Basel, 30 January 2003 - Novartis announced today that its Japanese affiliate has filed an application with health authorities in Japan for marketing approval of Glivec® (imatinib)* for the treatment of patients with gastrointestinal stromal tumors (GISTs), a life-threatening cancer. This filing is based on clinical data from studies conducted in Japan and Western countries, such as the United States and member states of the European Union where Glivec is already approved for this indication.
"GISTs are very difficult to treat and there are very few options beyond surgery for these patients," said David Epstein, President Novartis Oncology. "We will work closely with the Japanese authorities to facilitate the review and to make Glivec available to appropriate GIST patients in Japan as quickly as possible."
GISTs are the most common malignant form of sarcoma found in the gastrointestinal tract. Worldwide, there are approximately 12 000 new cases each year. The incidence is highest in people 30-60 years of age. Historically, GISTs have been very difficult to treat due to their resistance to available chemotherapy and radiation therapy. For patients with metastatic or unresectable disease, GISTs were an incurable malignancy with a median survival of 20 months and, with local recurrence, a median survival of 9-12 months. Until now, surgery has been the only treatment option, resulting essentially in palliation of the disease.
Glivec is approved in the EU, US, and more than 45 other countries for the treatment of patients with Kit (CD 117)-positive unresectable (inoperable) and/or metastatic malignant
GISTs.
Glivec is also indicated for treatment of adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the EU, US and Japan and a number of other markets. Marketing approval in the EU, Switzerland and other countries includes the treatment of pediatric patients. In addition, Glivec is already approved in over 80 countries for the treatment of adult patients with Ph+ CML in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.
The Japanese trials in patients with GIST confirmed the safety profile previously found in trials from other countries. The most common undesirable effects experienced during Glivec treatment in CML and GIST are: headache, nausea, vomiting, diarrhoea, dyspepsia, myalgia, muscle spasm and cramps, joint swelling, dermatitis, eczema, rash, oedema, fluid retention, neutropenia, thrombocytopenia or anaemia. Glivec is contraindicated in patients with known hypersensitivity to imatinib or any of its excipients. Women of childbearing potential should be advised to avoid becoming pregnant while taking Glivec.
The foregoing release contains forward-looking statements that can be identified by terminology or by discussions regarding potential marketing approvals for new indications for Glivec. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Glivec to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Glivec will be approved for any additional indications in any market. Neither can there be any guarantee regarding the long-term impact of a patients' use of Glivec. In particular, management's ability to ensure satisfaction of the health authorities' further requirements is not guaranteed and management's expectations regarding commercialization of
Glivec could be affected by, among other things, additional analysis of Glivec clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company's ability to btain or maintain patent or other proprietary intellectual property protection; competition in general; 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.
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of CHF 32.4 billion (USD 20.9 billion) and a net income of CHF 7.3 billion (USD 4.7 billion). The Group invested approximately CHF 4.3 billion (USD 2.8 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 72 900 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
Additional information on Novartis Oncology and Glivec can be found at www.novartisoncology.com or www.glivec.com. Additional media information can be found at www.novartisoncologyvpo.com.
