Basel, 2 June 2003 - Early data from more than 6 600 patients in a global program that provided patients with early access to Glivec® (imatinib)*, prior to its regulatory approval, are consistent with published results on survival from the Phase II clinical trials in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.
Novartis established the Expanded Access Program (EAP) in April 2000 to provide early access to Glivec in response to the extraordinary patient demand for the drug that resulted from unprecedented response rates reported in the Phase I Ph+ CML clinical trials. The EAP provided the drug at no cost to patients in 37 countries prior to the drug's approval. The data presented at the meeting of the American Society of Clinical Oncology (ASCO) this week in Chicago, Illinois, were collected from EAP participants, and were not needed for marketing authorization. They are consistent with previous findings on time to progression, overall survival and safety data.
"We feel gratified that our efforts to speed access to Glivec for patients with limited treatment options have helped so many people," said David Epstein, President, Novartis Oncology.
EAP Results
In the EAP, patients in the blast crisis (BC) and accelerated phases (AP), received 600mg Glivec daily, while those in chronic phase (CP) who had failed treatment with interferon-alpha, received 400mg daily. The results collected from 6 617 EAP patients and 1 027 patients in the Phase II trials, in all three of these phases of Ph+ CML, were as follows:
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In addition, discontinuation rates of less than 6% were consistent with the previously reported tolerability profile. An additional 595 patients in the EAP had cancers other than Ph+ CML and are not included in this comparison.
Recognizing the need to continue helping patients gain access to Glivec even after its approval, Novartis established the Glivec International Patient Assistance Program (GIPAP). The program provides Glivec free of charge to eligible patients, according to each country's approved registration, who are not insured or reimbursed and have no other financial recourse. Since its inception, GIPAP has provided Glivec to more than 1 500 patients in 34 countries. A similar program, PAP (Patient Assistance Program), is offered in the US
About Glivec
Glivec is indicated for the treatment of newly diagnosed adult and pediatric patients with Ph+ CML in the EU, Switzerland, and a number of other markets. Glivec is approved in the US for newly diagnosed adult patients with Ph+ chronic phase CML and pediatric patients with Ph+ chronic phase CML whose disease has recurred after stem cell transplant or who are resistant to interferon-alpha therapy. 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.
Glivec is also approved in the EU, US and more than 45 other countries for the treatment of patients with Kit (CD 117)-positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GISTs).
Contraindications, Warnings and Adverse Events
In the first-line study (IRIS), the safety profile with Glivec was similar to that of previous Phase II studies in other CML patients. The majority of patients treated with Glivec experienced adverse events at some time. Most events were of mild to moderate grade and treatment was discontinued for adverse events only in 2% of patients in chronic phase, 3% in accelerated phase and 5% in blast crisis. The most common side effects included nausea, superficial edema, muscle cramps, skin rash, vomiting, diarrhea, hemorrhage, fatigue, headache, joint pain, cough, dizziness, dyspepsia and dyspnea, as well as neutropenia and thrombocytopenia.
The most common undesirable effects experienced during Glivec treatment in GIST are: headache, nausea, vomiting, diarrhea, dyspepsia, myalgia, muscle spasm and cramps, joint swelling, dermatitis, eczema, rash, edema, fluid retention, neutropenia, thrombocytopenia or anemia.
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 such as "early data", or similar expressions, or by express or implied discussions regarding potential future revenue from Glivec, or regarding the long-term impact of a patient's use of 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 achieve any particular revenue levels in the future. Neither can there be any guarantee regarding the long-term impact of a patient's use of Glivec. In particular, management's expectations regarding 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 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.
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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*In the US: Gleevec(TM) (imatinib mesylate)
