New Phase III data presented for
the first time demonstrated that the investigational treatment Reclast(R)^
(zoledronic acid) 5 mg was highly effective in reducing the incidence of
bone fracture in women with postmenopausal osteoporosis across the most
common fracture sites -- hip, spine and non-spine^^ -- with sustained
effect over three years.(1) Further data demonstrated that postmenopausal
osteoporosis patients currently taking oral alendronate can be directly
switched to Reclast and maintain beneficial bone effects for a full 12
months after a single dose.(2) These studies were presented today at the
annual meeting of the American Society of Bone and Mineral Research (ASBMR)
in Philadelphia.
Postmenopausal osteoporosis (osteoporosis) is a serious condition affecting millions of women worldwide.(3) An estimated one out of every two women over age 50 with osteoporosis will suffer an osteoporotic fracture in her lifetime.(4) Of those women age 65 years or older who fracture a hip, 21% will die within one year.(5) Reclast is the only once-yearly bisphosphonate treatment being studied for the treatment of osteoporosis.
An interim analysis encompassing 99% of the data from the now completed three-year HORIZON Pivotal Fracture Trial showed that patients treated with Reclast experienced a 70% risk reduction in new spine fractures (p<0.0001) and a 40% risk reduction in hip fractures (p=0.0032) over three years compared to placebo. This met the study's two primary endpoints. Additionally, the study met all secondary endpoints including risk reduction in clinical spine fractures and non-spine fractures.
In the study, the overall incidence of adverse events experienced with Reclast was comparable to placebo. The most common adverse events associated with Reclast were the following post-dose symptoms: fever, muscle pain, flu-like symptoms, headache, and bone pain, the majority of which occurred within the first three days following Reclast administration. The majority of these symptoms resolved within the first three days of the event onset. The incidence decreased markedly with subsequent doses of Reclast. Analysis of key safety parameters, including kidney and jaw safety, found Reclast to be comparable to placebo.(1)
"The efficacy and safety data show that for the first time women may have the option of a once yearly treatment for osteoporosis," stated Dr. Dennis Black, the study steering committee chair from University of California, San Francisco. "The results show that Reclast effectively protects women against fractures including those of the hip, which can be devastating."
Additional Phase III data presented at the meeting from a study of 225 women with osteoporosis demonstrated that patients treated with weekly Fosamax therapy can directly switch to Reclast. In the study, the beneficial effects of alendronate on bone mineral density levels in postmenopausal women were maintained for 12 months after a single infusion of Reclast, and, at 12 months, bone mineral density values for patients randomized to receive Reclast were similar to bone mineral density values for patients randomized to continued treatment with alendronate, meeting the study's primary endpoint. In patients taking Reclast, bone turnover remained within the normal pre-menopausal range at 12 months after an infusion.(2) The most common adverse events reported in this study were similar to those observed in the pivotal fracture trial.(1,2,6)
Furthermore, two separate studies of women being treated for osteoporosis have shown that a majority preferred a once-yearly infusion to a once-weekly pill.(7,8)
"We believe once-yearly Reclast may offer advantages for the millions of women suffering from osteoporosis and potentially provide the most comprehensive protection across the most common osteoporotic fracture sites," said James Shannon, MD, Global Head of Development at Novartis Pharma AG.
Reclast In Post-Menopausal Osteoporosis: Study Designs
The Health Outcomes and Reduced Incidence with Zoledronic acid Once yearly (HORIZON) Pivotal Fracture Trial is a multi-national, multi-center, randomized, placebo-controlled trial of 7,736 women. The study evaluated the potential of a once-yearly infusion of Reclast to decrease the risk of fracture in postmenopausal women with osteoporosis. Primary endpoints were incidence of new vertebral fractures and hip fractures at three years compared to placebo. All study participants received elemental calcium (1000 to 1500 mg per day) and vitamin D (400 to 1200 IU per day).
The second Phase III Reclast study presented at ASBMR investigated the safety and efficacy of treating patients with Reclast who were previously taking Fosamax. This randomized, double-blind, double-dummy, multi-center trial compared a single infusion of 5 mg Reclast vs. continuation of therapy with oral alendronate weekly for 52 weeks. The study included postmenopausal women with low bone mineral density (n=225). The women must have been treated with Fosamax for at least one year prior to randomization. The primary endpoint of the study was percent change in lumbar spine bone mineral density from baseline to one year.
About Reclast
Reclast is being studied worldwide in a series of multi-national and multi-center clinical trials program called HORIZON. This clinical development program studies a once-yearly dosing with Reclast for osteoporosis. It also includes studies in the prevention of clinical fractures following a hip fracture in men and women, male osteoporosis, corticosteroid-induced osteoporosis, prevention of osteoporosis, treatment of Paget's disease of the bone, and the treatment of osteogenesis imperfecta in children. Approximately 13,000 patients have participated in the ongoing HORIZON program in more than 400 trial centers worldwide. The HORIZON program is one of the most comprehensive drug evaluation programs ever undertaken in the area of metabolic bone diseases.
Zoledronic acid 5mg, under the brand name Aclasta(R), has been approved in approximately 50 countries worldwide, including the EU and Canada, for the treatment of Paget's disease. The U.S. Food and Drug Administration (FDA) issued an "approvable letter" for Reclast for the treatment of Paget's disease of the bone in February 2006. The FDA requested additional data from the ongoing clinical trial program in osteoporosis. Novartis is working with the FDA to gain approval for this indication. Zoledronic acid, the active ingredient of Reclast, is also available under the brand name Zometa(R) for use in other indications.
About Postmenopausal Osteoporosis
Postmenopausal osteoporosis (PMO) is a serious condition affecting millions of women worldwide. Osteoporosis currently affects an estimated 50.7 million people in the UK, France, Germany, Italy, Spain, the USA and Japan.(3) Incidence of hip fracture in women is projected to rise by 240% worldwide by 2050, as populations grow and age.(9)
Disclaimer
The foregoing release contains forward-looking statements that can be identified by the use of terminology such as "may," "believe," "potentially," "potential," or similar expressions, or by express or implied discussions regarding potential regulatory filings, approvals or future sales for Reclast. Such forward-looking statements 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 is no guarantee that Reclast will be approved by the U.S. Food and Drug Administration or any other regulatory authority for any indication in any market. Neither can there be any guarantee regarding potential future sales of Reclast. In particular, management's ability to ensure satisfaction of any health authorities' requirements is not guaranteed and management's expectations regarding commercialization of Reclast could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including new clinical data and 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 Securities and Exchange Commission of the United States. 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 develops, manufactures, markets and sells leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas. 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 (NYSE: NVS) -. a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 91,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
References
1. Black DM, et al. Effect of once-yearly infusion of Zoledronic Acid 5 mg on spine and hip fracture reduction in postmenopausal women with osteoporosis: the HORIZON pivotal fracture trial. Presented at 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, USA.
2. McClung M, et al. Single infusion of zoledronic acid 5 mg provides sustained benefits in BMD and biomarkers at 12 months in postmenopausal women with low bone mineral density and prior alendronate therapy. Presented at 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, USA.
3. Decision Resources Inc. -- Dbase 9; Kanis JA, 2000 & Melton LJ, 1995.
4. National Institutes of Health Osteoporosis and Related Bone Diseases -- National Resource Center. Osteoporosis Overview. Department of Health and Human Services. Available at http://www.niams.nih.gov/bone/hi/overview.htm.
5. US Congress, Office of Technology Assessment, Hip Fracture Outcomes in People Age 50 and Over -- Background Paper, OTA-BP-H-120 (Washington, DC: US Government Printing Office, July 1994).
6. Recker R, et al. Bone histomorphetry demonstrates normal bone remodelling in postmenopausal women with osteoporosis/osteopenia switched from oral alendronate to IV zoledronic acid. Presented at 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, USA.
7. Lindsay R, et al. A single zoledronic acid 5 mg infusion is preferred over weekly 70 mg oral alendronate in a clinical trial of postmenopausal women with osteoporosis/osteopenia. Presented at Sixth European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ECCEO), 15-18 March 2006, Vienna, Austria.
8. Omizio M, et al. A single infusion is preferred to oral weekly treatment in post-menopausal women with low bone mineral density previously treated with alendronate. Presented at 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, USA.
9. Gullberg B, et al. World-wide projections for hip fracture. Osteoporosis Int 1997; 7:407-13.
Novartis Pharmaceuticals Corporation
http://www.novartis.com
Postmenopausal osteoporosis (osteoporosis) is a serious condition affecting millions of women worldwide.(3) An estimated one out of every two women over age 50 with osteoporosis will suffer an osteoporotic fracture in her lifetime.(4) Of those women age 65 years or older who fracture a hip, 21% will die within one year.(5) Reclast is the only once-yearly bisphosphonate treatment being studied for the treatment of osteoporosis.
An interim analysis encompassing 99% of the data from the now completed three-year HORIZON Pivotal Fracture Trial showed that patients treated with Reclast experienced a 70% risk reduction in new spine fractures (p<0.0001) and a 40% risk reduction in hip fractures (p=0.0032) over three years compared to placebo. This met the study's two primary endpoints. Additionally, the study met all secondary endpoints including risk reduction in clinical spine fractures and non-spine fractures.
In the study, the overall incidence of adverse events experienced with Reclast was comparable to placebo. The most common adverse events associated with Reclast were the following post-dose symptoms: fever, muscle pain, flu-like symptoms, headache, and bone pain, the majority of which occurred within the first three days following Reclast administration. The majority of these symptoms resolved within the first three days of the event onset. The incidence decreased markedly with subsequent doses of Reclast. Analysis of key safety parameters, including kidney and jaw safety, found Reclast to be comparable to placebo.(1)
"The efficacy and safety data show that for the first time women may have the option of a once yearly treatment for osteoporosis," stated Dr. Dennis Black, the study steering committee chair from University of California, San Francisco. "The results show that Reclast effectively protects women against fractures including those of the hip, which can be devastating."
Additional Phase III data presented at the meeting from a study of 225 women with osteoporosis demonstrated that patients treated with weekly Fosamax therapy can directly switch to Reclast. In the study, the beneficial effects of alendronate on bone mineral density levels in postmenopausal women were maintained for 12 months after a single infusion of Reclast, and, at 12 months, bone mineral density values for patients randomized to receive Reclast were similar to bone mineral density values for patients randomized to continued treatment with alendronate, meeting the study's primary endpoint. In patients taking Reclast, bone turnover remained within the normal pre-menopausal range at 12 months after an infusion.(2) The most common adverse events reported in this study were similar to those observed in the pivotal fracture trial.(1,2,6)
Furthermore, two separate studies of women being treated for osteoporosis have shown that a majority preferred a once-yearly infusion to a once-weekly pill.(7,8)
"We believe once-yearly Reclast may offer advantages for the millions of women suffering from osteoporosis and potentially provide the most comprehensive protection across the most common osteoporotic fracture sites," said James Shannon, MD, Global Head of Development at Novartis Pharma AG.
Reclast In Post-Menopausal Osteoporosis: Study Designs
The Health Outcomes and Reduced Incidence with Zoledronic acid Once yearly (HORIZON) Pivotal Fracture Trial is a multi-national, multi-center, randomized, placebo-controlled trial of 7,736 women. The study evaluated the potential of a once-yearly infusion of Reclast to decrease the risk of fracture in postmenopausal women with osteoporosis. Primary endpoints were incidence of new vertebral fractures and hip fractures at three years compared to placebo. All study participants received elemental calcium (1000 to 1500 mg per day) and vitamin D (400 to 1200 IU per day).
The second Phase III Reclast study presented at ASBMR investigated the safety and efficacy of treating patients with Reclast who were previously taking Fosamax. This randomized, double-blind, double-dummy, multi-center trial compared a single infusion of 5 mg Reclast vs. continuation of therapy with oral alendronate weekly for 52 weeks. The study included postmenopausal women with low bone mineral density (n=225). The women must have been treated with Fosamax for at least one year prior to randomization. The primary endpoint of the study was percent change in lumbar spine bone mineral density from baseline to one year.
About Reclast
Reclast is being studied worldwide in a series of multi-national and multi-center clinical trials program called HORIZON. This clinical development program studies a once-yearly dosing with Reclast for osteoporosis. It also includes studies in the prevention of clinical fractures following a hip fracture in men and women, male osteoporosis, corticosteroid-induced osteoporosis, prevention of osteoporosis, treatment of Paget's disease of the bone, and the treatment of osteogenesis imperfecta in children. Approximately 13,000 patients have participated in the ongoing HORIZON program in more than 400 trial centers worldwide. The HORIZON program is one of the most comprehensive drug evaluation programs ever undertaken in the area of metabolic bone diseases.
Zoledronic acid 5mg, under the brand name Aclasta(R), has been approved in approximately 50 countries worldwide, including the EU and Canada, for the treatment of Paget's disease. The U.S. Food and Drug Administration (FDA) issued an "approvable letter" for Reclast for the treatment of Paget's disease of the bone in February 2006. The FDA requested additional data from the ongoing clinical trial program in osteoporosis. Novartis is working with the FDA to gain approval for this indication. Zoledronic acid, the active ingredient of Reclast, is also available under the brand name Zometa(R) for use in other indications.
About Postmenopausal Osteoporosis
Postmenopausal osteoporosis (PMO) is a serious condition affecting millions of women worldwide. Osteoporosis currently affects an estimated 50.7 million people in the UK, France, Germany, Italy, Spain, the USA and Japan.(3) Incidence of hip fracture in women is projected to rise by 240% worldwide by 2050, as populations grow and age.(9)
Disclaimer
The foregoing release contains forward-looking statements that can be identified by the use of terminology such as "may," "believe," "potentially," "potential," or similar expressions, or by express or implied discussions regarding potential regulatory filings, approvals or future sales for Reclast. Such forward-looking statements 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 is no guarantee that Reclast will be approved by the U.S. Food and Drug Administration or any other regulatory authority for any indication in any market. Neither can there be any guarantee regarding potential future sales of Reclast. In particular, management's ability to ensure satisfaction of any health authorities' requirements is not guaranteed and management's expectations regarding commercialization of Reclast could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including new clinical data and 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 Securities and Exchange Commission of the United States. 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 develops, manufactures, markets and sells leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas. 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 (NYSE: NVS) -. a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 91,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
References
1. Black DM, et al. Effect of once-yearly infusion of Zoledronic Acid 5 mg on spine and hip fracture reduction in postmenopausal women with osteoporosis: the HORIZON pivotal fracture trial. Presented at 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, USA.
2. McClung M, et al. Single infusion of zoledronic acid 5 mg provides sustained benefits in BMD and biomarkers at 12 months in postmenopausal women with low bone mineral density and prior alendronate therapy. Presented at 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, USA.
3. Decision Resources Inc. -- Dbase 9; Kanis JA, 2000 & Melton LJ, 1995.
4. National Institutes of Health Osteoporosis and Related Bone Diseases -- National Resource Center. Osteoporosis Overview. Department of Health and Human Services. Available at http://www.niams.nih.gov/bone/hi/overview.htm.
5. US Congress, Office of Technology Assessment, Hip Fracture Outcomes in People Age 50 and Over -- Background Paper, OTA-BP-H-120 (Washington, DC: US Government Printing Office, July 1994).
6. Recker R, et al. Bone histomorphetry demonstrates normal bone remodelling in postmenopausal women with osteoporosis/osteopenia switched from oral alendronate to IV zoledronic acid. Presented at 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, USA.
7. Lindsay R, et al. A single zoledronic acid 5 mg infusion is preferred over weekly 70 mg oral alendronate in a clinical trial of postmenopausal women with osteoporosis/osteopenia. Presented at Sixth European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ECCEO), 15-18 March 2006, Vienna, Austria.
8. Omizio M, et al. A single infusion is preferred to oral weekly treatment in post-menopausal women with low bone mineral density previously treated with alendronate. Presented at 28th Annual meeting of the American Society for Bone and Mineral Research (ASBMR), 15-19 September 2006, Philadelphia, USA.
9. Gullberg B, et al. World-wide projections for hip fracture. Osteoporosis Int 1997; 7:407-13.
Novartis Pharmaceuticals Corporation
http://www.novartis.com
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