Bayer Schering Pharma’s oral anti-cancer drug sorafenib approved for treatment of liver cancer

PETALING JAYA, 18 June 2008 — Bayer Schering Pharma Malaysia today announced the approval of sorafenib (generic name) as the first and only oral targeted therapy for the treatment of liver cancer (hepatocellular carcinoma or HCC) by the Malaysian Ministry of Health.

Liver cancer is ranked as the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000 cases of liver cancer are diagnosed worldwide each year and incidence is increasing.

Revealing that the outlook for liver cancer has been dismal thus far, with no available effective treatment options, particularly in the final stages of the disease, Dr Chong Kwang Jeat, consultant in clinical oncology said, “In Malaysia, liver cancer is the 10th most common cancer among men and the 15th most common cancer among women. We estimate liver cancer to affect around 378 men and 150 women for every 100,000 in Malaysia. However, liver cancer is under-reported due to lack of awareness, and there is certainly a high medical need for an early and reliable diagnosis as well as for an effective life-prolonging treatment.”

The oral anti-cancer drug, sorafenib, is the first and only drug shown to significantly improve overall survival in patients with advanced HCC (a form of liver cancer). It is one of the new class of cancer therapies that works by targeting and blocking signaling proteins in cells to stop the proliferation of tumor cells as well as cuts off the blood supply to tumors.

“The approval of sorafenib is certainly a welcome and exciting step forward in the treatment and management of liver cancer in Malaysia. It is exciting to finally have something more effective to offer our patients”, Dr Chong continued.

Explaining that surgery and chemotherapy are used to treat liver cancer that is diagnosed in the earlier stages, when the tumor is confined to a small area of the liver, Professor Dr Peter Galle, Director of the Department of Internal Medicine, University of Mainz in Germany said, “Unfortunately, liver cancer is a devastating disease that is diagnosed too late, too often. This is because there are no symptoms in the early stages of the disease. It is only in the later stages that symptoms appear – which may include a lump, discomfort on the right hand side of the upper abdomen, pain around the right shoulder blade, or yellowing of the skin.”

Cancer is generally treated using chemotherapy and radiotherapy. However, in liver cancer patients particularly, treatment was a challenge as the toxicity of anti-cancer drugs is increased given that their liver function is compromised.

“Each year, the number of liver cancer related deaths continues to increase,” added Professor Dr Galle. “Previously, patients have no available effective treatment options in the final stages of liver cancer and many die within a year of diagnosis. With sorafenib we have a chance to improve a patient’s overall chances of survival by more than 44 percent. Sorafenib marks a turning point in improving treatment outcomes in patients facing the devastating impact of this disease globally.”

Concurring with Professor Dr Galle on the very encouraging treatment outcomes of sorafenib, Dr Chiun Hsu, Consultant Oncologist with the National Taiwan University Hospital in Taipei, said, “In Asia the underlying causes of liver diseases and the treatment guidelines for HCC are different from those in the Western countries. Initially, Asian-Pacific experts were a bit cautious about the positive results of the SHARP trial. However, the Asia Pacific Liver Cancer Study, which was presented this month at ASCO 2008 and showed equivalent survival benefit of sorafenib in Asian HCC patients, clearly demonstrates the efficacy of sorafenib across different geographic areas in the world.”

Liver cancer in the Asia-Pacific region continues to grow because of a high incidence of chronic hepatitis B viral infections, which now impacts approximately 275 million people in the region. Sorafenib is anticipated to set a new standard of care for liver cancer, as it is the only oral therapy that has been shown to improve overall survival in Asian patients with liver cancer.

The regulatory approval of sorafenib in the treatment of HCC complements Bayer Schering Pharma’s recent introduction of its liver-specific MRI contrast agent (gadoxetic acid disodium), and marks yet another milestone in the company’s commitment towards providing a more comprehensive range of services from diagnosis to life-prolonging therapies.

“Sorafenib was approved and launched in Malaysia for the treatment of kidney cancer in August 2008,” said Dr Victor Loh, Medical Director at Bayer Schering Pharma Malaysia. “We are delighted to receive regulatory approval for this new treatment indication in Malaysia, especially since it addresses a high, urgent unmet medical need in cancer treatment. Together, the introduction of our new MRI contrast agent as well as sorafenib enables us to offer the medical community a more complete and effective solution – from diagnosis to treatment.”

Sorafenib is currently approved over 40 countries for the treatment of liver cancer and in over 70 countries for the treatment of patients with advanced kidney cancer. As part of Bayer Schering Pharma’s commitment towards further expediting the clinical development of sorafenib as an innovative therapy, there are several ongoing studies to ascertain its effectiveness across additional tumor types, including breast cancer, malignant melanoma and adjuvant kidney cancer.