THOUSAND OAKS, Calif.,
Oct. 6, 2015 /PRNewswire/
-- Amgen (NASDAQ: AMGN) today announced that it will present
data from multiple studies for Prolia® (denosumab) and
investigational molecule romosozumab at the annual meeting of the
American Society for Bone and Mineral Research (ASBMR) in
Seattle on Oct. 9-12, 2015. The data highlight Amgen's
ongoing commitment to providing wide-ranging information emerging
from its bone biology portfolio.
"Amgen's leadership in bone biology is clearly articulated in
the findings shared at this year's ASBMR meeting," said
Sean E. Harper, M.D., executive vice
president of Research and Development at Amgen. "Osteoporosis is a
silent disease with no symptoms until a fracture occurs, a
potentially life-changing event for postmenopausal women and their
families. We are excited to share a broad set of results that
reinforce the clinical profile of our bone biology portfolio with
our heritage product Prolia and our investigational compound,
romosozumab."
Presentations will include results from a head-to-head,
double-blind, randomized study evaluating the safety and efficacy
of Prolia compared with zoledronic acid in postmenopausal women
with osteoporosis previously treated with oral bisphosphonates; and
new results from a previously reported exploratory sub-study of the
Phase 2 trial1 comparing the effects of romosozumab
versus open-label teriparatide on bone strength in postmenopausal
women with low bone mass. Osteoporosis disease-state study
presentations will provide key insights around unmet needs among
patients at high risk for fracture, and the potentially serious
consequences of inadequate osteoporosis treatment.
Romosozumab is being co-developed
by Amgen and UCB.
SELECTED ABSTRACTS OF INTEREST
Late-Breaking Abstracts of Interest
- Ten Years of Denosumab Treatment in Postmenopausal Women
With Osteoporosis: Results From the FREEDOM Extension
Trial
Abstract LB-1157, Oral Presentation, Monday,
Oct. 12, 12:18 p.m.–12:30 p.m. PT (Room 6C)
Prolia Oral Presentations
- Effects of Denosumab on Bone Matrix Mineralization: Results
From the Phase 3 FREEDOM Trial
Abstract 1054, Oral Presentation, Saturday,
Oct. 10, 3:15 p.m.-3:30 p.m.
PT (Hall 4A)
- Relationship Between Total Hip BMD T-score and Incidence of
Nonvertebral Fracture With up to 8 Years of Denosumab
Treatment
Abstract 1146, Oral Presentation, Monday, Oct. 12, 11:15
a.m.-11:30 a.m. PT (Room 6E)
Prolia Abstracts of Interest
- Denosumab Compared With Zoledronic Acid in Postmenopausal
Women With Osteoporosis Previously Treated With Oral
Bisphosphonates: Efficacy and Safety Results From a Randomized
Double-blind Study
Abstract SU0340, Poster Presentation, Sunday, Oct. 11, 12:30
p.m.-2:30 p.m. PT (Hall 4B)
- Can We Use Bone Turnover Markers as Targets for
Antiresorptive Treatment in Postmenopausal Osteoporosis? An
Analysis From the DECIDE and STAND Clinical Trials
Abstract SU0337, Poster Presentation, Sunday, Oct. 11, 12:30
p.m.-2:30 p.m. PT (Hall 4B)
- Safety Observations With Three Years of Denosumab Exposure:
Comparison Between Subjects Who Received Denosumab During FREEDOM
and Subjects Who Crossed Over to Denosumab During the FREEDOM
Extension
Abstract SU0346, Poster Presentation, Sunday, Oct. 11, 12:30
p.m.-2:30 p.m. PT (Hall 4B)
- Incidence Rate of Osteonecrosis of the Jaw among Women With
Postmenopausal Osteoporosis Treated with Prolia or
Bisphosphonates
Abstract MO0345, Poster Presentation, Monday, Oct. 12, 12:30
p.m.-2:30 p.m. PT (Hall 4B)
- Effect of Denosumab on BMD Outcomes in Persistent Patients
in a Prospective Observational Study
Abstract SA0341, Poster Presentation, Saturday, Oct. 10, 12:30
p.m.-2:30 p.m. PT (Hall 4B)
- Factors Affecting Persistence With Denosumab
(Prolia®) in Postmenopausal Women With Osteoporosis:
Results From a Prospective Observational Study
Abstract MO0344, Poster Presentation, Monday, Oct. 12, 12:30
p.m.-2:30 p.m. PT (Hall 4B)
Romosozumab Oral Presentations
- Romosozumab Improves Strength at the Lumbar Spine and Hip in
Postmenopausal Women With Low Bone Mass Compared With
Teriparatide
Abstract 1143, Oral Presentation, Monday, Oct. 12, 10:30
a.m.-10:45 a.m. PT (Room 6E)
- Romosozumab (Sclerostin Antibody) Improves Bone Mass and
Bone Strength in Ovariectomized Cynomolgus Monkeys After 12 Months
of Treatment
Abstract 1019, Oral Presentation, Friday,
Oct. 9, 2 p.m.-2:15 p.m. PT
(Room 6E)
Romosozumab Abstracts of Interest
- Effects of Romosozumab in Japanese Women With Postmenopausal
Osteoporosis: Phase 2 Trial Results
Abstracts FR0331 and SA0331, Poster Presentation, Friday, Oct. 9, 5:30
p.m.-7 p.m. PT and Saturday,
Oct. 10, 12:30 p.m.-2:30 p.m.
PT (Hall 4B)
Osteoporosis Disease State Abstracts of Interest
- The Loss of Quality of Life From Non-Traumatic
Fractures
Abstract SU0282, Poster Presentation, Sunday, Oct. 11, 12:30
p.m.-2:30 p.m. PT (Hall 4B)
- Potential Years of Life Lost (PYLL) From Non-Traumatic
Fractures in Canada
Abstract MO0284, Poster Presentation, Monday, Oct. 12, 12:30
p.m.-2:30 p.m. PT (Hall 4B)
- Predicting Imminent Risk for Fracture in Patients With
Osteoporosis Using Commercially Insured Claims Data
Abstract 1066, Oral Presentation, Saturday,
Oct. 10, 5:15 p.m.-5:30 p.m.
PT (Room 6B)
- Analysis of the Osteoblast Lineage Reveals Inhibition of
Mitogenesis and Cell Cycle Progression Associated With Attenuation
of Bone Formation in Response to Sclerostin Antibody in
Ovariectomized Rats
Abstract MO0193, Poster Presentation, Monday, Oct. 12, 12:30
p.m.-2:30 p.m. PT (Hall 4B)
- Stereological Analysis Reveals Differential Effects of
Sclerostin Antibody and Parathyroid Hormone on the Osteoblast
Lineage in Young Female Rats
Abstract MO0154, Poster Presentation, Monday, Oct. 12, 12:30
p.m.-2:30 p.m. PT (Hall 4B)
- Change in Physical Function Following Hip Fracture Among
Elderly Osteoporotic Women
Abstract MO0307, Poster Presentation, Monday, Oct. 12, 12:30
p.m.-2:30 p.m. PT (Hall 4B)
- Predictors of Imminent Fracture Risk in Women Aged ≥65 Years
With Osteoporosis
Abstract SA0282, Poster Presentation, Saturday, Oct. 10, 12:30
p.m.-2:30 p.m. PT (Hall 4B)
- Imminent Fracture Risk in Elderly Osteoporotic Women:
Underlying Relationships Between Risk Factors and Outcome
Abstract MO0292, Poster Presentation, Monday, Oct. 12, 12:30
p.m.-2:30 p.m. PT (Hall 4B)
- Utilization of Osteoporosis Medication After a Fragility
Fracture Among Elderly Medicare Beneficiaries
Abstract MO0350, Poster Presentation, Monday, Oct. 12, 12:30
p.m.-2:30 p.m. PT (Hall 4B)
- Hospitalizations for Osteoporosis-Related Fractures:
Economic Cost and Clinical Outcomes
Abstract SA0302, Poster Presentation, Saturday, Oct. 10, 12:30
p.m.-2:30 p.m. PT (Hall 4B)
- Awareness and Reasons for Lack of Post-Fracture Osteoporosis
Therapy: A Survey of Post-Menopausal Women
Abstract MO0350, Poster Presentation, Saturday, Oct. 10, 12:30
p.m.-2:30 p.m. PT (Hall 4B)
About Osteoporosis
Osteoporosis affects many women
after menopause as their ability to form new bone cannot counter
balance the rate at which bone is being
removed.2,3 This bone loss leads to weakened
bones over time, increasing the potential for a
break.4,5
About half of all women over age 50 will have an
osteoporosis-related fracture in their remaining
lifetime.6 Additionally, patients with a previous hip
fracture have a threefold greater risk of a subsequent fracture
within two years.7,8
The World Health Organization has officially declared
osteoporosis a public health crisis, while the International
Osteoporosis Foundation urges governments worldwide to make
osteoporosis a healthcare priority.
About Prolia® (denosumab)
Prolia is
the first approved therapy that specifically targets RANK Ligand,
an essential regulator of bone-removing cells (osteoclasts).
Prolia is approved in the U.S. for the treatment of
postmenopausal women with osteoporosis at high risk for fracture,
defined as a history of osteoporotic fracture, or multiple risk
factors for fracture; or patients who have failed or are intolerant
to other available osteoporosis therapy. Prolia is also approved
for treatment to increase bone mass in men with osteoporosis at
high risk for fracture, defined as a history of osteoporotic
fracture, or multiple risk factors for fracture; or patients who
have failed or are intolerant to other available osteoporosis
therapy.
Prolia is also indicated as a treatment to increase bone mass in
women at high risk for fracture receiving adjuvant aromatase
inhibitor therapy for breast cancer and in men at high risk for
fracture receiving androgen deprivation therapy for non-metastatic
prostate cancer.
Prolia is administered as a single subcutaneous injection of 60
mg once every six months. Please see the Important Safety
Information below.
Important Safety Information (U.S.)
Prolia is
contraindicated in patients with hypocalcemia. Preexisting
hypocalcemia must be corrected prior to initiating Prolia. Prolia
is contraindicated in women who are pregnant and may cause fetal
harm. Prolia is contraindicated in patients with a history of
systemic hypersensitivity to any component of the product.
Reactions have included anaphylaxis, facial swelling and
urticaria.
Prolia® contains the same active ingredient
(denosumab) found in XGEVA®. Patients receiving
Prolia® should not receive XGEVA®.
Clinically significant hypersensitivity including anaphylaxis
has been reported with Prolia®. Symptoms have included
hypotension, dyspnea, throat tightness, facial and upper airway
edema, pruritus, and urticaria. If an anaphylactic or other
clinically significant allergic reaction occurs, initiate
appropriate therapy and discontinue further use of
Prolia®.
Hypocalcemia may worsen with the use of
Prolia®, especially in patients with severe renal
impairment. In patients predisposed to hypocalcemia and
disturbances of mineral metabolism, clinical monitoring of calcium
and mineral levels is highly recommended within 14 days of
Prolia® injection. Adequately supplement all patients
with calcium and vitamin D.
ONJ, which can occur spontaneously, is generally associated with
tooth extraction and/or local infection with delayed healing, and
has been reported in patients receiving
Prolia®. An oral exam should be performed
by the prescriber prior to initiation of
Prolia®. A dental examination with
appropriate preventive dentistry is recommended prior to treatment
in patients with risk factors for ONJ such as invasive dental
procedures, diagnosis of cancer, concomitant therapies (e.g.
chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral
hygiene, and co-morbid disorders. Good oral hygiene practices
should be maintained during treatment with
Prolia®.
For patients requiring invasive dental procedures, clinical
judgment should guide the management plan of each patient.
Patients who are suspected of having or who develop ONJ should
receive care by a dentist or an oral surgeon. Extensive
dental surgery to treat ONJ may exacerbate the condition.
Discontinuation of Prolia® should be considered
based on individual benefit-risk assessment.
Atypical low-energy, or low trauma fractures of the shaft have
been reported in patients receiving Prolia®.
Causality has not been established as these fractures also occur in
osteoporotic patients who have not been treated with
anti-resorptive agents.
During Prolia® treatment, patients should be
advised to report new or unusual thigh, hip, or groin pain. Any
patient who presents with thigh or groin pain should be evaluated
to rule out an incomplete femur fracture. Interruption of
Prolia® therapy should be considered, pending a
risk/benefit assessment, on an individual basis.
In a clinical trial (N = 7808) in women with postmenopausal
osteoporosis, serious infections leading to hospitalization were
reported more frequently in the Prolia® group than in
the placebo group. Serious skin infections, as well as
infections of the abdomen, urinary tract and ear, were more
frequent in patients treated with Prolia®.
Endocarditis was also reported more frequently in
Prolia®-treated patients. The incidence of opportunistic
infections and the overall incidence of infections were similar
between the treatment groups. Advise patients to seek prompt
medical attention if they develop signs or symptoms of severe
infection, including cellulitis.
Patients on concomitant immunosuppressant agents or with
impaired immune systems may be at increased risk for serious
infections. In patients who develop serious infections while
on Prolia®, prescribers should assess the need
for continued Prolia® therapy.
In the same clinical trial in women with postmenopausal
osteoporosis, epidermal and dermal adverse events such as
dermatitis, eczema and rashes occurred at a significantly higher
rate with Prolia® compared to placebo. Most
of these events were not specific to the injection site.
Consider discontinuing Prolia® if severe symptoms
develop.
Severe and occasionally incapacitating bone, joint, and/or
muscle pain has been reported in patients taking
Prolia®. Consider discontinuing use if
severe symptoms develop.
In clinical trials in women with postmenopausal osteoporosis,
Prolia® resulted in significant suppression of
bone remodeling as evidenced by markers of bone turnover and bone
histomorphometry. The significance of these findings and the effect
of long-term treatment are unknown. Monitor patients for
consequences, including ONJ, atypical fractures, and delayed
fracture healing.
The most common adverse reactions (>5% and more common than
placebo) in women with postmenopausal osteoporosis are back pain,
pain in extremity, musculoskeletal pain, hypercholesterolemia, and
cystitis.
The most common adverse reactions (> 5% and more common than
placebo) in men with osteoporosis are back pain, arthralgia, and
nasopharyngitis. Pancreatitis has been reported with
Prolia®.
In women with postmenopausal osteoporosis, the overall incidence
of new malignancies was 4.3% in the placebo group and 4.8% in the
Prolia® groups. In men with osteoporosis, new
malignancies were reported in no patients in the placebo group and
4 (3.3%) patients in the Prolia® group. A causal
relationship to drug exposure has not been established. Denosumab
is a human monoclonal antibody. As with all therapeutic proteins,
there is potential for immunogenicity.
The Prolia Postmarketing Active Safety Surveillance Program is
available to collect information from prescribers on specific
adverse events. Please see https://www.proliasafety.com/ or
call 18007726436 for more information.
For more information, please see the Prolia Prescribing
Information, and Medication Guide.
About Romosozumab
Romosozumab is an investigational
bone-forming monoclonal antibody and is not approved by any
regulatory authority for the treatment of osteoporosis. It is
designed to work by inhibiting the protein sclerostin, thereby
increasing bone formation and decreasing bone breakdown.
Romosozumab is being studied for its potential to reduce the risk
of fractures in an extensive global Phase 3 program. This program
evaluating the safety and efficacy of romosozumab includes two
large fracture trials comparing romosozumab to either placebo or
active comparator in more than 10,000 postmenopausal patients with
osteoporosis. First results from the Phase 3 study FRAME are
expected in the first half of 2016. Romosozumab is being
co-developed by Amgen and UCB.
About Amgen
Amgen is committed to unlocking the
potential of biology for patients suffering from serious illnesses
by discovering, developing, manufacturing and delivering innovative
human therapeutics. This approach begins by using tools like
advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages
its biologics manufacturing expertise to strive for solutions that
improve health outcomes and dramatically improve people's lives. A
biotechnology pioneer since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has reached
millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
Forward Looking Statements
This news release contains
forward-looking statements that are based on management's current
expectations and beliefs and are subject to a number of risks,
uncertainties and assumptions that could cause actual results to
differ materially from those described. All statements, other than
statements of historical fact, are statements that could be deemed
forward-looking statements, including estimates of revenues,
operating margins, capital expenditures, cash, other financial
metrics, expected legal, arbitration, political, regulatory or
clinical results or practices, customer and prescriber patterns or
practices, reimbursement activities and outcomes and other such
estimates and results. Forward-looking statements involve
significant risks and uncertainties, including those discussed
below and more fully described in the Securities and Exchange
Commission (SEC) reports filed by Amgen, including Amgen's most
recent annual report on Form 10-K and any subsequent periodic
reports on Form 10-Q and Form 8-K. Please refer to Amgen's most
recent Forms 10-K, 10-Q and 8-K for additional information on the
uncertainties and risk factors related to our business. Unless
otherwise noted, Amgen is providing this information as of
Oct. 6, 2015, and expressly disclaims
any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project. Discovery or
identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, preclinical results do not
guarantee safe and effective performance of product candidates in
humans. The complexity of the human body cannot be perfectly, or
sometimes, even adequately modeled by computer or cell culture
systems or animal models. The length of time that it takes for us
to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar
variability in the future. We develop product candidates internally
and through licensing collaborations, partnerships and joint
ventures. Product candidates that are derived from relationships
may be subject to disputes between the parties or may prove to be
not as effective or as safe as we may have believed at the time of
entering into such relationship. Also, we or others could identify
safety, side effects or manufacturing problems with our products
after they are on the market. Our business may be impacted by
government investigations, litigation and products liability
claims. We depend on third parties for a significant portion of our
manufacturing capacity for the supply of certain of our current and
future products and limits on supply may constrain sales of certain
of our current products and product candidate development.
In addition, sales of our products are affected by the
reimbursement policies imposed by third-party payors, including
governments, private insurance plans and managed care providers and
may be affected by regulatory, clinical and guideline developments
and domestic and international trends toward managed care and
healthcare cost containment as well as U.S. legislation affecting
pharmaceutical pricing and reimbursement. Government and others'
regulations and reimbursement policies may affect the development,
usage and pricing of our products. In addition, we compete with
other companies with respect to some of our marketed products as
well as for the discovery and development of new products. We
believe that some of our newer products, product candidates or new
indications for existing products, may face competition when and as
they are approved and marketed. Our products may compete against
products that have lower prices, established reimbursement,
superior performance, are easier to administer, or that are
otherwise competitive with our products. In addition, while we
routinely obtain patents for our products and technology, the
protection offered by our patents and patent applications may be
challenged, invalidated or circumvented by our competitors and
there can be no guarantee of our ability to obtain or maintain
patent protection for our products or product candidates. We cannot
guarantee that we will be able to produce commercially successful
products or maintain the commercial success of our existing
products. Our stock price may be affected by actual or perceived
market opportunity, competitive position, and success or failure of
our products or product candidates. Further, the discovery of
significant problems with a product similar to one of our products
that implicate an entire class of products could have a material
adverse effect on sales of the affected products and on our
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may experience difficulties, delays or unexpected costs and not
achieve anticipated benefits and savings from our ongoing
restructuring plan. Our business performance could affect or
limit the ability of our Board of Directors to declare a dividend
or their ability to pay a dividend or repurchase our common
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The scientific information discussed in this news release
related to our product candidates is preliminary and investigative.
Such product candidates are not approved by the U.S. Food and
Drug Administration (FDA), and no conclusions can or should be
drawn regarding the safety or effectiveness of the product
candidates. Further, the scientific information discussed in this
news release relating to new indications for our products is
preliminary and investigative and is not part of the labeling
approved by the FDA for the products. The products are not
approved for the investigational use(s) discussed in this news
release, and no conclusions can or should be drawn regarding the
safety or effectiveness of the products for these uses.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
1 McClung MR, Grauer A, Boonen S, et al. Romosozumab
in postmenopausal women with low bone mineral density. N Engl J
Med. 2014 Jan 30;370(5):412-20.
2 U.S. Department of Health and Human Services, Office
of the Surgeon General. The 2004 Surgeon General's Report on Bone
Health and Osteoporosis: What It Means to You.
http://www.ncbi.nlm.nih.gov/books/NBK45513/pdf/Bookshelf_NBK45513.pdf.
Published October 14, 2004. Accessed
August 5, 2015.
3 National Osteoporosis Foundation. Clinician's Guide to
Prevention and Treatment of Osteoporosis.
http://nof.org/files/nof/public/content/file/344/upload/159.pdf.
Published January 2010. Accessed
August 5, 2015.
4 Chavassieux P, et al. Insights into material and
structural basis of bone fragility from diseases associated with
fractures: how determinants of the biomechanical properties of bone
are compromised by disease. Endocr Rev. 2007;28:151-164.
5 Seeman E, Delmas PD. Bone quality – the material and
structural basis of bone strength and fragility. N Engl J Med.
2006;354:2250-2261.
6 American Academy of Orthopedic Surgeons. Osteoporosis
and Bone Health.
http://www.aaos.org/news/aaosnow/may09/clinical8.asp. Accessed
August 5, 2015.
7 Colón-Emeric C, Kuchibhatla M, Pieper C, et al. The
contribution of hip fracture to risk of subsequent fractures: data
from two longitudinal studies. Osteoporos Int. 2003;14:879-883.
8 Lyles KW, Schenck AP, Colón-Emeric CS. Hip and other
osteoporotic fractures increase the risk of subsequent fractures in
nursing home residents. Osteoporos Int. 2008;19:1225-1233.
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