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Data in The New England Journal of Medicine Show Novartis AG (NVS) Drug Aclasta® Significantly Reduced the Risk of Fracture in Men With Osteoporosis With Once-Yearly Infusion


11/1/2012 3:37:12 PM

? In this first and only study in male osteoporosis to use fractures as the primary endpoint, Aclasta demonstrated a fracture risk reduction of 67% versus placebo1

? Osteoporosis in men is often underdiagnosed and undertreated2 yet among people over 50, approximately 40% of all osteoporotic fractures occur in men3

? New findings add to strong body of data confirming existing safety and efficacy profile of Aclasta4,5,6,7,8 approved since 2008 for osteoporosis treatment in men

Basel, November 1, 2012 – Novartis announced today that the New England Journal of Medicine (NEJM) published results from a study which found that once-yearly Aclasta® (zoledronic acid 5 mg) significantly reduced the risk of spine fractures by 67% versus placebo over two years in men with osteoporosis (p=0.002)

This is the first and only study in men with osteoporosis to use fractures as the primary endpoint

. “These data now published in the NEJM provide convincing evidence that Aclasta significantly reduced fracture risk in men with osteoporosis,” said Professor Steven Boonen, University of Leuven, Belgium and lead author of the study publication. “The development of recommendations for detecting and treating osteoporosis in men has been limited until now by the lack of unambiguous evidence of effective anti-fracture therapies in men. This study should have positive implications for the treatment of male patients with osteoporosis and should pave the way for improvements in care.”

The study also showed that Aclasta reduced the risk of one or more new moderate-to- severe spine fractures by 81% at month 12 (p=0.01) and 63% at month 24 (p=0.03) compared with the placebo group. In addition, Aclasta produced significant and sustained improvements in bone mineral density at the spine and hip bones (lumbar spine, total hip and femoral neck bone (p=<0.05 for all comparisons)) and reduced the risk of height loss (-2.2 mm and -4.5 mm at month 24 for Aclasta and placebo (p=0.002), respectively).

"These data reinforce once-yearly Aclasta as highly effective at protecting patients against fracture, over a two-year period," said Lutz Hegemann, Global Head of Development, Established Medicines, Novartis Pharma. "The identification and treatment of men with osteoporosis at risk of fractures with Aclasta may reduce the substantial morbidity, mortality and the public health costs that result from osteoporotic fractures.”

Aclasta was approved in 2008 for the treatment of osteoporosis in men, and is now approved for up to six indications to treat a broad spectrum of patients, from the newly diagnosed to those with more severe forms of osteoporosis9

. About the study
The male osteoporosis fracture study was a 24-month, randomized, placebo-controlled, parallel-group study. The study was conducted at approximately 150 centers in Europe, South America, Africa and Australia, with a total of 1,199 men (aged 50-85 years) with primary osteoporosis or osteoporosis associated with low serum testosterone levels. Inclusion criteria considered baseline bone mineral density and/or the presence of one to three prevalent vertebral fractures. Patients received Aclasta or placebo as an annual 15- 30 minute intravenous infusion at baseline and 12 months. Patients also received daily calcium 1,000-1,500 mg and vitamin D 800-1200 IU.

The primary endpoint was the proportion of patients with one or more new morphometric vertebral fractures over 24 months. Secondary endpoints included percentage changes in lumbar spine, total hip and femoral neck bone mineral density, change in height and the proportion of one or more new moderate-to-severe, or new or worsening vertebral fracture over 12 and 24 months. Overall safety of Aclasta versus placebo was also assessed as a secondary objective.

Over two years, 1.6% of patients, (9 patients out of 553) randomized to the Aclasta group experienced one or more new morphometric vertebral fractures, or fractures of the spine, diagnosed by X-ray, compared with 4.9% of patients (28 patients out of 557) randomized to the placebo group. This represents a statistical significant fracture reduction of 67% in the Aclasta group (p=0.002). Total testosterone status did not affect the anti-fracture effect of Aclasta.

The incidence of serious adverse events was similar between treatment groups (25.3% in the Aclasta group compared with 25.2% in the placebo group), with the exception of myocardial infarction (9 events (1.5%) in the Aclasta group compared with 2 events (0.3%) in the placebo group). None of the events were considered treatment-related by the investigator. The number of cardiac serious events in the two groups were 31 (5.3%) and 30 (4.9%), respectively (p=0.79). The most common adverse events associated with Aclasta were transient flu-like symptoms, such as fever and muscle pain.

This study was first presented at the European Congress on Osteoporosis & Osteoarthritis in March 2011.

About Aclasta
Aclasta provides year-long bisphosphonate compliance with a single infusion. Aclasta is the only yearly treatment approved in the US (marketed under the tradename Reclast ®) and EU to reduce the risk of fractures in areas of the body typically affected osteoporosis, including the hip, spine and non-spine (e.g., wrist and ribs).

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.

Available in more than 100 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. 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. More than 3 million infusions of Aclasta have been administered worldwide. Zoledronic acid, the active ingredient in Aclasta, is also available in a different dosage under the trade name Zometa® for use in oncology indications.

The incidence of post-dose symptoms occurring within the first three days after administration of Aclasta can be reduced with the administration of paracetamol or ibuprofen shortly following Aclasta administration.

About osteoporosis
Osteoporosis is a condition in which bones become weak and break more easily. Among people over 50, approximately 40% of all osteoporotic fractures occur in men. The reported prevalence in men is further increasing due to the increasing life expectancy of men. Contrary to popular opinion, men are significantly impacted by osteoporosis. For example, osteoporotic hip fractures in men are associated with a 70-100% higher mortality rate than in women. In one US study, the 12-month mortality was 32% in men, compared with 17% in women, however only 4.5% of men who experienced hip fractures were treated for osteoporosis.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as “should,” “may,” 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 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; unexpected manufacturing issues; 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 innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2011, the Group achieved net sales of USD 58.6 billion, while approximately USD 9.6 billion (USD 9.2 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Novartis Group companies employ approximately 127,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.

References
1. Boonen S, Réginster JY, Kaufman JM, et al. Fracture Risk and Zoledronic Acid Therapy in Men with Osteoporosis. N Eng J Med 2012:367:1704-13.
2. Feldstein AC, Nichols G, Orwoll E, et al. The near absence of osteoporosis treatment in older men with fractures. Osteoporos Int 2005:16:953–962.
3. Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteopororic fractures. Osteoporos Int 2006:17:1726-33.
4. Black D, Delmas S, Eastell R, et al. Once Yearly Zoledronic Acid for Treatment of Postmenopausal Osteoporosis. N Eng J Med 2007:356:1809-1822.
5. Black DM, Reid IR, Boonen S, et al. The Effect of 3 Versus 6 Years of Zoledronic Acid Treatment of Osteoporosis: A Randomized Extension to the HORIZON-Pivotal Fracture Trial (PFT). J Bone Miner Res 2012:27(2):243–254.
6. Lyles K, Colón-Emeric C, Magaziner J, et al. Zoledronic Acid and Clinical Fractures and Mortality after Hip Fracture. N Eng J Med 2007:357:1799-1809.
7. Reid I, Miller P, Lyles K, et al. Comparison of a single infusion of zoledronic acid with risedronate for Paget’s Disease. N Eng J Med 2005:353:898-908.
8. Reid D, Devogelaer J, Saag K, et al. Zoledronic acid and risodronate in the prevention and treatment of glucocortisone-induced osteoporosis (HORIZON): a multi-centre double blind, double dummy randomised controlled study. The Lancet 2009:373:1253-1263.
9. Aclasta Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- _Product_Information/human/000595/WC500020940.pdf Last accessed October 18, 2012.
10. IMS MIDAS Quarterly data, July 2012.
11. International Osteoporosis Foundation “What is Osteoporosis?” Available at: http://www.iofbonehealth.org/what-osteoporosis-1 Last accessed on October 11, 2012.
12. Kiebzak GM, Beinart GA, Perser K et al. Undertreatment of osteoporosis in men with hip fracture. Arch Intern Med. 2002 Oct 28;162(19):2217-22.

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