Basel, 12 June 2003 - Novartis announced today that it has received approval from the European Agency for the Evaluation of Medicinal Products (EMEA) to expand the current marketing authorization for Zometa® (zoledronic acid) to include data on long-term treatment for patients with advanced cancers that have spread to the bone.
Novartis submitted the marketing authorization application for the updated labeling to the EMEA in October 2002 and received a positive opinion from the Committee for Proprietary Medicinal Products (CPMP) in February 2003. The data upon which the application was based confirm the long-term (approximately two years) benefits of Zometa including a decrease in number of patients experiencing bone complications, delay in initial onset of bone complications and reduced risk of developing complications. Bone complications, also known as skeletal related events (SREs), include, among others, pathological fractures, a need for radiation or surgery to bone, spinal cord compression, and hypercalcemia.
This Phase III long term data, recently presented at the American Society of Clinical Oncology (ASCO) meeting, show treatment with Zometa significantly reduced the risk of developing bone complications in patients with breast cancer, multiple myeloma, prostate cancer, lung cancer and other solid tumor types, according to a prospective multiple event analysis. This prospective multiple event analysis demonstrated that breast cancer patients treated with Zometa 4 mg in a 15-minute infusion have a 20% lower risk of developing bone complications compared with those treated with pamidronate 90 mg in a two-hour infusion. Multiple event analysis is a rigorous and sensitive measure of the risk of developing the first as well as subsequent bone complications over the entire course of treatment.
Zometa is the first bisphosphonate to demonstrate efficacy in treating bone complications across a broad range of tumor types such as breast, prostate, renal cell and lung cancers, as well as multiple myeloma. Zometa was granted marketing authorization by the EMEA in July 2002 for the prevention of bone complications in patients with advanced malignancies involving bone. This indication was based on data from three large pivotal trials of more than 3,000 patients that evaluated the drug for a treatment period of approximately one year.
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, anaemia, weakness, cough, dyspnoea and oedema.
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 "longer-term," "long-term" or similar expressions, or by express or implied discussions 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 regarding 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 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.
About Novartis
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 77 200 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
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