SLIDES USED IN MEETINGS WITH STOCKHOLDERS OF DENDREON CORPORATION AND OF CORVAS INTERNATIONAL, INC. BEGINNING APRIL 15, 2003
Filed by Dendreon Corporation Pursuant to Rule 165 and Rule 425 under the Securities Act of 1933 and deemed filed pursuant to Rule 14a-12 under the Securities Exchange Act of 1934
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Subject Company: Corvas International, Inc. Form S-4 File No. 333-104167 |
This filing relates to the proposed 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 (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 as an exhibit to the Current Report on Form 8-K filed by Dendreon on February 25, 2003, and is incorporated by reference into this filing.
The following are slides from presentations made to various stockholders of Dendreon and of Corvas beginning April 15, 2003.
DENDREON
CORPORATION
CORVAS
INTERNATIONAL
Building a Premier Biotechnology Company
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), filed on March 31, 2003, under the caption "Risk Factors."
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 preliminary joint proxy statement/prospectus with respect to the combination and other relevant materials. The Registration Statement has not been declared effective by the SEC. 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 WHEN IT BECOMES AVAILABLE, BECAUSE THEY CONTAIN IMPORTANT INOFRMATION ABOUT DENDREON, CORVAS AND THE COMBINATION. The preliminary joint proxy statement/prospectus and other relevant materials, and any other 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.
In addition, investors and security holders may obtain free copies of the 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 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 preliminary joint proxy statement/prospectus. Information about the executive officers and directors of Corvas and their ownership of Corvas common stock is set forth 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 preliminary joint proxy statement/prospectus.
Dendreon Corporation
Developing targeted therapies for the treatment of cancer
o Immunotherapeutic cancer programs
- Provenge®, MylovengeTM, APC8024, Trp-p8, NY-ESO, CEA, MN, Telomerase
o Monoclonal antibodies and small molecules
- Trp-p8, DN1921, DN1924
o Industry leading collaborators
- Genentech, Inc., Kirin Brewery Co., Ltd.
Momentum Continues in 2003
Corvas Acquisition
o Stock for stock transaction
o Valued at $73 M, based on Dendreon stock price as of 2/24/03, an 83% premium to Corvas' stock price as of the same date
o Dendreon will own 68.3% and Corvas stockholders will own 31.7%, based on current capitalization
o 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
Combining Strengths
Technology
o Broad oncology portfolio covering 4 platforms
o 5 ongoing clinical programs
o Enhanced intellectual property estate, 87 issued U.S. patents
o Small molecule, medicinal chemistry expertise
Operations
o Experienced management team
o Clinical development expertise
o Research and development expertise
o Collaborations with industry leaders
Financial
o Combined balance sheet of approximately $110M at 6/30/03
o Resources to fuel Provenge development
o Resources to advance other clinical and preclinical programs
Preclinical Synergies 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 |
DVDN
CVAS
Advanced Clinical Trial Pipeline
Product / Target Phase 1 Phase 2 Phase 3
Provenge(®)
Androgen Independent Prostate Cancer
D9901
D9902
Androgen Dependent Prostate Cancer
Mylovenge(TM)
Multiple Myeloma
rNAPc2
Acute Coronary Syndromes
APC8024
Breast, Ovarian, Colon Cancers
DVDN
CVAS
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
Provenge® Phase 3 Trial (D9901)
(Chart)
- First randomized, double blind, placebo controlled Phase 3 study of a cancer vaccine
- Advanced androgen independent prostate cancer patients
- No existing treatment options (except palliatives for pain)
- Primary endpoint - Median time to objective disease progression
- Secondary endpoint - Delay in onset of disease-related pain
Primary Efficacy Analysis (ITT)
Time from randomization to disease progression
(Chart)
Phase 3 Trial #D9901
Gleason Score
o Routinely performed prostate grading system
- Histologic measure of aggressiveness of tumor
- Patients with score of < 7 tend to have better prognosis
o Majority (75%) of androgen independent patients have a score of 7 or less
o Pre-specified subgroup for analysis
o Single most important predictor of response to Provenge treatment
Efficacy Analysis: Gleason < 7
Time to objective disease progression (Kaplan-Meier method): Primary Efficacy Analysis, Gleason Score < 7, Intent-to-Treat Patients
(Chart)
Phase 3 Trial #D9901
Comparison of Gleason Subgroups
Subgroup Analysis: Gleason < 7
(Chart)
Subgroup Analysis: Gleason > 8
(Chart)
Phase 3 Trial #D9901
Progression Analysis: Gleason < 7
Time to Progression (weeks)
Provenge Placebo
(N=50) (N=25) Treatment Effect
Median 16.0 9.0 1.78
Progression Free Survival Rate
(percent)
Provenge Placebo Treatment Effect
Months
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
Secondary Endpoint
Time to Onset of Disease-Related Pain (Gleason < 7 and > 8)
Gleason < 7
(Chart)
Gleason > 8
(Chart)
Phase 3 Trial #D9901
Provenge Very Well Tolerated*
| Event [n(%)] | |||
| Rigor | |||
| Pyrexia | |||
| Headache NOS | |||
| Paresthesia | |||
| Dyspnea | |||
Number (%) of patients with Adverse Events
*Occurring in >10% of patients
p= <0.05 vs. placebo
Phase 3 Trial #D9901
Results of Recent FDA Discussions
o Recognized that D9901 data is promising and would be supportive to filing
o Patients with Gleason score < 7 are relevant population on which to base approval
o Modified existing D9902 trial (D9902B) will provide basis for registration
o Approximately 275 patients will be enrolled into study D9902B to support BLA
Worldwide Prostate Cancer
Therapeutic Sales
$2.76 billion in 2001
(Chart)
Source: Med Ad News; IMS Health
Provenge Collaboration Discussions
o Large market with unmet need
o Receipt of 9901 data and agreement from FDA have driven high level of interest in Provenge
o Competitive process
o Will be structured as co-development and co-promotion agreement
o Global agreement minus Asia and Oceania
APC8024 Phase 1 Trials
Patient Population
o Advanced, metastatic breast, ovarian and colon cancer patients
o Her-2 positive
o Failed all conventional therapies including Herceptin
Endpoints
o Safety
o Clinical response
o Immune response
D2000-2 Clinical Response
Status of 11 patients evaluated
Stable 5 (45%)
Partial Response* 1 (9%)
* As determined by a more than 50% reduction in tumor volume
Dendreon & Genentech
Trp-p8 Collaboration
Trp-p8 Characteristics
o Trans-membrane voltage gated Ca2+ channel
o Over-expressed in breast, prostate, lung and colon cancers as well as hyperplastic prostate
o 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
In Normal Human Tissue, Trp-p8 Expression is Restricted to the Prostate
(Chart)
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 (Chart)
Normal Colon Tissue
Colon/CA RNA Tissue (Chart)
Trp-p8 -Architecture
Trp-p8 -Therapeutics
Genentech Trp-p8 Collaboration
o Structured as a co-development, co-promotion agreement with profit sharing rights in the U.S.
o Significant upfront and milestone payments
o Genentech responsible for manufacturing and funds majority of manufacturing and clinical trial costs
o Leverage Corvas' medicinal chemistry expertise for small molecule development
o Dendreon maintains all development and commercialization rights in Asia and Oceania
Collaboration Milestones
o Equity purchases and cash milestone payments
o Milestone Events
- At deal signing
- Drug candidate identification
- IND filing
- Clinical trial milestones
- BLA submission
- BLA approvals
o Total milestone payments could exceed $110 Million
Corvas Oncology Programs
DENDREON CORPORATION
CORVAS INTERNATIONAL
Serine Protease Cancer Programs
[CHART]
- Relevant for prostate cancer
- Most well known is PSA
- Provide a number of therapeutic opportunities
–Inhibition with small molecules or monoclonal antibodies
–As a target for monoclonal antibodies and therapeutic vaccines
–Leverage enzymatic activity for delivery of Prodrugs(PACT)
Protease Activated Cancer Therapy (PACT) Program
[CHART]
CVS-10290 PK - Acute dose of 25mg/kg CVS-10290, IP in DU145 bearing nude mice
Dox peaks at 4 hours in tumors
At 24 hours dox is still detectable in tumors
[CHART]
CVS-10290 Efficacy Study Q1dx5
[CHART]
| Dose Group | % body weight loss | growth inhibition | (p-value) | |
| Control | ||||
| Dox 1.0 mg/kg | ||||
| CVS-10290 20mg/kg |
Corvas Cardiovascular Program
DENDREON CORPORATION
CORVAS INTERNATIONAL
rNAPc2 Potent Anticoagulant
- Acts at initiation of coagulation cascade by blocking Tissue Factor/Factor VIIa complex
- Produces sustained suppression of thrombin generation - - a key element in acute coronary syndrome (ACS)
- Potent and prolonged duration of action
- May complement downstream products (heparins)
- Manufacturing process in place
- Antidote readily available (NovoSeven®)
- Phase 2 studies in patients with ACS
[CHART]
ANTHEM TIMI 32 Phase 2 Trial design
| Part 1 - Dose Escalation Initial safety experience Go or no go decision 2H 2003 | ||
| Part 2 - Dose Ranging Evaluate safety & efficacy Seek Collaborator | ||
| Part 3 - Dose Confirmation Select dose for Phase 3 Conducted with Collaborator | ||
Pro Forma Balance Sheet
| Year Ending Dec. 31, 2002 ($ in millions) | |
| Pro Forma 2002 | |
| Cash, cash equivalents, short-term & long-term investments | $145.5 |
| Working capital | 100 |
| Total assets | 158.3 |
| Total stockholder's equity | 119.9 |
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
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 monoclonal antibodies, small molecules, and prodrugs
- Industry leading partners
- Capitalized to invest in promising programs
DENDREON CORPORATION
©Dendreon 2003