Novartis submitted the sNDA for the updated labelling to the US FDA on existing approved indications in October 2002. The data upon which the application was filed provides clinicians long-term data (approximately two years) to advance their understanding of the role of Zometa in the treatment of cancer related bone complications. Bone complications, also known as skeletal related events (SREs), include, among others, bone pain, pathological fractures, a need for radiation or surgery to bone, spinal cord compression, and hypercalcemia.
"Nearly 500 000 patients worldwide have received Zometa to date, making it the most widely used bisphosphonate for the treatment of cancer-related bone complications," said David Epstein, President, Novartis Oncology. "These data of up to 24 months filed with the FDA provide valuable insights on the broad utility and appropriate use of Zometa."
About Zometa
Novartis has received marketing authorization for Zometa in more than 60 countries, including the member states of the European Union and the United States, for the prevention of skeletal related events in patients with advanced malignancies involving bone. These malignancies include multiple myeloma, prostate cancer, breast cancer, lung cancer, renal cancer and other solid tumors. The EU authorities approved early June 2003 the expansion of this marketing authorization to include data on long-term treatment.
Novartis also has received marketing clearance for Zometa in the treatment of tumor-induced hypercalcemia (TIH), also known as hypercalcemia of malignancy (HCM), in more than 80 countries throughout the world. The proven safety and efficacy of this treatment has resulted in nearly 500 000 patients worldwide receiving Zometa to date.
Contraindications and Adverse Events
In clinical trials in patients with bone metastases, Zometa had a safety profile similar to other intravenous bisphosphonates. The most commonly reported adverse events in bone metastases clinical trials, regardless of causality with Zometa, included flu-like syndrome (fever, arthralgias, myalgias, skeletal pain), fatigue, gastrointestinal reactions, anemia, weakness, cough, dyspnea and edema.
Zometa is contraindicated during pregnancy, in breast-feeding women and in patients with clinically significant hypersensitivity to zoledronic acid or other bisphosphonates, or any of the excipients in the formulation of Zometa. Zometa and other bisphosphonates have been associated with reports of renal insufficiency. Patients should have serum creatinine assessed prior to receiving each dose of Zometa. Due to the risk of clinically significant deterioration in renal function, single doses of Zometa should not exceed 4 mg and the duration of infusion should be no less than 15 minutes. Since safety and pharmacokinetic data are limited in patients with severe renal impairment, Zometa is not recommended in patients with bone metastases with severe renal impairment. In the clinical studies, patients with serum creatinine >3.0 mg/dL were excluded.
The foregoing release contains forward-looking statements that can be identified by terminology such as "approvable," "long-term," "pending future," or similar expressions, or by discussions regarding the potential approval of an updated label for Zometa, or regarding potential future sales of Zometa. Such forward-looking statements reflect the current views of the company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Zometa to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Zometa will be approved for an updated labelling. Neither can there be any guarantee regarding potential future sales of Zometa. In particular, management's expectations regarding Zometa could be affected by, among other things, additional analysis of Zometa clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government pricing pressures; and other risks and factors referred to in the Company'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 AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of USD 20.9 billion and a net income of USD 4.7 billion. The Group invested approximately USD 2.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78 200 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
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Additional information on Novartis Oncology and Zometa can be found at www.novartisoncology.com or www.zometa.com. Additional media information can be found at www.novartisoncologyVPO.com.
