Novartis awarded 2002 international Galien Prize for innovative cancer therapy, Glivec®

After obtaining the national Galien Prize 2002 in six countries, Glivec has now received a supreme award on an international level

Basel, 3 June 2002 For the first time, Novartis has been awarded the prestigious international Galien Prize for therapeutic innovation. It was awarded to the innovative drug, Glivec® (imatinib)*, a molecularly-targeted treatment for certain forms of chronic myeloid leukemia (CML) in cancer patients. Glivec, a signal transduction inhibitor, is one of the first cancer drugs to be developed using rational drug design, based on an understanding of how some cancer cells work. In the past two years, Novartis research was honoured nine** times with Galien Prizes for therapeutic innovation.

According to Dr. Daniel Vasella, Chairman and CEO of Novartis AG, "This prestigious award is a testament to the success of our research and development efforts and the tremendous medical and scientific potential of Glivec. We are pleased that eminent professors from all the partner countries of the Galien Prize have recognised once again this drug which has opened new horizons in oncology."

This award follows on the heels of additional encouraging research results presented at the 2002 meeting of the American Society of Clinical Oncology in Orlando, Florida, USA and the approval of the European Commission for the treatment of patients with Kit (CD 117) positive unresectable (inoperable) and/or metastatic malignant gastrointestinal stromal tumors (GISTs).

The international Galien Prize is awarded every two years. The award recognises innovative therapeutic drugs that have made a substantial improvement in therapy. Drugs that have already won a prize on a national level compete for the international prize. This year, Glivec was awarded with the national Galien Prize in Belgium, Canada, France, Luxembourg, Netherlands and Portugal. The deliberation meeting for the international Galien Prize was held in Madrid, under the aegis of the press group MediMedia Spain. The international jury brought together 13 renowned scientists who represented the national juries. The prize will be awarded in Madrid on 17 October 2002.

Since 1970, Novartis has received 12 national Prix Galien in six countries for the innovative therapies Rimactan®, Parlodel®, Sandimmune®, Sandostatin®, Simulect®, Visudyne® and recently Glivec®. Further, research into Glivec has garnered additional prizes including the Bruce F. Cain Award from the American Association for Cancer Research (AACR) on April 9 2002 and the Warren Alpert Foundation Scientific Prize, awarded by Harvard Medical School on May 2 2002. Both prizes were awarded for the discovery and the preclinical work on Glivec.

Glivec

Glivec targets the activity of a type of enzyme, called tyrosine kinases, which play an important role within certain cancer cells. It works by inhibiting the Philadelphia chromosome, the abnormality that characterises CML in most patients. Additionally, the activity of one of the tyrosine kinases that Glivec has been shown to inhibit, known as c-kit, is thought to drive the growth and division of most gastrointestinal stromal tumors (GISTs). For patients with metastatic or unresectable (inoperable) disease, GISTs represent an incurable malignancy with a median survival of approximately one year. Until now, surgery has been the only effective treatment option for most GISTs, resulting essentially in palliation of the disease.

Glivec was approved in the EU on 7 November 2001 for its initial treatment of Philadelphia chromosome-positive CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. To date, Novartis has received marketing clearance for Glivec for the CML indication worldwide. The recent approval in GIST marks the second approval for Glivec within seven months in the EU.

Contraindications and adverse events

The majority of CML-patients treated with Glivec experience 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, fluid retention, vomiting, diarrhoea, haemorrhage, muscle cramps, skin rash, fatigue, headache, dyspepsia and dyspnoea, as well as neutropenia and thrombocytopenia.

Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 72, 600 people and operate in over 140 countries around the world. For further information please consult

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