425 1 d425.htm 425 FILING 425 Filing

SLIDES USED IN MEETINGS WITH PROSPECTIVE

INVESTORS AND STOCKHOLDERS OF

DENDREON CORPORATION AND OF

CORVAS INTERNATIONAL, INC. AND

MADE AVAILABLE ON JULY 7, 2003

AT WWW.DENDREON.COM AND WWW.CORVAS.COM

 

Filed by Dendreon Corporation

Pursuant to Rule 165 and Rule 425

under the Securities Act of 1933 and

deemed filed pursuant to Rule 14a-6

under the Securities Exchange Act of 1934

 

Subject Company: Corvas International, Inc.

Form S-4 File No. 333-104167

 

This filing relates to the proposed acquisition (“Acquisition”) by Dendreon Corporation (“Dendreon”) of Corvas International, Inc. (“Corvas”) pursuant to the terms of an Agreement and Plan of Merger, dated February 24, 2003, as amended on June 12, 2003 (the “Merger Agreement”), by and among Dendreon, Seahawk Acquisition, Inc., Charger Project LLC and Corvas. The Merger Agreement is on file with the Securities and Exchange Commission (“SEC”) as an exhibit to the Current Report on Form 8-K filed by Dendreon on February 25, 2003, and the Waiver and Amendment to the Merger Agreement, dated June 12, 2003, is on file with the SEC as an exhibit to Amendment No. 2 to the Registration Statement on Form S-4 filed by Dendreon on June 19, 2003, both of which are incorporated by reference into this filing.

 

Additional Information About the Acquisition and Where to Find It

 

Dendreon and Corvas have filed with the Securities and Exchange Commission (“SEC”) a Registration Statement on Form S-4, which contains a joint proxy statement/prospectus with respect to the Acquisition and other relevant materials. INVESTORS AND SECURITY HOLDERS OF DENDREON AND CORVAS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS BECAUSE IT CONTAINS IMPORTANT INFORMATION ABOUT DENDREON, CORVAS AND THE ACQUISITION. The joint proxy statement/prospectus, including the annexes attached to, and the reports incorporated by reference in, the joint proxy statement/prospectus, and any other reports and documents filed by Dendreon or Corvas with the SEC, may be obtained free of charge at the SEC’s web site at www.sec.gov.

 

Investors and security holders may obtain free copies of the reports and documents filed with the SEC by Dendreon by directing a request to: Dendreon Corporation, 3005 First Avenue, Seattle, WA 98121, Attn: Investor Relations. Investors, and security holders may obtain free copies of the reports and documents filed with the SEC by Corvas by contacting Corvas Investor Relations at 3030 Science Park Road, San Diego CA 92121.

 

Dendreon, Corvas and their respective executive officers and directors may be deemed to be participants in the solicitation of proxies from the stockholders of Dendreon and Corvas in favor of the Acquisition. Information about the executive officers and directors of Dendreon and their ownership of Dendreon common stock is set forth in the joint proxy statement/prospectus. Information about the executive officers and directors of Corvas and their ownership of Corvas common stock is set forth in the joint proxy statement/prospectus and in Corvas’ Annual Report on Form 10-K, which was filed with the SEC on March 14, 2003. Certain directors and executive


officers of Corvas may have direct or indirect interests in the Acquisition due to securities holdings, pre-existing or future indemnification arrangements, vesting of options, or rights to severance payments if their employment is terminated following the Acquisition. Additional information regarding Dendreon, Corvas, and the interests of their respective executive officers and directors in the Acquisition is contained in the joint proxy statement/prospectus.

 

Investors and security holders are urged to read the joint proxy statement/prospectus, including the annexes attached to, and the reports incorporated by reference in, the joint proxy statement/prospectus, and any future report and document filed with the SEC by Dendreon and Corvas, before making any voting or investment decision with respect to the Acquisition.

 

Forward-looking Statements

 

Except for historical information contained herein, the slides contain forward-looking statements, including statements about the Acquisition and future financial and operating results of the combined company. These statements are based on management’s current expectations and beliefs and are subject to a number of risks and uncertainties, particularly those risks and uncertainties inherent in any acquisition transaction and the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, that could cause actual results to differ materially from those described in the forward-looking statements.

 

Statements of expected synergies, benefits, accretion, timing of closing, execution of integration plans and management and organizational structure are all forward-looking statements. Risks and uncertainties include the possibility that the market for the sale of certain products may not develop as expected; that development of the companies’ products, including potential cardiovascular and cancer products, may not proceed as planned; risks associated with completing ongoing clinical trials, including the rNAPc2 clinical trial for the treatment of patients with unstable angina and non-ST-segment elevation myocardial infarction; the risk that the results of one clinical trial will not be repeated in another clinical trial; the risk that results in preclinical studies may not be confirmed in clinical trials or that other preclinical studies will reveal adverse characteristics that preclude further development of a preclinical product candidate; the risk that the results of a clinical trial, including Phase 3 trials of Provenge, will not support applying for or approval of a biologics license by the FDA; the risk that the Acquisition does not close or that the companies may be required to modify aspects of the transaction to achieve regulatory approval; that prior to the closing of the Acquisition, the businesses of the companies, including the retention of key employees, suffer due to uncertainty; that the parties are unable to successfully execute their integration strategies or achieve planned synergies; risks related to Dendreon’s limited operating history; the risk that the companies may not secure or maintain relationships with collaborators; the companies’ dependence on intellectual property; and other risks and uncertainties that are described in the reports filed by Dendreon and Corvas with the SEC. Additional information on the risks and uncertainties that could affect the companies’ business, financial condition and results of operations are contained in their respective filings with the SEC, which are available at www.sec.gov.

 

The following are slides regarding the Acquisition used in presentations to prospective investors and stockholders of Dendreon and of Corvas and made available on July 7, 2003, by following the appropriate links, by Dendreon on its website at www.dendreon.com and by Corvas on its website at www.corvas.com/investor-relations.html.


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Dendreon Corporation

Corvas International

 

Building a Premier Biotechnology Company


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Forward-Looking Statement Disclaimer

 

This presentation includes forward-looking statements, including statements about Dendreon’s proposed acquisition of Corvas, post-closing business synergies and product opportunities, and product development and commercialization. Actual results may differ materially from those projected in the forward-looking statements. Factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Dendreon’s filings with the SEC, including its Registration Statement on Form S-4 (Reg. No. 333-104167) under the caption “Risk Factors.”


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Additional Information About the Acquisition and Where to Find It

 

Dendreon and Corvas have filed with the Securities and Exchange Commission (“SEC”) a Registration Statement on Form S-4, which contains a joint proxy statement/prospectus with respect to the combination and other relevant materials. INVESTORS AND SECURITY HOLDERS OF DENDREON AND CORVAS ARE URGED TO READ THE COMPANIES’ RELEVANT FILINGS WITH THE SEC, INCLUDING THE DEFINITIVE JOINT PROXY STATEMENT/PROSPECTUS, BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT DENDREON, CORVAS AND THE COMBINATION. The joint proxy statement/prospectus, including the annexes attached to, and the reports incorporated by reference in, the joint proxy statement/prospectus, and any other reports and documents filed by Dendreon or Corvas with the SEC, may be obtained free of charge at the SEC’s web site at www.sec.gov.

 

Investors and security holders may obtain free copies of the reports and documents filed with the SEC by Dendreon by directing a request to: Dendreon Corporation, 3005 First Avenue, Seattle, WA 98121, Attn: Investor Relations. Investors and security holders may obtain free copies of the reports and documents filed with the SEC by Corvas by contacting Corvas Investor Relations at 3030 Science Park Road, San Diego CA 92121.

 

Dendreon, Corvas and their respective executive officers and directors may be deemed to be participants in the solicitation of proxies from the stockholders of Dendreon and Corvas in favor of the combination. Information about the executive officers and directors of Dendreon and their ownership of Dendreon common stock is set forth in the joint proxy statement/prospectus. Information about the executive officers and directors of Corvas and their ownership of Corvas common stock is set forth in the joint proxy statement/prospectus and in Corvas’ Annual Report on Form 10-K, which was filed with the SEC on March 14, 2003. Certain directors and executive officers of Corvas may have direct or indirect interests in the combination due to securities holdings, pre-existing or future indemnification arrangements, vesting of options, or rights to severance payments if their employment is terminated following the combination. Additional information regarding Dendreon, Corvas, and the interests of their respective executive officers and directors in the combination is contained in the joint proxy statement/prospectus.


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Dendreon Corporation

 

Developing targeted therapies for the treatment of cancer

 

  Immunotherapeutic cancer programs

-Provenge®, MylovengeTM, APC8024, Trp-p8, NY-ESO, CEA, MN, Telomerase

 

  Monoclonal antibodies and small molecules

-Trp-p8, DN1921, DN1924

 

  Industry leading collaborators

-Genentech, Inc., Kirin Brewery Co., Ltd.


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Momentum Continues in 2003

 

Corvas Acquisition

 

  Stock for stock transaction

 

  Valued to $73 M, based on Dendreon closing stock price of $5.79 on 2/24/03, an 83% premium to Corvas’ stock price as of the same date

 

  Dendreon stockholders will own 71.6% and Corvas stockholders will own 28.4%, based on current capitalization

 

  Combination is expected to increase stockholder value by creating a more diversified and sustainable organization

 

- Two Phase 3 programs

- Two Phase 2 programs

- One Phase 1 program


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Combining Strengths

 

Technology

 

  Broad oncology portfolio covering 4 platforms
  5 ongoing clinical programs
  Enhanced intellectual property estate, 87 issued U.S. patents
  Small molecule, medicinal chemistry expertise

 

Operations

 

  Experienced management team
  Clinical development expertise
  Research and development expertise
  Collaborations with industry leaders

 

Financial

 

  Combined balance sheet of approximately $125M upon closing
  Resources to fuel Provenge development
  Resources to advance other clinical and preclinical programs


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Breadth in Oncology

 

Vaccine Targets


   Antibodies

     Small Molecules

     Prodrug Program

NY-ESO    Trp-p8      Trp-p8      uPA
CEA    DN1924     

Urokinase

(uPA)

Inhibitors

     Other
Serine
Proteases

MN

  

DN1921

(autoimmune
diseases)

    

Matriptase

Inhibitors

      
Telomerase    Serine
Protease
Inhibitors
             
Trp-p8                   
ARF                   

 

DNDN

CVAS


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Advanced Clinical Trial Pipeline

 

Product/Target


   Phase 1

   Phase 2

   Phase 3

Provenge®

              

Androgen Independent Prostate Cancer

             Completed

D9901

              

D9902

              

Androgen Dependent Prostate Cancer

              

P-11 (Provenge alone)

              

P-16 (Provenge+Avastin)

              

Mylovenge

              

Multiple Myeloma

              

rNAPc2

              

Acute Coronary Syndromes

              

APC8024

              

Breast, Ovarian, Colon Cancers

              

*NCI-Sponsored Trial

              

 

DNDN

CVAS


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Leading Cancer Vaccine Platform

 

  Well validated and well characterized antigen targets manufactured as recombinant proteins
  Proprietary Antigen Delivery CassetteTM technology
  Induces strong and reproducible immune responses


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Provenge® Phase 3 Trial (D9901)

 

Double Blind, Placebo Controlled

 

Vaccinate at Weeks 0 2 4

 

•   First randomized, double blind, placebo controlled Phase 3 study of a cancer vaccine

  

•   Primary endpoint – Median time to objective disease progression

•   Advanced androgen independent prostate cancer patients

  

•   Secondary endpoint – Delay in onset of disease-related pain

•   No existing treatment options (except palliatives for pain)

    

 


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Primary Efficacy Analysis (ITT)

 

Time from randomization to disease progression

 

Provenge (n=82)

Placebo (n=45)

 

p=0.085

HR=1.394 (95% CI 0.953 - 2.037)

 

Proportion Without Progression

Time to Disease Progression (weeks)

 

Phase 3 Trial #D9901


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Gleason Score

 

  Routinely performed prostate grading system

 

- Histologic measure of aggressiveness of tumor

- Patients with score of £ 7 tend to have better prognosis

 

  Majority (75%) of androgen independent patients have a score of 7 or less

 

  Pre-specified subgroup for analysis

 

  Single most important predictor of response to Provenge treatment


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Efficacy Analysis: Gleason £ 7

 

Time to objective disease progression (Kaplan-Meier method):

Primary Efficacy Analysis, Gleason Score £ 7, Intent-to-Treat Patients

 

Provenge (n=50)

Placebo (n=25)

 

P=0.002

HR=2.222 (95% Cl: 1.331 – 3.710)

 

Proportion Progression Free

Time (weeks)

 

Phase 3 Trial #D9901

 


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Comparison of Gleason Subgroups

 

Subgroup Analysis: Gleason £ 7    Subgroup Analysis: Gleason ³ 8

Provenge (n=50)

Placebo (n=25)

  

Provenge (n=32)

Placebo (n=20)

log rank p=0.002

   log rank p=0.043

Proportion Progression Free

Time (weeks)

  

Proportion Progression Free

Time (weeks)

 

Phase 3 Trial #D9901


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Progression Analysis: Gleason £ 7

 

Time to Progression (weeks)

 

    Provenge (N=50)   Placebo (N=25)   Treatment Effect
Median   16.0   9.0   1.78

 

Progression Free Survival Rate

(percent)

 

Months   Provenge   Placebo   Treatment Effect
6   34.7   4.0   8.7
9   17.7   4.0   4.4
12   10.1   0   >10.1
18   6.7   0   >  6.7

 

Phase 3 Trial #D9901


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Secondary Endpoint

Time to Onset of Disease-Related Pain (Gleason £ 7 and ³ 8)

 

Gleason £ 7

  Gleason ³ 8

[CHART]

  [CHART]

 

Phase 3 Trial #D9901


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Provenge Very Well Tolerated*

 

   

APC8015

(n=82)

 

Placebo

(n=45)

 

Median Duration

(days)

Event [n(%)]

           

Rigor

  49 (59.8)   3 (6.7)   1.0

Pyrexia

  24 (29.3)   1 (2.2)   2.0

Headache NOS

  11 (13.4)   1 (2.2)   1.0

Paresthesia

  11 (13.4)   1 (2.2)   2.0

Dyspnea

  9 (11.0)   1 (2.2)   1.0

 

Number (%) of patients with Adverse Events

 

*Occurring in ³10% of patients

p=£0.05 vs. placebo

 

Phase 3 Trial #D9901


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Provenge Trial D9902B

 

  Special Protocol Assessment received from FDA – D9902B will serve as basis for BLA application

 

  Trial enrolling AIPC patients with Gleason score £ 7

 

  Approximately 275 patients will be enrolled into study to support BLA


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Provenge Collaboration Discussions

 

    Discussions progressing as planned

 

    Large market, data and regulatory plan have driven interest

 

    Competitive process

 

    Will be structured as co-development and co-promotion agreement

 

    Global agreement minus Asia and Oceania


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APC8024 Phase 1 Trials

 

Patient Population

 

    18 patients enrolled; 16 evaluated
    Advanced, metastatic breast cancer patients
    Her-2 positive (2+, 3+)
    Failed multiple courses of chemotherapy including 15/16 who failed Herceptin
    Historical median time to progression 3-6 months

 

Endpoints

 

    Safety
    Clinical response
    Immune response


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APC8024 Clinical Response

 

Clinical Benefit

   25% (4/16 patients evaluated)

Partial Response*:

   1 patient, lasting more than 25 weeks

Ongoing Stable Disease:

   1 patient stable 48+ weeks
    

2 patients stable for more than one year

 

No significant side effects reported, no evidence of any cardio toxicity

 

* As determined by a more than 50% reduction in tumor volume


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Dendreon & Genentech

 

Trp-p8 Collaboration


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Trp-p8 Characteristics

 

    Trans-membrane voltage gated Ca2+ channel
    Over-expressed in breast, prostate, lung and colon cancers as well as hyperplastic prostate
    Multiple therapeutic opportunities

- Vaccines

- Monoclonal antibodies

- Small molecules

 

References:

U.S. Patent 6,194,152: Prostate tumor polynucleotide compositions and methods of detection thereof

Published in Cancer Research 61, 3760-9, 2001


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In Normal Human Tissue, Trp-p8 Expression

is Restricted to the Prostate

 

[CHART]


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Trp-p8 is Detected in Primary Cancer

Samples by In Situ Hybridization

 

Tissue Type  

Prostate

Adeno

Ca

 

Breast

Adeno

Ca

  Melanoma  

Colorectal
Adeno

Ca

 

Lung

Ca

Number of samples positive/studied

  16/16   10/14   3/4   13/14   8/10

Normal Breast Tissue

Breast/CA RNA Tissue

  [GRAPHIC]        

Normal Colon Tissue

Colon/CA RNA Tissue

  [GRAPHIC]        


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Trp-p8 – Architecture


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Genentech Trp-p8 Collaboration

 

    Structured as a co-development, co-promotion agreement with profit sharing rights in the U.S.
    Significant upfront and milestone payments
    Genentech responsible for manufacturing and funds majority of manufacturing and clinical trial costs
    Leverage Corvas’ medicinal chemistry expertise for small molecule development
    Dendreon maintains all development and commercialization rights in Asia and Oceania


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Collaboration Milestones

 

    Equity purchases and cash milestone payments

 

    Milestone Events

 

- At deal signing

- Drug candidate identification

- IND filing

- Clinical trial milestones

- BLA submission

- BLA approvals

 

    Total milestone payments could exceed $110 Million


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Corvas Oncology Programs

 

Dendreon Corporation

 

Corvas International


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Serine Protease Cancer Programs

 

    Relevant for prostate cancer

 

    Most well known is PSA

 

    Provide a number of therapeutic opportunities

 

- Inhibition with small molecules or monoclonal antibodies

- As a target for monoclonal antibodies and therapeutic vaccines

- Leverage enzymatic activity for delivery of Prodrugs(PACT)


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Protease Activated Cancer Therapy

(PACT) Program

 

[GRAPHIC]


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CVS-10290 PK—Acute dose of 25mg/kg CVS-10290, IP in DU145 bearing nude mice

 

    Dox peaks at 4 hours in tumors
    At 24 hours dox is still detectable in tumors

 

JB017 25mg/kg CVS-10290 PK

in nude mice/DU145 tumors

 

JB017 25mg/kg CVS-10290 PK

in nude mice/DU145 tumors

[CHART]   [CHART]


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CVS-10290 Efficacy Study Q1dx5

 

DU145 Tumor Volume

Rx Q1 Dx5 d0-4 (imp -29)

 

[CHART]

 

Dose Group

 

max group

% body

weight loss

 

% Tumor

growth

inhibition

 

t test

(p-value)

   

Control

      -        

Dox 1.0mg/kg

  -12%   42   0.1980   3/10 toxic deaths

CVS-10290 20mg/kg

  -9%   71   0.0112    


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Corvas Cardiovascular Program

 

Dendreon Corporation

Corvas International


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rNAPc2 Potent Anticoagulant

 

    Acts at initiation of coagulation cascade by blocking Tissue Factor/Factor VIIa complex

 

    Produces sustained suppression of thrombin generation – a key element in acute coronary syndrome (ACS)

 

    Potent and prolonged duration of action

 

    May complement downstream products (heparins)

 

    Manufacturing process in place

 

    Antidote readily available (NovoSeven®)

 

    Phase 2 studies in patients with ACS

 


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Pro Forma Balance Sheet

 

     Quarter Ending March 31, 2003
     ($ in millions)
     Pro Forma

Cash, cash equivalents, short-term & long-term investments

   $133.8

Working capital

   88.7

Total assets

   143.6

Total stockholders’ equity

   107.6

 


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Expected Milestones and News

Flow

 

Type

     

2003

  2004                   2005

Clinical Data

 

Presentations at upcoming scientific meetings.

Regulatory

     

  Fast track designation — Provenge

Preclinical Milestone

         

Trp-p8 Mab lead selection and DNA milestone payment

Clinical Trials

         

 Complete Phase II Mylovenge studies

Clinical Trials

         

  Complete Phase I studies of APC8024, Design and begin Phase II studies

Business Dev

         

    Announce Provenge collaboration agreement

Business Dev

         

      Trp-p8 collaboration in Asia

   

Clinical Trials

         

      Complete enrollment of Provenge hormone sensitive study (P-11)

Clinical Trials

         

      Complete enrollment of D9902B – Pivotal Provenge study

Clinical Trials

         

        Complete rNAPc2 part I/Phase II program

Preclinical Milestone

             

Trp-p8 small molecule lead and DNA milestone payment

Clinical Trials

                IND CVS-10290 Pro-drug program

Clinical Trials

             

        DN1924 Mab IND

 

DNDN

CVAS

 


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The New Dendreon

 

    Creating a top tier biotech company

 

    Validated therapeutic cancer platform

 

- Near-term market opportunities

- Significant clinical benefit demonstrated with Provenge®

 

    Broad portfolio includes vaccines, monoclonal antibodies, small molecules and prodrugs

 

    Industry leading partners

 

    Capital to invest in promising programs

 


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Dendreon Corporation

 

© Dendreon 2003