Interim Data from a Randomized, Head-to-Head Phase II Study Shows Weekly ABRAXANE Increased Tumor Response Rate by Greater Than 60 Percent versus Taxotere in First-Line Treatment of Metastatic Breast Cancer.

Abraxis to Initiate Worldwide Head-to-Head Phase III Registration Trial Comparing ABRAXANE versus Taxotere in First-Line Metastatic Breast Cancer

SAN ANTONIO -- Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global biopharmaceutical company, today presented data in an oral presentation at the 29th Annual San Antonio Breast Cancer Symposium (SABCS) from an interim analysis of a randomized, head-to-head Phase II trial of ABRAXANE([R]) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) versus Taxotere([R]) (docetaxel) Injection Concentrate, in the first-line treatment of metastatic breast cancer. The interim analysis showed that first-line treatment with weekly ABRAXANE (100 and 150 mg/m2) increased tumor response rate by greater than 60 percent with less toxicity versus Taxotere (100 mg/m2) given every three weeks in patients with metastatic breast cancer. The interim analysis also showed that weekly ABRAXANE nearly doubled the response rate with less toxicity compared to ABRAXANE (300 mg/m2) dosed every three weeks. Although the data are not fully mature, the interim analysis showed that all three ABRAXANE regimens currently have longer progression-free survivals than Taxotere dosed every three weeks. A blinded, independent radiological review of the response data is in process and the company intends to submit the final analysis of the data to the American Society of Clinical Oncology (ASCO) in 2007.

Based on these encouraging data, Abraxis plans to initiate a worldwide head-to-head Phase III registration trial comparing weekly ABRAXANE to every three week Taxotere for the treatment of first-line metastatic breast cancer. The Phase III registration trial is expected to begin in the first half of 2007 in multiple sites throughout North America, Eastern and Western Europe, and Asia-Pacific.

"These interim data show that weekly ABRAXANE, when used in the first-line treatment of patients with metastatic breast cancer, increased the response rate by over 60 percent with less toxicity than the FDA-approved dose of Taxotere given every three weeks," said William Gradishar, M.D., F.A.C.P, Director, Breast Medical Oncology at Robert H. Lurie Comprehensive Cancer Center Northwestern University, a lead investigator in the study. "These data are consistent with previous study results of both ABRAXANE and Taxotere, and are very encouraging for both physicians and patients."

"The high response rate to weekly ABRAXANE observed in this study is consistent with other data presented at this symposium by the NSABP Foundation Research Group and the International Oncology Network, and provides new insight into the clinical development of ABRAXANE," said Michael Hawkins, M.D., chief medical officer of Abraxis BioScience. "The Phase II results provide the direction needed to initiate a Phase III trial examining weekly ABRAXANE versus Taxotere in first-line treatment of metastatic breast cancer. We look forward to presenting the final analysis of this Phase II study next year."

About the Study

In the randomized Phase II study more than 300 patients with stage 4 metastatic breast cancer and no prior chemotherapy treatments received one of four treatment regimens: ABRAXANE 300 mg/m2 (n= 76) dosed every three weeks, ABRAXANE 100 mg/m2 (n= 76) or 150 mg/m2 (n= 74) dosed weekly for three weeks out of four, and Taxotere 100 mg/m2 (n= 76) dosed every three weeks. The purpose of the study was to obtain comparative toxicity and preliminary anti-tumor response data addressing three issues:

* ABRAXANE versus Taxotere;

* Weekly versus every three week dosing of ABRAXANE; and

* A high and low dose of ABRAXANE.

The secondary endpoint of the study was progression-free survival. Data from this trial were intended to provide direction for the design of future trials with ABRAXANE.

The prospectively planned interim analysis demonstrated that first-line treatment with ABRAXANE 100 or 150 mg/m2 weekly compared to Taxotere resulted in a statistically significant increase in response rates of 61 percent (58% vs. 36%, p=.004) and 72 percent (62% vs. 36%, p=.0016), respectively. Both weekly dose regimens of ABRAXANE also increased the response rate compared to every three week ABRAXANE (58% and 62% vs. 33%; p < 0.001). Although these data are not mature with only 33 percent of potential events having occurred, in the current analysis, all three ABRAXANE treatment arms have longer progression-free survivals compared to Taxotere (by log rank).

Compared to Taxotere, all three ABRAXANE treatment arms (300 mg/m2 q3w, 100 mg/m2 wkly, 150 mg/m2 wkly) demonstrated less frequent adverse events with regard to:

* Grade 4 Neutropenia (74% Taxotere vs. 4%, 3%, 7% ABRAXANE, respectively);

* Febrile neutropenia (7% Taxotere vs. 1%, 1%, 1% ABRAXANE, respectively); and

* Grade 1/2 Mucositis/stomatitis (20% Taxotere vs. 3%, 1%, 0% ABRAXANE, respectively).

There was no grade 4 peripheral neuropathy reported in any of the treatment arms. There were no statistical differences in peripheral neuropathy between the ABRAXANE regimens compared to Taxotere.

In this study, ABRAXANE (100 mg/m2 wkly) demonstrated a better therapeutic index as compared to the other two regimens of ABRAXANE and Taxotere, demonstrating a response rate of 58 percent versus 36 percent for Taxotere with improvement in the adverse event profile. There was no statistical difference in arthralgias between ABRAXANE 100 mg/m2 compared to Taxotere. Fatigue was significantly lower in ABRAXANE 100 mg/m2 compared to Taxotere (21% vs. 46%, p < 0.001). ABRAXANE 100 mg/m2 weekly compared to the other two ABRAXANE treatment arms (300 mg/ m2 q3w, 150 mg/m2 wkly) resulted in less peripheral neuropathy (37% vs. 51% and 47%, respectively), arthralgias (16% vs. 33% and 35%, respectively), and fatigue (21% vs. 33% and 39%, respectively). The only adverse event occurring at a greater frequency with ABRAXANE (300 mg/m2 q3w and 150 mg/m2 wkly) compared to Taxotere was arthralgia (33% and 35% vs. 16%, respectively, p en 0.03).

Other Data Presented on ABRAXANE

Neoadjuvant chemotherapy with sequential weekly nanoparticle albumin-bound paclitaxel (ABI-007, ABRAXANE) followed by 5-fluorouracil, epirubicin and cyclophosphamide (FEC) in locally advanced breast cancer (LABC): a phase II trial of the NSABP Foundation Research Group (Poster Number: 3068)

Single agent ABRAXANE given weekly (3/4) as first-line therapy for metastatic breast cancer (an International Oncology Network Study, #I-04-012) (Poster Number: 6073)

Conference Call Information

On Monday, December 18, 2006, the company will host a conference call with interested parties beginning at 11:00 a.m. ET/8:00 a.m. PT to discuss the data presented at the San Antonio Breast Cancer Symposium. The conference call may be heard through a live audio Internet broadcast at www.abraxisbio.com and www.earnings.com. For those unable to listen to the live broadcast, a playback of the webcast will be available at both websites for approximately six months beginning shortly after the conclusion of the call. In addition, the slides presented at the San Antonio Breast Cancer Symposium will be available at www.sabcs.org.

About Breast Cancer

According to the American Cancer Society, breast cancer is the most common cancer among women, other than skin cancer, and is the second leading cause of cancer death in women in the United States. The risk of having breast cancer for a woman sometime during her life is about one in eight. In 2006 alone, an estimated 213,000 new cases of breast cancer are expected to occur in women, and an estimated 41,000 women are expected to die from the disease.

About ABRAXANE([R])

The U.S. Food and Drug Administration approved ABRAXANE([R]) 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. 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([R]), please visit www.abraxane.com.

ABRAXANE was developed by Abraxis BioScience, Inc. ABRAXANE is marketed in the United States under a co-promotion agreement between Abraxis and AstraZeneca Pharmaceuticals LP.

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, ABRAXANE([R]), was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the NASDAQ Stock Market under the symbol ABBI. For more information about the company and its products, please visit www.abraxisbio.com.

FORWARD-LOOKING STATEMENT 

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, including statements regarding future clinical trials for ABRAXANE. 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 continued market adoption and demand of ABRAXANE in North America and its potential market penetration outside of the U.S., the costs associated with the ongoing launch of ABRAXANE, the success of our co-promotion agreement with AstraZeneca, 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, 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.

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.

Taxotere([R]) is a registered trademark of Sanofi Aventis.