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Novartis Pharmaceuticals UK Limited (NVS) 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) (imatinib)


5/20/2008 7:24:30 AM

FRIMLEY, England, May 20 /PRNewswire-FirstCall/ --

- Tasigna(R) (nilotinib) Effective in 77% of Patients Resistant or Intolerant to Prior Treatment in the Chronic (Early) Phase of Chronic Myeloid Leukaemia (CML)(1)

- Highly Targeted Nature of Tasigna(R) Tackles the Root Cause of CML Whilst Providing an Acceptable Tolerability Profile for Patients(1)(2)

- Tasigna Expands CML Portfolio for Novartis, Providing Effective Treatment Options for the Majority of Patients With Tasigna(R) and the CML Gold-Standard, Glivec(R)(imatinib)

Tasigna(R) (nilotinib) is now available in the UK as a new option to treat adult patients who are intolerant or resistant to previous therapies for Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia (CML). The availability of Tasigna(R) means that the majority of patients with CML can now be effectively treated, even those who did not respond to or cannot tolerate previous therapies including Glivec(R) (imatinib).

Data that led to the European approval of Tasigna(R) show that 77% of patients who had no haematological response when they started taking Tasigna(R) achieved a complete haematological response with the drug (ie. blood cell counts returned to normal)(1); Furthermore 40% of patients achieved a complete cytogenic response(1) (meaning that no abnormal chromosomes, the root cause of CML, are detected in the bone marrow cells)(1). At 12 months the overall survival rate was 95%(1).

Based on the success of the current gold standard treatment for CML, Glivec(R) (imatinib), also made by Novartis, scientists developed Tasigna(R) to more specifically target the cause of CML (Bcr-Abl). Other newer treatments for CML have a broad mechanism of action which can lead to increased side effects. The highly targeted nature of Tasigna(R) means that it has a positive tolerability profile(2) and few patients who suffered side effects from other therapies suffered the same significant side effects with Tasigna(R)(2).

Tasigna(R) works quickly in patients who have undergone other therapies, laboratory trials have shown it is effective in 32 out of 33 known imatinib resistant mutant cell lines.(3)

Tasigna trialist, Professor Richard Clark, Consultant Haematologist at Royal Liverpool University Hospital said:

"Running out of treatment options is a terrible scenario for any patient with CML, a disease where the prognosis has not always been good. The arrival of Tasigna(R) is a major step forward for those patients that do not respond to existing treatments. To be able to offer patients a reliable and effective option with a good safety profile is a significant advance in the treatment of CML."

CML is one of the four most common leukaemias in the world affecting 4000 people in the UK(4) Most people with CML can be treated in the long term with Glivec (imatinib) but a small amount of people, estimated at 3% per year cannot take Glivec(R) because of intolerance or because their cancer mutates and becomes resistant to Glivec(R)(5) Tasigna(R) offers an effective and well tolerated treatment option to the majority of people with imatinib resistant CML.

Sandy Craine, CML Support UK, welcomes the launch of Tasigna:

"Tasigna is an important advance as it provides an effective treatment option for the small number of CML patients who develop resistance to or are intolerant of Glivec. Glivec signified a revolution in the way we think about treating cancers and has proven to be very effective in the long term. Tasigna offers patients resistant or intolerant to previous therapies the chance to regain control of their health and continue to live normal and productive lives."

References

(1). Kantarjian, H et al. Nilotinib is Highly Active and Safe in Chronic Phase Chronic Myelogenous Leukemia (CML-CP) Patients with Imatinib-resistance or Intolerance. Oral Presentation. American Society of Hematology Annual Meeting, 2007. Abstract #735.

(2). Cortes, J et al. Nilotinib is associated with minimal cross intolerance to imatinib in patients with imatinib intolerant Philadelphia chromosome positive CML in either chronic phase or accelerated phase. Oral presentation. American Society of Haematology Annual meeting. 2007. Abstract # 1040.

(3). Kantarjian, H et al. Nilotinib in Imatinib-Resistant CML and Philadelphia Chromosome-Positive ALL. N Engl J Med. 354, no. 24 (2006).

(4). CancerBackup, Nice one - CancerBACUP welcomes decision on treatment for leukaemia

http://www.cancerbackup.org.uk/News/Mediacentre/Pressreleasesstatements/

2002/4352

(Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your Internet browser's URL address field. Remove the space if one exists.)

Last accessed 28 April 2008

(5). Hochhaus, A et al. IRIS 6-Year Follow-Up: Sustained Survival and Declining Annual Rate of Transformation in Patients with Newly Diagnosed Chronic Myeloid Leukaemia in Chronic Phase (CML-CP) Treated with Imatinib. Oral presentation. Blood (ASH Annual Meeting Abstracts) 2007 110: Abstract 25

Notes to editors

About Tasigna(R) (nilotinib)

Taken orally, twice daily, nilotinib works by inhibiting the proliferation of cells containing an abnormal chromosome. It does this by targeting the production of the Bcr-Abl protein, which is produced only by cells containing the abnormal Philadelphia chromosome. This protein is recognised as the key driver of the overproduction of cancer cells in patients with Ph+ CML.

Applying experience gained from the development of Glivec(R), a team of Novartis scientists created nilotinib in August 2002, just a year after the launch of Glivec(R). In preclinical studies, the medicine was able to overcome resistance resulting from Bcr-Abl kinase mutations in 32 of 33 imatinib resistant mutant cell lines. Patients with a variety of these mutations also responded to treatment with nilotinib. Nilotinib was specifically designed to target the Bcr-Abl protein more preferentially than Glivec(R), without adding new mechanisms of action.

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.

About Novartis

Novartis AG is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.

CONTACT: For more information, please contact: Novartis Pharmaceuticals UK
Ltd, Tel: +44(0)1276-698086, Fax: +44(0)1276-698605, Email:
fiona.turner@novartis.com; Pip Rogan / James HumphreysRed Health, Tel:
+44(0)207-025-6566 / +44(0)207-025-6522, Fax: +44(0)207-025-6499, Email:
pip.rogan@redconsultancy.com / james.humphreys@redconsultancy.com


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