ABII » Topics » Strategy

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

Strategy

Our goal is to become the leading fully integrated global biotechnology company focused on the discovery, development, marketing and sale of next-generation therapeutics for cancer and other critical illnesses, including multiple sclerosis and Alzheimer’s. The key elements of our strategy include:

 

 

 

Commercialize Abraxane® Globally. We have a dedicated sales and marketing team, comprised of approximately 180 sales, marketing and medical professionals and support staff members, who will continue to target key segments of the oncology markets, including leading oncologists, cancer centers and the oncology distribution channel. In April 2006, to accelerate the market penetration of Abraxane®, we entered into a co-promotion and strategic marketing services agreement with AstraZeneca UK Limited to co-promote Abraxane® in the United States. 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 addition, 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. 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 all, Abraxane® has received regulatory approval in 33 countries. We have filed for regulatory approval of Abraxane® in Australia, China, Japan, Korea and Russia. We plan to file for regulatory approval of Abraxane® for various indications in Taiwan and other countries. We plan to develop or acquire regulatory, sales and marketing expertise in each of our target jurisdictions.

 

 

 

Expand Indications for Abraxane®. 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. 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. We currently are seeking a strategic partner for the ongoing clinical development of Coroxane™ for various cardiovascular applications.

 

   

Develop our Clinical Pipeline. We intend to continue to leverage our nab™ tumor targeting technology and our internal clinical development and regulatory expertise to develop numerous product candidates for the treatment of cancer and other critical illnesses. The following product candidates have reached the clinical development phase: nab™-docetaxel (ABI-008), nab™-rapamycin (ABI-009) and nab™-17AAG (ABI-010), each for the treatment of solid tumors. In the second quarter of 2007, we initiated

 

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two of four planned Phase I/II trials with nab™-docetaxel. These two Phase I/II trials will evaluate the safety, tolerability and anti-tumor activity of nab™-docetaxel given every three weeks for the treatment of hormone refractory prostate cancer and metastatic breast cancer. We filed an investigational new drug application, or IND, for nab™-rapamycin in December 2006, and clinical studies for this product candidate began in the fourth quarter of 2007. We have confirmed with the FDA our clinical development plan for nab™-17AAG and intend to submit an IND for nab™-17AAG in the first half of 2008. We anticipate filing an IND for nab™-thiocolchine dimer (ABI-011), a novel chemical entity with anti-topoisomerase and tubulin activity, in 2008. An important strategy underway is the development of an informatics and electronic systems to streamline our clinical trial management processes, including establishing alliances to enhance patient accrual and provide efficient methods of data capture.

 

   

Develop our Discovery Pipeline. We have established a proprietary natural product library of broad chemical diversity for drug discovery. The library currently represents approximately 100,000 semi-purified screening samples derived from microorganisms retrieved from over 30,000 soil samples representing geographic, habitat and genetic diversity from all over the world. New strains of microorganisms are continuously being added from our soil sample collection, and we believe the millions of microorganisms in each soil sample provide us with an almost limitless resource for continuing to create new and targeted libraries of natural product chemical diversity for drug discovery. Natural products are an important component of our drug discovery strategy and, with the capability of overcoming water insolubility through the use of our nab™ technology, we believe we have the unique opportunity to translate water insoluble compounds discovered from our natural product library into clinical applications.

 

   

Pursue the Discovery and Development of Product Candidates Based on the Approach of Predictive, Personalized Evidence-Based Medicine. In recent years, research studies on a global scale have attempted to define subsets of biochemical markers that may be useful predictors of response to treatments (evaluated through clinical response, toxicity and time to disease progression) and prognostic markers which are equally as important in determining the aggressiveness of cancers as well as other diseases. The era of predictive, personalized evidence-based medicine has emerged, and a strategic focus for our company will be to identify compounds with specific activity linked to specific biological markers related to specific disease states. One of our goals is to combine prognostic markers with specific therapeutic agents, which would enable clinicians to tailor therapy to the molecular profile of the patient while minimizing life-threatening toxicities.

 

   

Pursue Proprietary Pharmaceutical Product Opportunities. We intend to acquire or license rights to proprietary pharmaceutical products in our focus therapeutic areas, allowing us to enhance our market presence and visibility. We intend to take advantage of our relationships and resources in the oncology area by entering into marketing and distribution collaborations with pharmaceutical companies that are developing proprietary products. We also intend to explore unique business expansion opportunities relating to our nab™ tumor targeting technology, including collaborative relationships to reformulate the products of others using our nab™ technology.

 

   

Complement Internal Growth with Strategic Acquisitions. We believe opportunities exist for us to enhance our competitive position by acquiring companies with complementary products and technologies. We also may invest in or acquire additional manufacturing capacity to meet projected demand for our future products.

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

Strategy

Our goal is to become the leading fully integrated global biotechnology company focused on the discovery, development, marketing and sale of next-generation therapeutics for cancer and other critical illnesses, including multiple sclerosis and Alzheimer’s. The key elements of our strategy include:

 

 

 

Commercialize Abraxane® Globally. We have a dedicated sales and marketing team, comprised of approximately 165 sales, marketing and medical sales and support staff members, who will continue to target key segments of the oncology markets, including leading oncologists, cancer centers and the oncology distribution channel. In April 2006, to accelerate the market penetration of Abraxane®, we entered into a co-promotion and strategic marketing services agreement with AstraZeneca UK Limited to co-promote Abraxane® in the United States. 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 addition, 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. We have filed for regulatory approval of Abraxane® in Australia, China, the European Union, Korea and Russia. 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. We plan to file for regulatory approval of Abraxane® for various indications in Japan and Taiwan, among other countries. We plan to develop or acquire regulatory, sales and marketing expertise in each of our target jurisdictions.

 

 

 

Expand Indications for Abraxane®. 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®. 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. Patient enrollment in the Phase III NSCLC trial will begin immediately, and the Phase III melanoma trial is expected to begin in the fourth quarter

 

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of 2007. We currently are seeking a strategic partner for the ongoing clinical development of Coroxane for various cardiovascular applications.

 

 

 

Develop our Clinical Pipeline. We intend to continue to leverage our nab tumor targeting technology and our internal clinical development and regulatory expertise to develop numerous product candidates for the treatment of cancer and other critical illnesses. The following product candidates have reached the clinical development phase: nab-docetaxel (ABI-008), nab-rapamycin (ABI-009) and nab-17AAG (ABI-010), each for the treatment of solid tumors. In the second quarter of 2007, we initiated two of four planned Phase I/II trials with nab-docetaxel. These two Phase I/II trials will evaluate the safety, tolerability and anti-tumor activity of nab-docetaxel given every three weeks for the treatment of hormone refractory prostate cancer and metastatic breast cancer. We filed an investigational new drug application, or IND, for nab-rapamycin in December 2006, and clinical studies for this product candidate are expected to begin in the fourth quarter of 2007. We have confirmed with the FDA our clinical development plan for nab-17AAG and intend to submit an IND for nab-17AAG in the fourth quarter of 2007. We anticipate filing an IND for nab-thiocolchine dimer (ABI-011), a novel chemical entity with anti-topoisomerase and tubulin activity, in 2008. An important strategy underway is the development of an informatics and electronic systems to streamline our clinical trial management processes, including establishing alliances to enhance patient accrual and provide efficient methods of data capture.

 

   

Develop our Discovery Pipeline. We have established a proprietary natural product library of broad chemical diversity for drug discovery. The library currently represents approximately 100,000 semi-purified screening samples derived from microorganisms retrieved from over 30,000 soil samples representing geographic, habitat and genetic diversity from all over the world. New strains of microorganisms are continuously being added from our soil sample collection, and we believe the millions of microorganisms in each soil sample provide us with an almost limitless resource for continuing to create new and targeted libraries of natural product chemical diversity for drug discovery. Natural products are an important component of our drug discovery strategy and, with the capability of overcoming water insolubility through the use of our nab™ technology, we believe we have the unique opportunity to translate water insoluble compounds discovered from our natural product library into clinical applications.

 

   

Pursue the Discovery and Development of Product Candidates Based on the Approach of Predictive, Personalized Evidence-Based Medicine. In recent years, research studies on a global scale have attempted to define subsets of biochemical markers that may be useful predictors of response to treatments (evaluated through clinical response, toxicity and time to disease progression) and prognostic markers which are equally as important in determining the aggressiveness of cancers as well as other diseases. The era of predictive, personalized evidence-based medicine has emerged, and a strategic focus for our company will be to identify compounds with specific activity linked to specific biological markers related to specific disease states. One of our goals is to combine prognostic markers with specific therapeutic agents, which would enable clinicians to tailor therapy to the molecular profile of the patient while minimizing life-threatening toxicities.

 

   

Pursue Proprietary Pharmaceutical Product Opportunities. We intend to acquire or license rights to proprietary pharmaceutical products in our focus therapeutic areas, allowing us to enhance our market presence and visibility. We intend to take advantage of our relationships and resources in the oncology area by entering into marketing and distribution collaborations with pharmaceutical companies that are developing proprietary products. We also intend to explore unique business expansion opportunities relating to our nab™ tumor targeting technology, including collaborative relationships to reformulate the products of others using our nab™ technology.

 

   

Complement Internal Growth with Strategic Acquisitions. We believe opportunities exist for us to enhance our competitive position by acquiring companies with complementary products and technologies. We also may invest in or acquire additional manufacturing capacity to meet projected demand for our future products.

 

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EXCERPTS ON THIS PAGE:

10-K
Mar 31, 2008
8-K
Nov 8, 2007
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