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* Steroids, widely used to treat inflammatory conditions, can cause
bone loss and increase risk of fractures in up to 50% of patients
on long-term therapy[1]
* European approval based on data showing Aclasta better at
increasing bone mass than oral risedronate, a current established
therapy[2],[3]
* Clinical trial results also reaffirm efficacy and safety of
Aclasta, used in more than 500,000 patients worldwide since
launch in 2007[4],[5]
* Approval is fifth indication for once-yearly Aclasta, already
approved worldwide to treat postmenopausal osteoporosis[6]
Basel, June 26, 2009 - Once-yearly Aclasta® (zoledronic acid 5 mg)*
has been approved in the European Union to treat men and
postmenopausal women with osteoporosis caused by long-term use of
glucocorticoids, commonly known as steroids[6]. Glucocorticoids are
widely used to treat inflammatory conditions such as asthma and
rheumatoid arthritis, but also cause bone loss and can increase the
risk of fracture in up to 50% of patients on long-term glucocorticoid
therapy[1].
The new indication for men and women with glucocorticoid-induced
osteoporosis (GIO) is based on study data showing that Aclasta, given
once a year as a 15-minute infusion, is more effective at treating
bone loss than daily oral risedronate, a current established
therapy[2],[3].
The study results, recently published in The Lancet, show that
Aclasta produced a significantly greater increase in bone mineral
density (BMD) than risedronate at six months, indicating a faster
onset of efficacy[2].
"Oral bisphosphonates have been used for many years for the treatment
of GIO, but they are associated with poor compliance as patients
frequently fail to take them as prescribed," said Professor David M.
Reid, Head of the Division of Applied Medicine at the University of
Aberdeen, UK. "Available data show that patients who remember to take
their medicines only half of the time receive little or no
protection[7]."
He added: "The approval of Aclasta is a significant step forward, as
it is more effective and faster-acting than a current established
therapy for the treatment of GIO and has the advantage of year-long
compliance and sustained osteoprotection."
This is the fifth indication for Aclasta, which is approved to treat
osteoporosis in men and postmenopausal women, including those who
have experienced a low-trauma hip fracture. Aclasta is the only
bisphosphonate approved in the EU and US to reduce the risk of
fractures at all key osteoporotic fracture sites, like the hip,
spine, and other bones in the treatment of postmenopausal
osteoporosis[8]. It is also approved to treat Paget's disease of the
bone.
In the US, the same medicine under the trade mark Reclast® has also
been approved by the Food and Drug Administration (FDA) to treat and
prevent GIO in men and women. In May it was approved in the US as the
only therapy to prevent postmenopausal osteoporosis with less
frequent dosing (i.e. a single dose every two years)[9].
The GIO indication is important because it is estimated that between
700,000 and 1.3 million adults in Western Europe, and between 1.5 and
2.7 million adults in the US, are receiving prolonged courses of oral
glucocorticoids[10],[11]. Up to 50% of patients receiving long-term
glucocorticoid therapy are at increased risk of fracture, as their
use is associated with side effects such as bone loss and
consequently osteoporosis[1].
"This European approval marks another important achievement for
Aclasta by adding to the broad spectrum of patients who can now be
treated with this therapy," said Trevor Mundel, MD, Global Head of
Development at Novartis Pharma AG. "Aclasta has a strong efficacy and
safety profile established during eight years of clinical trials.
Since its launch in 2007, Aclasta has been used in more than 500,000
patients, demonstrating that an annual infusion has become a valuable
treatment option."
The latest approval was based on a study of 833 men and women which
investigated both the prevention and treatment of GIO (288 and 545
patients respectively)[2]. The study had several advantages over
previous trials studying the effects of bisphosphonate drugs on GIO,
including the large sample size, the inclusion of both prevention and
treatment subgroups, and an excellent retention rate.
The study showed that over one year, a single intravenous infusion of
Aclasta produced increases in BMD of the lumbar spine and femoral
neck, trochanter and total hip that were significantly greater than
those seen with once-daily oral risedronate (Actonel®)[2].
The greater efficacy of Aclasta was evident at six months in both the
treatment group (Aclasta 4.03%, risedronate 2.70%; P=0.0002) and
prevention group (Aclasta 2.34%, risedronate 0.36%; P<0.0001)[2].
Aclasta was better than risedronate at increasing lumbar spine BMD at
12 months in both the treatment group (Aclasta 4.1%, risedronate
2.7%; P=0.0001) and prevention group (Aclasta 2.6%, risedronate 0.6%;
P<0.0001)[2].
Results from the study showed that Aclasta is generally safe and well
tolerated[2], supporting previous clinical trial evidence from more
than 14,000 patients[4]. The most common adverse events associated
with Aclasta were transient post-dose symptoms such as fever and
muscle pain. Most of these symptoms occurred in the first three days
after Aclasta administration and resolved within the same period of
time. Post-dose symptoms can be reduced by taking paracetamol or
ibuprofen shortly after the Aclasta infusion[2],[6],[8].
In this trial there were no cases of osteonecrosis of the jaw or
delayed fracture healing, and no evidence of an increased risk of
atrial fibrillation[2].
Zoledronic acid, the active ingredient in Aclasta/Reclast, is also
available under the trade name Zometa® for use in oncology
indications.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "can," "risk," "estimated," 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
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 regulatory actions or delays or
government regulation generally; 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; 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 AG 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 2008, the
Group's continuing operations achieved net sales of USD 41.5 billion
and net income of USD 8.2 billion. Approximately USD 7.2 billion was
invested in R&D activities throughout the Group. Headquartered in
Basel, Switzerland, Novartis Group companies employ approximately
98,000 full-time-equivalent associates and operate in more than 140
countries around the world. For more information, please visit
http://www.novartis.com.
References
[1.] Sambrook PN. Corticosteroid Osteoporosis: Practical Implications
of Recent Trials. JBMR 2000; 15:1645-1649.
[2.] Reid DM, Devogelaer J-P, Saag K, Roux C, et al. Zoledronic acid
and risedronate in the prevention and treatment of
glucocorticoid-induced osteoporosis (HORIZON): a multicenter,
double-blind, double-dummy, randomized controlled trial. Lancet 2009;
373: 1253-63.
[3.] Actonel 5mg Film Coated Tablets SPV. Available at:
http://emc.medicines.org.uk/document.aspx?documentId=3340. Last
accessed June 8, 2009.
[4.] Novartis data on file. Novartis Pharma AG; June, 2009.
[5.] Novartis - NPMR, May 2009, based on vials sold (retreatments
taken into account).
[6.] Aclasta Summary of Product Characteristics. West Sussex, United
Kingdom: Novartis Europharm Limited, 2009.
[7.] Siris SE, Harris ST, Rosen CT et al. Adherence to Bisphosphonate
Therapy and Fracture Rates in Osteoporotic Women: Relationship to
Vertebral and Nonvertebral Fractures From 2 US Claims Databases. Mayo
Clin Proc., August 2006;81(8):1013-1022.
[8.] Black D, Delmas S, Eastell R et al for the HORIZON Pivotal
Fracture Trial Group. Once-Yearly Zoledronic Acid for Treatment of
Postmenopausal Osteoporosis. NEJM 2007; 356(18): 1809-22.
[9.] Reclast® (zoledronic acid) Injection [Prescribing Information].
East Hanover, NJ: Novartis Pharmaceuticals Corporation; May 2009.
[10.] Gluck O, Colic G. Recognizing and Treating
Glucocorticoid-Induced Osteoporosis in Patients with Pulmonary
Diseases. CHEST 2004; 125: 1859-1876.
[11.] United Nations. Department of Economic and Social Affairs.
Population Division. The 2008 Revision. Western Europe and United
States of America Population Statistics. Available at:
http://esa.un.org/unpp. Last accessed 30 March, 2009. The estimated
figures for glucocorticoid use in Western Europe and the US were
calculated by extrapolating the percentage of UK adults receiving
oral glucocorticoids at any given time (between 0.5% and 0.9% of the
adult population) to the populations of Western Europe (145 million
adults) and the US (300 million adults).
[*] The tradename is Reclast® in the US and Aclasta® in the rest of
the world.
# # #
Novartis Media Relations
Eric Althoff Irina Ferluga
Novartis Global Media Relations Novartis Pharma Communications
+41 61 324 7999 (direct) +41 61 324 2422 (direct)
+41 79 593 4202 (mobile) +41 79 824 1121 (mobile)
eric.althoff@novartis.com irina.ferluga@novartis.com
e-mail: media.relations@novartis.com
Novartis Investor Relations
Central phone: +41 61 324 7944
Ruth Metzler-Arnold +41 61 324 9980 North America:
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Bringer 1065 2433
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2445
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e-mail: e-mail:
investor.relations@novartis.com investor.relations@novartis.com
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