Afinitor(R) (everolimus) Now Licensed in UK for Advanced Kidney Cancer Patients After Failure of First Line Vascular Targeted Therapy (1,2)

FRIMLEY, England -

- This Press Release is Intended for Consumer Media Only

- Afinitor More Than Doubles the Median Time Without Tumour Growth and Reduces the Risk of Disease Worsening or Death by 67% Compared With Placebo (2)

- Patients With Advanced Kidney Cancer Have Limited Options Once Tumours Progress After First Line Standard Therapy(3)

- Recently Published UK Expert Clinical Consensus Recommend Afinitor as Second-Line Therapy for Advanced Kidney Cancer Based on Class I Evidence(4)

Afinitor(R) (everolimus) has recently been licensed for the treatment of advanced kidney cancer after failure of treatments which prevent the growth of the tumour’s blood vessels. The growth of the blood vessels are essential for the cancer to survive.(1) The European Commission (EC) approved everolimus for this use on 3rd August 2009.(1)

Prior to this date, there were no licensed treatment options for advanced kidney cancer patients whose cancer progressed while on or after treatment with these targeted therapies.

“I am delighted that there is now a proven treatment option available to people living with advanced kidney cancer in the UK, who have progressed after treatment with a targeted therapy. The availability of Afinitor is an important step in ensuring this population of poor prognosis patients have the potential to control their disease even further,” said Professor Tim Eisen, Professor of Medical Oncology at the University of Cambridge.

Expert consensus opinion, recently published in a review journal, has been updated to recommend everolimus as a treatment option for advanced kidney cancer therapy after progression on targeted therapies.(4)

Data that led to the European approval show that everolimus, when compared with placebo, more than doubled the median time without tumour growth or death in patients with advanced kidney cancer whose disease progressed following prior vascular targeted therapy (4.9 vs. 1.9 months).(2,3) The data showed the reduction of the risk of disease progression or death by 67% based on the primary endpoint of progression-free survival (PFS) (hazard ratio=0.33 with 95% confidence interval 0.25 to 0.43; P<0.001).(2)

“Every year there are 7,000 newly diagnosed cases of kidney cancer which also causes around 3,700 deaths a year(5),” said Pat Hanlon, Kidney Cancer UK. “While many of kidney cancer patients will be diagnosed early and undergo surgery to cure them, 40% of patients will be diagnosed in the advanced stages when prognosis is extremely poor and the cancer is notoriously difficult to treat.”(6)

James Whale, Founder of The James Whale Fund for Kidney Cancer, adds: “We at the Fund are pleased everolimus has been granted a license in the UK as, given the poor prognosis of kidney cancer, it is critical for people living with the disease to have access to life-extending treatments. This has been proven to provide benefit to kidney cancer patients, enabling them to spend precious time with family and friends.”

About kidney cancer

Kidney cancer accounts for approximately 2% of all new Cancers(7). In the UK, the incidence of kidney cancer is increasing(5), due in part to obesity and smoking.(8)

In kidney cancer, cancer cells develop in the lining of the kidney’s tubes and grow into a tumour. If left untreated, the tumour can spread to neighbouring lymph nodes and eventually to other organs.

About Everolimus

In the UK, everolimus is indicated for patients with advanced kidney cancer whose disease progressed on or after treatment with VEGF-targeted therapy.(4)

In cancer cells, everolimus continuously targets mTOR, a protein that acts as a central regulator of tumour cell division, blood vessel growth and cell metabolism.(9)

Important safety information

In the phase III trials, the most common adverse reactions irrespective of causality (incidence more than or equal to 30%) were stomatitis, infections, asthenia, fatigue, cough and diarrhoea. The most common grade 3/4 adverse reactions irrespective of causality (incidence more than or equal to 3%) were infections, dyspnoea, fatigue, stomatitis, dehydration, pneumonitis, abdominal pain and asthenia. The most common laboratory abnormalities (incidence more than or equal to 50%) were anaemia, hypercholesterolaemia, hypertriglyceridaemia, hyperglycaemia, lymphopaenia and increased creatinine. The most common grade 3/4 laboratory abnormalities (incidence more than or equal to 3%) were lymphopaenia, hyperglycaemia, anaemia, hypophosphataemia and hypercholesterolaemia. Deaths due to acute respiratory failure (0.7%), infection (0.7%) and acute renal failure (0.4%) were observed in patients receiving Afinitor. Afinitor may cause foetal harm in pregnant women.(3)

About Novartis

Novartis AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2008, the Group’s continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit www.novartis.com.

Notes to Editors

References

1. EPARs for Authorised Medicinal Products for Human Use www.emea.europa.eu/humandocs/Humans/EPAR/afinitor/afinitor.htm. Accessed September 2009

2. Escudier, B et al. 72O - Phase III Randomised Trial of Everolimus (RAD001) vs Placebo in Metastatic Renal Cell Carcinoma. Presented at the European Society for Medical Oncology (ESMO) 33rd Congress, Stockholm, Sweden on 16 September 2008

3. Motzer RJ, Escudier B, Oudard S et al for the RECORD-1 study group. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. The Lancet. August 2008; 372;9637:449-456

4. Nathan, P. et al. UK Guidelines for the Systemic Treatment of Renal Cell Carcinoma. British Journal of Hospital Medicine. Vol. 70, Iss. 5, May 13, 2009

5. Cancer Research UK: info.cancerresearchuk.org/cancerstats/types/kidney/incidence/. Accessed September 2009

6. The University of Texas MD Anderson Cancer Center. Kidney Cancer. Available at www.mdanderson.org/patient-and-cancer-information/cancer-information/c ancer-types/kidney-cancer/index.html. Accessed September 2009

7. McLaughlin JK, Lipworth L, Tarone RE. Epidemiological aspects of renal cell carcinoma. Semin Oncol. 2006 Oct;33(5):527-33. [Abstract]

8. Eisen, et al. Sorafenib for Older Patients With Renal Cell Carcinoma: Subset Analysis From a Randomized Trial. Journal of the National Cancer Institute. 2008; 100(20):1454-1463

9. Highlights of the NCCN 13th Annual Conference: Clinical Practice Guidelines & Quality Cancer Care, published as a supplement to The Oncology Report www.nccn.org/professionals/meetings/13thannual/highlights/1316.html. Accessed September 2009

Source: Novartis Oncology

Novartis UK Press Office: Novartis Pharmaceuticals UK Ltd, Tel: +44(0)1276-698-691, Fax: +44(0)1276-698-605, Email: sally.robinson at novartis.com; Kate Aldous, Red Health, Tel: +44(0)207-025-6404, Fax: +44(0)207-025-6499, Email: kate.aldous at redconsultancy.com