- First Agent Ever to Demonstrate Significant Survival Benefit in
Liver Cancer - CHICAGO, June 4 /PRNewswire-FirstCall/ -- Bayer
HealthCare Pharmaceuticals Inc. (NYSE:BAY) and Onyx
Pharmaceuticals, Inc. (NASDAQ:ONXX) today announced that Nexavar(R)
(sorafenib) tablets significantly extended overall survival in
patients with hepatocellular carcinoma (HCC), or primary liver
cancer versus those taking placebo by 44% (HR=0.69;
p-value=0.0006). Results were presented at the 43rd annual meeting
of the American Society of Clinical Oncology (ASCO). The
international, Phase 3, placebo-controlled Sorafenib HCC Assessment
Randomized Protocol (SHARP) Trial randomized and evaluated 602
liver cancer patients who had no prior systemic therapy at sites in
the Americas, Europe, and Australia/New Zealand. The primary
objective of the study was to compare overall survival in patients
administered Nexavar versus those administered placebo. Median
overall survival was 10.7 months in Nexavar-treated patients
compared to 7.9 months in those taking placebo. "Because there are
no therapies that significantly improve survival for the thousands
of patients with liver cancer, these findings demonstrate the
compelling study results of Nexavar as the new reference standard
of care for the first-line treatment of HCC," said Dr. Josep M.
Llovet, co-principal investigator and Professor of Research,
Barcelona Clinic Liver Cancer (BCLC) Group, IDIBAPS, Liver Unit,
Hospital Clinic Barcelona; Director of Research, HCC Program,
Associate Professor of Medicine, Mount Sinai School of Medicine,
New York. Bayer and Onyx halted the SHARP trial in February 2007
when an independent data monitoring committee determined in a
pre-scheduled analysis that the overall survival endpoint had been
met. There were no significant differences in serious adverse event
rates between the Nexavar and placebo-treated groups, with the most
commonly observed serious adverse events in patients receiving
Nexavar being diarrhea and hand-foot-skin reaction. Based on the
strength of the data, the companies are now in the process of
preparing applications to the U.S. Food and Drug Administration
(FDA) and European health authorities for a supplemental indication
for Nexavar in treatment of patients with liver cancer. "Although
much progress has been made in cancer research, the number of lives
lost to liver cancer is increasing," said Dr. Jordi Bruix,
co-principal investigator and Director of the Barcelona Clinic
Liver Cancer (BCLC) Group; Senior Consultant, Liver Unit, Hospital
Clinic of Barcelona. "For that reason, these results represent an
unprecedented achievement and Nexavar could become the first
widely-approved new therapy for this difficult to treat cancer."
Hepatocellular carcinoma is the most common form of liver cancer
and is responsible for about 90 percent of the primary malignant
liver tumors in adults.(1,2) It is the fifth most common cancer in
the world(3) and the third leading cause of cancer-related deaths
globally.(4) Over 600,000 new cases of HCC are diagnosed globally
each year(4) (19,000 in the United States(5) and 32,000 in the
European Union(6)), and in 2002 approximately 600,000 people (about
13,000 Americans and 57,000 Europeans) died of HCC.(7) Although
overall cancer incidence and mortality are decreasing in the United
States, both the incidence and mortality of liver cancer are
increasing.(8) Nexavar's Differentiated Mechanism Nexavar targets
both the tumor cell and tumor vasculature and is the only oral
multi-kinase inhibitor that does not require patients to interrupt
their treatment schedule. 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 the Raf/MEK/ERK pathway has a role in HCC;
therefore blocking signaling through Raf-1 may offer therapeutic
benefits in HCC. Nexavar is currently approved in more than 50
countries, including the United States and those in the European
Union, for the treatment of patients with advanced kidney cancer.
In Europe, Nexavar is approved for the treatment of patients with
advanced renal cell carcinoma (RCC) who have failed prior
interferon-alpha or interleukin-2 based therapy or are considered
unsuitable for such therapy. Nexavar is also being evaluated by the
companies, international study groups, government agencies and/or
individual investigators as a single agent or combination treatment
in a wide range of other cancers, including adjuvant therapy for
kidney cancer, metastatic melanoma, breast cancer and non-small
cell lung cancer (NSCLC). The Phase 3 ESCAPE (Evaluation of
sorafenib, carboplatin, and paclitaxel efficacy in NSCLC) trial
recently completed enrollment of more than 900 previously untreated
patients with NSCLC of all histologies. "HCC is the second tumor
type in which Nexavar has demonstrated a clinical benefit. We
intend to move swiftly with our partner Onyx to file these data for
health authority review," said Susan Kelley, MD, Vice President,
Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals. "Our
strategy of leveraging the unique attributes of Nexavar, the only
approved orally administered anti-angiogenic that targets the Raf
pathway, has led to a robust ongoing clinical program that could
bring the potent cancer fighting properties of this oral
multi-kinase inhibitor to an even broader number of patients in the
coming years." Important Safety Considerations for U.S. Patients
Taking Nexavar Based on the currently approved package insert for
the treatment of patients with advanced kidney cancer, 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. Incidence of bleeding regardless of causality
was 15% for Nexavar vs. 8% for placebo and the incidence of
treatment-emergent cardiac ischemia/infarction was 2.9% for Nexavar
vs. 0.4% for placebo. Most common treatment-emergent adverse events
with Nexavar were diarrhea, rash/desquamation, fatigue, hand-foot
skin reaction, alopecia, and nausea. Grade 3/4 adverse events were
38% for Nexavar vs. 28% 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 U.S. Nexavar
prescribing information, visit http://www.nexavar.com/ or call
1.866.NEXAVAR (1.866.639.2827). About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company
developing innovative therapies that target the molecular
mechanisms that cause cancer. The company is developing Nexavar(R),
a small molecule drug, with Bayer Pharmaceuticals Corporation.
Nexavar has been approved for the treatment of advanced kidney
cancer. For more information about Onyx's pipeline and activities,
visit the company's web site at: http://www.onyx-pharm.com/. About
Bayer HealthCare 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 United States,
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 Bayer Schering Pharma AG, Germany Bayer Schering Pharma is a
worldwide leading specialty pharmaceutical company. Its research
and business activities are focused on the following areas:
Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care,
Specialized Therapeutics and Women's Healthcare. With innovative
products, Bayer Schering Pharma aims for leading positions in
specialized markets worldwide. Using new ideas, Bayer Schering
Pharma aims to make a contribution to medical progress and strives
to improve quality of life. Forward Looking Statements This news
release contains forward-looking statements based on current
assumptions and forecasts made by Bayer Group 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 filed with the Frankfurt Stock Exchange and
with the U.S. Securities and Exchange Commission (including its
Form 20-F). Bayer 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 timing, progress and results of the
clinical development, regulatory processes, and commercialization
efforts 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,
2005, 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
Pharmaceuticals Corporation. References 1. World Health
Organization. Hepatitis B. Available at:
http://www.who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/.
Accessed April 10, 2007 2. Penn State Milton S. Hershey Medical
Center College of Medicine. Malignant Hepatoma. Available at:
http://www.hmc.psu.edu/healthinfo/m/malignanthepatoma.htm. Accessed
April 10, 2007. 3. World Health Organization. Estimates by WHO
Region: Incidence. Available at:
http://www.who.int/healthinfo/statistics/gbdwhoregionincidence2002.xls.
Accessed April 10, 2007. 4. International Agency for Cancer
Research. GLOBOCAN 2002. Available at: http://www/ dep.iarc.fr.
Accessed April 23, 2007. 5. Jemal A et al. CA Cancer J Clin.
2007;57:43-66. 6. International Agency for Cancer Research. EUCAN
1998. Available at: http://www-dep.iarc.fr/eucan/eucan.htm.
Accessed April 26, 2007. 7. Ferlay J, et al., GLOBOCAN 2002. Cancer
Incidence, Mortality and Prevalence Worldwide. IARC CancerBase
No.5, Version 2.0. IARCPress, Lyon, 2004. Available at:
http://www-dep.iarc.fr/. Accessed April 10, 2007. 8. Ries LAG,
Melbert D, Krapcho M, Mariotto A, Miller BA, Feuer EJ, Clegg L,
Horner MJ, Howlader N, Eisner MP, Reichman M, Edwards BK (eds).
SEER Cancer Statistics Review, 1975-2004, National Cancer
Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2004/,
based on November 2006 SEER data submission, posted to the SEER web
site, 2007. DATASOURCE: Bayer HealthCare Pharmaceuticals Inc.; Onyx
Pharmaceuticals, Inc. CONTACT: Mark Bennett Bayer HealthCare
Pharmaceuticals +1-203-314-5556, Julie Wood, Onyx Pharmaceuticals,
Inc., +1-510-597-6505, Jost Reinhard, Bayer Schering Pharma,
+49-30-468-15062, Alicia Samuels (media), GCI Group,
+1-914-720-4635, Geoff Curtis (media), WeissComm Partners,
+1-312-550-8138 Web site: http://www.nexavar.com/
http://www.onyx-pharm.com/
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