Bayer Schering Pharma (BSP) announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending the approval of Nexavar (sorafenib) tablets for the treatment of patients with hepatocellular carcinoma (HCC).

The CHMP's positive recommendation will be reviewed by the European Commission, which has authority to approve medicines for the European Union. BSP anticipates a final decision from the Commission in the coming months.

Commenting on receiving the positive opinion for sorafenib, Philip Ashman, Business Unit Head of BSP's Oncology Division in the UK, said: "It is very welcome news for patients with HCC and it reinforces Bayer Schering Pharma's commitment to research and development in oncology."

Sorafenib

Philip Johnson, Professor of Oncology at the University of Birmingham said "For the thousands of patients with advanced HCC there are currently no licensed therapies in the UK or Europe that significantly improve survival. The CHMP's positive opinion for sorafenib is an exciting step towards the availability of a new treatment option for patients with advanced HCC, which has been shown to improve overall survival for these patients."

"The positive opinion for sorafenib issued by the CHMP was delivered more rapidly than anticipated and marks another significant milestone for the product in HCC," said Philip Ashman, "The Committee's decision underscores the potential of Sorafenib to become the standard of care for the treatment of HCC."

The CHMP positive opinion was based on data from the Phase III Sorafenib HCC Assessment Randomized Protocol (SHARP) trial which demonstrated that sorafenib extended overall survival by 44 percent in patients with advanced HCC (HR=0.69; p=0.0006) versus placebo. The rate of serious adverse events was similar between the sorafenib and placebo-treated groups. The most commonly observed (occurring in >5% of subjects) CTC-Grade 3-4 treatment-emergent adverse drug reactions were diarrhoea and hand-foot skin reaction. Based on these data, a supplemental New Drug Application for sorafenib was also granted Priority Review status by the U.S. Food and Drug Administration (FDA) in August 2007.

About Hepatocellular Carcinoma (HCC)

HCC, the most common form of primary liver cancer, is responsible for about 80-90 percent of the primary malignant liver tumors in adults.1 Liver cancer is the sixth most common cancer worldwide,2 and the third leading cause of cancer-related deaths globally.3

Liver cancer disproportionately affects men, giving a male: female ratio of around 3:2.4 There are approximately 2,800 new diagnoses of liver cancer in the UK every year and every year liver cancer is responsible for causing around 2,800 deaths in the UK.5 The prognosis for patients diagnosed with liver cancer is often poor as the disease typically does not cause symptoms until the cancer is in its later stages.6

Sorafenib is currently approved in the UK for the treatment of patients with advanced renal cell carcinoma (the most common form of kidney cancer), who have failed prior interleukin-2 or interferon-alpha based therapy, or are considered unsuitable for such therapy.

Glossary:
Overall Survival (OS) - The time that a patient continues to live
Progression free survival (PFS) - The time that a patient lives without evident tumour growth
Renal Cell Carcinoma (RCC) - The most common type of kidney cancer in adults
Hepatocellular Carcinoma (HCC) - The most common form of primary liver cancer
Systemic Therapy - A drug which when administered affects the whole body and not just part of it.

About sorafenib

When approved by the EMEA in July 2006, there had not been any new classes of licensed kidney cancer treatment in Europe for over 10 years.

Sorafenib's differentiated mechanism

Sorafenib targets both the tumor cell and tumor vasculature. In preclinical studies, sorafenib has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) - two important processes that enable cancer growth. These kinases included Raf kinase,, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-37 and RET8. Preclinical models have also demonstrated that Raf/MEK/ERK has a role in HCC9.

Bayer Schering Pharma:

Bayer Schering Pharma is a leading, worldwide speciality pharmaceutical company. Its research and business activities are focussed on the fields of oncology, haematology & cardiology, diagnostic imaging, primary care, specialised therapeutics and women's healthcare. With innovative products and using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life of patients - a factor of particular importance in Oncology.

Bayer Schering Pharma's portfolio of oncological products include treatments for both solid and haematological malignancies. Intensive research is ongoing as Bayer Schering Pharma strives to discover and advance therapeutic solutions for the benefit of all cancer patients.

For more information, please visit bayerscheringpharma

Nexavar® (sorafenib) tablets is a registered trademark of Bayer Pharmaceuticals Corporation.

References

1.Wilson,,J.F."Liver cancer on the rise". Ann Int Med, 2005; 102(12):1029-32.

2. Cancer Research UK. Cancer Worldwide. Figure 3. Click here. Accessed September 18th, 2007. Data taken from International Agency for Cancer Research. GLOBOCAN 2002. Available at: www-dep.iarc.fr

3. World Health Organisation. Fact sheet N°297: Cancer. Click here Accessed September 18th, 2007.

4. Cancer Research UK. Liver Cancer Incidence Statistics. Available here Accessed September 18th, 2007.

5. Cancer Research UK. Liver Cancer Incidence Statistics. Available here Accessed September 18th, 2007.

6. Cancer Backup. Available here Accessed September 18th, 2007.

7. Nexavar (sorafenib) Summary of Product Characteristics, Bayer HealthCare AG, 2007.

8. Carlomagno, F., S. Anaganti, et al. 2006 "BAY 57-9352 43-9006 inhibition of oncogenic RET mutants". J Natl Cancer Inst 98:326-34.

9. Liu, L.., Y. Cao, et al. 2006. "Sorafenib blocks the RAF.MEK.ERK pathway, inhibits tumour angiogenesis, and induces tumour cell apoptosis in the hepatocellular carcinoma model PLC/PRF/5." Cancer Res 66(24):11851-8.

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