RR Slides 11-6-07 new -...

November 2007

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

BIOPURE CORPORATION | 20072

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


– 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


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


~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


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


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


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


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


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)


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


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


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


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


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


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


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


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


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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