Note On Forward Looking StatementsNote On Forward Looking StatementsNote On Forward-Looking StatementsNote On Forward-Looking Statements
This Presentation contains forward-looking statements Forward-looking statements areThis Presentation contains forward looking statements. Forward looking statements arestatements other than historical information or statements of current conditions. Therecan be no assurance that the Company will realize favorable clinical trial results, meet itsanticipated milestones, attain FDA or non-U.S. approvals for its products, obtainadequate financing for its plans or find market acceptance if Hemopure obtainsregulatory approvals. The inclusion of forward-looking statements in this Presentationshould not be regarded as a representation by the Company that the objectives or plans
f C Cof the Company will be achieved. There are many risks that could cause the Company’splans not to be achieved. Please refer to the risk factors that can be found in theCompany’s filings with the U.S. Securities and Exchange Commission, which can beaccessed at www sec gov or through the investor section of the Company’s web site ataccessed at www.sec.gov or through the investor section of the Company s web site atwww.biopure.com. The content of this Presentation does not necessarily reflect theposition or the policy of the Government or the Department of Defense, and no officialendorsement should be inferred. The Navy-Biopure collaborative development program
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y p p p gfor Hemopure in trauma is contingent upon funding.
Biopure TodayBiopure TodayBiopure TodayBiopure Today
Large market opport nitLarge market opportunity
Strong patents and trade secrets
Established manufacturing capability
Leveraging our experience in anemia through…
– ESA adjunct therapy
– Palliative care
– Trauma
Continue to evaluate ischemic rescue
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– COR-003 heart attack trial
Hemopure is an Oxygen Bridge™ for:Hemopure is an Oxygen Bridge™ for:Hemopure is an Oxygen Bridge™ for:Hemopure is an Oxygen Bridge™ for:
A iAnemia – Anemia may be caused by:
• Blood loss from trauma or surgery• Medical therapy (e.g., chemotherapy)• Disorders that affect red blood cell production
Ischemia– Ischemia may be caused by obstructed or constricted blood
vessels and can lead to stroke, heart attack and organ dysfunction
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Approved Oxygen Therapeutic ProductsApproved Oxygen Therapeutic ProductsApproved Oxygen Therapeutic ProductsApproved Oxygen Therapeutic Products
South Africa
Marketed and used in humans for treating ti t h t l isurgery patients who are acutely anemic
Increase in usage since beginning of 2007
United States and European Union
On the market for treating anemia in On the market for treating anemia in dogs
>188,000 units sold
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~100,000 animals treated
Hemopure Product CharacteristicsHemopure Product CharacteristicsHemopure Product CharacteristicsHemopure Product Characteristics
Polymerized bovine hemoglobin solution
Delivers oxygen immediately upon infusion
Long shelf life
– 3 years at room temperature (2 to 30 C)
– 1.5 years at elevated temperature (40 C)
Universally compatible RBC
Hemopure
Small molecule (<1/1000th the size of a RBC)
Low viscosity
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Low viscosity
Sources of Possible Capital AppreciationSources of Possible Capital AppreciationSources of Possible Capital AppreciationSources of Possible Capital Appreciation
1. UK Market Approval
2. Anemia-Cancer Therapy Program
3. Trauma Programg
4. Heart Attack Program
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1. Possible United Kingdom Approval and Implications
1. Possible United Kingdom Approval and ImplicationsImplicationsImplications
– Biopure’s dossier for registration of Hemopure in the United Kingdom is progressing as anticipated
If t d d t ld b i th fi t d t f 2008– If granted, endorsement could be in the first or second quarter of 2008
– A registration in the United Kingdom may allow a roll-out across selected European Union (EU) markets using the UK as the reference countryEuropean Union (EU) markets using the UK as the reference country
– If granted, Biopure may also use this registration to apply for registration in other countries outside EUin other countries outside EU
– Malaysia joint venture opportunity post UK approval
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Malaysia Joint Venture Malaysia Joint Venture Malaysia Joint Venture Malaysia Joint Venture
A i dAs previous announced
A direct investment in Biopure
Licensing rights for Hemopure in certain markets
The funding by Malaysia of a joint venture company to be owned by Biopure and a Malaysian entity
A large-scale plant for manufacturing Hemopure in M l i t ti t d t i f $100 illiMalaysia, at an estimated cost in excess of $100 million, with government financing
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2. New Market Opportunity: FDA Black Box of ESAs
2. New Market Opportunity: FDA Black Box of ESAsFDA Black Box of ESAsFDA Black Box of ESAs
ESAs Black Box Warning H E th i tiESAs Black Box Warning (March 2007)
– FDA added Black Box Warnings for cancer patients taking Erythropoietin
Hemopure as an Erythropoietic Agent & Oxygen Bridge
– In certain circumstances Hemopure may be a useful substitute or adjunct tocancer patients taking Erythropoietin
Stimulating Agents (ESA) drugs as they appear to promote tumor growth and decrease survival
may be a useful substitute or adjunct to the use of erythropoietic agent This may be particularly relevant in patients who are anemic as a result of cancer therapy– Q2 2007, the first full quarter after the
new black box warnings, sales of Aranesp and Procrit immediately declined $130 million from the previous
t
therapy
– A number of our compassionate use cases are in the treatment of anemia in
quarter
– Possible annual market opportunity between $500 million to $1 billion as an ESA replacement or adjunct therapy
cancer patients where blood is not available or an option
– Supported by preclinical studies of
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an ESA replacement or adjunct therapy in cancer patient Hemopure
Anemia in Palliative Care Anemia in Palliative Care Anemia in Palliative Care Anemia in Palliative Care
I t t d f 105 lli ti ti t f hIn a recent study of 105 palliative care patients, of whom 95 (90.5%) had advanced cancer, anemia was found in:
– 77% of men (Hb <13.0 mg/dl)68 2% f (Hb 12 0 /dl)– 68.2% of women (Hb <12.0 mg/dl)
Hemopure will be evaluated on its oxygen carrying capacity to increase perfusion and improve the quality ofcapacity to increase perfusion and improve the quality of life associated with the "anemia”
Patient population that is typically Erythropoiesis-S ( S )Stimulating Agents (ESA) resistant
Study protocol in cooperation with clinicians from Duke Cancer Care Research Program (DCCRP)
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Cancer Care Research Program (DCCRP)
3. U.S. Navy Continues Commitment to Hemopure
3. U.S. Navy Continues Commitment to Hemopureto Hemopureto Hemopure
Acute Anemia: Trauma
– Continued support from U.S. Navy Medical Research Center (NMRC)(NMRC)
– On-going NMRC research in hemorrhagic shock and traumatic brain injurytraumatic brain injury
– Approximately $22 million in congressional appropriations
– U.S. trauma market >$350 million
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4 Heart Attack4 Heart Attack4. Heart Attack4. Heart Attack
This proposed phase II trial in Europe is designed to evaluate safety and efficacy of Hemopure in the event of a major heart attack
Preclinical and clinical evidence that Hemopure supports the heart’s metabolic function
Preclinical evidence that Hemopure rescues ischemic
dimyocardium
>2 million heart attack patients per year in U S and Europe combined
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1 U.S. data: American Heart Association Heart Disease and Stroke
Statistics – 2004 Update
year in U.S. and Europe combined (~800,000 STEMI)1
Hemopure May Provide An Oxygen Bridge™
Until Blood Flow Is RestoredHemopure May Provide An Oxygen Bridge™
Until Blood Flow Is RestoredUntil Blood Flow Is RestoredUntil Blood Flow Is Restored
Typically 2 or more hours to first treatmentyp y
Onset of symptomsOnset of
symptoms
Ambulance arrives at
home
Ambulance arrives at
home
Arrival and initial
assessment and treatment
Arrival and initial
assessment and treatment
Thrombolysisor
PCI/CABG
Thrombolysisor
PCI/CABGBlockage RemovedBlockage Removed
and treatmentin ER
and treatmentin ER
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Time is Muscle
Proposed Planned Phase II Trials FY 2008Proposed Planned Phase II Trials FY 2008Proposed Planned Phase II Trials - FY 2008Proposed Planned Phase II Trials - FY 2008
Anemia
ESA Adjunct / Replacement– ESA Adjunct / Replacement
– Palliative Care
– Trauma
IschemiaIschemia
– Heart Attack
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Broad Clinical Trial ExperienceBroad Clinical Trial ExperienceBroad Clinical Trial ExperienceBroad Clinical Trial Experience
1500 t t l ti t (836 H 676 t l )>1500 total patients (836 Hemopure, 676 controls)
TypeType HemopurePatients (n)HemopurePatients (n)
Control Patients (n)
Control Patients (n)
UnitsUnits( )( ) ( )( )
Healthy Volunteers
Non-Surgery
Surgery with ANH*
64
34
31
29
14
36
1.5 -4.6
1.5 - 41
1 - 3
General Surgery
Advanced Surgery Trials
Coronary Angioplasty
146
531
30
95
487
15
1 - 10
4 - 10
0.5 - 1
836 676 0.5 – 41 unitsCompleted Trials
* ANH = Acute normovolemic hemodilution
0.5 41 unitsp
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Hemopure in the United States: Compassionate Use BasisHemopure in the United States: Compassionate Use BasisCompassionate Use BasisCompassionate Use Basis
J 2007 tJanuary 2007 - present
– Compassionate use reinitiated on a case-by-case basis in Jan 2007
• Single-patient INDs granted by FDA
– Treatment of life-threatening anemia when suitable RBCs are not available or not acceptable for medical or personal reasonsavailable or not acceptable for medical or personal reasons
– Receiving regular inquiries for Hemopure on a compassionate use basis
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Pharmaceutical Manufacturing ProcessPharmaceutical Manufacturing ProcessPharmaceutical Manufacturing ProcessPharmaceutical Manufacturing Process
~100,000 unit per year capacity (validated for 75,000/year)Consistent purity, potency and stabilityAbundant, controlled raw material source (managed U.S. cattle herds)Process validated to remove or inactivate contaminants if present
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Process validated to remove or inactivate contaminants, if present, including bacteria, viruses, prions
Commercialization: South AfricaCommercialization: South AfricaCommercialization: South AfricaCommercialization: South Africa
So th AfricaSouth Africa– Hemopure is marketed and sold in South Africa. Promotion commenced
in March 2007
– This market is showing Biopure how clinicians use and therefore how to market the product
Gain valuable insight into use of the product and gain key opinion leader– Gain valuable insight into use of the product and gain key opinion leader support
– In recent weeks Biopure has seen re-ordering of Hemopurep g p
– Sales in South Africa are not expected to be a significant contributor to the company’s cash needs
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Catalyst for GrowthCatalyst for GrowthCatalyst for GrowthCatalyst for Growth
Only approved product in its class
Possible near term UK approvalPossible near term UK approval
Multi-application pipeline in large markets
Unique product features
Demonstrated clinical benefitDemonstrated clinical benefit
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