WAYNE, N.J., EMERYVILLE, Calif. and MELVILLE, N.Y., May 28
/PRNewswire-FirstCall/ -- Bayer HealthCare LLC., Onyx
Pharmaceuticals, Inc. (NASDAQ:ONXX), OSI Pharmaceuticals, Inc.
(NASDAQ:OSIP) and Roche today announced the initiation of a Phase 3
trial examining Nexavar(R) (sorafenib) tablets in combination with
Tarceva(R) (erlotinib) tablets as a potential new treatment option
for patients with advanced hepatocellular carcinoma (HCC), or
primary liver cancer. The SEARCH (Sorafenib and erlotinib, a
randomized trial protocol for the treatment of patients with
hepatocellular carcinoma) trial aims to further build on data from
the Phase 3 SHARP trial, which demonstrated that Nexavar
significantly extended overall survival in patients with
unresectable liver cancer by 44 percent (HR=0.69; p-value=0.0006).
Based on the strength of these data, Nexavar was approved for the
treatment of patients with unresectable HCC in the United States
and in Europe for the treatment of HCC. Nexavar is currently
approved in more than 70 countries for the treatment of HCC,
including China where more than half of all liver cancer cases
worldwide occur each year. "Nexavar is the only approved targeted
therapy with efficacy and tolerability in liver cancer," said
Dimitris Voliotis, MD, vice president, Nexavar Clinical
Development, Bayer HealthCare Pharmaceuticals. "We look forward to
seeing the potential of combining Nexavar with another effective
cancer treatment, Tarceva, in treating this disease and further
extending the lives of patients." "This study will enable us to
learn whether combining two oral targeted therapies, Nexavar and
Tarceva, can improve survival in a disease that is difficult to
treat since most patients are diagnosed at an advanced stage," said
Karsten Witt, M.D., Vice President, Clinical Development Oncology
and Drug Safety, OSI Pharmaceuticals. "We are pleased to
collaborate with Roche, Bayer and Onyx to explore Tarceva in
hepatocellular carcinoma, a new disease area which if successful,
has the potential to expand the use of Tarceva beyond its current
indications in second/third-line non-small cell lung cancer and
first-line pancreatic cancer." About the Phase 3 Study The
international multicenter randomized placebo-controlled Phase 3
study is expected to enroll approximately 700 patients with
advanced liver cancer. The study will examine whether Nexavar in
combination with Tarceva prolongs survival as compared to Nexavar
alone. The primary endpoint of the study is overall survival and
the secondary endpoints are safety, time to radiographic
progression, disease control rate and patient-reported outcome.
Patients will be randomized to receive either 400 mg of Nexavar
twice daily and 150 mg of Tarceva once daily or 400 mg of Nexavar
twice daily with matching placebo. The study will be conducted at
more than 95 sites in North America, Europe and the Asia-Pacific
region. For more information about enrolling in the study, please
visit http://www.clinicaltrials.gov/. About Hepatocellular
Carcinoma 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) Liver cancer is the sixth
most common cancer in the world and the third leading cause of
cancer-related deaths globally.(3) 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.(3,4) 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.(3) Nexavar's Differentiated Mechanism Nexavar, an oral
anti-cancer therapy, 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 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. Nexavar, which is
co-developed by Bayer Healthcare Pharmaceuticals and Onyx
Pharmaceuticals, Inc., is 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 other cancers, including breast cancer, lung cancer,
ovarian cancer, colorectal cancer, and as an adjuvant therapy for
kidney cancer 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 http://www.nexavar.com/ or call
1.866.NEXAVAR (1.866.639.2827). About Tarceva Tarceva is a
once-a-day pill that targets the EGFR pathway. Tarceva is designed
to inhibit the tyrosine kinase activity of the EGFR signaling
pathway inside the cell, one of the critical growth factors in
NSCLC and pancreatic cancers. Tarceva is indicated as a monotherapy
for patients with locally advanced or metastatic NSCLC whose
disease has progressed after one or more courses of chemotherapy.
Results from two multicenter, placebo-controlled, randomized Phase
3 trials conducted in first-line patients with locally advanced or
metastatic NSCLC showed no clinical benefit with the concurrent
administration of Tarceva with platinum-based chemotherapy
(carboplatin and paclitaxel or gemcitabine and cisplatin) and its
use is not recommended in that setting. In pancreatic cancer,
Tarceva is indicated in combination with gemcitabine for the
first-line treatment of patients with locally advanced pancreatic
cancer, pancreatic cancer that cannot be surgically removed or
pancreatic cancer that has spread to distant body organs. Important
Safety Information For Tarceva There have been infrequent reports
of serious Interstitial Lung Disease (ILD)-like events including
deaths in patients taking Tarceva. Serious side effects (including
deaths) in patients taking Tarceva include liver and/or kidney
problems; gastrointestinal (GI) perforations (the development of a
hole in the stomach, small intestine, or large intestine); and
severe blistering skin reactions including cases similar to
Stevens-Johnson syndrome. Patients taking Tarceva plus gemcitabine
were more likely to experience bleeding and clotting problems such
as heart attack or stroke. Eye irritation and damage to the cornea
have been reported in patients taking Tarceva. Women should avoid
becoming pregnant and avoid breastfeeding while taking Tarceva.
Patients should call their doctor right away if they have these
signs or symptoms: new or worsening skin rash; serious or ongoing
diarrhea, nausea, loss of appetite, vomiting, or stomach pain; new
or worsening shortness of breath or cough; fever; eye irritation.
Rash and diarrhea were the most common side effects associated with
Tarceva in the non-small cell lung cancer clinical study. Fatigue,
rash, nausea, loss of appetite, and diarrhea were the most common
side effects associated with Tarceva plus gemcitabine therapy in
the pancreatic cancer clinical study. For full prescribing
information, please call 1-877-TARCEVA or visit
http://www.tarceva.com/. 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
http://www.onyx-pharm.com/. About OSI Pharmaceuticals OSI
Pharmaceuticals is committed to "shaping medicine and changing
lives" by discovering, developing and commercializing high-quality,
novel and differentiated targeted medicines designed to extend life
and improve the quality of life for patients with cancer and
diabetes/obesity. For additional information about OSI, please
visit http://www.osip.com/. About Roche Headquartered in Basel,
Switzerland, Roche is a leader in research-focused healthcare with
combined strengths in pharmaceuticals and diagnostics. Roche is the
world's largest biotech company with truly differentiated medicines
in oncology, virology, inflammation, metabolism and CNS. Roche is
also the world leader in in-vitro diagnostics, tissue-based cancer
diagnostics and a pioneer in diabetes management. Roche's
personalised healthcare strategy aims at providing medicines and
diagnostic tools that enable tangible improvements in the health,
quality of life and survival of patients. Forward-Looking
Statements This 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 website at http://www.bayer.com/. 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 timing, progress and results of the
clinical development, safety, 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, 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. This news release also contains forward-looking statements of
OSI. These statements are subject to known and unknown risks and
uncertainties that may cause actual future experience and results
to differ materially from the statements made. Factors that might
cause such a difference include, among others, OSI's and its
collaborators' abilities to effectively market and sell Tarceva and
to expand the approved indications for Tarceva, OSI's ability to
protect its intellectual property rights, safety concerns regarding
Tarceva, competition to Tarceva and OSI's drug candidates from
other biotechnology and pharmaceutical companies, the completion of
clinical trials, the effects of FDA and other governmental
regulation, including pricing controls, OSI's ability to
successfully develop and commercialize drug candidates, and other
factors described in OSI Pharmaceuticals' filings with the
Securities and Exchange Commission (1) El-Serag HB, Mason AC.
Rising incidence of hepatocellular carcinoma in the United States.
N Engl J Med. 1999;340:745-750 (2) Available at American Society of
Clinical Oncology:
http://www.asco.org/patient/Cancer+Types/Liver+Cancer. (3) 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/. (4) 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.; OSI
Pharmaceuticals; Onyx CONTACT: David Freundel, Media Relations of
Bayer HealthCare, +1-973-305-5310; or Julie Wood, Investor
Relations, +1-510-597-6505, or Lori Murray, Media Relations,
+1-510-597-6394, both of Onyx Pharmaceuticals; or Kathy Galante,
Investors/Media, +1-631-962-2043, or Media, Kim Wittig,
+1-631-962-2135, both of OSI Pharmaceuticals Web Site:
http://www.osip.com/ http://www.clinicaltrials.gov/
http://www.nexavar.com/ http://www.onyx-pharm.com/
http://www.bayer.com/
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