BPUR » Topics » Oxyglobin

These excerpts taken from the BPUR 10-K filed Mar 3, 2009.

Oxyglobin

In May 2008, the Company entered into an agreement with Dechra Veterinary Products as exclusive U.S. distributor for Oxyglobin solution, the Company’s veterinary oxygen therapeutic. Dechra is a division of Dechra Pharmaceuticals, PLC, an animal healthcare marketing company headquartered in England. A UK affiliate of Dechra markets Oxyglobin in Europe. In January 2009, the Company sold its entire existing Oxyglobin inventory to its distributors. Consequently, Oxyglobin sales revenues will cease until the Company can resume production of product and Dechra places additional orders.

Oxyglobin

STYLE="margin-top:6px;margin-bottom:0px; text-indent:4%">In May 2008, the Company entered into an agreement with Dechra Veterinary Products as exclusive U.S. distributor for Oxyglobin solution, the
Company’s veterinary oxygen therapeutic. Dechra is a division of Dechra Pharmaceuticals, PLC, an animal healthcare marketing company headquartered in England. A UK affiliate of Dechra markets Oxyglobin in Europe. In January 2009, the Company
sold its entire existing Oxyglobin inventory to its distributors. Consequently, Oxyglobin sales revenues will cease until the Company can resume production of product and Dechra places additional orders.

STYLE="margin-top:18px;margin-bottom:0px; margin-left:2%">Research

During 2008, the Company
produced and the Navy bought both Hemopure and modified versions of Hemopure for preclinical testing. Biopure formulated and manufactured the modified versions of Hemopure to test hypotheses concerning changes in formulation in relation to
physiological effects. Preclinical testing is ongoing under grants from the Navy and at Navy facilities. The Company does not anticipate that these modifications will supplant Hemopure but expects the Navy to seek FDA clearance to begin clinical
testing of Hemopure with the use of a concomitant drug, a trial designed to address vasoactivity. Product sales to the Navy were $257,000 in fiscal 2008. In December 2008 additional investigational product was manufactured by the Company for the
Navy.

Oxyglobin

The Company’s veterinary product, Oxyglobin, is similar to Hemopure except for its molecular size. The FDA Center for Veterinary Medicine approved Oxyglobin in 1998 and the European Commission approved it in 1999, in both cases for the treatment of canine anemia, regardless of the cause of the anemia. Anemia in dogs often results from blood loss, disease or ineffective red blood cell production. Oxyglobin sales were $2.6 million in fiscal 2008 and $2.1 million in fiscal 2007.

There were no backorders for Oxyglobin at October 31, 2008, or the two previous fiscal year ends.

Oxyglobin


The Company’s veterinary product, Oxyglobin, is similar to Hemopure except for its molecular size. The FDA Center for Veterinary Medicine approved
Oxyglobin in 1998 and the European Commission approved it in 1999, in both cases for the treatment of canine anemia, regardless of the cause of the anemia. Anemia in dogs often results from blood loss, disease or ineffective red blood cell
production. Oxyglobin sales were $2.6 million in fiscal 2008 and $2.1 million in fiscal 2007.

There were no backorders for Oxyglobin at
October 31, 2008, or the two previous fiscal year ends.

Oxyglobin

Oxyglobin is sold through distributors in the United States and Europe. Currently, Oxyglobin is not being produced but the Company believes that the distributors have adequate inventory for sales in the 2009 calendar year.

These excerpts taken from the BPUR 10-K filed Feb 13, 2009.

Oxyglobin

In May 2008, the Company entered into an agreement with Dechra Veterinary Products as exclusive U.S. distributor for Oxyglobin solution, the Company’s veterinary oxygen therapeutic. Dechra is a division of Dechra Pharmaceuticals, PLC, an animal healthcare marketing company headquartered in England. A UK affiliate of Dechra markets Oxyglobin in Europe. In January 2009, the Company sold its entire existing Oxyglobin inventory to its distributors. Consequently, Oxyglobin sales revenues will cease until the Company can resume production of product and Dechra places additional orders.

Oxyglobin

STYLE="margin-top:6px;margin-bottom:0px; text-indent:4%">In May 2008, the Company entered into an agreement with Dechra Veterinary Products as exclusive U.S. distributor for Oxyglobin solution, the
Company’s veterinary oxygen therapeutic. Dechra is a division of Dechra Pharmaceuticals, PLC, an animal healthcare marketing company headquartered in England. A UK affiliate of Dechra markets Oxyglobin in Europe. In January 2009, the Company
sold its entire existing Oxyglobin inventory to its distributors. Consequently, Oxyglobin sales revenues will cease until the Company can resume production of product and Dechra places additional orders.

STYLE="margin-top:18px;margin-bottom:0px; margin-left:2%">Research

During 2008, the Company
produced and the Navy bought both Hemopure and modified versions of Hemopure for preclinical testing. Biopure formulated and manufactured the modified versions of Hemopure to test hypotheses concerning changes in formulation in relation to
physiological effects. Preclinical testing is ongoing under grants from the Navy and at Navy facilities. The Company does not anticipate that these modifications will supplant Hemopure but expects the Navy to seek FDA clearance to begin clinical
testing of Hemopure with the use of a concomitant drug, a trial designed to address vasoactivity. Product sales to the Navy were $257,000 in fiscal 2008. In December 2008 additional investigational product was manufactured by the Company for the
Navy.

 


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Table of Contents


Oxyglobin

The Company’s veterinary product, Oxyglobin, is similar to Hemopure except for its molecular size. The FDA Center for Veterinary Medicine approved Oxyglobin in 1998 and the European Commission approved it in 1999, in both cases for the treatment of canine anemia, regardless of the cause of the anemia. Anemia in dogs often results from blood loss, disease or ineffective red blood cell production. Oxyglobin sales were $2.6 million in fiscal 2008 and $2.1 million in fiscal 2007.

There were no backorders for Oxyglobin at October 31, 2008, or the two previous fiscal year ends.

Oxyglobin

The
Company’s veterinary product, Oxyglobin, is similar to Hemopure except for its molecular size. The FDA Center for Veterinary Medicine approved Oxyglobin in 1998 and the European Commission approved it in 1999, in both cases for the treatment of
canine anemia, regardless of the cause of the anemia. Anemia in dogs often results from blood loss, disease or ineffective red blood cell production. Oxyglobin sales were $2.6 million in fiscal 2008 and $2.1 million in fiscal 2007.

STYLE="margin-top:12px;margin-bottom:0px; text-indent:4%">There were no backorders for Oxyglobin at October 31, 2008, or the two previous fiscal year ends.

STYLE="margin-top:18px;margin-bottom:0px">Manufacturing

The Company uses proprietary and
patented purification and polymerization processes in the manufacture of our oxygen therapeutic products. The scientific and engineering team has designed and managed the construction of our large-scale process specific equipment and our commercial
scale manufacturing facilities. In addition, this team developed the proprietary computer program that operates and monitors most aspects of this process. Both Hemopure and Oxyglobin were first produced in 1991.

STYLE="margin-top:18px;margin-bottom:0px; margin-left:2%">Raw Material Source

The
products consist of bovine hemoglobin that has been purified, chemically modified and cross-linked for stability. Controlled herds of U.S. cattle raised for beef provide the raw material, bovine hemoglobin, used in the products. Cattle must
meet the requirements of a herd management program put in place by the Company to assure the origin, health, feed and quality of the cattle to be used as a raw material source. Suppliers are contracted to maintain traceable records on animal origin,
health, feed and care as part of the Company’s effort to assure the use of controlled, healthy animals.

Oxyglobin

Oxyglobin is sold through distributors in the United States and Europe. Currently, Oxyglobin is not being produced but the Company believes that the distributors have adequate inventory for sales in the 2009 calendar year.

These excerpts taken from the BPUR 10-K filed Jan 29, 2008.
Oxyglobin
 
We estimate that there are at least 15,000 small animal veterinary practices in the United States, another 4,000 mixed animal practices treating small and large animals in the United States and approximately 22,000 small animal practices in Europe. We believe that the average veterinary practice treats only a small percentage of canine anemia cases with red blood cell transfusion. The remaining animals receive either cage rest or treatment such as fluid administration, iron supplements, nutritional supplements or inspired oxygen.
 
We sell Oxyglobin direct to veterinarians in the United States, although we expect to enter into marketing arrangements with one or more third parties in order to expand Oxyglobin sales. We sell Oxyglobin through distributors in Europe. Total foreign revenues from Oxyglobin sales were $614,000 in fiscal 2007, $278,000 in fiscal 2006 and $277,000 in fiscal 2005. Oxyglobin revenues in the United States were $1.5 million in 2007, $990,000 in 2006 and $883,000 in 2005.
 
Oxyglobin


 



We estimate that there are at least 15,000 small animal
veterinary practices in the United States, another 4,000 mixed
animal practices treating small and large animals in the United
States and approximately 22,000 small animal practices in
Europe. We believe that the average veterinary practice treats
only a small percentage of canine anemia cases with red blood
cell transfusion. The remaining animals receive either cage rest
or treatment such as fluid administration, iron supplements,
nutritional supplements or inspired oxygen.


 



We sell Oxyglobin direct to veterinarians in the United States,
although we expect to enter into marketing arrangements with one
or more third parties in order to expand Oxyglobin sales. We
sell Oxyglobin through distributors in Europe. Total foreign
revenues from Oxyglobin sales were $614,000 in fiscal 2007,
$278,000 in fiscal 2006 and $277,000 in fiscal 2005. Oxyglobin
revenues in the United States were $1.5 million in 2007,
$990,000 in 2006 and $883,000 in 2005.


 




This excerpt taken from the BPUR 10-K filed Jan 29, 2007.
Oxyglobin
 
We estimate that there are at least 15,000 small animal veterinary practices in the United States, another 4,000 mixed animal practices treating small and large animals in the United States and approximately 22,000 small animal practices in Europe. We believe that the average veterinary practice treats only a small percentage of canine anemia cases with red blood cell transfusion. The remaining animals receive either cage rest or treatment such as fluid administration, iron supplements, nutritional supplements or inspired oxygen.
 
We sell Oxyglobin direct to veterinarians in the United States. We sell Oxyglobin through a distributor in the United Kingdom and a distributor in Germany. Total foreign revenues were $278,000 in fiscal 2006.
 
This excerpt taken from the BPUR 10-K filed Jan 17, 2006.
Oxyglobin
 
We estimate that there are at least 15,000 small animal veterinary practices in the United States, another 4,000 mixed animal practices treating small and large animals in the United States and approximately 22,000 small animal practices in Europe. We believe that the average veterinary practice treats only a small percentage of canine anemia cases with red blood cell transfusion. The remaining animals receive either cage rest or treatment such as fluid administration, iron supplements, nutritional supplements or inspired oxygen.


13


Table of Contents

We sell Oxyglobin direct to veterinarians in the United States. To carry out our decision to curtail Oxyglobin sales and selling expenses in fiscal 2004, we terminated all of the U.S. distribution arrangements we had in place for Oxyglobin and are selling directly to a limited number of customers. Foreign revenues, consisting of revenues from our distributor in the United Kingdom, were $277,000 in fiscal 2005.
 
This excerpt taken from the BPUR 10-K filed Jan 14, 2005.
Oxyglobin

      Our veterinary product, Oxyglobin, is similar to Hemopure except for its molecular size distribution. The FDA Center for Veterinary Medicine approved Oxyglobin in 1998 and the European Commission approved Oxyglobin in 1999, in both cases for the treatment of canine anemia, regardless of the cause of the anemia. Anemia in dogs often results from blood loss, disease or ineffective red blood cell production. Oxyglobin sales were $2.4 million in fiscal 2004, $4.0 million in fiscal 2003 and $2.0 million in fiscal 2002. The decline in fiscal 2004 sales is attributable to our decision to curtail the manufacture and marketing of Oxyglobin in order to reduce our operating costs until such time, if ever, that we can realize manufacturing economies of scale. Although some of our customers account for more than 10% of Oxyglobin sales, we are not dependent upon a single customer or group of customers, the loss of which would have a material adverse effect on our Oxyglobin business.

      As of December 31, 2004 and December 31, 2003, we had no backorders for Oxyglobin. As of December 31, 2002 we had $1.3 million in backorders, attributed to a plant shutdown during expansion. All of the backlog was filled in fiscal year 2003.

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