Filed by Discovery Partners International, Inc. Pursuant to Rule 425
Under the Securities Act of 1933
and Deemed Filed Pursuant to Rule 14a-12
Under the Securities Exchange Act of 1934
Subject Company: Infinity Pharmaceuticals, Inc.
Commission File No. 333-134438
This filing relates to the Agreement and Plan of Merger and Reorganization, dated as of April 11, 2006 (the Merger Agreement), by and among Discovery Partners International, Inc. (DPI), Darwin Corp. and Infinity Pharmaceuticals, Inc. (Infinity). The Merger Agreement was attached as Exhibit 1.1 to a Form 8-K filed by DPI with the SEC on April 12, 2006, and is incorporated by reference into this filing.
Infinity gave the following presentation at the Pacific Growth Equities Life Science Growth Conference on June 12, 2006.
Pacific Growth Equities Life Science Growth Conference Steven Holtzman, CEO June 12, 2006
Forward-Looking Statement
Various statements in this presentation concerning our future expectations, plans and prospects constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding the proposed transaction with Discovery Partner Internationals (DPI), DPI and the combined companys net cash at closing, the trading of the combined companys shares on the NASDAQ National Market, the potential value created by the proposed merger for DPIs and Infinitys stockholders, DPIs deployment of its resources and ability to engage in strategic transactions or divest its various business units, the efficacy, safety, and intended utilization of Infinitys product candidates, the conduct and results of discovery efforts and clinical trials, and plans regarding regulatory filings, future research and clinical trials and plans regarding current and future collaborative activities. Actual results may differ materially from those indicated by such forward-looking statement as a result of various factors, including risks related to: the ability of DPI and Infinity to complete the proposed transaction; the availability of funds to continue research and development activities; the results of future clinical trials with respect to Infinitys product candidates and compounds; the success of Infinitys collaborations and its ability to enter into additional collaborations; Infinitys ability to successfully develop and commercialize product candidates; the timing and success of regulatory filings; DPIs ability to divest itself of or otherwise transfer ownership of some or all of its operating assets on satisfactory terms or at all; the amount of DPIs net cash at closing; the scope of Infinitys patents and the patents of others; Infinitys ability to attract and retain qualified personnel; and other risks and uncertainties more fully described in DPIs filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2005, quarterly report on Form 10-Q for the quarter ended March 31, 2006 and Registration Statement on Form S-4, as filed on May 24, 2006. The proposed transaction is subject to customary closing conditions, including approval of DPIs and Infinitys stockholders.
Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. DPI undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
2 |
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Mission
To develop targeted therapies for the treatment of cancer and related conditions discovered through the use of our innovative small molecule drug technologies
3 |
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Making Cancer a Non-Lethal Disease
Strategy
Choose drug targets that are well-credentialed, but not well-trodden
Develop first-in-class or fast-follower best-in-class medicines
Pursue fastest path to registration; broaden thereafter
Enter selective strategic alliances to maximize value, retaining significant product rights
Leverage Infinitys small molecule technologies
Create a culture and community maximally conducive to innovation
4 |
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Product Pipeline: IPI-504 (Hsp90)
Discovery
Preclinical
IND Filing
Clinical Trials
IPI-504 (Hsp90)
2005
Phase I ongoing
Phase II expected by early 2007
Hedgehog
Pathway
(e.g., IPI-609)
Phase I expected by early 2007
Bcl2/Bcl-xL &
Additional
Targets
2007/2008 forward
On-going studies
TBD based on data/results
5 |
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Lead Clinical Product: IPI-504
Broad activity, multiple cancers
Single agent activity
Synergy in combination
Activity in resistant settings
Large therapeutic window
2nd generation oral formulation under development
Cl -
H+H
NH
OH
Me
NH2
IPI-504
6 |
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IPI-504: Clinical Plan
Phase I
Multiple myeloma
GIST
Combinations
Phase II
MM / GIST
Other indications
2005
2006
2007
2008
Multiple myeloma
GIST
Phase Ib combinations
Phase II MM or GIST
Phase II additional indication or combination
On-going trial
TBD based on data/results
7 |
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IPI-504: Broad Market Potential
Hematologic
malignancies
Indications
Multiple Myeloma (MM)
Chronic Myelogenous Leukemia (CML)
Acute Myelogenous Leukemia (AML)
Non-Hodgkins Lymphoma (NHL)
Solid
tumors
Gastrointestinal Stromal Tumors (GIST)
Breast cancer (HER2+)
Non-small cell lung cancer (NSCLC)
Renal cell carcinoma
Malignant Melanoma
Hormone Refractory Prostate cancer (HRPC)
8 |
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Heat Shock Protein 90 (Hsp90)
Emerging cancer target
Stabilizes proteins in
functional conformations
Two roles in cancer
Generally: Maintaining protein homeostasis in cancer cells
Specifically: Stabilization of key oncoproteins, including drug-resistant ones
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Targeted Cancer Therapies
The New Frontier
Hematologic
Molecular Target
NF-kB
Bcr-Abl
Flt3
Targeted therapy
Velcade
Gleevec / Dasatinib
Investigational
Indication
Myeloma
CML
AML
Solid tumor
c-Kit
HER2
EGFR
VEGFR / HIF-1a
b-Raf
p-Akt
Gleevec / Sutent
Herceptin
Tarceva / Erbitux
Sorafenib / Sutent
Sorafenib
Investigational
GIST
Breast (HER2+)
NSCLC
Renal cell
Melanoma
Prostate (PTEN -/-)
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Targeted Cancer Therapies
The New Frontier
Molecular Target
Hematologic
Solid tumor
NF-kB
Bcr-Abl
Flt3
c-Kit
HER2
EGFR
VEGFR / HIF-1a
b-Raf
p-Akt
All are Hsp90 clients
Inhibiting Hsp90 affects the stability of these targets
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Hsp90: Potential Universal Salvage Therapy
Disease
CML
GIST
NSCLC
Hsp90 Client
BCR-ABL
KIT
EGFR
Drug
Gleevec,
Dasatinib
Gleevec,
Sutent
Iressa, Tarceva
Kinase Inhibitor Resistance
Mutation
T315I
T670I
T790M
Highly responsive to Hsp90 inhibition
Alternative to chasing mutations
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Oral IPI-504: Survival Benefit
Gleevec-resistant T315I
CML transplantation model
% survival
100.0% 80.0% 60.0% 40.0% 20.0% 0.0%
15 17 19 21 23 25 27 29 31 33
Days
Placebo
Gleevec
IPI-504
Collaboration:
Shauguang Li, Jackson Labs
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Oral IPI-504: Survival Benefit
Gleevec-resistant T315I
CML transplantation model
% survival
100.0% 80.0% 60.0% 40.0% 20.0% 0.0%
15 17 19 21 23 25 27 29 31 33
Days
Placebo
Gleevec
IPI-504
Collaboration:
Shauguang Li, Jackson Labs
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Oral IPI-504: Survival Benefit
Gleevec-resistant T315I
CML transplantation model
% survival
100.0% 80.0% 60.0% 40.0% 20.0% 0.0%
15 17 19 21 23 25 27 29 31 33
Days
Placebo
Gleevec
IPI-504
Collaboration:
Shauguang Li, Jackson Labs
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IPI-504: Clinical Goals for Remainder 2006/Early 2007
Phase I MM trial: complete
Phase I GIST trial: complete
Phase II MM and/or GIST trial: initiate
Additional potential indications and milestone events
Phase I combination studies (e.g. Taxotere, Velcade, Gleevec)
Additional Phase II studies (e.g. NSCLC, CML, CLL)
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Product Pipeline: Hedgehog Pathway (e.g., IPI-609)
Discovery
Preclinical
IND Filing
Clinical Trials
IPI-504 (Hsp90)
2005
Phase I ongoing
Phase II expected by early 2007
Hedgehog
Pathway
(e.g., IPI-609)
Phase I expected by early 2007
Bcl2/Bcl-xL &
Additional
Targets
2007/2008 forward
On-going studies
TBD based on data/results
17
IPI-609: Most Advanced Preclinical Candidate
Potent hedgehog pathway inhibitor
Expected first-in-class systemic hedgehog inhibitor
Proprietary NCE
Oral product
Back-up candidates identified
Broad anti-cancer potential
Strong data supporting pancreatic, metastatic prostate, SCLC, others
Single agent activity
Potential for synergy with standards of care
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Hedgehog Pathway (e.g., IPI-609): Clinical Plan
2005
IND-enabling studies
Pharmacology
GLP toxicology
Manufacturing
2006
F
I
L
E
I
N
D
2007
Clinical development
Phase I
Pancreatic
SCLC
Met Prostate, etc.
Heme malignancies
2008
Phase II
Single or combo
Phase II or III
Registration trial
On-going studies
TBD based on data
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IPI-609: Preclinical Efficacy Rationale
PC3 prostate cancer xenograft
Tumor volume (mm3)
Tumor Volume
1600 1400 1200 1000 800 600 400 200 0
Vehicle
IPI-609 10 mpk/day
31 36 41 46 51 56 61
Days
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Hedgehog Pathway: Broad Rationale in Solid Tumors
Human tumor biopsy data
State |
|
Pathway activation |
Normal |
|
OFF |
Basal |
|
cell carcinoma1,2 ON |
Medulloblastoma3 |
|
ON |
Pancreatic |
|
cancer4,5,6 ON |
Prostate |
|
cancer7,8 ON |
Small |
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cell lung cancer9 ON |
Hepatocellular |
|
cancer10 ON |
Breast |
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Cancer11 ON |
1Hahn et al., 1996, Cell 85: 841
2Bale & Yu, 2001, Human Molec. Genetic. 10: 757 (review) 3Berman et al., 2002 Science 297: 1559 4Berman et al., 2003 Nature 425: 846 5Kayed et al., 2004 Int. J. Cancer 110: 668
6Thayer et al., 2003 Nature 425: 851
7 Karhadkar et al., 2004 Nature, 431: 707
8 Fan et al., 2004 Endocrinology 145: 3961
9 Watkins et al., 2003, Nature 422: 313
10 Sicklick 2005 ASCO; Mohini, 2005 AACR
11 Kubo et al., 2004 Cancer Res. 64 :6071
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Product Pipeline: Bcl and Additional Targets
Discovery
Preclinical
IND Filing
Clinical Trials
IPI-504 (Hsp90)
2005
Phase I ongoing
Phase II expected by early 2007
Hedgehog Pathway (e.g., IPI-609)
Phase I expected by early 2007
Bcl2/Bcl-xL & Additional Targets
2007/2008 forward
On-going studies
TBD based on data/results
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Bcl-2 / Bcl-xL Antagonists: Opportunities
Therapeutic Applications
Bcl family of proteins: key anti-apoptotic factors
Up-regulated in many cancers
Up-regulated in response to chemotherapy in many cancers
Highly attractive but historically intractable
Protein-protein interaction targets
Prospective products
Combination with chemotherapy: general chemo-sensitizing agent
Single agent: in cancers dependent on Bcl family members for survival
Types of products:
Bcl-2 selective
Bcl-2 and Bcl-xL dual selective
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Bcl: 2006 Novartis Alliance
ACTIVITIES
Joint discovery (led by Infinity) Joint development (led by Novartis) Worldwide marketing by Novartis with Infinity US co-promotion
FINANCIALS
Upfront & near $30M term committed
Total potential >$400M payments* Royalties on WW sales
Accelerates, expands value creation
* If all development and commercialization milestones for multiple product candidates are met.
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DOS Technology Alliances: Small Molecules
Diversity Oriented Synthesis (DOS)
2004 2006: > $60 million upfront/committed cash
Non-dilutive capital and capability expansion
Additional milestone and royalty potential No license of proprietary Infinity product rights
R3 O
N O H
H
O R3 N H H
R2 O
R4
R1
N R3 R2 O O
O
NR4
O
SR2
OH
R1O N
R3
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Pipeline & Partnerships
Ownership of most advanced candidates retained
Discovery
Preclinical
Start Clinical Trials
IPI-504 (Hsp90)
2005
100% owned
Hedgehog Pathway (e.g., IPI-609)
By early 2007
100% owned
Bcl2/Bcl-xL
2007/2008
Novartis
Non-exclusive
Amgen Novartis J&J
Small molecule drug technologies
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Leadership: Combined Company
Mr. Steven Holtzman, Chairman & CEO
Millennium, DNX
Dr. Julian Adams, President & CSO
Millennium, ProScript Boehringer Ingelheim, Merck
Ms. Adelene Perkins, EVP & CBO
Transform, Genetics Institute, Bain, GE
Dr. Christine Bellon, Sr Patent Counsel
Wyeth, Fish & Richardson
Dr. Michael Foley, VP Chemistry
Harvard ICCB, Glaxo, BMS
Dr. Christian Fritz, Sr Dir Cancer Biology
Millennium, Chemgenix
Dr. David Grayzel, VP Clinical Dev/Med Affairs
Dyax, Mass General Hospital
Dr. Vito Palombella, VP Biology
Syntonix, Millennium, ProScript
Dr. Margaret Read, Sr Dir Cancer Biology
Millennium, ProScript
Dr. Jeffrey Tong, VP Corp & Product Dev
McKinsey & Co, Harvard Center for Genomics Research
Dr. Jim Wright, VP Pharm Dev
Millennium, Alkermes, Boehringer Ingelheim, U. of Wisconsin
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Projected Board of Directors: Combined Company
Steven Holtzman, Chairman Ron Daniel Dr. Tony Evnin Dr. Eric Lander Patrick Lee Dr. Arnold Levine Dr. Frank Moss Dr. Vicki Sato Dr. James Tananbaum Dr. Michael Venuti Mr. Harry Hixson Mr. Herm Rosenman
Infinity Pharmaceuticals, Inc
McKinsey & Co. (former Managing Partner) Venrock Associates Director Broad Institute, Whitehead, MIT Advent Venture Partners Institute for Advance Study Director MIT Media Lab; Founding CEO Tivoli Former Vertex and Biogen Prospect Venture Partners Discovery Partners, Celera BrainCells, Amgen Gen-Probe
28
Infinitys Financial and Pharmaceutical Investors
Prospect Venture Partners Venrock Associates Advent Venture Partners HBM BioVentures Vulcan Ventures Wellcome Trust POSCO BioVentures Tallwood Alexandria Equities Lotus BioScience
Amgen Novartis J&J
29
Reverse Merger with
Discovery Partners International, Inc.
(Nasdaq: DPII)
30
Infinity-Discovery Partners International (DPII) Merger
DPII rationale
Response to dramatic changes in discovery business
Outsourcing to India, China
Price pressures
Better upside for investors in near-term product opportunities with significant potential Therefore: divest and invest
31
Why DPII Chose Infinity?
Thorough evaluation
Top-tier private company
Multiple near-term value driving events
Ongoing clinical trials
Pipeline
Partnerships
Management that has discovered drugs and built companies Invest in/create a security with market-recognized value
32
Infinity-DPII Merger
Infinity rationale
Efficient, timely access to capital
Clinical trial / preclinical pipeline funding
Generate efficacy data on lead product candidate, IPI-504
Accelerate and expand Infinity pipeline
33
Snapshot of Post-Merger Infinity
Lead clinical product in two ongoing Phase I cancer studies
Phase II expected by early 2007
Pipeline of preclinical cancer drug candidates
Internally discovered and developed, chemistry platform
4 Pharma/Biotech corporate alliances
Amgen, J & J and Novartis (2)
Cash pro forma Q1: $100 million Proven biotech leadership team
34
Key Merger Terms
A financing event
DPII invests cash and divests operating units
If DPII cash between $70M and $75M, ownership:
DPII shareholders = 31%
Infinity shareholders = 69%
If cash above $75M or below $70M, adjustment applied
35
Merger Timetable
Approval of both companies BOD Public announcement of transaction File S-4 SEC comment period
Joint proxy statement / prospectus to DPII, Infinity stockholders
DPII and Infinity Stockholder votes
If approved
DPII shares issued
Infinity traded as public company
April 11
April 12
May 24 By Early July
By Late-July By Late-August Following vote
36
2006 Goals, Achievements and Anticipated News Flow
Product Pipeline
IPI-504: Complete Phase I trials
IPI-504: Expect to initiate Phase II by early 2007
Hedgehog Pathway (e.g., IPI-609): Expect to initiate Phase I by early 2007
Pipeline: New INDs / programs for 2007+
Successful alliance execution (Novartis, J&J, Amgen) At least one new corporate alliance Financing event
Year-end cash runway: > 12-24 months
NVS Bcl
Pending
DPII merger
37
www.IPI.com
Forward Looking Statements
Various statements in this filing concerning Infinity Pharmaceuticals, Inc. (Infinity), Discovery Partners International, Inc. (DPI) and the combined companys future expectations, plans and prospects constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding the proposed transaction between Infinity and DPI, DPI and the combined companys net cash at closing, the trading of the combined companys shares on the NASDAQ National Market, the potential value created by the proposed merger for DPIs and Infinitys stockholders, DPIs deployment of its resources and ability to engage in strategic transactions or divest its various business units, the efficacy, safety, and intended utilization of Infinitys product candidates, the conduct and results of discovery efforts and clinical trials, and plans regarding regulatory filings, future research and clinical trials and plans regarding current and future collaborative activities. Actual results may differ materially from those indicated by such forward-looking statement as a result of various factors, including risks related to: the ability of DPI and Infinity to complete the proposed transaction; the availability of funds to continue research and development activities; the results of future clinical trials with respect to Infinitys product candidates and compounds; the success of Infinitys collaborations and its ability to enter into additional collaborations; Infinitys ability to successfully develop and commercialize product candidates; the timing and success of regulatory filings; DPIs ability to divest itself of or otherwise transfer ownership of some or all of its operating assets on satisfactory terms or at all; the amount of DPIs net cash at closing; the scope of Infinitys patents and the patents of others; Infinitys ability to attract and retain qualified personnel; and other risks and uncertainties more fully described in DPIs filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2005, quarterly report on Form 10-Q for the quarter ended March 31, 2006 and Registration Statement on Form S-4, as filed on May 24, 2006. The proposed transaction is subject to customary closing conditions, including approval of DPIs and Infinitys stockholders.
Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. DPI undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Additional Information about the Merger and Where to Find It
In connection with the proposed merger between DPI and Infinity described herein, DPI filed a registration statement on Form S-4 on May 24, 2006 with the SEC, that contains a proxy statement/prospectus. Investors and security holders of DPI and Infinity are urged to read the proxy statement/prospectus (including any amendments or supplements to the proxy statement/prospectus) regarding the proposed merger because it contains important information about DPI, Infinity and the proposed merger. Security holders will be able to obtain a copy of the proxy statement/prospectus, as well as other filings containing information about DPI and Infinity, without charge, at the SECs Internet site (http://www.sec.gov). Copies of the proxy statement/prospectus can also be obtained, without charge, by directing a request to Discovery Partners International, Inc., 9640 Towne Centre Drive, San Diego, CA 92121, Attention: Investor Relations, Telephone: (858) 455-8600.
Participants in the Solicitation
DPI and its directors and executive officers and Infinity and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of DPI in connection with the proposed merger of DPI with Infinity. Information regarding the special interests of these directors and executive officers in the merger transaction is included in the proxy statement/prospectus referred to above. Additional information regarding the directors and executive officers of DPI is also included in DPIs proxy statement for its 2006 Annual Meeting of Stockholders, which was filed with the SEC on April 6, 2006. This document is available free of charge at the SECs web site (www.sec.gov) and from Investor Relations at DPI at the address described above.