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Onyx names new CEO, Renton to step down as chairman
Tuesday February 26, 2:08 pm ET
Emeryville's Onyx Pharmaceuticals Inc. has tapped Dr. Anthony Coles as its new president and chief executive officer and a member of the board of directors, the company said Tuesday.
He will succeed Hollings Renton at Onyx (NASDAQ: ONXX - News). Renton announced his retirement plans last October. Renton had said he would remain as chairman, but the company said Tuesday he would retire on the same date.
Coles is the former chief executive and member of the board of directors of NPS Pharmaceuticals Inc., a biotechnology company in Bedminster, N.J.
Before that, he held management roles at several other East Coast pharmaceutical companies including Vertex Pharmaceuticals Inc., Bristol-Myers Squibb Co. and Merck & Co. Inc.
I would just stay away from ONXX, it could drop to Feb 2007 lows and can continue to fall for several weeks or until it gets to those lows.
surf
Onyx Pharmaceuticals Reports Fourth Quarter and Twelve-Month 2007 Financial Results
Tuesday February 19, 7:00 am ET
Annual Nexavar Net Sales Increased 125% to $372 million in 2007; Fourth Quarter Sales up 96% over same period last year
EMERYVILLE, Calif., Feb. 19 /PRNewswire-FirstCall/ -- Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today reported its financial results for the three and twelve months ended December 31, 2007. Onyx reported a net loss of $11.7 million, or $0.21 per share, for the fourth quarter of 2007 compared to a net loss of $20.7 million, or $0.47 per share, in the same period in the prior year. For the twelve months ended December 31, 2007, Onyx recorded a net loss of $34.2 million, or $0.67 per share, compared with a net loss of $92.7 million, or $2.20 per share, for the same period in 2006.
Nexavar net sales were $124.9 million for the quarter ended December 31, 2007, which represents a 96% increase over the $63.7 million reported in the same period in 2006 and a 19% increase over the $104.6 million reported in the quarter ended September 30, 2007. Nexavar net sales were $371.7 million in 2007, a 125% increase over the $165.0 million reported in 2006. Onyx, with its collaborator, Bayer HealthCare Pharmaceuticals Inc., or Bayer, is marketing and developing Nexavar® (sorafenib) tablets, an anticancer therapy currently approved for the treatment of advanced kidney cancer and liver cancer in the U.S., European Union, and other territories internationally. In accordance with Onyx's collaboration agreement with Bayer, Bayer recognizes all revenue from the sale of Nexavar.
"We are pleased with Nexavar's continued commercial growth, generating worldwide net sales of $124.9 million for the fourth quarter and $371.7 million for 2007," said Hollings C. Renton, president, chief executive officer, and chairman of Onyx. "The approvals of Nexavar in liver cancer and advanced kidney cancer reinforce our commitment to invest in Nexavar, both commercially and clinically, to maximize the full value of this proven anticancer agent."
The net loss for the quarter ended December 31, 2007, included employee stock-based compensation expense of $3.9 million, or $0.07 per share. The net loss for the quarter ended December 31, 2006, included employee stock-based compensation expense of $3.2 million, or $0.07 per share.
Net Expense due to (from) Unconsolidated Joint Business
Onyx reports the net expense due to (from) unconsolidated joint business for Nexavar as a single line item within the Statement of Operations. This item consists of Nexavar product revenue and the reimbursement of Onyx and Bayer for each company's shared expenses under the collaboration and is, in effect, the net amount due to or from Bayer to balance the companies' economics under the Nexavar collaboration. According to the terms of the collaboration, the companies share all research and development, marketing, and non-U.S. sales expenses. Onyx and Bayer each bears its own U.S. sales force and medical science liaison expenses. Bayer recognizes all revenue under the Nexavar collaboration and incurs the majority of expenses relating to the development and marketing of Nexavar. The calculation of the net expense due to (from) unconsolidated joint business is shown in the table following the Condensed Statement of Operations. In the fourth quarter of 2007, Onyx reported a net amount due from Bayer of $4.4 million compared to a net amount due to Bayer of $3.8 million for the fourth quarter of 2006. This change was primarily due to an increase in Nexavar revenue recognized by Bayer partially offset by an increase in the combined commercial and research and development expenses for Nexavar.
Operating Expenses
In the fourth quarter of 2007, Onyx recorded research and development expenses of $5.5 million, a decrease of $1.3 million compared to the fourth quarter of 2006. The decrease in expenses incurred in the fourth quarter of 2007 was primarily due to a reduction in study costs associated with the melanoma program offset by higher costs incurred for the breast cancer program. Research and development expenses included $0.9 million of employee stock-based compensation for the fourth quarter of 2007 and $0.5 million for the fourth quarter of 2006.
In the fourth quarter of 2007, selling, general and administrative expenses were $16.4 million, an increase of $3.3 million as compared to the fourth quarter of 2006. The increase in selling, general and administrative expenses was primarily related to a planned increase in personnel in the commercial and administrative functions to support Nexavar. Selling, general and administrative expenses included $3.0 million of employee stock-based compensation for the fourth quarter of 2007 and $2.7 million for the fourth quarter of 2006.
Cash, Cash Equivalents and Marketable Securities
As of December 31, 2007, the company had cash, cash equivalents, and short and long-term marketable securities of $469.7 million compared to $271.4 million at December 31, 2006. This increase was primarily due to net proceeds from financing activities offset by cash used in operations for the twelve months ended December 31, 2007.
Conference Call with Management Today
Onyx's management will host a teleconference and web cast to provide an update on Nexavar and discuss fourth quarter and full year 2007 financial results. The event will begin at 10:00 a.m. Eastern Time (7:00 a.m. Pacific Time) on February 19, 2008. Interested parties may access a live web cast of the presentation on our website at:
Bayer stops late-stage Nexavar trial
Monday February 18, 11:04 am ET
(Reuters) - Bayer HealthCare, a U.S.-based unit of Bayer AG (XETRA:BAYG.DE - News), stopped a late-stage trial of Nexavar in patients with non-small cell lung cancer, after an independent data monitoring committee concluded that the study would not meet the main goal of improved overall survival.
In the late-stage study, patients received Nexavar in combination with chemotherapeutic drugs carboplatin and paclitaxel.
Bayer said higher mortality was observed in a certain subset of patients treated with the combination of Nexavar and the chemotherapeutic drugs, versus those treated with carboplatin and paclitaxel alone.
Bayer and co-developer Onyx Pharmaceuticals Inc (NasdaqGM:ONXX - News) will review the findings of the analysis to determine what, if any, impact they have on other ongoing Nexavar lung cancer trials.
Nexavar, also known as sorafenib, is approved in the United States and Europe for kidney cancer and liver cancer. The companies are studying the drug for treatment of a broad range of cancers, including breast cancer.
Bayer AG shares were trading down more than 2 percent at 54.36 euros at 1559 GMT. Shares of its co-developer Onyx closed at $44.98 Friday on Nasdaq.
(Reporting by Jennifer Robin Raj in Bangalore; Editing by Himani Sarkar)
Nexavar shows promise in acute myeloid leukemia
Tue Jan 29, 2008 4:13pm EST
By Julie Steenhuysen
CHICAGO (Reuters) - The kidney cancer pill Nexavar has shown promise in treating a small number of people with a type of blood cancer known as acute myeloid leukemia or AML, U.S. researchers said on Tuesday.
They said the Bayer AG and Onyx Pharmaceuticals Inc drug Nexavar, also known as sorafenib, dramatically reduced the percentage of leukemia cells circulating in the blood of 16 people whose cancer is linked with a mutation of the FLT3 gene. This mutation occurs in about one third of all AML patients.
"AML patients with this mutation have a particularly poor prognosis, so this highly targeted drug appears to be a significant step forward in leukemia therapy," said Dr. Michael Andreeff of M.D. Anderson Cancer Center at the University of Texas.
AML is a type of cancer in which the bone marrow makes abnormal blood cells. It is the most common type of acute leukemia in adults.
The percentage of cancer cells circulating in the blood of patients in the study dropped to 7.5 percent, from 81 percent. In two patients, leukemia cells circulating in the blood dropped to zero, the researchers reported in the Journal of the National Cancer Institute.
People in the study had failed other treatments.
But Andreeff said in a statement the drug alone would not be able to defeat the disease, which attacks patients in several ways. He said Nexavar would need to be combined with other treatments.
So far, there have been no major side effects. Andreeff said the drug has little effect on AML patients who do not have the genetic defect. Continued...
http://www.reuters.com/article/marketsNews/idUKN2923470920080129?rpc=44
Huge growth ahead here........also like GERN and BTIM
Nexavar First FDA-Approved Drug Therapy for Liver Cancer
Monday November 19, 8:00 am ET
Only Systemic Therapy Proven to Significantly Improve Overall Survival in Patients with Liver Cancer
WAYNE, N.J. and EMERYVILLE, Calif., Nov. 19 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application for Nexavar® (sorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC), or liver cancer. Nexavar, an oral anticancer drug, is the first approved systemic therapy for liver cancer and the only one shown to significantly improve overall survival in patients with the disease. In 2005 Nexavar became the first new treatment in more than a decade for advanced kidney cancer, and is currently approved in more than 60 countries for this indication.
"The approval of Nexavar in liver cancer marks the second time in two years that this novel kinase inhibitor has been granted FDA approval on a Priority Review basis, making it rapidly available to patients who previously had limited treatment options," said Arthur Higgins, chairman of the Executive Committee of Bayer HealthCare. "This milestone will likely establish Nexavar as the standard systemic therapy for the treatment of liver cancer, and is a turning point in improving treatment outcomes in patients facing the devastating impact of this disease."
"Liver cancer is one of the cancers in which the number of related deaths continues to increase," said Hollings C. Renton, chairman, president and chief executive officer of Onyx Pharmaceuticals, Inc. "This second approval for Nexavar demonstrates our commitment to expediting the clinical development of this innovative therapy to treat today's unmet needs in cancer. We are grateful to the patients, families and investigators who make this important research possible."
HCC, the most common form of liver cancer, 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(3) (about 19,000 in the United States,(4) 54,000(5) in Europe,(6) and 390,000 in China, Korea and Japan(6)) and incidence is increasing.(7) In 2002 approximately 600,000 people died of liver cancer including 13,000 in the United States, 57,000(5) in Europe and approximately 360,000 in China, Korea and Japan.(6) Currently, the 5-year survival rate for liver cancer patients in the United States is 11 percent.(8)
"The American Liver Foundation (ALF) is always pleased when new therapies prove effective for those affected by liver disease. Researchers worldwide, including those supported by ALF, have spent decades studying liver cancer," said James L. Boyer, M.D., chairman, board of directors, American Liver Foundation. "This new treatment provides a valuable option for liver cancer patients and will enable ALF to further promote the treatment of liver disease through our education and advocacy efforts."
The companies also announced that an innovative patient support program - Resources for Expert Assistance and Care Helpline (REACH®) - is available to answer questions about Nexavar treatment, reimbursement, and patient support. For more information, healthcare providers and patients may contact the REACH program at 1.866.NEXAVAR (1.866.639.2827).
Phase 3 Data Summary
The FDA approval was based on positive data from the international Phase 3 placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial which demonstrated that Nexavar improved overall survival by 44 percent in patients with HCC (HR=0.69; p=0.0006) versus placebo. In the study, median overall survival was 10.7 months in Nexavar-treated patients compared to 7.9 months in those taking placebo. No indication of imbalances was observed in serious adverse events between the Nexavar and placebo-treated groups with the most commonly observed adverse events in patients receiving Nexavar being diarrhea and hand-foot skin reaction. Based on these data, the European Commission granted marketing authorization to Nexavar for the treatment of patients with hepatocellular carcinoma on October 29, 2007.
http://biz.yahoo.com/prnews/071119/nym050.html?.v=100
AP
Onyx Pharma Swings to 3Q Profit
Tuesday November 6, 6:26 pm ET
Onyx Pharmaceuticals Swings to 3rd-Quarter Profit As Loss From Operations Narrow
EMERYVILLE, Calif. (AP) -- Biotechnology company Onyx Pharmaceuticals Inc. Tuesday said it swung to a profit in the third quarter, as its loss from operations narrowed, and sales of its cancer drug Nexavar drug rose.
The company earned $555,000, or a penny per share, compared with a loss of $20.1 million, or 49 cents per share, in the same quarter a year ago.
The company didn't record revenue in the third quarter. Onyx's revenue totaled $100,000 in the year-ago quarter.
Analysts polled by Thomson Financial expected a loss of 21 cents per share, on revenue of $9.6 million.
Sales for Onyx's anticancer drug Nexavar more than doubled to $104.6 million for the quarter. Bayer Pharmaceuticals Inc. recognizes all revenue from the drug as part of a partnership agreement. Bayer markets and develops Nexavar, which is approved for the treatment of advanced kidney cancer in the U.S., European Union and other territories internationally.
In the third quarter, Onyx reported a net expense amount due from Bayer of $17.6 million, as part of its unconsolidated joint business for Nexavar. The two companies share the drug's expenses.
In the year-earlier period, Onyx owed Bayer a net amount of $3.6 million. Onyx said the change was primarily due to an increase in Nexavar revenue recognized by Bayer that was partially offset by higher combined commercial expenses for the drug.
Loss from operations declined to $5.5 million from $23 million in the third quarter of 2006.
Shares of Onyx rose $1.19, or 2.5 percent, to close at $49.35.
http://biz.yahoo.com/ap/071106/earns_onyx_pharmaceuticals.html?.v=1
AP
Onyx Pharma Shares Fall on Downgrade
Tuesday October 2, 1:16 pm ET
Onyx Pharma Shares Fall After Bear Stearns Downgrades Stock to 'Peer Perform' on Valuation
NEW YORK (AP) -- Shares of Onyx Pharmaceuticals Inc. declined Tuesday after a Bear Stearns analyst cut his rating on the biopharmaceutical company, saying share valuation is approaching his $45 price target.
Onyx develops and sells therapies to treat cancer. Its key product, Nexavar, is approved in over 50 countries for patients with advanced kidney cancer, and the company is seeking regulatory approval in the United States and Europe for hepatocellular carcinoma, or liver cancer.
In a note to clients, Bear Stearns analyst Akhtar Samad downgraded Onyx to "Peer Perform" from "Outperform," saying that although he expects solid off-label use of Nexavar in hepatocellular carcinoma through 2007 and a strong launch of the drug for that indication in 2008, he thinks short-term upside may be limited for new investors.
The analyst maintained his sales estimates for Nexavar.
Shares of Emeryville, Calif.-based Onyx fell $1.45, or 3.3 percent, to $42.46 in afternoon trading, on lower-than-average volume. The stock has ranged between $10.38 and $45.71 over the past year.
Nexavar Significantly Improved Overall Survival in Phase 3 Asia-Pacific Liver Cancer Trial
Trial to be Stopped Early to Allow All Patients Access to Nexavar
WAYNE, N.J. and EMERYVILLE, Calif., Aug. 27 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that a planned review by an independent data monitoring committee (DMC) found that Nexavar(R) (sorafenib) tablets significantly improved overall survival, progression free survival, and time to progression in an Asia-Pacific regional Phase 3 trial of patients with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. Based on the DMC's recommendation, the trial will be stopped to allow all patients to receive treatment with Nexavar. Data from this study will be submitted for presentation at an upcoming scientific meeting.
The Asia-Pacific liver cancer study was conducted at the request of Asian health authorities in order to provide supplemental information on Nexavar's efficacy and safety in Asia-Pacific patient populations. Supplemental regulatory filings have been completed in several countries/regions including Europe, China and the United States for Nexavar in the treatment of liver cancer. These filings were based on positive data from the pivotal Phase 3 SHARP study announced earlier this year. Additional regulatory submissions for Nexavar in liver cancer are being finalized.
'Liver cancer incidence continues to rise in the Asia-Pacific region, due to the high prevalence of hepatitis B virus infection,' said Dr. Ann-Lii Cheng, principal investigator and professor of medicine, National Taiwan University Hospital. 'These study results confirm that Nexavar's efficacy and tolerability in liver cancer extends across ethnic groups and geographies and suggest that Nexavar could meet a tremendous unmet need for patients and families impacted by this devastating disease.'
HCC, the most common form of liver cancer, 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) Over 600,000 cases of liver cancer are diagnosed globally each year.(3) In 2002, approximately 600,000 people died of liver cancer including approximately 360,000 in China, Korea and Japan, 57,000 in Europe and 13,000 in the United States.(4) Risk factors for liver cancer include ongoing (chronic) infection with hepatitis B virus (HBV) and/or hepatitis C virus (HCV).(5)
About the Asia-Pacific Liver Cancer Study
This double-blind, randomized, placebo-controlled Phase 3 trial was designed to evaluate Nexavar in patients with advanced HCC, or primary liver cancer, who had no prior systemic therapy. The study enrolled 226 patients from sites in China, Korea and Taiwan. The primary objectives of the study were to compare overall survival, time to progression (TTP) and progression free survival (PFS) in patients administered Nexavar 400 mg twice daily versus patients administered placebo.
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 50 countries, including the United States and those in the European Union, for the treatment of patients with advanced kidney cancer. Nexavar is also being evaluated by the companies, international study groups, government agencies or individual investigators as a single agent or combination treatment in a wide range of other cancers, including adjuvant therapy for kidney cancers, metastatic melanoma, breast cancer and non-small cell lung cancer (NSCLC). In addition, the companies recently confirmed that they are going to conduct a company-sponsored Phase 3 study of Nexavar in the adjuvant treatment of HCC following the complete removal of early stage liver cancer.
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 in patients with advanced kidney cancer 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.
ONXX has filed a BLA for liver cancer this A.M. based on a survival benefit:
http://biz.yahoo.com/prnews/070627/nyw038.html?.v=101
I find the lack of retail investor interest in ONXX puzzling.
Nexavar should get an average of almost $50,000 per patient for liver cancer in the U.S. There are an estimated 19,000 deaths per year in the U.S., over 30,000 deaths per year in Europe, over 40,000 deaths per year in Japan, and well over 300,000 deaths per year in Asia.
ONXX has about 55 million shares outstanding and a partnership with Bayer for Nexavar. ONXX splits U.S. profits 50/50, gets a lower profit percentage from the rest of the world ex-Japan but does not share in the expenses, and will receive a royalty from Japanese sales.
With Nexavar already on the market in the U.S. and Europe for kidney cancer, doctors are writing prescriptions for Nexavar for liver cancer right now.
ONXX filled the downside gap from Dec 06, hasn't filled the upside gap from Feb 07, so I would stay out of ONXX until lower prices.
I am taking profits on ONXX, but it is one to watch if it has any sell-off.
A few months ago it had a huge gap down and now a MASSIVE gap up, crazyyy. I like big dawgs like this that run so much bc even if it falls u can get out and not have to worry about it dropping 50% in 2 mins like most pennies that soar so high. GLUCK all
ONXX has good news out this morning & should run.
WEST HAVEN, Conn., and EMERYVILLE, Calif., Feb. 12 /PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation (NYSE: BAY - News) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today announced that an independent data monitoring committee (DMC) has reviewed the safety and efficacy data from the companies' pivotal Phase 3 trial in patients with advanced hepatocellular carcinoma (HCC), or primary liver cancer. Based on this planned interim analysis, the DMC has concluded that the trial met its primary endpoint resulting in superior overall survival (OS) in those patients receiving Nexavar® (sorafenib) tablets versus those patients receiving placebo. The DMC also noted that there was no demonstrated difference in serious adverse event rates between the two treatment arms (Nexavar and placebo). Based on these conclusions, the DMC recommended that the trial be stopped early.
As a result of this recommendation, Bayer and Onyx will stop the trial and allow all patients enrolled in this trial access to Nexavar. Given that there are limited approved systemic therapies for this disease, the companies will continue discussions with health authorities worldwide, including the U.S. Food and Drug Administration (FDA) and European health authorities regarding the next steps in filing for approval for the treatment of HCC. Following these discussions, the companies will proceed to file as rapidly as possible. The two companies also reported that they plan to submit the results from the trial to the American Society of Clinical Oncology (ASCO), for presentation at its annual meeting, June 1-5, 2007.
"The observed superiority in overall survival for Nexavar-treated patients over patients receiving placebo demonstrates the efficacy of Nexavar in advanced primary liver cancer," said Dr. Jordi Bruix, co-principal investigator and Head of the Barcelona Clinic Liver Cancer Group, Liver Unit, Hospital Clinic Barcelona, Spain.
Dr. Josep M. Llovet, co-principal investigator and Associate Professor of Medicine/Director, HCC Research Program, Division of Liver Diseases, Mount Sinai School of Medicine, New York, and Professor of Research at Barcelona Clinic Liver Cancer Group, Liver Unit, Hospital Clinic Barcelona added, "These results point to new potential treatment options for those patients suffering from this devastating disease."
WEST HAVEN, Conn., and EMERYVILLE, Calif., Feb. 12 /PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation (NYSE: BAY - News) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today announced that an independent data monitoring committee (DMC) has reviewed the safety and efficacy data from the companies' pivotal Phase 3 trial in patients with advanced hepatocellular carcinoma (HCC), or primary liver cancer. Based on this planned interim analysis, the DMC has concluded that the trial met its primary endpoint resulting in superior overall survival (OS) in those patients receiving Nexavar® (sorafenib) tablets versus those patients receiving placebo. The DMC also noted that there was no demonstrated difference in serious adverse event rates between the two treatment arms (Nexavar and placebo). Based on these conclusions, the DMC recommended that the trial be stopped early.
As a result of this recommendation, Bayer and Onyx will stop the trial and allow all patients enrolled in this trial access to Nexavar. Given that there are limited approved systemic therapies for this disease, the companies will continue discussions with health authorities worldwide, including the U.S. Food and Drug Administration (FDA) and European health authorities regarding the next steps in filing for approval for the treatment of HCC. Following these discussions, the companies will proceed to file as rapidly as possible. The two companies also reported that they plan to submit the results from the trial to the American Society of Clinical Oncology (ASCO), for presentation at its annual meeting, June 1-5, 2007.
"The observed superiority in overall survival for Nexavar-treated patients over patients receiving placebo demonstrates the efficacy of Nexavar in advanced primary liver cancer," said Dr. Jordi Bruix, co-principal investigator and Head of the Barcelona Clinic Liver Cancer Group, Liver Unit, Hospital Clinic Barcelona, Spain.
Dr. Josep M. Llovet, co-principal investigator and Associate Professor of Medicine/Director, HCC Research Program, Division of Liver Diseases, Mount Sinai School of Medicine, New York, and Professor of Research at Barcelona Clinic Liver Cancer Group, Liver Unit, Hospital Clinic Barcelona added, "These results point to new potential treatment options for those patients suffering from this devastating disease."
WEST HAVEN, Conn., and EMERYVILLE, Calif., Feb. 12 /PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation (NYSE: BAY - News) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today announced that an independent data monitoring committee (DMC) has reviewed the safety and efficacy data from the companies' pivotal Phase 3 trial in patients with advanced hepatocellular carcinoma (HCC), or primary liver cancer. Based on this planned interim analysis, the DMC has concluded that the trial met its primary endpoint resulting in superior overall survival (OS) in those patients receiving Nexavar® (sorafenib) tablets versus those patients receiving placebo. The DMC also noted that there was no demonstrated difference in serious adverse event rates between the two treatment arms (Nexavar and placebo). Based on these conclusions, the DMC recommended that the trial be stopped early.
As a result of this recommendation, Bayer and Onyx will stop the trial and allow all patients enrolled in this trial access to Nexavar. Given that there are limited approved systemic therapies for this disease, the companies will continue discussions with health authorities worldwide, including the U.S. Food and Drug Administration (FDA) and European health authorities regarding the next steps in filing for approval for the treatment of HCC. Following these discussions, the companies will proceed to file as rapidly as possible. The two companies also reported that they plan to submit the results from the trial to the American Society of Clinical Oncology (ASCO), for presentation at its annual meeting, June 1-5, 2007.
"The observed superiority in overall survival for Nexavar-treated patients over patients receiving placebo demonstrates the efficacy of Nexavar in advanced primary liver cancer," said Dr. Jordi Bruix, co-principal investigator and Head of the Barcelona Clinic Liver Cancer Group, Liver Unit, Hospital Clinic Barcelona, Spain.
Dr. Josep M. Llovet, co-principal investigator and Associate Professor of Medicine/Director, HCC Research Program, Division of Liver Diseases, Mount Sinai School of Medicine, New York, and Professor of Research at Barcelona Clinic Liver Cancer Group, Liver Unit, Hospital Clinic Barcelona added, "These results point to new potential treatment options for those patients suffering from this devastating disease."
About the SHARP Trial
This analysis was conducted using data from the Sorafenib HCC Assessment Randomized Protocol (SHARP) Trial, an international Phase 3 double-blind, randomized, placebo-controlled trial designed to evaluate Nexavar in patients with advanced HCC, or primary liver cancer, who had no prior systemic therapy. Six hundred and two patients were randomized and enrolled at sites in the Americas, Europe, and Australia/New Zealand. The primary objectives of the study are to compare OS and time to symptom progression (TTSP) in patients administered Nexavar versus those patients administered placebo.
About Hepatocellular Carcinoma
Hepatocellular carcinoma, also known as primary liver cancer, is the most common form of liver cancer and is responsible for about 90 percent of the primary malignant liver tumors in adults. It is the fifth most common cancer in the world.
About Nexavar
Nexavar is an oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature. In preclinical models, Nexavar targeted 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 nearly 50 countries, including the United States and in the European Union, for the treatment of patients with advanced kidney cancer. In addition, Nexavar is being evaluated by the companies, international study groups, government agencies or individual investigators as a single agent or combination treatment in a wide range of cancers, including adjuvant RCC, advanced liver cancer, metastatic melanoma, non-small cell lung cancer and breast cancer.
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.
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