Novartis submits NDA for Zometa® (zoledronic acid for injection)

December 21, 1999

Potent IV bisphosphonate for common cancer complication East Hanover, NJ, December 22, 1999 - Novartis Pharmaceuticals Corporation today announced that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for Zometa® (zoledronic acid for injection) for the treatment of tumor-induced hypercalcemia (TIH). A potentially life-threatening disorder, TIH is characterized by elevated serum calcium levels in patients with cancer. Tumor-induced hypercalcemia is one of the most common metabolic complications associated with cancer. Zometa is currently the most potent intravenous (IV) bisphosphonate in clinical trials.

The clinical data upon which the NDA filing is based are from two identical pivotal studies comparing Zometa to Aredia (pamidronate disodium for injection), another Novartis agent, which currently is used in the treatment of TIH. In these studies, the combined results demonstrated that a statistically significant higher percentage of patients responded to Zometa 4 mg (88.4 percent) versus Aredia (70 percent) in reducing serum calcium levels to the normal range. In addition, Zometa was infused over 5 minutes, versus Aredia, which requires approximately two or more hours of infusion.

Novartis has submitted an abstract of the clinical trial data for presentation at the American Society of Clinical Oncology (ASCO) annual meeting May 20-23, 2000, in New Orleans.

"The development of Zometa is the most recent example of Novartis' long-standing commitment to the oncology community," said David Epstein, Chief Operating Officer, Novartis Pharmaceuticals Corporation. "We are excited by these results and the potential Zometa may offer to patients with a potentially life-threatening complication of cancer."

Contraindications and Adverse Effects

To date, the most common adverse effects of Zometa have been reported to be bone pain, anemia, fever, nausea, upper respiratory tract infection, fatigue and constipation. Its adverse effects profile is similar to that of Aredia.

Further Study of Zometa

Another common complication of cancer is bone metastases. Ongoing trials are currently investigating the role of Zometa in the treatment of bone metastases in breast, prostate and lung cancer, other solid tumors, and in multiple myeloma. Studies in the prevention of bone metastases have started in prostate cancer and will start in early 2000 for breast cancer. In addition, further studies will evaluate the potential anti-tumor effect of Zometa.

European Filing

In December, 1999, Novartis is filing a drug application in Europe for Zometa in the treatment of tumor-induced hypercalcemia.

Background: Hypercalcemia of Malignancy

Tumor-induced hypercalcemia - or hypercalcemia of malignancy - often occurs as a complication of bone metastases and is associated with cancer in general. It occurs most often in patients with breast cancer, multiple myeloma and non-small cell lung cancer. Tumor-induced hypercalcemia usually occurs late in malignancy with limited survival.

Signs and symptoms of TIH include nausea, vomiting, dehydration, renal insufficiency, mental confusion and very high serum calcium levels. Many of these symptoms of TIH can be confused easily with those of the underlying malignancy or the adverse effects of the therapy used to treat the malignancy.

Intravenous bisphosphonates have become a standard treatment for the management of metastatic bone complications of cancer, including TIH. Among bisphosphonates, laboratory tests demonstrate that Zometa is the most potent inhibitor of bone resorption, the process by which calcium is released into the blood stream to cause hypercalcemia.


Products represented by the Novartis oncology franchise include Aredia (pamidronate disodium for injection) for the treatment of osteolytic bone metastases in patients with multiple myeloma or breast cancer in conjunction with standard antineoplastic therapy, hypercalcemia of malignancy, and Paget's disease; Femara (letrozole tablets) for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy; and Sandostatin LAR Depot (octreotide acetate for injectable suspension) and Sandostatin (octreotide acetate injection) for control of symptoms in patients with metastatic carcinoid and vasoactive intestinal peptide-secreting tumors (VIPomas), and for the treatment of acromegaly. In addition, a product to address hematologic disorders is managed by this group. Sandoglobulin (Immune Globulin Intravenous (Human) [IGIV] is indicated for the maintenance therapy for primary immunodeficiency syndromes and for the treatment of immune thrombocytopenic purpura. Novartis also is investigating an agent for overcoming multidrug resistance in malignancies.

Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. 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, a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 1998, the Group (including Agribusiness) achieved sales of USD 21.8 billion and invested more than USD 2.6 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about 82,000 people and operates in over 140 countries around the world. The Group recently announced plans to spin off its Crop Protection and Seeds sectors and to merge them with the agrochemicals business of AstraZeneca in the second half of 2000.
For more information, contact:
(Media) (Investor)
Gloria C. Stone Joe Schepers
Novartis Pharmaceuticals Corporation Novartis Corporation
973-781-5587 908-522-6899

Ruder Finn Public Relations

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