Radius Health, Inc. (Nasdaq:RDUS) a science-driven fully integrated
biopharmaceutical company that is committed to developing and
commercializing innovative endocrine therapeutics in the areas of
osteoporosis and oncology, today announced two presentations
highlighting clinical data for TYMLOS™ (abaloparatide) injection at
ENDO 2018, the Endocrine Society’s 100th Annual Meeting and Expo in
Chicago, IL. The abstract titled: “Response Rates for Hip, Femoral
Neck, and Lumbar Spine Bone Mineral Density (BMD) in Patients
Treated with Abaloparatide Followed by Alendronate – Results from
Phase 3 ACTIVExtend,” will be presented in an oral session at ENDO
2018. Radius will also present a poster titled, “Fracture and Bone
Mineral Density Response by Baseline Risk in Patients Treated with
Abaloparatide Followed by Alendronate–Results from Phase 3
ACTIVExtend.”
TYMLOS was approved by the U.S. Food and Drug Administration on
April 28, 2017 for the treatment of postmenopausal women with
osteoporosis at high risk for fracture and has demonstrated
significant reductions in the risk of new vertebral and
nonvertebral fractures.
The oral presentation will take place during the oral abstracts
session titled “Osteoporosis, Vitamin D, and Mineral
Metabolism”:
- Response Rates for Hip, Femoral Neck, and Lumbar Spine Bone
Mineral Density in Patients Treated with Abaloparatide Followed by
Alendronate – Results from Phase 3 ACTIVExtend
(Deal)Session Date & Time: Saturday, March 17,
2018, 11:30 a.m. – 1:15 p.m. CTLocation: McCormick
Place West, Room W184
The poster will be presented during the poster abstracts session
titled “Osteoporosis Clinical Research”:
- Fracture and Bone Mineral Density Response by Baseline Risk in
Patients Treated with Abaloparatide Followed by Alendronate–Results
from Phase 3 ACTIVExtend highlighting pre-clinical and clinical
data for TYMLOS™ (abaloparatide) (Leder)Session Date &
Time: Saturday, March 17, 2018, 1 p.m. – 3 p.m.
CTLocation: ENDOExpo, Hall F, McCormick Place
West
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 ACTIVE and ACTIVExtend
The Phase 3 ACTIVE (Abaloparatide Comparator Trial In Vertebral
Endpoints) trial was a randomized, double-blind,
placebo-controlled, comparative, multicenter, 18-month
international study in 2,463 postmenopausal women with osteoporosis
designed to evaluate the efficacy and safety of abaloparatide-SC 80
mcg to reduce the risk of vertebral and nonvertebral fractures. The
results of ACTIVE were published in the Journal of the American
Medical Association in August of 2016. ACTIVExtend, an extension of
ACTIVE, enrolled patients who had completed 18 months of
abaloparatide-SC or placebo in ACTIVE to receive up to 24
additional months of open-label alendronate. The results of the
first six months of ACTIVExtend were published in the Mayo Clinic
Proceedings in February of 2017.
About TYMLOS (abaloparatide) injection
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 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 patch 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 endocrine therapeutics in the areas of osteoporosis and
oncology. 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' Marketing Authorisation Application (MAA) for
abaloparatide-SC for the treatment of postmenopausal women with
osteoporosis is under regulatory review in Europe. The Radius
clinical pipeline includes an investigational abaloparatide patch
for potential use in osteoporosis; the investigational drug
elacestrant (RAD1901) for potential use in hormone-receptor
positive breast cancer; and the investigational drug 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 the progress of abaloparatide-SC in the regulatory
process with the EMA, the incidence of osteoporotic fractures and
the health burden associated with osteoporosis, and the potential
clinical uses and therapeutic and other benefits of our product
candidates, including abaloparatide patch, elacestrant 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 Annual Report on Form 10-K for the period ending December 31,
2017 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.
Investor Relations Contact:Elhan Webb, CFAEmail:
ewebb@radiuspharm.comPhone: 617-551-4011
Media Contact:Tiffany H. BurkeEmail:
tburke@radiuspharm.comPhone: 484-582-6476
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