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Abraxis Bioscience Establishes Global Leadership Team
Business Wire, Feb 7, 2008
"These executives will now be contributing to the growth of Abraxis in capacities beyond North America, as we commercialize ABRAXANE globally, expand indications for ABRAXANE and develop our clinical and drug discovery pipeline," said Dr. Soon-Shiong. "They are among the best in their respective fields and bring expertise and passion to their work. I look forward to working closely with this dedicated and highly capable team to realize our collective vision to establish Abraxis as a leading global biotechnology company."
Recently, Abraxis announced that the European Commission has granted marketing approval for ABRAXANE([R])powder for suspension for infusion (an albumin-bound nanoparticle formulation of paclitaxel) for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline-containing therapy is not indicated. The Phase III clinical trial results on which this approval was based demonstrated that ABRAXANE doubled the response rate and significantly prolonged progression-free survival and overall survival in the approved indication, and showed comparable tolerability versus Taxol([R]).
About ABRAXANE([R])
ABRAXANE, the first in a new class of protein-bound nanometer-sized drugs utilizing the company's proprietary nanoparticle albumin-bound (nab[TM]) technology, is currently in various stages of development for the treatment of the following cancers: first-line metastatic breast, non-small cell lung, malignant melanoma, pancreatic, gastric, and head and neck.
The U.S. Food and Drug Administration (FDA) approved ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in 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 was approved in Canada in 2006 for the treatment of metastatic breast cancer including first-line disease. The product is currently under active review in Australia, Russia, Korea and China by their respective regulatory agencies. ABRAXANE is the fastest growing taxane in its indication in the U.S. and is used in approximately 5,000 patients with metastatic breast cancer per month in North America.
ABRAXANE uses albumin, a human protein, to deliver the active ingredient paclitaxel. Unlike other chemotherapy treatments, ABRAXANE does not contain chemical solvents, which eliminates the need for pre-medication with steroids or antihistamines often needed to prevent the toxic side effects associated with solvents. ABRAXANE is administered in 30 minutes as compared to three hours for solvent-based paclitaxel.
The most serious adverse events associated with ABRAXANE in the randomized metastatic breast cancer study for which FDA approval was based included neutropenia, anemia, infections, sensory neuropathy, nausea, vomiting and myalgia/arthralgia. Other common adverse reactions included anemia, asthenia, diarrhea, ocular/visual disturbances, fluid retention, alopecia, hepatic dysfunction, mucositis and renal dysfunction. For the full prescribing information for ABRAXANE, please visit www.abraxane.com.
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