BASEL, Switzerland, Oct. 30, 2003 (PRIMEZONE) -- Health authorities in the UK and Australia (the National Institute for Clinical Excellence (NICE) and the Minister of Health and Ageing, respectively) each made announcements last week endorsing the use of the Novartis (NYSE:NVS) drug Glivec(R) (imatinib)* as first-line treatment for patients newly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in all phases of the disease.
Both health authorities issued their announcements on 22 October 2003. In England and Wales, NICE issued guidelines recommending that newly diagnosed adult Ph+ CML patients should have access to Glivec as their first drug treatment option. The Australian Federal Government will subsidise Glivec for the treatment of newly diagnosed Ph+ CML patients (including pediatric patients).
Previously, each country endorsed the use of Glivec only for Ph+ CML patients in the blast crisis, accelerated phase or in chronic phase after failure or intolerance of interferon-alpha therapy (IFN), a traditional treatment for CML.
"We are pleased that the authorities in both the UK and Australia recognize the importance of providing Ph+ CML patients with access to Glivec as early as possible," said David Epstein, President, Novartis Oncology. "Data show that Glivec as initial therapy results in the greatest overall response and benefit to patients when compared to the previous standard treatment."
Worldwide, CML has an incidence of one-to-two cases per 100 000 population per year and is responsible for 15 to 20% of all adult cases of leukemia.
For people in chronic phase CML currently receiving IFN as first-line treatment in Australia and the UK, the choice of whether to change to Glivec should be based upon the response of the disease to current treatment and by the tolerance of the patient to IFN. This decision should be made after informed discussion between the patient and the responsible clinician.
In Australia, the Minister for Health and Ageing decides which drugs should be reimbursed on the PBS (Pharmaceutical Benefits "reimbursement" Scheme) based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). This follows approval from the Therapeutic Goods Administration (TGA), which ensures the quality, safety and efficacy of drugs, approving them for sale in Australia.
NICE was established on 1 April 1999 as a Special Institute for England and Wales. It is part of the NHS and its role is to promote high clinical standards in the NHS by developing or commissioning guidance on clinical and cost-effectiveness and disseminating guidance to clinicians, patients and commissioners.
About Glivec
Glivec is one of the first oncology drugs that validate rational drug design based on an understanding of how some cancer cells work. It is a signal transduction inhibitor, which interferes with the pathways that signal the growth of tumor cells. Glivec works by inhibiting an abnormally activated protein (enzyme) that is coded for by the Ph+, the genetic abnormality that characterizes CML in most patients.
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 IFN therapy. In addition, Glivec is already approved in more than 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, Japan and more than 70 other countries for the treatment of patients with Kit (CD 117)-positive unresectable (inoperable) and/or metastatic malignant GISTs.
Contraindications 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 "recommending," "should have access," "will subsidise," "should be based," "should be made," "should be reimbursed," or similar expressions, or by express or implied discussions regarding potential future revenue from 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 level of revenue. Neither can there be any guarantee regarding revenues from Glivec. In particular, management's ability to ensure satisfaction of the health authorities' further requirements is not guaranteed and 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 is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
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 78 200 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.
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