ABII » Topics » Abraxane clinical development, label expansion and global commercialization plans

This excerpt taken from the ABII 10-K filed Mar 12, 2010.

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, 2009, approximately 24 company-sponsored Abraxane® clinical studies and approximately 61 investigator-initiated Abraxane® clinical studies were planned or underway for various indications, of which more than 44 had patient participation. The investigator-initiated studies generally are intended to advance the clinical knowledge of Abraxane® and complement the knowledge gained through our clinical development program.

Results from five company-supported studies of Abraxane® were presented at the 32nd Annual San Antonio Breast Cancer Symposium in December 2009. A pilot neoadjuvant trial evaluated the efficacy and safety of lapatinib combined with nab-paclitaxel in HER2-positive breast cancer patients. Response data was available for 29 patients: 82.8 percent of patients (n=24) achieved an overall response rate; 13.8 percent (n=4) experienced a complete response; 69 percent (n=20) experienced a partial response. Additionally, 17.2 percent (n=5) of patients experienced stable disease, and 5 out of 27 patients achieved a pathological complete response (pCR). The most common toxicities were rash, neuropathy, fatigue and myalgias. No cardiac toxicity was observed. Another study assessed the predictive value of Mammaprint scores (poor vs. good), as well as basal vs. luminal vs. HER2 genotype profiling, for response to treatment on three different neoadjuvant chemotherapy (NCT) regimens. Gene profiling indicated 28 percent of the tumors were HER2-like, 26 percent were basal-like, 42% luminal-like, and 4 percent borderline luminal-like. Results indicated that HER2-like and basal-like genotype breast cancer is more likely to respond to NCT and is associated with poor-risk characteristics as determined by the 70-gene assay. We also presented pre-clinical data evaluating the effectiveness of different combination regimens for nab-rapamycin against human breast tumor xenografts. Another pre-clinical study further explored the role of SPARC characterizing the identity of its albumin-binding and angiogenic domain. Health economic data was presented as well. The study was conducted to determine if differences exist in the total cost of care in patients receiving taxane-based chemotherapy for metastatic breast cancer (MBC). Additionally, a comparison between the taxanes - solvent-based paclitaxel (Taxol® and others); docetaxel (Taxotere®); and nab-paclitaxel (Abraxane®) - was performed on the use of ancillary medications (for neutropenia, anemia, and nausea and vomiting) and their associated costs. Costs per utilizing patient with MBC per month were calculated and compared. For patients with MBC, differences in total medical costs between the three taxanes were modest. Total medical costs were lowest for patients receiving solvent-based paclitaxel and comparable between docetaxel and nab-paclitaxel. Patients on nab-paclitaxel received more doses than the other taxanes. Nab-paclitaxel was associated with lower utilization and costs for colony stimulating factors compared with solvent-based paclitaxel and docetaxel. Additionally in November 2009, at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference in Boston, preclinical data was presented detailing the stromal targeting of the Abraxane-gemcitabine combination in pancreatic cancer.

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 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 is administered at AUC=6 on day 1 of each

 

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cycle repeated every three weeks in both treatment arms. The study has enrolled over 1,000 patients with Stage IIIb and IV non-small cell lung cancer. The primary endpoint of the study is overall response rate, while also being powered for statistically significant differences in progression-free survival (PFS) as a secondary endpoint. The Data Monitoring Committee (DMC) performed a pre-specified interim analysis on the first 400 patients and recommended that the trial proceed to completion with no changes to the protocol, treatment arms, or sample size. The Phase III melanoma trial comparing Abraxane to dacarbazine (DTIC) in patients with metastatic disease began enrolling patients in April 2009, and has a planned enrollment of 514 patients. Based on encouraging Phase I/II clinical trial data of Abraxane® in combination with gemcitabine in the treatment of metastatic pancreatic cancer, a Phase III registration study comparing Abraxane® plus gemcitabine versus gemcitabine monotherapy in metastatic pancreatic cancer was successfully filed with the FDA and began enrolling patients in May 2009. A total of 630 patients are expected to be enrolled in the study. Interim data for the Phase I/II study of Abraxane® plus gemcitabine in the treatment of metastatic pancreatic cancer was presented at the American Society of Clinical Oncology Annual Meeting in May 2009. 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 39 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 received approval to market Abraxane in Bhutan in April 2009 and in the United Arab Emirates in July 2009. We launched Abraxane® in India (through our partner Biocon) in July 2008, in 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, we are working towards launching 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 Sri Lanka and in Nepal in January 2009, and in New Zealand in June 2009.

These excerpts taken from the ABII 10-K filed Mar 6, 2009.

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®
clinical development, label expansion and global commercialization plans

SIZE="2">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 AbraxaneSIZE="1">® 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.

FACE="Times New Roman" SIZE="2">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, nabSIZE="1">®-rapamycin and nab®-IDN5404.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%;padding-bottom:3px;line-height:95%; vertical-align:top">We will continue to study the use of AbraxaneSIZE="1">® 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 AbraxaneSIZE="1">® (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.

SIZE="2">With regard to the global commercialization, Abraxane® is presently approved in 36 countries worldwide. Subsequent to the FDA approval of AbraxaneSIZE="1">® 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.

STYLE="margin-top:18px;margin-bottom:0px;padding-bottom:3px;line-height:95%; vertical-align:top">nab® Tumor Targeting
Technology Platform

We have identified a biological pathway specific to tumors
through which tumors preferentially accumulate albumin-bound complexes. This preferential accumulation of albumin appears to be facilitated through a tumor’s secretion of a protein called SPARC, which binds to and accumulates albumin. A body of
research has suggested that the secretion of SPARC occurs in most solid tumors that are difficult to treat, including in breast, lung, ovarian, head and neck, melanoma, gastric, esophageal, glioma and cervical tumors. Exploiting these tumors’
attraction for albumin, we have developed a novel mechanism to deliver chemotherapy agents in high concentrations preferentially to all tumors secreting SPARC. This is accomplished through our nabSIZE="1">® tumor targeting technology, which encapsulates chemotherapy agents in nanometer-sized particles of albumin that is approximately 1/100th the size of a single red blood cell. Millions of these particles can be
injected in a single dose of medication. This albumin-bound medication enters the bloodstream where it is transported across the blood vessel wall through a specific albumin receptor (gp60) on the blood vessel wall and targeted by SPARC secreted
from the tumor cell.

The following diagram depicts our nabFACE="Times New Roman" SIZE="1">® tumor targeting technology and the proposed mechanism by which high concentrations of chemotherapy agents are delivered preferentially to tumors through the biological gp60 receptor pathway
and through albumin binding to SPARC.



LOGO

In April 2007, at the 98th Annual Meeting of the
American Association for Cancer Research (AACR), we announced results from various pre-clinical studies that support the role of SPARC and our nab® tumor targeting

 


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technology. The results from one pre-clinical study demonstrated that SPARC is an albumin-binding protein and that the level of the SPARC expression could be
correlated with the response of tumors to Abraxane®. This provides concrete support for the earlier hypothesis that higher levels of SPARC protein may lead to enhanced anti-tumor effect of
Abraxane®. The pre-clinical study results also provided evidence for chemotherapy induced angiogenesis and a rationale for combining AbraxaneSIZE="1">® with VEGF inhibitor drugs like Avastin® . We continue to explore the role of our nab®
technology for targeting SPARC and other biological pathways, as well as for the development of new therapeutic candidates, including our clinical product candidates described below.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%;padding-bottom:3px;line-height:95%; vertical-align:top">We believe we can apply our nabSIZE="1">® tumor targeting technology to numerous chemotherapy agents. By exploiting the abnormal vascular growth (angiogenesis) and the overexpression of albumin-binding proteins (gp60 and SPARC) in advanced tumor cells
and by overcoming water insolubility of many active chemotherapy agents, we believe that our technology may revolutionize the delivery of chemotherapy agents to cancer patients. As shown below, AbraxaneSIZE="1">® represents the first clinical and commercial validation of our nab® technology 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.

STYLE="margin-top:12px;margin-bottom:0px" ALIGN="center">

LOGO

We believe that our nabSIZE="1">® tumor targeting technology will serve as the platform for the development of numerous other drugs for the treatment of cancer and other critical illnesses. We are committed to maximizing the potential application
of our technology.

 


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This excerpt taken from the ABII 10-K filed Mar 31, 2008.

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.

This excerpt taken from the ABII 8-K filed Nov 8, 2007.

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.

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