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News Release - September 17, 2007
First Osteoporosis Study in Hip Fracture Patients Finds Once-Yearly Reclast(R) Prevents Additional Fractures and Improves SurvivalMajor study of more than 2,100 patients with hip fracture shows significant 35% reduction in subsequent osteoporotic fractures with Reclast
Results published in The New England Journal of Medicine show significant 28% reduction in overall mortality seen in study patients treated with Reclast
Few patients currently receive osteoporosis treatments following hip fracture despite high risk of morbidity and mortality (1)
Reclast, recently FDA approved for treatment of postmenopausal osteoporosis, shown effective in reducing spine and hip fractures in another study
EAST HANOVER, N.J., Sept. 17 (HSMN NewsFeed) -- Results of the first ever clinical study in osteoporosis patients who have had a hip fracture show that a once-yearly infusion of Reclast® (zoledronic acid) Injection reduced the risk of subsequent fractures by 35% compared to placebo.
This study found that the risk of death was significantly reduced by 28% in the Reclast group compared to the placebo group (101 versus 141 deaths, respectively). Osteoporosis patients with hip fractures may face devastating consequences, with almost a quarter of people over age 50 who suffer a hip fracture dying within one year (2). Among those who survive, 50% require assistance walking, 25% require long-term nursing care and all remain at high risk for fracture (3). Yet, few men and women with hip fractures are diagnosed and treated for osteoporosis following a hip fracture (1).
The landmark study, which included more than 2,100 men and women, was published online today as an early release article in The New England Journal of Medicine and presented simultaneously at the annual meeting of the American Society for Bone & Mineral Research (ASBMR).
"Experts agree that the serious consequences of osteoporosis can be prevented, yet the condition is often under-diagnosed and under-treated," said Ethel Siris, MD, Professor of Clinical Medicine, Columbia University Medical Center.
"This study underscores the importance of more aggressive evaluation and management of patients with osteoporotic fractures, including hip fracture. We know that such patients are at very high risk of future fractures and it is critical that we lower that risk to reduce the human suffering and economic costs from this disease worldwide," said Dr. Siris.
Data from this new study, called the Recurrent Fracture Trial, will be submitted to regulatory authorities worldwide by the end of 2007 to broaden the treatment indication for Reclast.
"This study builds upon the body of evidence for Reclast and is the first to show that osteoporosis treatment after a hip fracture can have a positive impact on the lives of patients," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "Reclast is an important new treatment option for millions of people who suffer from the potentially life-threatening consequences of osteoporosis."
In the Recurrent Fracture Trial, Reclast significantly reduced the risk of all new clinical fractures by 35%. The risk of new spine fractures was reduced by 46% and new non-spine fractures (i.e., hip, wrist, arm, leg, rib) by 27%. The study was not designed to measure significant differences in hip fracture, but a trend was seen towards reduction in new hip fractures (30%).
Fewer patients who received Reclast died following a fracture than those treated with placebo (9.6% vs. 13.3%, respectively). This reduction in mortality is probably multifactorial but may have been partially related to reduction in subsequent new fractures after the hip fracture. However, further investigation is needed to more clearly understand all the factors that may have contributed to this finding.
This study further supports the demonstrated safety profile of Reclast. Analysis of key safety parameters, including kidney and cardiovascular safety (including atrial fibrillation), found Reclast to be comparable with placebo. Incidence of renal events were similar between the Reclast and placebo group (6.2% versus 5.6%, respectively). Atrial fibrillation serious adverse events occurred in 1.1% of Reclast-treated patients compared to 1.3% of placebo- treated patients. No cases of osteonecrosis of the jaw (ONJ) were seen in the study. The most common adverse events with Reclast were transient post-dose symptoms (such as fever, muscular pain, etc).
About the Study
The Recurrent Fracture Trial was an international, multi-center, randomized, double-blind, placebo-controlled Phase III study designed to evaluate the efficacy and safety of Reclast in preventing subsequent fractures in men and women following the surgical repair of a low-trauma hip fracture (i.e., a fall from standing height or less or equivalent force).
It is part of the Novartis HORIZON clinical trial program, one of the most comprehensive drug evaluation programs ever undertaken in the area of metabolic bone diseases involving 13,000 patients in more than 400 centers worldwide.
Men and women between the ages of 50 and 98 who had experienced a recent hip fracture sustained with minimal trauma were randomized to receive a once- yearly infusion of Reclast or placebo within 90 days of undergoing surgery to repair the hip fracture and every 12 months thereafter for up to three years.
The primary endpoint of the study was to determine the effect of Reclast on new clinical fractures following baseline hip fracture. Secondary endpoints included the change in bone mineral density (BMD) in the non- fractured hip measured annually; spine, non-spine and hip fractures; and pre- specified safety endpoints, including death.
Reclast was approved by the US Food and Drug Administration (FDA) on August 17, 2007 as the first and only once-yearly treatment for postmenopausal osteoporosis. Approval for postmenopausal osteoporosis was based on the results of the Pivotal Fracture Trial, which involved more than 7,700 women. In the study, published in The New England Journal of Medicine in May 2007, Reclast was shown to increase bone strength and reduce fractures in areas of the body typically affected by osteoporosis, including the hip, spine and non- spine (i.e., hip, wrist, arm, leg, rib). Reclast is the only treatment approved to reduce the risk of fractures across all of these key sites. The study showed Reclast reduced the risk of spine fractures by 70% and hip fractures by 41% (4).
Reclast belongs to a class of drugs called bisphosphonates, which are used to treat osteoporosis, the most common metabolic bone disease affecting more than 10 million people in the US (2). Unlike oral bisphosphonate treatments, where patients take daily, weekly or monthly doses of medication, Reclast is given as a once-yearly infusion.
In July 2007, the Committee for Medicinal Products for Human Use (CHMP) also issued a positive opinion recommending approval in the European Union, under the brand name Aclasta®. The European Commission generally follows the CHMP's recommendations and is expected to issue a final decision within three months.
Reclast is approved in more than 60 countries, including the US, Canada and the EU for the treatment of Paget's disease of the bone, the second most common metabolic bone disorder. Additional studies are ongoing to examine the use of Reclast to treat corticosteroid-induced osteoporosis, male osteoporosis and bone loss in postmenopausal women with osteopenia.
The active ingredient in Reclast is zoledronic acid, which is also available in a different dosage under the brand name Zometa® (zoledronic acid 4 mg) Injection for use in certain oncology indications.
Reclast is contraindicated in patients with hypocalcemia (low blood calcium) and those who are allergic to zoledronic acid. Reclast contains the same active ingredient found in Zometa. Patients already being treated with Zometa should not be treated with Reclast. Reclast should not be used during pregnancy because of potential harm to the fetus. Reclast is not recommended for use in patients with severe renal impairment (creatinine clearance <35 mL/min) and infusion time should not be less than 15 minutes.
The most common side effects associated with Reclast are fever; pain in the muscles, bones or joints; flu-like symptoms; and headache. These symptoms usually occur within the first three days following Reclast administration and usually resolve within 3 to 4 days of onset but resolution could take up to 7 to 14 days. Patients have reported severe bone, joint and/or muscle pain after using bisphosphonates. Osteonecrosis of the jaw (ONJ) has been reported rarely in postmenopausal osteoporosis patients treated with bisphosphonates. A routine oral examination should be performed by the prescriber prior to initiation of bisphosphonate treatment. Hypocalcemia may occur with Reclast therapy.
All patients with Paget's disease should receive 1500 mg of calcium in divided doses and 800 IU of vitamin D daily, particularly in the two weeks following Reclast administration. It is recommended that patients with postmenopausal osteoporosis take calcium and vitamin D supplements, if dietary intake is not sufficient.
For more information about Reclast, visit www.reclast.com or call 866- RECLAST (866-732-5278).
The foregoing press release contains forward-looking statements that can be identified by the use of forward-looking terminology such as "can", "will", "probably", "may", "generally follows", "expected", or similar expressions, or by express or implied discussions regarding potential future regulatory approvals of Reclast/Aclasta, or for additional indications or labeling for Reclast/Aclasta, or potential future sales of Reclast/Aclasta. Such forward- looking statements reflect the current views of Novartis regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Reclast/Aclasta will be approved for sale, or for any additional indications or labeling in any market, or that Reclast/Aclasta will reach any particular level of sales. In particular, management's expectations regarding Reclast/Aclasta could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected additional analysis of existing clinical data, and unexpected new clinical data; competition in general; government, industry, and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; as well as the additional factors discussed in Novartis AG's Form 20-F filed 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 described herein as anticipated, believed, estimated or expected. Novartis is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets 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, GI 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, cure 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. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ more than 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
(1) Gardner, MJ, Brophy RH, Demetrakopoulos D, et al. Interventions to improve osteoporosis treatment following hip fracture. Journal of Bone and Joint Surgery. 2005; 87-A: 3-7.
(2) National Osteoporosis Foundation. About Osteoporosis: Fast Facts. Available at: http://www.nof.org/osteoporosis/diseasefacts.htm Accessed on August 31, 2007.
(3) Beatriz JE, Perry HM III. Age-related osteoporosis. Clin Geriatr Med. 1994; 10:575-587.
(4) Black D, Delmas, S, Eastell R et al for the HORIZON Pivotal Fracture Trial. Once-Yearly Zoledronic Acid for Treatment of Postmenopausal Osteoporosis. NEJM 2007; 356(18):1809-22.
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