Healthcare Industry News: Bristol Myers-Squibb
News Release - June 7, 2006
Abraxis BioScience Receives Approval in Canada for ABRAXANE to Treat Metastatic Breast Cancer Including First-Line DiseaseNewly Released Data From Pivotal Trial Demonstrate ABRAXANE Significantly Improves Progression-Free Survival and Time to Tumor Progression and Nearly Doubles the Response Rate Versus Taxol
LOS ANGELES & TORONTO--(HSMN NewsFeed)--June 7, 2006--Abraxis BioScience, Inc. (NASDAQ:ABBI ), an integrated, global biopharmaceutical company, today announced it has received approval for ABRAXANE(TM) for Injectable Suspension (paclitaxel powder for injectable suspension) (nanoparticle, albumin-bound (nab) paclitaxel) from the Therapeutic Products Directorate of Health Canada under a Notice of Compliance for the treatment of metastatic breast cancer in Canada. Canada is the first major commercial market to grant an approval for ABRAXANE that includes first-line treatment of metastatic breast cancer. The company, through its Canadian affiliate of Abraxis Oncology, anticipates launching ABRAXANE late in the third quarter of 2006.
Data from the pivotal head-to-head trial results demonstrated that ABRAXANE nearly doubled the overall target lesion response rate versus TaxolŽ and achieved a 37 percent improvement in progression-free survival when compared to Taxol. In addition, time to tumor progression versus Taxol was significantly prolonged in patients receiving ABRAXANE. ABRAXANE is the first and only protein bound particle chemotherapy, and unlike other taxane-based chemotherapies such as Taxol, does not used solvents to help deliver the medicine to tumors.
"I am very pleased that this approval of ABRAXANE includes first-line treatment for metastatic breast cancer. This approval allows doctors to offer their patients with metastatic breast cancer ABRAXANE earlier, providing them a chance to fight tumors more aggressively," said Patrick Soon-Shiong, M.D., chief executive officer and chairman of the board of Abraxis BioScience.
"I have seen promising results from my recent experience with ABRAXANE in clinical trials, and I'm heartened to hear that it has now been approved for use in Canada. The efficacy of ABRAXANE provides patients dealing with this life-threatening disease hope for better outcomes," said Dr. Andre Robidoux, M.D., and Professor of Surgery at the Hotel-Dieu Hospital in Montreal.
ABRAXANE was approved in the United States in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. ABRAXANE is currently in various stages of development for the treatment of the following cancers: first-line metastatic breast and non-small cell lung, adjuvant breast, neo-adjuvant breast, malignant melanoma, ovarian, prostate, pancreatic, gastric, and head and neck. Recent data presented at this year's American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated in a Phase 2 study that ABRAXANE administered weekly achieved a 50 percent response rate and an 86 percent disease control rate in patients with non-small cell lung cancer receiving the drug in combination with Carboplatin as first-line therapy. By comparison, previous clinical trial experience with solvent-based paclitaxel given weekly and standard carboplatin demonstrated a 32 percent response rate in a similar patient population. The grade three and four adverse events observed with ABRAXANE were neutropenia, thrombocytopenia and anemia.
The nanoparticle albumin-bound (nab) tumor-targeting technology developed by Abraxis exploits the natural properties of a human protein, albumin, for drug delivery. By wrapping albumin around active drug and creating particles of approximately 130 nanometers, Abraxis has found a way to eliminate the need for solvents and deliver higher concentrations of chemotherapy without the solvent-related toxicities compared with solvent-based taxanes.
Clinical Trial Results
This first-line approval for ABRAXANE is based on the results of data from the pivotal Phase III multicenter, randomized, comparative study of 460 women with metastatic breast cancer. This randomized trial was designed to compare ABRAXANE at a dose of 260 mg/m2 given as a 30-minute infusion without pre-medication versus paclitaxel injection (Taxol) at 175 mg/m2 given as a 3-hour infusion with standard steroid and antihistamine pre-medication. Of the patient population, 41 percent were first-line patients, and 59 percent received study drug as second or greater than second-line therapy. Seventy-seven percent of patients had been previously exposed to anthracyclines. Despite a 50 percent higher dose of chemotherapy infused over 30 minutes without pre-medication for hypersensitivity, ABRAXANE was well tolerated in the pivotal Phase III trial.
Patients in the ABRAXANE treatment arm had a superior investigator overall target lesion response rate of 33.2 percent, compared to 18.7 percent for patients in the paclitaxel injection treatment arm. Time to Tumor Progression (TTP) was significantly prolonged in the ABRAXANE group than in the paclitaxel injection group for all patients (23.0 vs. 16.6 weeks (5.3 vs. 3.8 months), (p=0.003)). Median Progression-Free Survival (PFS) was significantly longer for the ABRAXANE group than for the paclitaxel injection group for all patients (22.7 vs. 16.6 weeks (5.2 vs. 3.8 months), (p=0.002)). Survival for patients treated with ABRAXANE was prolonged by 10 weeks; median time to death for Abraxane and paclitaxel injection groups for all patients was 65.0 vs. 55.3 weeks (14.9 vs. 12.7 months) respectively.
Most patients taking ABRAXANE will experience side effects, although it is not always possible to tell whether such effects are caused by ABRAXANE, another medicine they may be taking, or the cancer itself. Important side effects are described below; however, some patients may experience other side effects that are less common. In the randomized metastatic breast cancer study, the most important adverse events included neutropenia (all cases 80%; severe 9%), anemia (all 33%; severe 1%), infections (24%), sensory neuropathy (any symptoms 71%; severe 10%), nausea (any 30%; severe 3%), vomiting (any 18%; severe 4%), diarrhea (any 26%; severe <1%), myalgia/arthralgia (any 44%; severe 8%), and mucositis (any 7%; severe <1%). Other adverse reactions included asthenia (any 47%; severe 8%), ocular/visual disturbances (any 13%; severe 1%), fluid retention (any 10%; severe 0%), alopecia (90%), hepatic dysfunction (elevations in bilirubin 7%, alkaline phosphatase 36%, AST (SGOT) 39%), and renal dysfunction (any 11%; severe 1%). Thrombocytopenia (any 2%; severe <1%), hypersensitivity reactions (any 4%; severe 0%), cardiovascular reactions (severe 3%), and injection site reactions (1%) were uncommon.
Canadian Market for ABRAXANEŽ
Breast cancer is the most common cancer among Canadian women, and in 2006, an estimated 22,300 will be diagnosed with breast cancer and 5,300 will die from the disease.
The U.S. Food and Drug Administration approved ABRAXANEŽ for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ABRAXANE, the first commercially approved product based on the nab(TM) technology platform, received approval by the U.S. Food and Drug Administration (FDA) in January 2005 for the treatment of breast cancer. For the full prescribing information for ABRAXANEŽ please visit www.abraxane.com.
About Abraxis BioScience, Inc.
Abraxis BioScience, Inc. is an integrated global biopharmaceutical company dedicated to meeting the needs of critically ill patients. The company develops, manufactures and markets one of the broadest portfolios of injectable products and leverages revolutionary technology such as its nab(TM) platform to discover and deliver breakthrough therapeutics that transform the treatment of cancer and other life-threatening diseases. The first FDA approved product to use this nab platform, ABRAXANEŽ, was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the Nasdaq National Market under the symbol ABBI. For more information about the company and its products, please visit www.abraxisbio.com.
The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include statements regarding our expected launch of ABRAXANE in Canada. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward- looking statements. These factors include, without limitation, the market adoption and demand of ABRAXANE in Canada, the costs associated with the ongoing launch of ABRAXANE, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, the ability to successfully manufacture products in a time-sensitive and cost effective manner, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in Abraxis BioScience's Form 10-K for the year ended December 31, 2005 and other documents it has filed with the Securities and Exchange Commission.
TaxolŽ is a registered trademark of Bristol Myers-Squibb Company.
Source: Abraxis BioScience
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