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These excerpts taken from the ABII 10-K filed Mar 12, 2010. Overview We are a Delaware corporation that was formed in June 2007. Our business was conducted as part of Old Abraxis prior to the separation. References in this Annual Report on Form 10-K to the historical assets, liabilities, products, businesses or activities of our company are generally intended to refer to the historical assets, liabilities, products, businesses or activities of the business as it was conducted as part of Old Abraxis prior to the separation. We are one of the few fully integrated biotechnology companies, with a breakthrough marketed product (Abraxane®), global ownership of our proprietary technology platform and clinical pipeline, and dedicated nanoparticle manufacturing capabilities for worldwide supply integrated with seasoned in-house capabilities, including discovery, clinical drug development, regulatory and sales and marketing. We are 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. Our portfolio includes the worlds first and only protein-based nanoparticle chemotherapeutic compound (Abraxane®), which is based on our proprietary tumor targeting technology known as the nab® technology platform. This nab® technology platform is the first to exploit the tumors biology against itself, taking advantage of an albumin-specific, receptor-mediated transport system and allowing the delivery of a drug from the vascular space across the blood vessel wall to the underlying tumor tissue. Abraxane® is the first clinical and commercial validation of our nab® technology platform. From the discovery and research phase to development and commercialization, we are committed to rapidly enhancing our product pipeline and accelerating the delivery of breakthrough therapies that will transform the lives of patients who need them. We own the worldwide rights to Abraxane®, a next-generation, nanometer-sized, solvent-free taxane that was approved by the U.S. Food and Drug Administration, or the FDA, in January 2005 for its initial indication in
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Table of Contentsthe treatment of metastatic breast cancer and launched in February 2005. We believe the successful launch of Abraxane® validates our nab® tumor targeting technology, a novel biologically interactive (receptor-mediated) system to deliver chemotherapeutic agents. Abraxane® revenue for the year ended December 31, 2009, 2008 and 2007 was $314.5 million, $335.6 million and $324.7 million, respectively, which in 2008 and 2007 included the recognition of deferred revenue related to our co-promotion agreement with AstraZeneca UK Limited. In January 2009, we re-acquired from AstraZeneca the exclusive rights to market Abraxane® in the United States, thereby ending the co-promotion agreement. Our research and development approach is based on the integration of our nab® tumor targeting technology, our natural product drug discovery platform, our multi-functional chemistry capabilities with our in-house clinical trial and regulatory strengths, combined with our unique nanoparticle manufacturing capabilities. Our product pipeline includes over five clinical oncology and cardiovascular product candidates in various stages of testing and development, including Abraxane® and Coroxane for various indications. We also have several discovery product candidates and novel chemical entities for various diseases, including cancer, multiple sclerosis and Alzheimers. We believe the application of our nab® technology will serve as the platform for the development of numerous drugs for the treatment of cancer and other critical illnesses. To leverage in-house manufacturing, clinical trial and regulatory expertise, we will continue to supplement our discovery efforts through technology acquisitions and external collaborations with academia and start-up biotechnology companies. 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 2009, Abraxane was approved for marketing in 39 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® in the U.S., which facilitates reimbursement from Medicare and Medicaid as well as private payors. OVERVIEW The following managements discussion and analysis of financial condition and results of operations, or MD&A is intended to assist the reader in understanding our company. The MD&A is provided as a supplement to, and should be read in conjunction with the other sections of this Annual Report on Form 10-K, including Item 1: Business; Item 1A: Risk Factors, Item 6: Selected Financial Data; and Item 8: Financial Statements and Supplemental Data. These excerpts taken from the ABII 10-Q filed May 8, 2009. OVERVIEW The following managements discussion and analysis of financial condition and results of operations, or MD&A, is intended to assist the reader in understanding our company. The MD&A is provided as a supplement to, and should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2008, including Item 1: Business; Item 1A: Risk Factors; Item 6: Selected Financial Data; and Item 8: Financial Statements and Supplementary Data. Overview The following table summarizes key elements of our financial position and sources and (uses) of cash and cash equivalents as follows:
These excerpts taken from the ABII 10-K filed Mar 6, 2009. Overview We are a Delaware corporation that was formed in June 2007. Our business was conducted as part of Old Abraxis prior to the separation. References in this Annual Report on Form 10-K to the historical assets, liabilities, products, businesses or activities of our company are generally intended to refer to the historical assets, liabilities, products, businesses or activities of the business as it was conducted as part of Old Abraxis prior to the separation. We are one of the few fully integrated biotechnology companies, with a breakthrough marketed product (Abraxane®), global ownership of our proprietary technology platform and clinical pipeline, dedicated nanoparticle manufacturing capabilities for worldwide supply integrated with seasoned in-house capabilities, including discovery, clinical drug development, regulatory and sales and marketing. We are 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. Our portfolio includes the worlds first and only protein-based nanoparticle chemotherapeutic compound (Abraxane®) which is based on our proprietary tumor targeting technology known as the nab® technology platform. This nab® technology platform is the first to exploit the tumors biology against itself, taking advantage of an albumin-specific, receptor-mediated transport system and allowing the delivery of a drug from the vascular space across the blood vessel wall to the underlying tumor tissue. Abraxane® is the first clinical and commercial validation of our nab® technology platform. From the discovery and research phase to development and commercialization, we are committed to rapidly enhancing our product pipeline and accelerating the delivery of breakthrough therapies that will transform the lives of patients who need them. We own the worldwide rights to Abraxane®, a next-generation, nanometer-sized, solvent-free taxane that was approved by the U.S. Food and Drug Administration, or the FDA, in January 2005 for its initial indication in the treatment of metastatic breast cancer and launched in February 2005. We believe the successful launch of Abraxane® validates our nab® tumor targeting technology, a novel biologically interactive (receptor-mediated) system to deliver chemotherapeutic agents in high concentrations preferentially to all tumors secreting a protein called SPARC, which attracts and binds to albumin. Abraxane® revenue for the year ended December 31, 2008 and 2007 was $ 335.6 million and $324.7 million, respectively, which included the recognition of previously deferred revenue related to our June 2006 co-promotion agreement with AstraZeneca UK Limited. In January 2009, we re-acquired from AstraZeneca the exclusive rights to market Abraxane® in the United States, thereby ending the co-promotion agreement.
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Table of ContentsOur research and development approach is based on the integration of our nab® tumor targeting technology, our natural product drug discovery platform, our multi-functional chemistry capabilities with our in-house clinical trial and regulatory strengths, combined with our unique nanoparticle manufacturing capabilities. Our product pipeline includes over five clinical oncology and cardiovascular product candidates in various stages of testing and development, including Abraxane® and Coroxane for various indications. We also have over 45 discovery product candidates and novel chemical entities for various diseases, including cancer, multiple sclerosis and Alzheimers. We believe the application of our nab® technology will serve as the platform for the development of numerous drugs for the treatment of cancer and other critical illnesses. To leverage in-house manufacturing, clinical trial and regulatory expertise, we will continue to supplement our discovery efforts through technology acquisitions and external collaborations with academia and start-up biotechnology companies. Overview STYLE="margin-top:6px;margin-bottom:0px; text-indent:4%">We are a Delaware corporation that was formed in June 2007. Our business was conducted as part of Old Abraxis prior to the separation. References in thisAnnual Report on Form 10-K to the historical assets, liabilities, products, businesses or activities of our company are generally intended to refer to the historical assets, liabilities, products, businesses or activities of the business as it was conducted as part of Old Abraxis prior to the separation. We are one of the few core technologies that offer patients safer and more effective treatments for cancer and other critical illnesses. Our portfolio includes the worlds first and only protein-based nanoparticle chemotherapeutic compound (AbraxaneFACE="Times New Roman" SIZE="1">®) which is based on our proprietary tumor targeting technology known as the nab® technology platform. This nabFACE="Times New Roman" SIZE="1">® technology platform is the first to exploit the tumors biology against itself, taking advantage of an albumin-specific, receptor-mediated transport system and allowing the delivery of a drug from the vascular space across the blood vessel wall to the underlying tumor tissue. Abraxane® is the first clinical and commercial validation of our nabFACE="Times New Roman" SIZE="1">® technology platform. From the discovery and research phase to development and commercialization, we are committed to rapidly enhancing our product pipeline and accelerating the delivery of breakthrough therapies that will transform the lives of patients who need them. We
5 Table of ContentsOur research and development approach is based on 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. Overview STYLE="margin-top:6px;margin-bottom:0px; text-indent:4%;padding-bottom:3px;line-height:95%; vertical-align:top">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 nabSIZE="1">® 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. OVERVIEW The following managements discussion and analysis of financial condition and results of operations, or MD&A is intended to assist the reader in understanding our company. The MD&A is provided as a supplement to, and should be read in conjunction with the other sections of this Annual Report on Form 10-K, including Item 1: Business; Item 1A: Risk Factors, Item 6: Selected Financial Data; and Item 8: Financial Statements and Supplemental Data. OVERVIEW SIZE="2">The following managements discussion and analysis of financial condition and results of operations, or MD&A is intended to assist the reader in understanding our company. The MD&A is provided as a supplement to, and should be Overview The following tables summarize key elements of our financial position and sources and (uses) of cash and cash equivalents for the three years ended December 31, 2008:
This excerpt taken from the ABII 10-Q filed Nov 14, 2008. Overview The following table summarizes key elements of our financial position and sources and (uses) of cash and cash equivalents as follows:
This excerpt taken from the ABII 10-Q filed Aug 14, 2008. Overview The following table summarizes key elements of our financial position and sources and (uses) of cash and cash equivalents as follows:
This excerpt taken from the ABII 10-Q filed May 15, 2008. Overview The following table summarizes key elements of our financial position and sources and (uses) of cash and cash equivalents as follows:
These excerpts taken from the ABII 10-K filed Mar 31, 2008. Overview The following table summarizes key elements of our financial position and sources and (uses) of cash and cash equivalents for the three years ended December 31, 2007:
Overview FACE="Times New Roman" SIZE="2">The following table summarizes key elements of our financial position and sources and (uses) of cash and cash equivalents for the three years ended December 31, 2007: STYLE="font-size:12px;margin-top:0px;margin-bottom:0px">
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