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, that at present is used in the treatment of TIH. In these studies, the combined results have showed that statistically a 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, compared to 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, which will take place in May from 20 to 23, 2000, in New Orleans. The development of Zometa is the most recent example of Novartis' long-standing commitment to the oncology community, according to David Epstein, the Chief Operating Officer at Novartis Pharmaceuticals Corporation. The company is excited by these results as well as by the potential Zometa might offer to patients with a potentially life-threatening complication of cancer.
To date, the most common adverse effects of Zometa have been reported to be anemia, fever, nausea, upper respiratory tract infection, fatigue, bone pain, and constipation. Its adverse effects profile is similar to that of Aredia. Another common complication of cancer is bone metastases. Ongoing trials are now investigating the role of Zometa in the treatment of bone metastases in breast, prostate and lung cancer, other solid tumours, and in multiple myeloma. The studies in the prevention of bone metastases have started in prostate cancer and will begin in early 2000 for breast cancer. In addition, further research will evaluate the potential anti-tumour effect of Zometa.
Last December 1999, Novartis has been filing a drug application in Europe for Zometa in the treatment of tumour-induced hypercalcemia. This tumour-induced hypercalcemia - or hypercalcemia of malignancy - often occurs as a complication of bone metastases and is associated with cancer in general. It appears most often in patients with breast cancer, multiple myeloma, and non-small cell lung cancer. Tumour-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 TIH symptoms are likely to be confused with those of the underlying malignancy or the adverse effects of the therapy, which is applied to treat the malignancy. Intravenous bisphosphonates have become a standard therapy 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.
The products represented by the Novartis oncology franchise include Aredia or pamidronate disodium for injection to treat osteolytic bone metastases in patients with multiple myeloma or breast cancer in conjunction with the standard antineoplastic therapy, hypercalcemia of malignancy, and Paget's disease; Femara or letrozole tablets for the treatment of advanced breast cancer in post-menopausal women with disease progression which follows antiestrogen therapy; and Sandostatin LAR Depot (octreotide acetate for injectable suspension) and Sandostatin (octreotide acetate injection) for the control of symptoms in patients with metastatic carcinoid and vasoactive intestinal peptide-secreting tumours (VIPomas), and also for the treatment of acromegaly.
In addition, a product to address haematological disorders is managed by this group. Sandoglobulin or Immune Globulin Intravenous [IGIV] (Human) is indicated for the maintenance therapy for primary immuno-deficiency syndromes and for the treatment of immune thrombocytopenic purpura. Novartis also is investigating an agent for overcoming multi-drug resistance in malignancies. As such, Novartis Pharmaceuticals Corporation researches, designs, 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, arthritis, respiratory disorders, dermatological diseases, and cancer.
The company's mission is to improve people's lives by pioneering innovative health care solutions. Located in New Jersey, the Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, a world leader in health care with core businesses in pharmaceuticals, consumer health, eye-care, generics, and animal health. In 1998, the group including Agribusiness achieved sales of $21.8 billion and invested more than $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 only recently announced plans to spin off its Crop Protection and Seeds sectors and to merge them with the agro-chemicals business of AstraZeneca in the second half of 2000.