lie
down. For the first several doses, TYMLOS should be administered
where the patient can sit or lie down if necessary.
Hypercalcemia: TYMLOS may cause hypercalcemia.
TYMLOS is not recommended in patients with pre-existing
hypercalcemia or in patients who have an underlying hypercalcemic
disorder, such as primary hyperparathyroidism, because of the
possibility of exacerbating hypercalcemia.
Hypercalciuria and Urolithiasis: TYMLOS may
cause hypercalciuria. It is unknown whether TYMLOS may exacerbate
urolithiasis in patients with active or a history of urolithiasis.
If active urolithiasis or pre-existing hypercalciuria is suspected,
measurement of urinary calcium excretion should be considered.
Adverse Reactions: The most common adverse
reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea,
headache, palpitations, fatigue, upper abdominal pain and
vertigo.
INDICATIONS AND USAGE
TYMLOS is indicated for the treatment of postmenopausal women
with osteoporosis at high risk for fracture defined as a history of
osteoporotic fracture, multiple risk factors for fracture, or
patients who have failed or are intolerant to other available
osteoporosis therapy. In postmenopausal women with osteoporosis,
TYMLOS reduces the risk of vertebral fractures and nonvertebral
fractures.
Limitations of Use
Because of the unknown relevance of the rodent osteosarcoma
findings to humans, cumulative use of TYMLOS and parathyroid
hormone analogs (e.g., teriparatide) for more than 2 years during a
patient's lifetime is not recommended.
For the TYMLOS prescribing information, including Boxed Warning,
please visit www.tymlospi.com.
About Postmenopausal Osteoporosis
Osteoporosis is a silent disease, often displaying no signs or
symptoms until a fracture occurs, leaving a majority of patients
undiagnosed and undertreated. Osteoporotic fractures create a
significant healthcare burden, and represent a significant unmet
medical need. The majority of osteoporosis-related fractures in the
U.S. among those 50 and older (71 percent) occur in women.
The National Osteoporosis Foundation (NOF) has estimated that
nearly 8.2 million women in the U.S. over the age of 50 have
osteoporosis, and nearly one in two women over the age of 50 will
have a fragility fracture (or low-impact fracture that is often the
result of a fall from standing height or lower) in her remaining
lifetime.
The annual incidence of osteoporotic fractures is higher than
that of stroke, heart attack and breast cancer combined;
osteoporotic fractures also account for more hospitalizations and
associated costs than cardiovascular disease and breast
cancer.
About TYMLOS
(abaloparatide)
TYMLOS (abaloparatide) was approved in April 2017 by the U.S.
Food and Drug Administration for the treatment of postmenopausal
women with osteoporosis at high risk for fracture defined as
history of osteoporotic fracture, multiple risk factors for
fracture, or patients who have failed or are intolerant to other
available osteoporosis therapy. Radius' Marketing Authorisation
Application (MAA) for abaloparatide-SC for the treatment of women
with postmenopausal osteoporosis was validated and is currently
undergoing regulatory review by the European Medicines Agency
(EMA).
Radius also is developing abaloparatide-transdermal
(abaloparatide-TD) based on 3M's patented Microstructured
Transdermal System technology for potential use as a treatment for
postmenopausal women with osteoporosis.
About Radius
Radius is a science-driven fully integrated biopharmaceutical
company that is committed to developing and commercializing
innovative therapeutics in the areas of osteoporosis, oncology and
endocrine diseases. Radius' lead product, TYMLOS (abaloparatide)
injection, was approved by the U.S. Food and Drug Administration
for the treatment of postmenopausal women with osteoporosis at high
risk for fracture. Radius’ clinical pipeline includes an
investigational abaloparatide transdermal patch for potential use
in osteoporosis; the investigational drug elacestrant (RAD1901) for
potential use in hormone-driven and/or hormone-resistant breast
cancer, and vasomotor symptoms in postmenopausal women; and RAD140,
a non-steroidal, selective androgen receptor modulator (SARM) under
investigation for potential use in hormone receptor positive breast
cancer. For more information, please visit www.radiuspharm.com.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. All statements contained in this press
release that do not relate to matters of historical fact should be
considered forward-looking statements, including without limitation
statements regarding expectations of the significance of health
economics data related to the treatment of osteoporosis and/or
TYMLOS, the potential benefit and cost-effectiveness of treatment
with TYMLOS for postmenopausal women with osteoporosis, the
progress of abaloparatide-SC in the regulatory process with the
EMA, and the potential clinical uses for abaloparatide-TD,
elacestrant (RAD1901) and RAD140.
These forward-looking statements are based on management’s
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including, but not limited to, the
following: we expect to need to raise additional funding, which may
not be available; risks related to raising additional capital; our
limited operating history; quarterly fluctuation in our financial
results; our dependence on the success of TYMLOS, and our inability
to ensure that TYMLOS will obtain regulatory approval outside the
U.S. or be successfully commercialized in any market in which it is
approved, including as a result of risk related to coverage,
pricing and reimbursement; risks related to competitive products
and any collaboration agreements failing to be successful; risks
related to clinical trials, including our reliance on third parties
to conduct key portions of our clinical trials and uncertainty that
results will support our product candidate claims; the risk that
adverse side effects will be identified during the development of
our product candidates or during commercialization, if approved;
risks related to manufacturing, supply and distribution; and the
risk of litigation or other challenges regarding our intellectual
property rights. These and other important risks and uncertainties
discussed in our filings with the Securities and Exchange
Commission, or SEC, including under the caption "Risk Factors" in
our most recent Quarterly Report on Form 10-Q and subsequent
filings with the SEC, could cause actual results to differ
materially from those indicated by the forward-looking statements
made in this press release. Any such forward-looking
statements represent management's estimates as of the date of this
press release. While we may elect to update such
forward-looking statements at some point in the future, we disclaim
any obligation to do so, even if subsequent events cause our views
to change. These forward-looking statements should not be
relied upon as representing our views as of any date subsequent to
the date of this press release.
Media Contact
Tiffany H. BurkeEmail: tburke@radiuspharm.com Phone:
484-582-6476
Radius Recycling (NASDAQ:RDUS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Radius Recycling (NASDAQ:RDUS)
Historical Stock Chart
From Apr 2023 to Apr 2024