Abraxis BioScience Presents Data at AACR Showcasing Proprietary Nab(R) Technology in the Treatment of Cancer and Its SPARC Biomarker

Newswise — Abraxis BioScience Inc. (NASDAQ: ABII) today announced that multiple studies showcasing its proprietary tumor targeting technology, known as the nab® (nanoparticle albumin-bound) technology platform, and secreted protein acidic and rich in cysteine (SPARC) biomarker will be presented at the American Association for Cancer Research (AACR) Annual Meeting in Denver, April 18-22, 2009. Abraxis BioScience will have a significant presence at this year's AACR meeting, presenting a total of 10 abstracts, including one oral presentation on preclinical studies for the company's leading product, ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), the biomarker SPARC and its development pipeline, including:

ABRAXANE (Nab-Paclitaxel) and SPARC"¢ Poster 1478: Mechanisms of Nab-Paclitaxel and Anti-VEGF Combination Therapy in the Inhibition of Breast Tumor Survival and Inflammatory Response"¢ Poster 2572: Detection of SPARC with mRNA with Q3 Deletion in Clinical Samples"¢ Poster 3769: Nab-Paclitaxel Results in Reduced Therapy-Related Fatigue in Mice as Compared to Cremophor-based Paclitaxel"¢ Poster 4017: Identification of the albumin binding domain and the angiogenic domain of SPARC"¢ Poster 5168: DNMT3a Mediates Promoter Hypermethylation of SPARC in Ovarian Cancer

Abraxis BioScience Pipeline"¢ Poster 136: CNS Safety, Antitumor Activity, and Anti-Angiogenic Activity of Nab-Rapamycin (ABI-009)"¢ Poster 4576: Potent Anti-tumor Effects of Nab-Rapamycin (ABI-009) in Combination with Kinase Inhibitors Erlotinib and Perifosine"¢ Poster 2927: Pharmacokinetic and Cardiovascular Safety Profile of ABI-011 in Cynomolgus Monkeys"¢ Poster 5571: Vascular Disrupting Activity of ABI-011"¢ Oral Presentation 5638: Sequence-dependent enhancement of antitumor activity of the vascular disrupting agent ABI-011 by Nab-Paclitaxel and Bevacizumab

Highlights From Poster No. 4017, Desai: Identification of the albumin binding domain and the angiogenic domain of SPARC One important study being presented examines the relationship between a tumor biomarker, SPARC, and tumor blood vessel growth and metastasis, also referred to as angiogenesis (Poster No. 4017, Desai: Identification of the albumin binding domain and the angiogenic domain of SPARC). These findings reinforce the role of Abraxis' novel chemotherapy agent ABRAXANE in increased anti-angiogenic and anti-tumor activity due to the unique albumin-bound delivery mechanism provided through the nab® technology platform.

"Preliminary clinical studies have suggested a direct correlation between elevated levels of SPARC and positive response to ABRAXANE," said Patrick Soon-Shiong, M.D., chairman and chief executive officer of Abraxis BioScience. "These new data improve our understanding of SPARC and further confirm the benefits of albumin-bound nab technology in enhancing delivery of chemotherapy."

The data support ABRAXANE's unique nab® technology, which exploits tumor biology to deliver more effective and targeted chemotherapy treatment. In normal tumor biology, SPARC secreted by the tumor would be used to recruit nutrients carried by naturally occurring albumin. This research further reinforces that with ABRAXANE's nab® technology, SPARC binds to the albumin-bound medicine; instead of delivering nutrients to the tumor, it delivers chemotherapy, killing cancer cells and halting tumor growth.

The study was designed to define the role of SPARC in fostering blood vessel growth and tumor invasiveness and characterize the protein's angiogenic and albumin binding-domains " the lock and key formations that allow albumin to bind to the SPARC protein. "¢ Using recombinant human SPARC (rhSPARC) grown in vitro, researchers determined that rhSPARC fostered the growth of new blood vessels (pro-angiogenesis) at physiological levels of SPARC found in cancer tumors."¢ The addition of rhSPARC also resulted in the development of more mature blood vessels well-supported by pericytes (smaller, supporting blood vessels wrapped around capillaries), suggesting that SPARC plays a greater role in the angiogenic process beyond initiating the growth of new blood vessels. "¢ Researchers determined that the protein's angiogenic domain was located on the carboxyl, or C-terminus, of the SPARC molecule."¢ The albumin binding domain was found to be localized to amino acids 209-223 of the SPARC molecule."¢ rhSPARC and albumin were found to bind sustainably at levels similar to the plasma concentration of albumin in the body.

"Abraxis' research on SPARC is part of our ongoing commitment to pursue scientific models that support giving the right treatment to the right patient at the right time," said Neil Desai, PhD, Senior Vice President, Global Research and Development. "This research further confirms that our nab technology platform provides a novel approach to cancer treatment through a unique delivery mechanism."

Additional data presented at the meeting included combination studies of the pipeline drugs ABI-009 (nab-rapamycin) and the vascular disruptive agent ABI-011 (nab-5404). ABI-009 is a signal transduction inhibitor that targets the mTOR pathway, which is critical to cell proliferation and survival. ABI-011 is an investigational agent designed to directly disrupt tumor vasculature to compromise tumor growth and progression. Both agents utilize Abraxis' proprietary nab delivery mechanism and are currently being studied for a wide range of solid tumor types.

About ABRAXANE® ABRAXANE is a solvent-free chemotherapy treatment option for metastatic breast cancer. Developed using Abraxis BioScience's proprietary nab® technology platform, ABRAXANE is a protein-bound chemotherapy agent, which combines paclitaxel with albumin, a naturally-occurring human protein. By wrapping the albumin around the active drug, ABRAXANE can be administered safely to patients at higher doses, delivering higher concentrations of the drug at the tumor site with greater efficacy.

With ABRAXANE, a solvent-free paclitaxel, patients do not require premedication before treatment to avoid solvent-related anaphylactic and allergic reactions enabling the use of higher concentrations of the drug at the tumor site with higher efficacy.

(Solvent-based paclitaxel contains the toxic solvent Cremophor, which is associated with significant treatment-related side effects such as severe hypersensitivity reactions, despite pretreatment with steroids and antihistamines. Solvent-based paclitaxel has a black box warning in its labeling which states, "Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving TAXOL in clinical trials. Fatal reactions have occurred in patients despite premedication." )

In a comparative Phase III clinical trial in patients with metastatic breast cancer, tumor response rate was nearly double for patients who received ABRAXANE, at a dose of 260 mg/m2 every three weeks, compared to those who received solvent-based paclitaxel (TAXOL®, Bristol-Myers Squibb) at a dose of 175 mg/m2, every three weeks). In addition, patients treated with ABRAXANE experienced a significant improvement in progression-free survival and prolonged time to tumor progression compared to patients treated with solvent-based paclitaxel. The most serious adverse events associated with ABRAXANE in the randomized metastatic breast cancer study on which the 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.

ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: expanded applications for 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.

BOXED WARNING: ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

ABRAXANE therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of less than 1,500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE.

Note: An albumin form of paclitaxel may substantially affect a drug's functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS.

IMPORTANT SAFETY INFORMATION The use of ABRAXANE has not been studied in patients with hepatic or renal dysfunction. In the randomized controlled trial, patients were excluded for baseline serum bilirubin >1.5 mg/dL or baseline serum creatinine >2 mg/dL.

ABRAXANE can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with ABRAXANE.

Men should be advised to not father a child while receiving treatment with ABRAXANE.

It is recommended that nursing be discontinued when receiving ABRAXANE therapy.

ABRAXANE contains albumin (human), a derivative of human blood.

Caution should be exercised when administering ABRAXANE concomitantly with known substrates or inhibitors of CYP2C8 and CYP3A4.

ABRAXANE therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of less than 1,500 cells/mm3. It is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE. Patients should not be retreated with subsequent cycles of ABRAXANE until neutrophils recover to a level >1,500 cells/mm3 and platelets recover to a level >100,000 cells/mm3In the case of severe neutropenia (<500 cells/mm3 for 7 days or more) during a course of ABRAXANE therapy, a dose reduction for subsequent courses is recommended.Sensory neuropathy occurs frequently with ABRAXANE.

If grade 3 sensory neuropathy develops, treatment should be withheld until resolution to grade 1 or 2 followed by a dose reduction for all subsequent courses of ABRAXANE.

Severe cardiovascular events possibly related to single-agent ABRAXANE occurred in approximately 3% of patients in the randomized trial. These events included chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary embolism, and hypertension.

In the randomized metastatic breast cancer study, the most important adverse events included alopecia (90%), neutropenia (all cases 80%; severe 9%), sensory neuropathy (any symptoms 71%; severe 10%), asthenia (any 47%; severe 8%), myalgia/arthralgia (any 44%; severe 8%), anemia (all 33%; severe 1%), infections (24%), nausea (any 30%; severe 3%), vomiting (any 18%; severe 4%), diarrhea (any 27%; severe <1%), and mucositis (any 7%; severe <1%).

Other adverse reactions have included ocular/visual disturbances (any 13%; severe 1%), fluid retention (any 10%; severe 0%), hepatic dysfunction (elevations in bilirubin 7%, alkaline phosphatase 36%, AST [SGOT] 39%), 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%). During postmarketing surveillance, rare occurrences of severe hypersensitivity reactions have been reported with ABRAXANE.

For full prescribing information and Boxed Warning for ABRAXANE, please visit www.abraxane.com.

About Abraxis BioScience 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 nab® platform. The first FDA approved product to use this nab platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the NASDAQ Global Market under the symbol ABII. For more information about the company and its products, please visit www.abraxisbio.com.