Long-Term Data Show Novartis Once-Yearly Reclast Preserves Bone Mass and Provides Fracture Protection in Postmenopausal Osteoporosis

EAST HANOVER, N.J., Oct. 16 /PRNewswire/ -- Novartis announced today that new six-year data reinforce the long-term efficacy and safety profile of once-yearly Reclast® (zoledronic acid) injection in postmenopausal women with osteoporosis.(1) The study of more than 1,200 women was presented this weekend at the annual meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, ON, Canada.

The study showed that Reclast maintained bone mass in postmenopausal osteoporotic patients who received annual infusions for six years.(1) In patients who stopped Reclast treatment after three years, the bone mineral density (BMD) decreased significantly but remained well above the levels measured at the beginning of the study (difference between the two groups at six years: 1.04%, p-value = 0.0009).(1)

Patients who stayed on Reclast therapy for six years reduced their risk of new morphometric spine fractures by 52%, compared to those who stopped treatment at three years (p-value = 0.04).(1) Morphometric fractures can occur unaccompanied by pain and therefore may not be diagnosed and treated; they can be felt or seen over time 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 reduce 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 Reclast as an important therapeutic option for doctors when considering osteoporosis treatment 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 Reclast after three years, there was no evidence of accelerated bone loss.(1) This builds upon existing data from extensive clinical studies and confirms that Reclast helps preserve bone turnover, the balanced process by which the bone is constantly renewed and remodeled throughout adult life.

"Reclast 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 National Osteoporosis Foundation (NOF), approximately 10 million people(4) in the US are affected by this disease, which caused approximately 547,000 vertebral fractures in the US in 2005.(4)

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 Reclast 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 a Reclast infusion (n=616) or an annual placebo infusion (n=617) for an 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)

Reclast provides year-long bisphosphonate compliance with a single infusion. Reclast is the only yearly treatment approved 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).(5)  Additionally, it is also the only proven therapy to reduce new clinical fracture after a recent low trauma hip fracture.(6)

Reclast is approved for five indications to treat a broad spectrum of osteoporosis patients, from early to advanced bone loss.(2) These include treatment of postmenopausal osteoporosis, prevention of postmenopausal osteoporosis, 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)

Reclast is available in all 50 US states and is reimbursed for the treatment of osteoporosis by all Medicare Part B carriers and virtually all health insurance.

You should not take Reclast if you're on Zometa® (zoledronic acid) Injection because it contains the same active ingredient. Additionally, you should not take Reclast if you are pregnant, plan to become pregnant, you are nursing, have low blood calcium, kidney problems, or are allergic to Reclast.

It's important to drink fluids before getting Reclast to help prevent kidney problems. The most common side effects include flu-like symptoms, fever, muscle or joint pain, and headache. Tell your doctor if you have dental problems because rarely, problems with the jaw have been reported with Reclast. Discuss all medicines you are taking, including prescription and non-prescription drugs, vitamins, and herbal supplements. If you develop severe bone, joint, or muscle pain, numbness, tingling or muscle spasms, contact your doctor.

Zoledronic acid, the active ingredient in Reclast, is also available under the trade-name Zometa for use in oncology indications.

For more information about Reclast, visit www.reclast.com or call 866-RECLAST (866-732-5278).

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "confidence" or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Reclast or regarding potential future revenues from Reclast. 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 Reclast to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Reclast will be submitted or approved for any additional indications or labeling in any market. Nor can there be any guarantee that Reclast will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Reclast 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 Pharmaceuticals Corporation researches, develops, manufactures and markets innovative prescription drugs used to treat a number of diseases and conditions, including cardiovascular, dermatological, central nervous system, bone disease, cancer, organ transplantation, psychiatry, infectious disease and respiratory. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which 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 visit http://www.novartis.com.

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.)  Reclast (zoledronic acid) Injection Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals Corporation. January 2010.

(3.)  Novartis – Data on file_1 million infusions_June 2010 Aclasta FINAL.

(4.)  National Osteoporosis Foundation. Fast Facts on Osteoporosis Brochure. February 2008.

(5.)  Black DM et al. Once Yearly Zoledronic Acid for Treatment of Postmenopausal Osteoporosis. NEJM 2007: 356:1809 - 1822.

(6.)  Lyles KW et al. Zoledronic Acid and Clinical Fractures and Mortality after Hip Fracture. NEJM 2007; 357:1799 - 1809.

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