Launch of Highly Targeted Cancer Treatment Tasigna(R) (nilotinib) Offers Potential Lifeline to Ph+ CML Patients Intolerant or Resistant to Existing Therapies, Including Glivec(R) ...(of 33imatinib resistant mutant cell line...),Health

Nilotinib was approved in Switzerland in July 2007, followed by approvals by the U.S. Food and Drug Administration (FDA) and the European Commission in November 2007. Nilotinib was also submitted for approval in Japan in June 2007.

About Glivec(R) (Imatinib)

Glivec(R) is approved in more than 90 countries including the US, EU and Japan for the treatment of all phases of Ph+ CML. Glivec is also approved in the EU, US and other countries for the treatment of patients with Kit (CD117)-positive gastrointestinal tumours (GIST), which cannot be surgically removed and/or have already spread to other parts of the body (metastasized). In Japan, Glivec(R) is approved for the treatment of patients with Kit (CD117)-positive GIST. In the EU, Glivec(R) is also approved for the treatment of adult patients with newly diagnosed Ph+ acute lymphoblastic leukaemia (Ph+ ALL) in combination with chemotherapy and as a single agent for patients with relapsed or refractory Ph+ ALL. Glivec(R) is also approved for the treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP) who are not eligible for surgery. Glivec(R) is also approved for the treatment of patients with myelodysplastic/myeloproliferative diseases (MDS/MPD). Glivec(R) is also approved for hypereosinophilic syndrome and/or chronic eosinophilic leukaemia (HES/CEL).

The effectiveness of Glivec(R) is based on overall haematologic and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL and on objective response rates in GIST and DFSP.

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