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Results from Five Company-Sponsored Studies Presented at the 31st Annual San Antonio Breast Cancer Symposium
Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, today announced that multiple studies of ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) will be presented at the 31st Annual San Antonio Breast Cancer Symposium on December 10-14, 2008. Data will be presented from a study highlighting the potential use of ABRAXANE (nab™-paclitaxel) in combination with other chemotherapy agents in the neoadjuvant treatment setting. The company also will present pre-clinical data evaluating the potential antitumor activity of nab-paclitaxel given in combination with two investigational therapies that utilize the company's proprietary nanoparticle technology, nab-rapamycin and nab-IDN5404.
ABRAXANE, a protein-bound chemotherapeutic agent, was developed by Abraxis BioScience and is marketed in the United States under a co-marketing and sales agreement between Abraxis and AstraZeneca Pharmaceuticals LP.
Interim data from a study that evaluates neoadjuvant treatment with nab-paclitaxel, gemcitabine and epirubicin in patients with locally advanced breast cancer will be presented as a poster on Saturday, December 13, from 5:00 p.m. - 7:00 p.m. The study, titled "Preliminary Progression Free Survival and SPARC Tumor Correlatives from a Phase II Neoadjuvant Trial of Gemcitabine, Epirubicin and nab-Paclitaxel" (Abstract 5116), assesses nab-paclitaxel (175 mg/m2) given in combination with gemcitabine (2,000 mg/m2) and epirubicin (50 mg/m2) once every two weeks for 12 weeks followed by surgery. After surgery, patients were given an additional four cycles of nab-paclitaxel (220 mg/m2) and gemcitabine (2,000 mg/m2) once every two weeks.
Results will also be presented from two pre-clinical studies evaluating the antitumor and antiangiogenic effects of nab-paclitaxel in combination with investigational targeted agents, including nab-rapamycin and nab-IDN5404. The poster presentation titles, times and locations include:
* Nanoparticle Albumin-Bound (nab) IDN5404: A Novel Vascular Disrupting Agent With Potent Antitumor and Antiangiogenic Effects (Abstract 2138)
Poster Presentation: Friday, December 12, 2008, 7:00 a.m. to 9:00 a.m., Exhibit Hall B
* Antitumor Activity and Antiangiogenic Activity of Nanoparticle Albumin-Bound (Nab)-Rapamycin in Combination with Nab-Paclitaxel (Abstract 3125)
Poster Presentation: Friday, December 12, 2008, 5:00 p.m. to 7:00 p.m., Exhibit Hall B
Abraxis also will present data from a separate pre-clinical study evaluating the mechanism underlying the stress response in tumor cells surviving chemotherapy. The study, titled "Mechanisms of Nab-Paclitaxel and Bevacizumab Cooperation in Inhibition of Breast Tumor Growth and Metastasis" (Abstract 1032), will be presented as a poster on Thursday, December 11, from 5:30 p.m. to 7:30 p.m. (Exhibit Hall B).
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 is a solvent-free chemotherapy treatment option for metastatic breast cancer. Developed using Abraxis BioScience's proprietary nabTM technology platform, ABRAXANE is a protein-bound chemotherapy agent, which combines paclitaxel with albumin, a naturally-occurring human protein.
ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: first-line metastatic breast, non-small cell lung, malignant melanoma, pancreatic, gastric, and head and neck.
Important Safety Information & Boxed Warning
WARNING: ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) should be given under the care of a doctor experienced with cancer therapy in a health care facility that is capable of managing possible complications.
ABRAXANE should not be given to patients who have dangerously low white blood counts because of the risk for serious infections. Frequent blood tests are used to check white blood cell count during therapy with ABRAXANE.
An albumin form of paclitaxel may behave differently in the body than other paclitaxel medications. ABRAXANE SHOULD NOT BE SUBSTITUTED FOR OR WITH OTHER PACLITAXEL FORMULATIONS. One of the more important side effects associated with chemotherapy is a decrease in the number of infection-fighting white blood cells (neutrophils) called "neutropenia." ABRAXANE should not be given to patients with dangerously low white blood cell counts because of the risk for serious infections. Your doctor will schedule blood tests to check your white blood cell count (absolute neutrophil count (ANC)) during therapy with ABRAXANE. Tell your doctor if you have a fever or notice any other signs of an infection.
Women should avoid becoming pregnant while being treated with ABRAXANE. Tell your doctor if you are pregnant, if you become pregnant, or you plan to become pregnant while taking ABRAXANE. Nursing a baby while taking ABRAXANE is not recommended because the drug may be present in breast milk. Men should be advised not to father a child while receiving treatment with ABRAXANE.
ABRAXANE contains albumin (human), a derivative of human blood.
The most important side effects have included hair loss, infections due to low white blood cell count, numbness, tingling or burning in the hands or feet, fatigue and weakness, low red blood cell count, mouth or lip sores, joint and muscle pain, stomach upset and diarrhea, heart and blood vessel (cardiovascular) effects and irritation at the injection site.
Numbness, tingling, or burning in the hands and feet (neuropathy) occurs with ABRAXANE and other paclitaxel medications. Be sure to tell your doctor if you experience these symptoms. Your doctor may interrupt treatment and restart at a lower dose after symptoms improve.
Other side effects have included blurred vision or eye irritation, fluid retention, liver and kidney dysfunction, low platelet counts, and allergic reactions (which in rare cases were severe). Tell your doctor about any side effects that bother you.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.35 billion dollar healthcare business with 12,200 employees committed to improving people's lives. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information, visit www.astrazeneca-us.com.
About Abraxis BioScience, Inc.
Abraxis BioScience is a fully integrated global biotechnology company dedicated to the discovery, development and delivery of next-generation therapeutics and core technologies that offer patients safer and more effective treatments for cancer and other critical illnesses. The company's portfolio includes the world's first and only protein-bound chemotherapeutic compound (ABRAXANE), which is based on the company's proprietary tumor targeting technology known as the nabTM platform. The first FDA approved product to use this nabTM platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the NASDAQ Global Market under the symbol ABII.
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 expectations, beliefs, hopes, goals, intentions, initiatives or strategies. 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, unexpected safety, efficacy or manufacturing issues with respect to ABRAXANE; the need for additional data or clinical studies for ABRAXANE; regulatory developments (domestic or foreign) involving the company’s manufacturing facilities; the market adoption and demand of ABRAXANE, the costs associated with the ongoing launch of ABRAXANE; the impact of pharmaceutical industry regulation; 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; and the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2007 and in other documents it has filed with the Securities and Exchange Commission.
The information contained in this press release is as of the date of this release. Abraxis assumes no obligations to update any forward-looking statements contained in this press release as the result of new information or future events or developments.
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