Abraxis BioScience (ABII)

Abraxane^®, A Proprietary Injectable Oncology Product

Overview

Abraxane^® is a next-generation, nanometer-sized, solvent-free taxane that was approved by the FDA in January 2005 for its initial indication in the treatment of metastatic breast cancer and launched in February 2005. As of December 2008, Abraxane was approved for marketing in 36 countries. Taxanes are one of the most widely used chemotherapy agents. We believe the successful launch of Abraxane^® validates our nab^® tumor targeting technology described below. Effective January 1, 2006, we received a unique reimbursement “J” code for Abraxane^®, which facilitates reimbursement from Medicare and Medicaid as well as private payors.

First clinical and commercial validation of our nab^® tumor targeting technology

Abraxane^® represents the first in a new class of protein-bound drug particles that takes advantage of albumin, a natural carrier of water insoluble molecules (e.g., various nutrients, vitamins and hormones) found in humans. Because tumors have an increased need for nutrients to support rapid malignant growth, albumin complexes accumulate preferentially in tumors. Recent molecular analyses have identified receptor-mediated pathways (gp60) facilitating active transport of albumin complexes from the blood into tissues and resulting in preferential accumulation in tumors by tumor-secreted proteins (SPARC), which attract albumin. Abraxane^® consists only of paclitaxel nanometer-sized albumin-bound particles and, in a pivotal 460 patient Phase III clinical trial, demonstrated an almost doubling of the response rate, a longer time to tumor progression in metastatic breast cancer as well as an increased survival in patients previously treated for metastatic disease when compared to Taxol^®. We believe that our nab^® tumor targeting technology and these albumin pathways allow more rapid delivery of paclitaxel to the cancer cells, with preferential accumulation while at the same time allowing less drug indiscriminately into normal, healthy cells. This is supported by the clinical findings demonstrated by Abraxane^®.

Overcoming the obstacles and toxicity of solvents

Many oncology drugs are water insoluble and thus require solvents to formulate the drugs for injection. Taxol^® and its generic solvent-based equivalents contain the active ingredient paclitaxel dissolved in the solvent Cremophor. The toxicity of Cremophor limits the dose of Taxol^® that can be administered, potentially limiting the efficacy of the drug. Furthermore, patients receiving Taxol^® require pre-medication with steroids and antihistamines to prevent the toxic side effects associated with Cremophor and, in some cases, require a growth factor such as G-CSF to overcome low white blood cell levels resulting from chemotherapy.

Abraxane^® utilizes our nab^® tumor targeting technology to encapsulate an amorphous form of paclitaxel in albumin, a human protein found in blood and avoids the need for Cremophor. Because it contains no Cremophor solvent, this next-generation taxane product enables the administration of 50% more chemotherapy with a well- tolerated safety profile, requires no routine premedication to prevent hypersensitivity reactions, can be given over a shorter infusion time using standard IV tubing and reduces the need for G-CSF support.

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Abraxane^® clinical development, label expansion and global commercialization plans

We will continue to pursue an aggressive and comprehensive clinical development plan to maximize the commercial potential and clinical knowledge of Abraxane^®. As of December 31, 2008, approximately 25 company-sponsored Abraxane^® clinical studies and approximately 62 investigator-initiated Abraxane^® clinical studies were planned or underway for various indications, of which more than 42 had patient participation. The investigator-initiated studies generally are intended to advance the clinical knowledge of Abraxane^® and support our clinical development program.

Results from five company-sponsored studies of Abraxane^® were presented at the 31st Annual San Antonio Breast Cancer Symposium in December 2008. Preliminary results from a single-arm, open-label, Phase II clinical trial evaluating Abraxane^® in combination with gemcitabine and epirubicin for the treatment of patients with locally advanced breast cancer (neoadjuvant treatment) indicated that 18 percent of patients (n=23) given a regimen of Abraxane^®, gemcitabine and epirubicin achieved a complete pathologic response (the disappearance of all target lesions), and 68 percent (n=84) achieved a partial response (a 30 percent or greater decrease in size of target lesions). The company also presented pre-clinical data evaluating the potential antitumor activity of nab^®-paclitaxel given in combination with two investigational therapies that utilize our proprietary nanoparticle technology, nab^®-rapamycin and nab^®-IDN5404.

We will continue to study the use of Abraxane^® in a variety of oncology settings and intend to focus our Phase III trials in first-line non-small cell lung cancer (NSCLC), melanoma and pancreatic cancer, all of which are expected to be superiority trials utilizing weekly dosing schedules of Abraxane^®. The Phase III NSCLC pivotal trial is a randomized, open-label trial comparing weekly 100 mg/m2 Abraxane^® (days 1, 8 and 15 of each cycle) and 200 mg/m2 Taxol^® (paclitaxel) injection every three weeks. Carboplatin will be administered at AUC=6 on day 1 of each cycle repeated every three weeks in both treatment arms. The study will enroll over 1,000 patients with Stage IIIb and IV non-small cell lung cancer. The primary endpoint of the study is overall response rate and the detection of meaningful differences in progression-free survival (PFS). Patient enrollment of this trial began in the fourth quarter of 2007 and is presently 60% enrolled. The Phase III melanoma trial is expected to begin in the first half of 2009. Based on encouraging Phase I/II clinical trial data of Abraxane^®in combination with gemcitabine in the treatment of metastatic pancreatic cancer, we filed with the FDA a Phase III randomized trial of Abraxane^®for use in both first and second line pancreatic cancer. A presentation of the Phase I/II study on use of Abraxane^®in treatment of pancreatic cancer was presented at the American Society of Clinical Oncology Annual Meeting in May 2008. We continue to expand our clinical experience with Abraxane^® and its potential in treating multiple tumor types as a single agent and in combination.

With regard to the global commercialization, Abraxane^® is presently approved in 36 countries worldwide. Subsequent to the FDA approval of Abraxane^® in the US in January 2005, Abraxis received regulatory approval from the Therapeutic Products Directorate of Health Canada to market Abraxane^® for the treatment of metastatic breast cancer in Canada in June 2006. In October 2007, Abraxis received regulatory approval from India’s Drug Controller General to market Abraxane^® for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. In January 2008, the European Commission granted marketing approval in 30 European countries (via the centralized procedure) for Abraxane^® in patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. In March 2008, we received regulatory approval with the Korean FDA to market Abraxane^® in South Korea for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease. In June 2008, we received regulatory approval with the State Food and Drug Administration of the People’s Republic of China to market Abraxane^® for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. In September 2008, we received regulatory approval from the Therapeutic Goods Administration, Australia to market Abraxane^® powder for injection (suspension) for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. We launched Abraxane^® in India (through our partner Biocon) in July 2008, in

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the United Arab Emirates with partner Neobiocon in October 2008, in the United Kingdom in December 2008, in Germany in February 2009 and in Australia in collaboration with Specialised Therapeutics Australia Pty Ltd. in February 2009. Additionally, in 2009, we expect to launch Abraxane^® in South Korea with partner Green Cross Corporation.

Marketing authorization applications have been submitted to several countries including Russia in June 2006, Japan in February 2008, and via the centralized procedure, in the Gulf Corporation Council countries (Saudi Arabia, Bahrain, Sultanate of Oman and Kuwait) in December 2008. In 2009, we further plan to submit marketing authorization applications for regulatory approval of Abraxane^® (for the metastatic breast cancer indication) in New Zealand, Bhutan, Sri Lanka, Brazil and Taiwan.

Abraxane^®, A Proprietary Injectable Oncology Product

Overview

Abraxane^® is a next-generation, nanometer-sized, solvent-free taxane that was approved by the FDA in January 2005 for its initial indication in the treatment of metastatic breast cancer and launched in February 2005. Taxanes are one of the most widely used chemotherapy agents. We believe the successful launch of Abraxane^®

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validates our nab™ tumor targeting technology described below. Effective January 1, 2006, we received a unique reimbursement “J” code for Abraxane^®, which facilitates reimbursement from Medicare and Medicaid as well as private payors.

First clinical and commercial validation of our nab™ tumor targeting technology

Abraxane^® represents the first in a new class of protein-bound taxane particles that takes advantage of albumin, a natural carrier of water insoluble molecules (e.g., various nutrients, vitamins and hormones) found in humans. Because tumors have an increased need for nutrients to support rapid malignant growth, albumin complexes accumulate preferentially in tumors. Recent molecular analyses have identified receptor-mediated pathways (gp60) facilitating active transport of albumin complexes from the blood into tissues and resulting in preferential accumulation in tumors by tumor-secreted proteins (SPARC), which attract albumin. Abraxane^® consists only of paclitaxel nanometer-sized albumin-bound particles and, in a pivotal 460 patient Phase III clinical trial, demonstrated an almost doubling of the response rate, a longer time to tumor progression in metastatic breast cancer as well as an increased survival in patients previously treated for metastatic disease when compared to Taxol^®. We believe that our nab™ tumor targeting technology and these albumin pathways allow more rapid delivery of paclitaxel to the cancer cells, with preferential accumulation while at the same time allowing less drug indiscriminately into normal, healthy cells. This is supported by the clinical findings demonstrated by Abraxane^®.

Overcoming the obstacles and toxicity of solvents

Many oncology drugs are water insoluble and thus require solvents to formulate the drugs for injection. Taxol^® contains the active ingredient paclitaxel dissolved in the solvent Cremophor. The toxicity of Cremophor limits the dose of Taxol^® that can be administered, potentially limiting the efficacy of the drug. Furthermore, patients receiving Taxol^® require pre-medication with steroids and antihistamines to prevent the toxic side effects associated with Cremophor and, in some cases, require a growth factor such as G-CSF to overcome low white blood cell levels resulting from chemotherapy.

Abraxane^® utilizes our nab™ tumor targeting technology to encapsulate an amorphous form of paclitaxel in albumin, a human protein found in blood and avoids the need for Cremophor. Because it contains no Cremophor solvent, this next-generation taxane product enables the administration of 50% more chemotherapy with a well- tolerated safety profile, requires no routine premedication to prevent hypersensitivity reactions, can be given over a shorter infusion time using standard IV tubing and reduces the need for G-CSF support.

Abraxane^® clinical development, label expansion and global commercialization plans

We will continue to pursue an aggressive and comprehensive clinical development plan to maximize the commercial potential and clinical knowledge of Abraxane^®. As of December 31, 2007, approximately 30 company-sponsored Abraxane^® clinical studies and approximately 90 investigator-initiated Abraxane^® clinical studies were planned or underway for various indications, of which more than 40 had patient participation. The investigator-initiated studies generally are intended to advance the clinical knowledge of Abraxane^® and support our clinical development program.

In June 2007, data was presented at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) updating results from an ongoing open-label, randomized head-to-head Phase II clinical trial comparing Abraxane^® and Taxotere^® in the first-line treatment of metastatic breast cancer. The updated analysis demonstrated that Abraxane^® administered weekly (150 mg/m2) and every three weeks (300 mg/m2) resulted in longer progression-free survival and an overall improved toxicity profile compared to Taxotere^® administered every three weeks (100 mg/m2). Abraxane^® administered weekly (100 mg/m2) resulted in comparable progression-free survival and significantly less toxicity compared to the Taxotere^® arm. Results from a planned independent radiology review were also presented, which demonstrated a strong correlation between investigator

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findings for response rate and progression-free survival and assessments made by independent radiology review. Radiologists were blinded to treatment assignment, investigator assessment of response, and target lesions selected by the investigator. Based on these data, we plan to initiate a global multi-center head-to-head Phase III registration trial comparing Abraxane^® at the 150 mg/m2 dose administered weekly to Taxotere^® at the 100 mg/m2 dose administered every three weeks for the first-line treatment of metastatic breast cancer. The trial is planned to begin in the second half of 2008 and will take place in multiple sites throughout North America, Eastern and Western Europe and Asia-Pacific.

We will continue to study the use of Abraxane^® in a variety of oncology settings and intend to focus our Phase III trials in first-line metastatic breast cancer, first-line non-small cell lung cancer (NSCLC) and melanoma, all of which are expected to be superiority trials utilizing weekly dosing schedules of Abraxane^®. Special Protocol Assessments (SPA) for the design of the NSCLC and melanoma Phase III trials were submitted to the FDA in the first quarter of 2007. In October 2007, we reached a definitive agreement with the FDA under the SPA process regarding the design of the Phase III NSCLC trial. In the agreement, the FDA determined that the design and planned analysis of the study addresses the objectives necessary to support a regulatory submission. The Phase III pivotal trial is a randomized, open-label trial comparing weekly 100 mg/m2 Abraxane^® (days 1, 8 and 15 of each cycle) and 200 mg/m2 Taxol^® (paclitaxel) injection every three weeks. Carboplatin will be administered at AUC=6 on day 1 of each cycle repeated every three weeks in both treatment arms. The study will enroll approximately 1,000 patients with Stage IIIb and IV non-small cell lung cancer. The primary endpoint of the study is overall response rate, and patient enrollment of this trial began in the fourth quarter of 2007. The Phase III melanoma trial is expected to begin in the second half of 2008. Based on encouraging Phase I clinical trial data of ABRAXANE in the treatment of metastatic pancreatic cancer, the company plans to initiate two randomized Phase III trials of ABRAXANE for use in both first and second line pancreatic cancer. A presentation of the Phase I study on use of ABRAXANE in treatment of pancreatic cancer has been accepted by the American Society of Clinical Oncology (ASCO) at the ASCO conference in May 2008. We also continue to expand our clinical experience with Abraxane^® and its potential in treating multiple tumor types as a single agent and in combination.

With regard to the global commercialization of Abraxane^®, in June 2006, we received regulatory approval from the Therapeutic Products Directorate of Health Canada to market Abraxane^® for the treatment of metastatic breast cancer in Canada. In June 2006, we submitted our application to market Abraxane^® in Russia for the treatment of breast, non-small cell lung and ovarian cancers. In January 2007, the Therapeutic Goods Administration (TGA) in Australia accepted for review our marketing application to use Abraxane^® for the treatment of metastatic breast cancer. In July 2007, we filed for regulatory approval with the State Food and Drug Administration of the People’s Republic of China to market Abraxane^® for the treatment of metastatic breast cancer in China. In October 2007, we received regulatory approval from India’s Drug Controller General to market Abraxane^® for the treatment of metastatic breast cancer in India. Commercial introduction of Abraxane^® in the Indian market is expected in 2008 following completion of the appropriate importation certifications. In August 2007, we filed for regulatory approval with the Korean FDA to market Abraxane^® for the treatment of metastatic breast cancer in Korea. In January 2008, the European Commission granted marketing approval for Abraxane^® for the treatment of metastatic breast cancer in women who have failed therapy in the first-line setting. In the first quarter of 2008, our partner, Taiho Pharmaceutical Co., Ltd., filed a Japanese New Drug Application (J-NDA) with the Ministry of Health, Labour and Welfare to market Abraxane^® for the treatment of breast cancer in Japan. We plan to file for regulatory approval of Abraxane^® for various indications in Taiwan and other countries.

Abraxane^®, A Proprietary Injectable Oncology Product

Overview

Abraxane^® is a next-generation, nanometer-sized, solvent-free taxane that was approved by the FDA in January 2005 for its initial indication in the treatment of metastatic breast cancer and launched in February 2005. Taxanes are one of the most widely used chemotherapy agents. We believe the successful launch of Abraxane^® validates our nab^™ tumor targeting technology described below. Effective January 1, 2006, we received a unique reimbursement “J” code for Abraxane^®, which facilitates reimbursement from Medicare and Medicaid as well as private payors.

First clinical and commercial validation of our nab^™ tumor targeting technology

Abraxane^® represents the first in a new class of protein-bound taxane particles that takes advantage of albumin, a natural carrier of water insoluble molecules (e.g., various nutrients, vitamins and hormones) found in humans. Because tumors have an increased need for nutrients to support rapid malignant growth, albumin complexes accumulate preferentially in tumors. Recent molecular analyses have identified receptor-mediated pathways (gp60) facilitating active transport of albumin complexes from the blood into tissues and resulting in preferential accumulation in tumors by tumor-secreted proteins (SPARC), which attract albumin. Abraxane^® consists only of paclitaxel nanometer-sized albumin-bound particles and, in a pivotal 460 patient Phase III clinical trial, demonstrated an almost doubling of the response rate, a longer time to tumor progression in metastatic breast cancer as well as an increased survival in patients previously treated for metastatic disease when compared to Taxol^®. We believe that our nab™ tumor targeting technology and these albumin pathways allow more rapid delivery of paclitaxel to the cancer cells, with preferential accumulation while at the same time allowing less drug indiscriminately into normal, healthy cells. This is supported by the clinical findings demonstrated by Abraxane^®.

Overcoming the obstacles and toxicity of solvents

Many oncology drugs are water insoluble and thus require solvents to formulate the drugs for injection. Taxol^® contains the active ingredient paclitaxel dissolved in the toxic solvent Cremophor. The toxicity of Cremophor limits the dose of Taxol^® that can be administered, potentially limiting the efficacy of the drug.

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Furthermore, patients receiving Taxol^® require pre-medication with steroids and antihistamines to prevent the toxic side effects associated with Cremophor and, in some cases, require a growth factor such as G-CSF to overcome low white blood cell levels resulting from chemotherapy.

Abraxane^® utilizes our nab^™ tumor targeting technology to encapsulate an amorphous form of paclitaxel in albumin, a human protein found in blood and avoids the need for Cremophor. Because it contains no Cremophor solvent, this next-generation taxane product enables the administration of 50% more chemotherapy with a well- tolerated safety profile, requires no routine premedication to prevent hypersensitivity reactions, can be given over a shorter infusion time using standard IV tubing and reduces the need for G-CSF support.

Abraxane^® clinical development, label expansion and global commercialization plans

We will continue to pursue an aggressive and comprehensive clinical development plan to maximize the commercial potential and clinical knowledge of Abraxane^®. As of June 30, 2007, approximately 20 company-sponsored Abraxane^® clinical studies and approximately 120 investigator-initiated Abraxane^® clinical studies were planned or underway for various indications, of which more than 40 had active patient enrollment. The investigator-initiated studies generally are intended to advance the clinical knowledge of Abraxane^®.

In June 2007, data was presented at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) updating results from an ongoing open-label, randomized head-to-head Phase II clinical trial comparing Abraxane^® and Taxotere^® in the first-line treatment of metastatic breast cancer. The updated analysis demonstrated that Abraxane^® administered weekly (150 mg/m2) and every three weeks (300 mg/m2) resulted in longer progression-free survival and an overall improved toxicity profile compared to Taxotere^® administered every three weeks (100 mg/m2). Abraxane^® administered weekly (100 mg/m2) resulted in comparable progression-free survival and significantly less toxicity compared to the Taxotere^® arm. Results from a planned independent radiology review were also presented, which demonstrated a strong correlation between investigator findings for response rate and progression-free survival and assessments made by independent radiology review. Radiologists were blinded to treatment assignment, investigator assessment of response, and target lesions selected by the investigator. Based on these data, we plan to initiate a global multi-center head-to-head Phase III registration trial comparing Abraxane^® at the 150 mg/m2 dose administered weekly to Taxotere^® at the 100 mg/m2 dose administered every three weeks for the first-line treatment of metastatic breast cancer. The trial is planned to begin in the fourth quarter of 2007 and will take place in multiple sites throughout North America, Eastern and Western Europe and Asia-Pacific.

We will continue to study the use of Abraxane^® in a variety of oncology settings and intend to focus our Phase III trials in first-line metastatic breast cancer, first-line non-small cell lung cancer (NSCLC) and melanoma, all of which are expected to be superiority trials utilizing weekly dosing schedules of Abraxane^®. Special Protocol Assessments (SPA) for the design of the NSCLC and melanoma Phase III trials were submitted to the FDA in the first quarter of 2007. In October 2007, we reached a definitive agreement with the FDA under the SPA process regarding the design of the Phase III NSCLC trial. In the agreement, the FDA determined that the design and planned analysis of the study addresses the objectives necessary to support a regulatory submission. The Phase III pivotal trial is a randomized, open-label trial comparing weekly 100 mg/m2 Abraxane^® (days 1, 8 and 15 of each cycle) and 200 mg/m2 Taxol^® (paclitaxel) injection every three weeks. Carboplatin will be administered at AUC=6 on day 1 of each cycle repeated every three weeks in both treatment arms. The study will enroll approximately 1,000 patients with Stage IIIb and IV non-small cell lung cancer. The primary endpoint of the study is overall response rate, and patient enrollment of this trial will begin immediately. The Phase III melanoma trial is expected to begin in the fourth quarter of 2007. We also continue to expand our clinical experience with Abraxane^® and its potential in treating multiple tumor types as a single agent and in combination.

With regard to the global commercialization of Abraxane^®, in June 2006, we received regulatory approval from the Therapeutic Products Directorate of Health Canada to market Abraxane^® for the treatment of metastatic breast cancer in Canada. In June 2006, we submitted our application to market Abraxane^® in Russia for the treatment of breast, non-small cell lung and ovarian cancers. In September 2006, the European Medicines

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Agency (EMEA) accepted for review our application for use of Abraxane^® in the treatment of breast cancer. In October 2007, we received a positive opinion from the European Committee for Human Medicinal Products (CHMP) in favor of approval of Abraxane^® for the treatment of metastatic breast cancer in women who have failed therapy in the first-line setting. The positive opinion from the CHMP is the final step before formal approval to market Abraxane^® in Europe. A formal decision by the European Commission on marketing authorization is expected within the next three to four months. In January 2007, the Therapeutic Goods Administration (TGA) in Australia accepted for review our marketing application to use Abraxane^® for the treatment of metastatic breast cancer. In July 2007, we filed for regulatory approval with the State Food and Drug Administration of the People’s Republic of China to market Abraxane^® for the treatment of metastatic breast cancer in China. In October 2007, we received regulatory approval from India’s Drug Controller General to market Abraxane^® for the treatment of metastatic breast cancer in India. Commercial introduction of Abraxane^® in the Indian market is expected in 2008 following completion of the appropriate importation certifications. In August 2007, we filed for regulatory approval with the Korean FDA to market Abraxane^® for the treatment of metastatic breast cancer in Korea. We plan to file for regulatory approval of Abraxane^® for various indications in Japan and Taiwan, among other countries.