Navigation Links
Nexavar Approved in Japan for the Treatment of Advanced Liver Cancer

- First and only oral targeted therapy to significantly improve overall survival in patients with the disease -

WAYNE, N.J. and EMERYVILLE, Calif., May 20 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Nexavar(R) (sorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that accounts for 95 percent of all liver cancer cases in Japan(1). Nexavar is also currently available in Japan as an approved treatment for unresectable or metastatic renal cell carcinoma (RCC).

The approval in Japan was based on the international, Phase 3 double-blind, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) study that evaluated more than 800 patients who received no prior systemic therapy. The study found that Nexavar improved overall survival in patients with HCC by 44 percent (HR=0.69; p=0.0006) versus placebo. Based on SHARP results, Nexavar is currently approved in more than 70 countries for liver cancer, including the U.S. and countries in Europe.

"Liver cancer is one of the leading causes of cancer-related deaths in Japan, and the incidence is continuing to rise," said Gunnar Riemann, member of the Executive Committee of Bayer HealthCare. "We are pleased with today's approval and what it may mean for liver cancer patients in Japan and their families who now have a therapy like Nexavar that has the potential to extend their lives."

In Japan, approximately 40,000 people are diagnosed with liver cancer each year and approximately 36,000 die from the disease, making primary liver cancer the third leading cause of cancer-related death in Japan.(2)

Hepatitis B viral infection (HBV) and hepatitis C viral infection (HCV) are leading risk factors for developing primary liver cancer worldwide, with HCV being the primary risk factor in Japan. An estimated 80 to 90 percent of Japanese patients diagnosed with liver cancer have HCV.(3)

"This is a significant milestone in the Japanese region where patients, who have high rates of liver cancer, are truly in need of a treatment option that improves survival," said Laura Brege, executive vice president and chief operating officer at Onyx Pharmaceuticals, Inc. "This latest approval provides further evidence that Nexavar is an important therapy for patients with liver cancer as well as kidney cancer, an indication for which Nexavar was first approved in Japan."

Hepatocellular carcinoma is the most common form of liver cancer(4) and is responsible for about 90 percent of the primary malignant liver tumors in adults(5). Liver cancer is the sixth most common cancer in the world(6) and the third leading cause of cancer-related deaths globally(7). More than 600,000 cases of liver cancer are diagnosed worldwide each year (more than 400,000 in China, South Korea, Japan and Taiwan, 54,000 in the European Union, and 15,000 in the United States) and the incidence is increasing(4). In 2002, approximately 600,000 people died of liver cancer including approximately 370,000 in China, South Korea and Japan, 57,000 in the European Union, and 13,000 in the United States(4).

Nexavar's Differentiated Mechanism

Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar 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-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET. Preclinical models have also demonstrated that Raf/MEK/ERK has a role in HCC; therefore blocking signaling through Raf-1 may offer therapeutic benefits in HCC.

Nexavar is currently approved in more than 70 countries for liver cancer and in more than 80 countries for the treatment of patients with advanced kidney cancer. Nexavar is also being evaluated by the companies, international study groups, government agencies and individual investigators as a single agent or combination treatment in a wide range of cancers, including, lung cancer, breast cancer, colorectal cancer, lung cancer, ovarian cancer, and as an adjuvant therapy for kidney and liver cancer.

Important Safety Considerations For Patients Taking Nexavar

Based on the currently approved U.S. package insert for the treatment of patients with unresectable hepatocellular carcinoma, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. Bleeding with a fatal outcome from any site was reported in 2.4% for Nexavar and 4% in placebo. The incidence of treatment-emergent cardiac ischemia/infarction was 2.7% for Nexavar vs. 1.3% for placebo. Most common adverse events reported with Nexavar in patients with unresectable HCC were diarrhea, fatigue, abdominal pain, weight loss, anorexia, nausea and hand-foot skin reaction. Grade 3/4 adverse events were 45% for Nexavar vs. 32% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.

For information about Nexavar including U.S. Nexavar prescribing information, visit or call 1.866.NEXAVAR (1.866.639.2827).

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world's leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics, Hematology/Cardiology and Oncology. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

About Onyx Pharmaceuticals, Inc.

Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar(R) (sorafenib) tablets, a small molecule drug. For more information about Onyx, visit the company's website at:

Forward Looking Statements

This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer Web site at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

This news release also contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the results of the clinical development, safety, regulatory processes, commercialization efforts or commercial potential of Nexavar. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2008, filed with the Securities and Exchange Commission under the heading "Risk Factors" and Onyx's Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.

Nexavar(R) (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals, Inc.

(1) British Medical Journal (BMJ), Liver cancer toll high in Japan, Adam Easton; 1999 June 5; 318(7197): 1510.

(2) Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004. Available at: Accessed April 2009.

(3) El-Serag HB, Rudolf KL. Hepatocellular carcinoma: epidemiology and molecular carcinogenesis. Gastroenterology. 2007; 132(7); 2557-2576.

(4) El-Serag HB, Mason AC. Rising incidence of hepatocellular carcinoma in the United States. N Engl J Med. 1999;340:745-750

(5) Available at American Society of Clinical Oncology:

(6) Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004. Available at: Accessed April 2009.

(7) Forner A, Hessheimer AJ, Isabel Real M, Bruix J. Treatment of hepatocellular carcinoma. Crit Rev Oncol Hematol. 2006; 60: 89- 98.

SOURCE Bayer HealthCare Pharmaceuticals; Onyx Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. New Analyses Confirm Nexavars Efficacy and Safety in Multiple Patient Subsets With Liver Cancer
2. Onyx Pharmaceuticals Announces a Teleconference and Webcast to Provide an Update on Nexavar; Previously Announced Fourth Quarter and Full Year 2007 Financial Results Teleconference Rescheduled
3. Career Step Approved to Train Military Spouses with Department of Defense CAA Funds
4. Takeda to Acquire IDM Pharma, Adding MEPACT(R) (Mifamurtide), the First Treatment Approved for Osteosarcoma in More Than 20 Years, to Its Oncology Franchise
5. IQAir HealthPro Plus Wins Parent Tested Parent Approved Seal of Approval Award
6. Nektar Announces UCBs Cimzia(R) Approved by U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis
7. UCBs CIMZIA(R) (certolizumab pegol) Approved by the U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis
8. MedClean Technologies, Inc. Approved in New Jersey
9. GADA Points to Safety of FDA Approved Generics in Wake of Wellington Polo Horse Deaths from Compounded Drugs
10. DRAXIMAGE(R)s generic Sestamibi Approved for launch in USA
11. New Botox(R) Alternative Dysport(TM) FDA Approved, Ready to Rumble
Post Your Comments:
(Date:11/26/2015)... ... November 26, 2015 , ... WorldCare ... participated in the 61st annual Employee Benefits Conference. The Employee Benefits Conference was ... November 8th through Wednesday, November 11th, 2015. The conference was held at the ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... has collaborated with Women’s Web – an online resource for Indian women ... mental and emotional well-being relationship, life balance, stress, professional development, and lifestyle. ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... more aggressive than those found on mammography, according to a study published online ... additional cancers not seen on mammography may necessitate a change in treatment. , ...
(Date:11/25/2015)... ... November 25, 2015 , ... The holiday season ... and pleasing the palates of attendees is of the utmost importance. Whether you ... seasonal get-together, give these recipes a try this holiday season. , Turkey Croquettes ...
(Date:11/25/2015)... ... November 25, 2015 , ... Medical Solutions, one ... for its stellar workplace culture with the company’s Cincinnati office being named a ... Cincinnati office was named a finalist in Cincinnati Business Courier’s 13th annual Greater ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... 2015 --> ... combineert immunotherapie met Bremachlorin-photodynamische therapie voor de ... ) --> ... ) Uit een ... (LUMC) blijkt dat ...
(Date:11/26/2015)... , November 26, 2015 ... addition of the "2016 Future Horizons ... of Abuse Testing Market: Supplier Shares, Country ... report to their offering. --> ... the "2016 Future Horizons and Growth ...
(Date:11/26/2015)... November 26, 2015 ... addition of the  "2016 Future Horizons ... Therapeutic Drug Monitoring (TDM) Market: Supplier ... Emerging Opportunities"  report to their offering.  ... announced the addition of the  "2016 ...
Breaking Medicine Technology: