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17-Mar-2009

Once-yearly Reclast® approved by FDA to treat and prevent steroid-induced osteoporosis, marking its fourth approved indication

• Reclast is more effective than established therapy at increasing bone mass in men and women with steroid-induced osteoporosis¹
• Long-term steroid therapy, widely used to treat inflammatory diseases, can increase risk of osteoporotic fractures in up to 50% of patients²
• New indication reinforces efficacy and safety of once-yearly Reclast, used in more than 425,000 patients worldwide since its launch in 2007³

East Hanover, NJ, March 16, 2009-The US Food and Drug Administration (FDA) has approved once-yearly Reclast® (zoledronic acid) Injection to treat and prevent osteoporosis caused by glucocorticoids¹, commonly known as steroids, for patients expected to be on glucocorticoids for at least 12 months. This is the fourth US indication for Reclast, adding to the growing body of FDA-recognized safety and efficacy data supporting its use in most osteoporosis patients.

The FDA based its approval on a multinational, double-blind, head-to-head study which showed that Reclast was more effective than an established therapy at increasing bone mass in men and women with steroid-induced osteoporosis¹.

Glucocorticoids are widely used to treat inflammatory diseases, such as asthma and rheumatoid arthritis, and are the number one cause of "secondary osteoporosis⁴." Up to 50% of patients receiving long-term glucocorticoid therapy are at increased risk of fracturing a bone due to osteoporosis².

"Before today, the only approved options for patients on long-term glucocorticoid therapy were oral therapies^5.6," said Kenneth G. Saag, MD, MSc, Professor of Medicine and Epidemiology, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham. "Now they can be prescribed a single 15-minute infusion to prevent bone loss for a full year."

In addition to this new indication, Reclast was approved in the US in 2007 for the treatment of postmenopausal osteoporosis and, in 2008, to increase bone mass in men with osteoporosis¹. In June 2008, the Reclast osteoporosis indication was broadened to include the reduction of new clinical fractures in men and women after they experienced a recent low trauma hip fracture¹. In April 2007, Reclast was approved to treat Paget's disease of bone in men and women¹.

Since its launch in 2007, Reclast has been used by more than 425,000 patients worldwide, including more than 220,000 in the US, to help prevent fractures³. It is available in all 50 US states and reimbursed by all Medicare Part B carriers and virtually all health insurance plans⁷. Reclast can be administered in physician offices or in one of the more than 5,500 infusion centers located throughout the US⁸.

Glucocorticoid-induced osteoporosis study The indication to treat and prevent glucocorticoid-induced osteoporosis in patients expected to be on glucocorticoids for at least 12 months was granted on the basis of a multinational, double-blind study in 833 men and women comparing the efficacy and safety of once-yearly Reclast with an established therapy¹.

The study included two subsets of patients: a treatment group with patients who were on high-dose glucocorticoid therapy for more than three months before the start of the study, and a prevention group with patients who were on high-dose glucocorticoids for less than three months before the start of the study¹. Patients were expected to stay on the therapy for at least 12 months¹.

Results showed that Reclast increased bone mineral density (BMD) at the lumbar spine significantly more than the active control during the 12-month period in both the treatment group (Reclast 4.1% vs. active control 2.7%; P<0.001) and prevention group (Reclast 2.6% vs. active control 0.6%; P<0.001)¹.

The active ingredient in Reclast is zoledronic acid 5 mg administered once a year¹. Reclast contains the same active ingredient found in Zometa® (zoledronic acid) Injection⁹.

Patients should not take Reclast if they're on Zometa as it contains the same ingredient; if they have low blood calcium, kidney problems, or are allergic to Reclast or Zometa. Or if they're pregnant, plan to become pregnant or nursing.

It is important for patients to drink fluids before getting Reclast to help prevent kidney problems. The most common side effects are flu-like symptoms, fever, muscle or joint pain and headache. Patients should tell their doctor if they have dental problems because rarely, problems with the jaw have been reported with Reclast. Patients should tell their doctor if they have low blood calcium or cannot take calcium and vitamin D, had surgery involving the neck or intestines, had recent vomiting, diarrhea or decreased appetite. In patients with Paget's disease of bone, it is especially important for them to take 1500 mg of calcium and 800 IU of vitamin D daily, particularly during the first 2 weeks after getting Reclast. Patients should discuss all medicines they're taking, including prescription and non-prescription, vitamins and herbal supplements. Patients should contact their doctor if they develop severe bone, joint or muscle pain, numbness, tingling or muscle spasms.

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 "can," "risk," "expected," 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 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 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; 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 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, 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, preventive vaccines, diagnostic tools, cost-saving generic pharmaceuticals, and consumer health products. Novartis is the only company with leading positions in these areas. In 2008, the Group's continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 96,700 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. Reclast® (zoledronic acid) Injection [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; March 2009.
2. Libanati CR, Baylink DJ. Prevention and treatment of glucocorticoid-induced osteoporosis: A pathogenetic perspective. CHEST 1992; 102:1426-1435.
3. Novartis Internal (NPMR), based on Aclasta/Reclast vials sold in the US since launch till Feb 2009.
4. U.S. Department of Health and Human Services. Bone Health and Osteoporosis: A Report of the Surgeon General. 2004.
5. Actonel® (risedronate sodium) [Prescribing Information]. Cincinnati, OH: Procter & Gamble Pharmaceuticals, Inc. April 2008.
6. Fosamax® (alendronate sodium) [Prescribing Information]. Whitehouse Station, NJ: Merck & Co., Inc. February 2008.
7. Novartis Health Policy; USMM; Lash Group.
8. Reclast Ready Report; 2009, Novartis Data on File. Novartis Pharmaceuticals Corporation.
9. Zometa® (zoledronic acid) Injection [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation. March 2008.

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