Long-term data show Novartis once-yearly Aclasta preserves bone mass and provides fracture protection in postmenopausal osteoporosis
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Novartis International AG /
Long-term data show Novartis once-yearly Aclasta preserves bone mass and
provides fracture protection in postmenopausal osteoporosis
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* Aclasta reduced the risk of new spine fractures by 52% over six years versus
patients who stopped treatment after three years[1]
* New data from six-year study validate Aclasta safety profile and support
long-term use of annual infusions in patients with postmenopausal
osteoporosis[1]
* More than one million Aclasta infusions administered worldwide[2]( )for the
treatment of early to advanced bone loss[3]
Basel, October 16, 2010 - Novartis announced today that new six-year data
reinforce the long-term efficacy and safety profile of once-yearly Aclasta*
(zoledronic acid 5 mg) in postmenopausal women with osteoporosis[1]. The study
of more than 1,200 women was presented at the annual meeting of the American
Society for Bone and Mineral Research (ASBMR) in Toronto, Canada.
The study showed that Aclasta preserved bone mass in postmenopausal osteoporotic
patients who received annual infusions for six years[1]. In patients who stopped
Aclasta treatment after three years, the bone mineral density (BMD) decreased
but remained well above the levels measured at the beginning of the study
(difference between the two groups at six years: 1.04%, p=0.0009)[1].
Patients who stayed on Aclasta therapy for six years reduced their risk of new
morphometric spine fractures by 52%, compared to those who stopped treatment at
three years (p=0.04)[1], the study also showed. Morphometric fractures can occur
unaccompanied by pain and therefore may not be diagnosed and treated[4]. Over
time patients can experience these fractures in the form of back pain, loss of
height, or stooped posture[4].
"These new findings show that continued treatment with zoledronic acid for six
years continues to maintain bone mass and reduces vertebral fractures risk with
no change to its favorable safety profile compared to discontinuation of
treatment after three years," said Dennis Black, PhD, the study's lead author
and Professor of Epidemiology and Biostatistics at the University of California,
San Francisco. "These new long-term data reconfirm Aclasta as an important
therapeutic option for doctors when considering an osteoporosis medicine for
their patients."
In both study groups, the bone markers were maintained over six years within the
normal premenopausal range[1]. In patients who discontinued Aclasta after three
years, there was no evidence of accelerated bone loss[1]. This builds upon
existing data from extensive clinical studies and confirms that Aclasta helps
preserve bone turnover, the balanced process by which the bone is constantly
renewed and remodeled throughout adult life.
"Aclasta is highly effective at protecting patients against osteoporotic
fractures for a long period of time and its once-yearly dosing represents an
important improvement for patients and doctors in terms of compliance for an
entire year," said Trevor Mundel, MD, Global Head of Development at Novartis AG.
"These long-term data affirm our confidence in the efficacy and safety profile
of this medicine."
Osteoporosis is a condition in which bones become weak and break more easily[4].
According to the International Osteoporosis Foundation (IOF), an estimated 75
million people in Europe, USA, and Japan are affected by this disease[5] and one
in three women over the age of 50 as well as one in five men will suffer an
osteoporotic fracture in their lifetime[5].
This long-term study, which extended the HORIZON (Health Outcomes and Reduced
Incidence with Zoledronic Acid Once Yearly) Pivotal Fracture Trial by three
years, is a multi-center, double-blind, randomized, placebo-controlled study to
evaluate the long-term efficacy and safety of Aclasta in the treatment of
postmenopausal osteoporosis[1]. The extension study evaluated more than 1,200
women aged 68 years or older[1]. After three years of therapy, participants were
randomized to either receive an Aclasta infusion (n=616) or an annual placebo
infusion (n=617) for additional three years[1].
The primary endpoint of the study was the percentage change in the BMD at the
femoral neck at year six vs. year three[1]. Secondary endpoints included
evaluation of BMD at other sites, fractures, changes in bone turnover markers
and overall safety[1]. The incidence of adverse events was comparable between
groups[1]. There was no long-term effect on renal function or increase in risk
of osteonecrosis of the jaw or atrial fibrillation[1].
Aclasta provides year-long bisphosphonate compliance with a single infusion.
Aclasta is the only yearly treatment approved in US and EU to reduce the risk of
fractures in areas of the body typically affected by osteoporosis, including the
hip, spine and non-spine (e.g., wrist and rib)[6]. Additionally, it is also the
only proven therapy to reduce new clinical fracture and all-cause mortality (28%
reduction in death) after a recent low trauma hip fracture[7].
Approved in more than 90 countries, Aclasta is approved for up to six
indications to treat a broad spectrum of patients, from the newly diagnosed to
those with more severe forms of osteoporosis[2]. These include treatment of
postmenopausal osteoporosis, prevention of postmenopausal osteoporosis,
prevention of subsequent fractures after a low-trauma fracture, increase in bone
mass in men with osteoporosis, treatment and prevention of glucocorticoid-
induced osteoporosis in men and women, and treatment of Paget's disease of bone
in men and women[2].
Aclasta is generally well tolerated. Given as an infusion, it by-passes the
gastrointestinal tract and avoids the potential side-effects like upper
gastrointestinal irritation. The most common adverse events associated with
Aclasta are transient post-dose symptoms such as fever and muscle pain. Most of
these symptoms occur within the first three days following Aclasta
administration and usually resolve within three days. The incidence of such
post-dose symptoms can be reduced with the administration of paracetamol or
ibuprofen shortly after Aclasta infusion. These data are based on one of the
most extensive osteoporosis clinical trial programs involving over 14,000 men
and women.
Zoledronic acid, the active ingredient in Aclasta, is also available in a
different dosage under the trade-name Zometa for use in certain oncology
indications.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "confidence," "will," "potential," or similar
expressions, or by express or implied discussions regarding potential new
indications or labeling for Aclasta or regarding potential future revenues from
Aclasta. You should not place undue reliance on these statements. Such forward-
looking statements reflect the current views of management regarding future
events, and involve known and unknown risks, uncertainties and other factors
that may cause actual results with Aclasta to be materially different from any
future results, performance or achievements expressed or implied by such
statements. There can be no guarantee that Aclasta will be submitted or approved
for any additional indications or labeling in any market. Nor can there be any
guarantee that Aclasta will achieve any particular levels of revenue in the
future. In particular, management's expectations regarding Aclasta could be
affected by, among other things, unexpected clinical trial results, including
unexpected new clinical data and unexpected additional analysis of existing
clinical data; the company's ability to obtain or maintain patent or other
proprietary intellectual property protection; competition in general;
government, industry and general public pricing pressures; unexpected regulatory
actions or delays or government regulation generally; the impact that the
foregoing factors could have on the values attributed to the Novartis Group's
assets and liabilities as recorded in the Group's consolidated balance sheet,
and other risks and factors referred to in Novartis AG's current Form 20-F on
file with the US Securities and Exchange Commission. Should one or more of these
risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated, believed,
estimated or expected. Novartis is providing the information in this press
release as of this date and does not undertake any obligation to update any
forward-looking statements contained in this press release as a result of new
information, future events or otherwise.
About Novartis
Novartis provides healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines, cost-
saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. Novartis is the only company with leading positions in
these areas. In 2009, the Group's continuing operations achieved net sales of
USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D
activities throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 102,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.
* The tradename in the US is Reclast®
References
[1] Black DM, et al. The Effect of 3 versus 6 Years of Zoledronic Acid Treatment
in Osteoporosis: a Randomized Extension to the HORIZON-Pivotal Fracture Trial
(PFT). American Society for Bone and Mineral Research (ASBMR) Annual Meeting.
October 16, 2010.
[2] Novartis, IMS MIDAS Quarterly data, June 2010.
[3] Reclast (zoledronic acid) Injection Prescribing Information. East Hanover,
NJ: Novartis Pharmaceuticals Corporation. January 2010.
[4] National Osteoporosis Foundation. "Fast Facts on Osteoporosis" brochure.
February 2008.
[5] International Osteoporosis Foundation fact sheet "Facts and Statistics about
Osteoporosis and its Impact." September 10, 2010
athttp://www.iofbonehealth.org/facts-and-statistics.html#factsheet-category-17.
[6] Black DM et al. Once Yearly Zoledronic Acid for Treatment of Postmenopausal
Osteoporosis. NEJM 2007: 356:1809 - 1822.
[7] Lyles KW et al. Zoledronic Acid and Clinical Fractures and Mortality after
Hip Fracture. NEJM 2007; 357:1799 - 1809.
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Datum: 16.10.2010 - 22:46 Uhr
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