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ABII » Topics » We are highly dependent upon the strong market acceptance of Abraxane ® .

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

We are highly dependent upon the strong market acceptance of Abraxane®.

Our future profitability is highly dependent on the strong market acceptance of Abraxane®. For the years ended December 31, 2009, 2008 and 2007, total Abraxane® revenue was $314.5 million, $335.6 million and $324.7 million, respectively. Included in Abraxane revenue in each year for the years ended December 31, 2008 and 2007 was $36.4 million of recognized deferred revenue relating to the co-promotion agreement with AstraZeneca. The co-promotion agreement ended in January 2009. Because Abraxane® is our only approved product, Abraxane® revenue represented approximately 87.6%, 97.2% and 97.3% of our revenues for the year ended December 31, 2009, 2008 and 2007, respectively. We anticipate that sales of Abraxane® will remain a substantial portion of our total revenue over the next several years. However, a number of pharmaceutical companies are working to develop alternative formulations of paclitaxel and other cancer drugs and therapies, any of which may compete directly or indirectly with Abraxane® and which might adversely affect the commercial success of Abraxane®.

Abraxane® could lose market share or revenue due to numerous factors, many of which are beyond our control, including:

 

  •  

lower prices offered on similar products by other manufacturers, including generic forms of Taxol or other taxanes;

 

  •  

substitute or alternative products or therapies;

 

  •  

development by others of new pharmaceutical products or treatments that are more effective than Abraxane®;

 

  •  

introduction of other generic equivalents or products that may be therapeutically interchanged with Abraxane®;

 

  •  

interruptions in manufacturing or supply;

 

  •  

changes in the prescribing practices of physicians;

 

  •  

changes in third-party reimbursement practices; and

 

  •  

migration of key customers to other manufacturers or sellers.

In addition, we will continue to make a significant investment in Abraxane®, including costs associated with conducting clinical trials and obtaining necessary regulatory approvals for the use of Abraxane® in other

 

23

Table of Contents

indications and settings and in other jurisdictions, expansion of our marketing, sales and manufacturing staff, the acquisition of paclitaxel raw material, expansion of manufacturing facilities and the manufacture of finished product. The success of Abraxane® in the Phase III trial for metastatic breast cancer and other clinical trials may not be representative of future clinical trial results for Abraxane® with respect to other clinical indications. The results from clinical, pre-clinical studies and early clinical trials conducted to date may not be predictive of results to be obtained in later clinical trials, including those ongoing at present. Further, the commencement and completion of clinical trials may be delayed by many factors that are beyond our control, including:

 

  •  

slower than anticipated patient enrollment;

 

  •  

difficulty in finding and retaining patients fitting the trial profile or protocols; and

 

  •  

adverse events occurring during the clinical trials.

This excerpt taken from the ABII 10-Q filed May 8, 2009.

We are highly dependent upon the strong market acceptance of Abraxane®.

Our future profitability is highly dependent upon the strong market acceptance of Abraxane®. For the year ended December 31, 2008 and three months ended March 31, 2009 and 2008, total Abraxane® revenue was $335.6 million, $70.6 million and $79.9 million, respectively. Because Abraxane® is our only approved product, Abraxane® revenue represented approximately 97% of our revenues for the year ended December 31, 2008, and the three months ended March 31, 2009 and 2008. We anticipate that sales of Abraxane® will remain a substantial portion of our total revenue over the next several years. However, a number of pharmaceutical companies are working to develop alternative formulations of paclitaxel and other cancer drugs and therapies, any of which may compete directly or indirectly with Abraxane® and which might adversely affect the commercial success of Abraxane®.

Abraxane® could lose market share or revenue due to numerous factors, many of which are beyond our control, including:

 

  •  

lower prices offered on similar products by other manufacturers, including generic forms of Taxol;

 

  •  

substitute or alternative products or therapies;

 

 

•

  

development by others of new pharmaceutical products or treatments that are more effective than Abraxane®;

 

 

•

  

introduction of other generic equivalents or products which may be therapeutically interchanged with Abraxane®;

 

  •  

interruptions in manufacturing or supply;

 

  •  

changes in the prescribing practices of physicians;

 

  •  

changes in third-party reimbursement practices; and

 

  •  

migration of key customers to other manufacturers or sellers.

In addition, we will continue to make a significant investment in Abraxane®, including costs associated with conducting clinical trials and obtaining necessary regulatory approvals for the use of Abraxane® in other indications and settings and in other jurisdictions, expansion of our marketing, sales and manufacturing staff, the acquisition of paclitaxel raw material, expansion of manufacturing facilities and the manufacture of finished product. The success of Abraxane® in the Phase III trial for metastatic breast cancer and other clinical trials may not be representative of future clinical trial results for Abraxane® with respect to other clinical indications. The results from clinical, pre-clinical studies and early clinical trials conducted to date may not be predictive of results to be obtained in later clinical trials, including those ongoing at present. Further, the commencement and completion of clinical trials may be delayed by many factors that are beyond our control, including:

 

  •  

slower than anticipated patient enrollment;

 

  •  

difficulty in finding and retaining patients fitting the trial profile or protocols; and

 

  •  

adverse events occurring during the clinical trials.

 

20

Table of Contents
This excerpt taken from the ABII 10-K filed Mar 6, 2009.

We are highly dependent upon the strong market acceptance of Abraxane®.

Our future profitability is highly dependent on the strong market acceptance of Abraxane®. For the years ended December 31, 2008 and 2007, total Abraxane® revenue was $335.6 million and $324.7 million, respectively, in each case including $36.4 million of recognized deferred revenue relating to the co-promotion agreement with AstraZeneca. The co-promotion agreement ended in January 2009. Because Abraxane® is our only approved product, Abraxane® revenue represented approximately 97.2% and 97.3% of our revenues for the year ended December 31, 2008 and 2007, respectively. We anticipate that sales of Abraxane® will remain a substantial portion of our total revenue over the next several years. However, a number of pharmaceutical companies are working to develop alternative formulations of paclitaxel and other cancer drugs and therapies, any of which may compete directly or indirectly with Abraxane® and which might adversely affect the commercial success of Abraxane®.

Abraxane® could lose market share or revenue due to numerous factors, many of which are beyond our control, including:

 

  •  

lower prices offered on similar products by other manufacturers, including generic forms of Taxol;

 

  •  

substitute or alternative products or therapies;

 

 

•

  

development by others of new pharmaceutical products or treatments that are more effective than Abraxane®;

 

 

•

  

introduction of other generic equivalents or products which may be therapeutically interchanged with Abraxane®;

 

  •  

interruptions in manufacturing or supply;

 

  •  

changes in the prescribing practices of physicians;

 

  •  

changes in third-party reimbursement practices; and

 

  •  

migration of key customers to other manufacturers or sellers.

In addition, we will continue to make a significant investment in Abraxane®, including costs associated with conducting clinical trials and obtaining necessary regulatory approvals for the use of Abraxane® in other indications and settings and in other jurisdictions, expansion of our marketing, sales and manufacturing staff, the acquisition of paclitaxel raw material, expansion of manufacturing facilities and the manufacture of finished product. The success of Abraxane® in the Phase III trial for metastatic breast cancer and other clinical trials may

 

22

Table of Contents

not be representative of future clinical trial results for Abraxane® with respect to other clinical indications. The results from clinical, pre-clinical studies and early clinical trials conducted to date may not be predictive of results to be obtained in later clinical trials, including those ongoing at present. Further, the commencement and completion of clinical trials may be delayed by many factors that are beyond our control, including:

 

  •  

slower than anticipated patient enrollment;

 

  •  

difficulty in finding and retaining patients fitting the trial profile or protocols; and

 

  •  

adverse events occurring during the clinical trials.

This excerpt taken from the ABII 10-Q filed Nov 14, 2008.

We are highly dependent upon the strong market acceptance of Abraxane®.

Our future profitability is highly dependent upon the strong market acceptance of Abraxane®. For the nine months ended September 30, 2008 and the year ended December 31, 2007, total Abraxane® revenue was $245.8 million and $324.7 million, respectively, including $27.3 million and $36.4 million, respectively, of recognized deferred revenue relating to the co-promotion agreement with AstraZeneca. Because Abraxane® is our only approved product, Abraxane® revenue represented approximately 97% and 97% of our revenues for the nine months ended September 30, 2008 and year ended December 31, 2007, respectively. We anticipate that sales of Abraxane® will remain a substantial portion of our total revenue over the next several years. However, a number of pharmaceutical companies are working to develop alternative formulations of paclitaxel and other cancer drugs and therapies, any of which may compete directly or indirectly with Abraxane® and which might adversely affect the commercial success of Abraxane®.

Abraxane® could lose market share or revenue due to numerous factors, many of which are beyond our control, including:

 

  •  

lower prices offered on similar products by other manufacturers, including generic forms of Taxol;

 

  •  

substitute or alternative products or therapies;

 

 

•

  

development by others of new pharmaceutical products or treatments that are more effective than Abraxane®;

 

 

•

  

introduction of other generic equivalents or products which may be therapeutically interchanged with Abraxane®;

 

  •  

interruptions in manufacturing or supply;

 

  •  

changes in the prescribing practices of physicians;

 

  •  

changes in third-party reimbursement practices; and

 

  •  

migration of key customers to other manufacturers or sellers.

In addition, we will continue to make a significant investment in Abraxane®, including costs associated with conducting clinical trials and obtaining necessary regulatory approvals for the use of Abraxane® in other indications and settings and in other jurisdictions, expansion of our marketing, sales and manufacturing staff, the acquisition of paclitaxel raw material, expansion of manufacturing facilities and the manufacture of finished product. The success of Abraxane® in the Phase III trial for metastatic breast cancer and other clinical trials may not be representative of future clinical trial results for Abraxane® with respect to other clinical indications. The results from clinical, pre-clinical studies and early clinical trials conducted to date may not be predictive of results to be obtained in later clinical trials, including those ongoing at present. Further, the commencement and completion of clinical trials may be delayed by many factors that are beyond our control, including:

 

  •  

slower than anticipated patient enrollment;

 

  •  

difficulty in finding and retaining patients fitting the trial profile or protocols; and

 

  •  

adverse events occurring during the clinical trials.

 

22

Table of Contents
This excerpt taken from the ABII 10-Q filed Aug 14, 2008.

We are highly dependent upon the strong market acceptance of Abraxane®.

Our future profitability is highly dependent upon the strong market acceptance of Abraxane®. For the six months ended June 30, 2008 and the year ended December 31, 2007, total Abraxane® revenue was $153.8 million and $324.7 million, respectively, including $18.2 million and $36.4 million, respectively, of recognized deferred revenue relating to the co-promotion agreement with AstraZeneca. Because Abraxane® is our only approved product, Abraxane® revenue represented approximately 96% and 97% of our revenues for the six months ended June 30, 2008 and year ended December 31, 2007, respectively. We anticipate that sales of Abraxane® will remain a substantial portion of our total revenue over the next several years. However, a number of pharmaceutical companies are working to develop alternative formulations of paclitaxel and other cancer drugs and therapies, any of which may compete directly or indirectly with Abraxane® and which might adversely affect the commercial success of Abraxane®.

Abraxane® could lose market share or revenue due to numerous factors, many of which are beyond our control, including:

 

  •  

lower prices offered on similar products by other manufacturers including generic forms of taxol;

 

  •  

substitute or alternative products or therapies;

 

 

•

  

development by others of new pharmaceutical products or treatments that are more effective than Abraxane®;

 

 

•

  

introduction of other generic equivalents or products which may be therapeutically interchanged with Abraxane®;

 

  •  

interruptions in manufacturing or supply;

 

  •  

changes in the prescribing practices of physicians;

 

  •  

changes in third-party reimbursement practices; and

 

  •  

migration of key customers to other manufacturers or sellers.

 

26

Table of Contents

In addition, we will continue to make a significant investment in Abraxane®, including costs associated with conducting clinical trials and obtaining necessary regulatory approvals for the use of Abraxane® in other indications and settings and in other jurisdictions, expansion of our marketing, sales and manufacturing staff, the acquisition of paclitaxel raw material, expansion of manufacturing facilities and the manufacture of finished product. The success of Abraxane® in the Phase III trial for metastatic breast cancer and other clinical trials may not be representative of future clinical trial results for Abraxane® with respect to other clinical indications. The results from clinical, pre-clinical studies and early clinical trials conducted to date may not be predictive of results to be obtained in later clinical trials, including those ongoing at present. Further, the commencement and completion of clinical trials may be delayed by many factors that are beyond our control, including:

 

  •  

slower than anticipated patient enrollment;

 

  •  

difficulty in finding and retaining patients fitting the trial profile or protocols; and

 

  •  

adverse events occurring during the clinical trials.

This excerpt taken from the ABII 10-Q filed May 15, 2008.

We are highly dependent upon the strong market acceptance of Abraxane®.

Our future profitability is highly dependent on the strong market acceptance of Abraxane®. For the three months ended March 31, 2008, total Abraxane® revenue was $79.9 million, including $9.1 million of recognized deferred revenue relating to the co-promotion agreement with AstraZeneca. For the three months ended March 31, 2007, total Abraxane® revenue was $70.9 million, including $9.1 million of recognized deferred revenue relating to the co-promotion agreement with AstraZeneca. Because Abraxane® is our only approved product, Abraxane® revenue represented approximately 97% and 99% of our revenues for the three months ended March 31, 2008 and 2007, respectively. We anticipate that sales of Abraxane® will remain a substantial portion of our total revenue over the next several years. However, a number of pharmaceutical companies are working to develop alternative formulations of paclitaxel and other cancer drugs and therapies, any of which may compete directly or indirectly with Abraxane® and which might adversely affect the commercial success of Abraxane®.

Abraxane® could lose market share or revenue due to numerous factors, many of which are beyond our control, including:

 

  •  

lower prices offered on similar products by other manufacturers;

 

  •  

substitute or alternative products or therapies;

 

 

•

  

development by others of new pharmaceutical products or treatments that are more effective than Abraxane®;

 

 

•

  

introduction of other generic equivalents or products which may be therapeutically interchanged with Abraxane®;

 

  •  

interruptions in manufacturing or supply;

 

25

Table of Contents
  •  

changes in the prescribing practices of physicians;

 

  •  

changes in third-party reimbursement practices; and

 

  •  

migration of key customers to other manufacturers or sellers.

In addition, we will continue to make a significant investment in Abraxane®, including costs associated with conducting clinical trials and obtaining necessary regulatory approvals for the use of Abraxane® in other indications and settings and in other jurisdictions, expansion of our marketing, sales and manufacturing staff, the acquisition of paclitaxel raw material, expansion of manufacturing facilities and the manufacture of finished product. The success of Abraxane® in the Phase III trial for metastatic breast cancer and other clinical trials may not be representative of future clinical trial results for Abraxane® with respect to other clinical indications. The results from clinical, pre-clinical studies and early clinical trials conducted to date may not be predictive of results to be obtained in later clinical trials, including those ongoing at present. Further, the commencement and completion of clinical trials may be delayed by many factors that are beyond our control, including:

 

  •  

slower than anticipated patient enrollment;

 

  •  

difficulty in finding and retaining patients fitting the trial profile or protocols; and

 

  •  

adverse events occurring during the clinical trials.

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

We are highly dependent upon the strong market acceptance of Abraxane®.

Our future profitability is highly dependent on the strong market acceptance of Abraxane®. For the year ended December 31, 2007, total Abraxane® revenue was $324.7 million, including $36.4 million of recognized deferred revenue relating to the co-promotion agreement with AstraZeneca. For the year ended December 31, 2006, total Abraxane® revenue was $174.9 million, including $18.2 million of recognized deferred revenue

 

23

Table of Contents

relating to the co-promotion agreement with AstraZeneca. Because Abraxane® is our only approved product, Abraxane® revenue represented approximately 97% and 96% of our revenues for the year ended December 31, 2007 and 2006, respectively. We anticipate that sales of Abraxane® will remain a substantial portion of our total revenue over the next several years. However, a number of pharmaceutical companies are working to develop alternative formulations of paclitaxel and other cancer drugs and therapies, any of which may compete directly or indirectly with Abraxane® and which might adversely affect the commercial success of Abraxane®.

Abraxane® could lose market share or revenue due to numerous factors, many of which are beyond our control, including:

 

  •  

lower prices offered on similar products by other manufacturers;

 

  •  

substitute or alternative products or therapies;

 

 

•

  

development by others of new pharmaceutical products or treatments that are more effective than Abraxane®;

 

 

•

  

introduction of other generic equivalents or products which may be therapeutically interchanged with Abraxane®;

 

  •  

interruptions in manufacturing or supply;

 

  •  

changes in the prescribing practices of physicians;

 

  •  

changes in third-party reimbursement practices; and

 

  •  

migration of key customers to other manufacturers or sellers.

In addition, we will continue to make a significant investment in Abraxane®, including costs associated with conducting clinical trials and obtaining necessary regulatory approvals for the use of Abraxane® in other indications and settings and in other jurisdictions, expansion of our marketing, sales and manufacturing staff, the acquisition of paclitaxel raw material, expansion of manufacturing facilities and the manufacture of finished product. The success of Abraxane® in the Phase III trial for metastatic breast cancer and other clinical trials may not be representative of future clinical trial results for Abraxane® with respect to other clinical indications. The results from clinical, pre-clinical studies and early clinical trials conducted to date may not be predictive of results to be obtained in later clinical trials, including those ongoing at present. Further, the commencement and completion of clinical trials may be delayed by many factors that are beyond our control, including:

 

  •  

slower than anticipated patient enrollment;

 

  •  

difficulty in finding and retaining patients fitting the trial profile or protocols; and

 

  •  

adverse events occurring during the clinical trials.

Although approved by the U.S. Food and Drug Administration, or the FDA, for the indication of metastatic breast cancer in January 2005, Abraxane® may not generate sales sufficient to recoup our investment. Our inability to successfully manufacture, market and commercialize Abraxane® would materially adversely affect our business, results of operations and financial condition.

This excerpt taken from the ABII 10-Q filed Dec 20, 2007.

We are highly dependent upon the strong market acceptance of Abraxane®.

Our future profitability is highly dependent on the strong market acceptance of Abraxane®. For the nine months ended September 30, 2007, total Abraxane® revenue was $235.9 million, including $27.3 million of recognized deferred revenue relating to the co-promotion agreement with AstraZeneca. Because Abraxane® is our only approved product, Abraxane® revenue represented approximately 97% and 95% of our revenues for the nine months ended September 30, 2007 and 2006, respectively. We anticipate that sales of Abraxane® will remain a substantial portion of our total revenue over the next several years. However, a number of pharmaceutical companies are working to develop alternative formulations of paclitaxel and other cancer drugs and therapies, any of which may compete directly or indirectly with Abraxane® and which might adversely affect the commercial success of Abraxane®.

Abraxane® could lose market share or revenue due to numerous factors, many of which are beyond our control, including:

 

  •  

lower prices offered on similar products by other manufacturers;

 

  •  

substitute or alternative products or therapies;

 

 

•

  

development by others of new pharmaceutical products or treatments that are more effective than Abraxane®;

 

 

•

  

introduction of other generic equivalents or products which may be therapeutically interchanged with Abraxane®;

 

  •  

interruptions in manufacturing or supply;

 

  •  

changes in the prescribing practices of physicians;

 

  •  

changes in third-party reimbursement practices; and

 

  •  

migration of key customers to other manufacturers or sellers.

In addition, we will continue to make a significant investment in Abraxane®, including costs associated with conducting clinical trials and obtaining necessary regulatory approvals for the use of Abraxane® in other indications and settings and in other jurisdictions, expansion of our marketing, sales and manufacturing staff, the acquisition of paclitaxel raw material, and the manufacture of finished product. The success of Abraxane® in the Phase III trial for metastatic breast cancer and other clinical trials may not be representative of future clinical trial results for Abraxane® with respect to other clinical indications. The results from clinical, pre-clinical studies and early clinical trials conducted to date may not be predictive of results to be obtained in later clinical trials, including those ongoing at present. Further, the commencement and completion of clinical trials may be delayed by many factors that are beyond our control, including:

 

  •  

slower than anticipated patient enrollment;

 

  •  

difficulty in finding and retaining patients fitting the trial profile or protocols; and

 

  •  

adverse events occurring during the clinical trials.

Although approved by the U.S. Food and Drug Administration, or the FDA, for the indication of metastatic breast cancer in January 2005, Abraxane® may not generate sales sufficient to recoup our investment. Our inability to successfully manufacture, market and commercialize Abraxane® would materially adversely affect our business, results of operations and financial condition.

 

32

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

We are highly dependent upon the strong market acceptance of Abraxane®.

Our future profitability is highly dependent on the strong market acceptance of Abraxane®. For the six months ended June 30, 2007, total Abraxane® revenue was $149.6 million, including $18.2 million of recognized deferred revenue relating to the co-promotion agreement with AstraZeneca. For the year ended December 31, 2006, total Abraxane® revenue was $174.9 million, including $18.2 million of recognized deferred revenue relating to the co-promotion agreement with AstraZeneca. Because Abraxane® is our only approved product, Abraxane® revenue represented approximately 96.4% and 96.0% of our revenues for the six months ended June 30, 2007 and the year ended December 31, 2006, respectively. We anticipate that sales of Abraxane® will remain a substantial portion of our total revenue over the next several years. However, a number of pharmaceutical companies are working to develop alternative formulations of paclitaxel and other cancer drugs and therapies, any of which may compete directly or indirectly with Abraxane® and which might adversely affect the commercial success of Abraxane®.

Abraxane® could lose market share or revenue due to numerous factors, many of which are beyond our control, including:

 

  •  

lower prices offered on similar products by other manufacturers;

 

  •  

substitute or alternative products or therapies;

 

 

•

  

development by others of new pharmaceutical products or treatments that are more effective than Abraxane®;

 

 

•

  

introduction of other generic equivalents or products which may be therapeutically interchanged with Abraxane®;

 

  •  

interruptions in manufacturing or supply;

 

  •  

changes in the prescribing practices of physicians;

 

  •  

changes in third-party reimbursement practices; and

 

  •  

migration of key customers to other manufacturers or sellers.

In addition, we will continue to make a significant investment in Abraxane®, including costs associated with conducting clinical trials and obtaining necessary regulatory approvals for the use of Abraxane® in other

 

10

Table of Contents

indications and settings and in other jurisdictions, expansion of our marketing, sales and manufacturing staff, the acquisition of paclitaxel raw material, and the manufacture of finished product. The success of Abraxane® in the Phase III trial for metastatic breast cancer and other clinical trials may not be representative of future clinical trial results for Abraxane® with respect to other clinical indications. The results from clinical, pre-clinical studies and early clinical trials conducted to date may not be predictive of results to be obtained in later clinical trials, including those ongoing at present. Further, the commencement and completion of clinical trials may be delayed by many factors that are beyond our control, including:

 

  •  

slower than anticipated patient enrollment;

 

  •  

difficulty in finding and retaining patients fitting the trial profile or protocols; and

 

  •  

adverse events occurring during the clinical trials.

Although approved by the U.S. Food and Drug Administration, or the FDA, for the indication of metastatic breast cancer in January 2005, Abraxane® may not generate sales sufficient to recoup our investment. Our inability to successfully manufacture, market and commercialize Abraxane® would materially adversely affect our business, results of operations and financial condition.

EXCERPTS ON THIS PAGE:

10-K
Mar 12, 2010
10-Q
May 8, 2009
10-K
Mar 6, 2009
10-Q
Nov 14, 2008
10-Q
Aug 14, 2008
10-Q
May 15, 2008
10-K
Mar 31, 2008
10-Q
Dec 20, 2007
8-K
Nov 8, 2007

RELATED TOPICS for ABII:

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