Study shows once-yearly Aclasta® better than risedronate at increasing bone mass in patients with osteoporosis caused by glucocorticoids

4/11/2008, 1:54 PM (Source: GlobeNewswire)

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Corporate news announcement processed and transmitted by Hugin ASA. The issuer is solely responsible for the content of this announcement. ---------------------------------------------------------------------- -------------- * Glucocorticoids, commonly known as steroids, widely used to treat inflammatory conditions but can increase risk of osteoporotic fractures with up to 50% of patients on long-term therapy at risk[1],[2] * Study of more than 800 men and women shows higher bone mineral density with Aclasta than risedronate, a current established therapy[3] * Regulatory approval sought for treatment and prevention of glucocorticoid-induced osteoporosis in EU and US
Corporate news announcement processed and transmitted by Hugin ASA.
The issuer is solely responsible for the content of this
announcement.
----------------------------------------------------------------------
--------------
* Glucocorticoids, commonly known as steroids, widely used to treat
inflammatory conditions but can increase risk of osteoporotic
fractures with up to 50% of patients on long-term therapy at
risk[1],[2]
* Study of more than 800 men and women shows higher bone mineral
density with Aclasta than risedronate, a current established
therapy[3]
* Regulatory approval sought for treatment and prevention of
glucocorticoid-induced osteoporosis in EU and US



* Glucocorticoids, commonly known as steroids, widely used to treat
inflammatory conditions but can increase risk of osteoporotic
fractures with up to 50% of patients on long-term therapy at
risk[1],[2]

* Study of more than 800 men and women shows higher bone mineral
density with Aclasta than risedronate, a current established
therapy[3]

* Regulatory approval sought for treatment and prevention of
glucocorticoid-induced osteoporosis in EU and US

Basel, April 11, 2008 - New data show that a once-yearly infusion of
Aclasta® (zoledronic acid 5 mg)[*] was significantly better than
risedronate at increasing bone mass in patients with osteoporosis
caused by glucocorticoids, commonly known as steroids[3]. These
medications are widely used to treat inflammatory conditions but can
cause bone loss and osteoporosis[1],[2].

Up to 50% of patients receiving long-term glucocorticoid therapy are
at increased risk of fracture due to osteoporosis[2], and
approximately nine million people worldwide are affected by
glucocorticoid-induced osteoporosis (GIO)[4],[5].

Results of a clinical study in 833 men and women were presented today
at the European Congress on Clinical and Economic Aspects of
Osteoporosis and Osteoarthritis (ECCEO) in Istanbul, Turkey[3].

"Recognizing and treating GIO is an important need, as glucocorticoid
therapy is so widely used and presents an ongoing challenge for
physicians," said Professor David M. Reid, Head of the Division of
Applied Medicine at the University of Aberdeen, UK. "The significant
efficacy of this once-yearly treatment, offering year-long bone
protection, will provide a very valuable treatment option for
healthcare professionals treating and managing osteoporosis induced
by glucocorticoids."

The trial investigated both prevention (288 patients) and treatment
(545 patients) of GIO[3]. Results demonstrated that a single yearly
infusion of Aclasta significantly increased bone mineral density
(BMD) in the lumbar spine at 12 months compared to risedronate 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)[3].

Risedronate is one of the established treatments for GIO[6] and, like
Aclasta, is a member of the bisphosphonate class of drugs[6].
Risedronate is taken in the form of a daily pill[6], whereas Aclasta
is given as a once-yearly 15-minute infusion[7],[8], promoting
compliance with bisphosphonate treatment and providing annual
protection against the consequences of osteoporosis.

Novartis is applying for an indication with the European Medicines
Agency (EMEA) and the US Food and Drug Administration (FDA) for the
treatment and prevention of GIO.

Aclasta is already approved in more than 50 countries for the
treatment of postmenopausal osteoporosis and in more than 70
countries for the treatment of Paget's disease of bone, the second
most common metabolic bone disorder. Additional indications for
Aclasta are being pursued worldwide for the prevention of clinical
fractures after hip fracture and the treatment of osteoporosis in
men.

A growing body of clinical evidence supports Aclasta as the only
treatment for postmenopausal osteoporosis approved in the US and EU
to reduce the risk of fractures in all key sites typically affected
by osteoporosis, including the hip, spine and non-spine (e.g. wrist
and rib)[7].

"These new data reinforce the efficacy of this novel once-yearly
treatment and confirm Aclasta's ability to increase bone mineral
density significantly in different populations," said Trevor Mundel,
MD, Head of Global Development Functions at Novartis Pharma AG. "We
already know from previous osteoporosis studies that patients prefer
a single yearly dose versus oral weekly treatment[9],[10], confirming
that Aclasta should provide a real benefit for patients affected by
osteoporosis."

The primary objective of the GIO study was to demonstrate
non-inferiority of Aclasta to risedronate in percentage change in
lumbar spine BMD from baseline at 12 months[3]. Secondary endpoints
included change in lumbar spine BMD at six months, and in the BMD of
femoral neck and total hip at six and 12 months[3].

Results from the study confirm that Aclasta is generally safe and
well-tolerated. The most common adverse events associated with
Aclasta were transient post-dose symptoms such as fever and muscle
pain. The majority of these symptoms occurred in the first three days
after Aclasta administration and resolved within three days.
Post-dose symptoms can be reduced by taking paracetamol or ibuprofen
shortly after the Aclasta infusion[7],[8],[11].

Analysis of key safety parameters, including osteonecrosis of the
jaw, atrial fibrillation, renal impairment and delayed fracture
healing, found Aclasta was comparable to risedronate[11].

The active ingredient in Aclasta is zoledronic acid, which is also
available in a different dosage under the brand name Zometa®
(zoledronic acid 4 mg) for use in certain oncology indications.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "can", "will", "should", or similar
expressions, or by express or implied discussions regarding potential
new indications or labelling for Aclasta or regarding potential
future revenues from Aclasta. Such forward-looking statements reflect
the current views of the Company 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 labelling 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, 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 growth areas in
healthcare, Novartis offers a diversified portfolio to best meet
these needs: innovative medicines, cost-saving generic
pharmaceuticals, preventive vaccines and diagnostic tools, and
consumer health products. Novartis is the only company with leading
positions in these areas. In 2007, the Group's continuing operations
(excluding divestments in 2007) achieved net sales of USD 38.1
billion and net income of USD 6.5 billion. Approximately USD 6.4
billion was invested in R&D activities throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 98,200 full-time associates and operate in over 140
countries around the world. For more information, please visit
http://www.novartis.com.
.

References
[1.] International Osteoporosis Foundation website. Last accessed
March 18, 2008.
http://www.iofbonehealth.org/patients-public/about-osteoporosis/symptoms-risk-factors.html
[2.]Sambrook PN Corticosteroid Osteoporosis: Practical Implications
of Recent Trials. Journal of Bone and Mineral Research 2000; 15:
1645-1649.
[3.]Reid DM, Devogelaer J-P, Saag K, et al. A single infusion of
zoledronic acid 5 mg is significantly more effective than daily oral
risedronate 5 mg in increasing bone mineral density of the lumbar
spine, hip, femoral neck and trochanter in patients with
glucocorticoid-induced osteoporosis. April 11, 2008.
[4.] Population Division of the Department of Economic and Social
Affairs of the United Nations Secretariat, World Population
Prospects: The 2006 Revision World Urbanization Prospects.
[5.] Van Staa TP, Leufkens HGM, Abenhaim L, Begaud B et al. Use of
oral corticosteroids in the United Kingdom. Q J Med 2000; 93:105-11.
[6.] Actonel® (risedronate sodium) Prescribing Information.
Cincinnati, OH: Procter & Gamble Pharmaceuticals, Inc., May 2007.
[7.] Black DM, Delmas PD, Eastell R, et al. for the HORIZON Pivotal
Fracture Trial. Once-yearly zoledronic acid for treatment of
postmenopausal osteoporosis. N Engl J Med. 2007; 356: 1809-1822.
[8.] Lyles KW, Colon-Emeric CS, Magaziner JS, et al. for the HORIZON
Recurrent Fracture Trial. Zoledronic acid and clinical fractures and
mortality after hip fracture. N Engl J Med. 2007:537:1799-1809.
[9.] Lindsay R, Saag K, Kriegman A et al. A single zoledronic acid
5mg infusion is preferred over weekly 70 mg oral alendronate in a
clinical trial of postmenopausal women with osteoporosis/osteopenia.
Osteo Int 2006; 17(1):S1-124.
[10.] McClung M, Recker R, Miller P et al. Intravenous zoledronic
acid 5 mg in the treatment of postmenopausal women with low bone
density previously treated with alendronate. Bone. 2007; 41:122-128.
[11.] Novartis data on file. Novartis Pharma AG; March 11, 2008.

[*] The tradename in the US is Reclast®

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