Company Profile and Portfolio

Transcription

1 Growing and Nurturing Right Ideas Company Profile and Portfolio January 29, 2008

2 Growing and Nurturing the Right Ideas EOS is a biopharmaceutical company focused on translational medicine in oncology EOS key assets include: A rationally-designed pipeline of innovative projects A founding team with shared values and patient centered attitude A management team and network of key partners with long-standing trust, multidisciplinary skills and track record in the industry EOS is backed since inception by Sofinnova Partners The company is designed and steered to build important value inflection over a 3 to 5-year horizon 2

3 EOS Management & Founders Silvano Spinelli, CEO and Founder Co-Founder and CEO of Novuspharma, proven leader, with 20+ years experience in translating basic science into clinical testing with solid therapeutic product orientation; fund raising, IPO and M&A experience Gabriella Camboni, VP Development and Founder MD, Clinical Pharmacologist, with 18 years of experience in oncology drug development at Sandoz and Boehringer Mannheim, Co-Founder of Novuspharma, and lately European Head of Medical Affairs for Novartis Oncology Ennio Cavalletti, VP Operations and Founder Co-Founder of Novuspharma, DVM, toxicologist, with 20+ years experience in preclinical development of anticancer drugs 3

4 EOS Board of Directors Jacques Theurillat, Chairman and Founder Former Deputy CEO, CFO, S&M President and Country General Manager for Serono where he served as SEVP Strategic Corporate Dev. and Deputy CEO till Dec. 2006; with 20+ years experience in operational, financial and strategic roles Antoine Papiernik Managing Partner at Sofinnova Partners, Paris, since Previously Board member and investor in Novuspharma. Silvano Spinelli 4

5 The Translational Gap The stumbling block in drug development is turning science into clinical progress, i.e. the translational medicine stage Its aim is to reach proof of concept (POC) quickly and reliably, to reduce development risk in the later phases The successful completion of a sound translational medicine program leads to a significant surge in project value Too many products of low clinical potential advance to preregistration disappointing historical success rates in phase III Undeserving programs should be promptly spotted and terminated, focussing resources on the most likely winners Major business opportunities will be harvested by those who can: Select innovative projects and progress them with rigor and discipline Conduct competent, creative and cost effective development, with the ultimate goal of providing significant benefit to patients 5

6 Fitting the Translational Gap 200 M Pharma 1 Bi 20 M 400 M 1 M 100K Project Costs ( ) Research Institutions/ small Biotech 2-3 years Value Inflection & Risk of Failure Reduction 3-5 years 3-6 years 10 M Project Value ( ) Basic Research Target Lead Selection Lead Optimization Preclinical Dev. Phase I Phase IIa Phase IIb Phase III Regulatory Time/Process 6

7 Value Inflection Benchmark of trade sales/partnering deals centered on successful Translational Medicine programs on hot targets in Oncology Trade Sales Acquirer Acquiree Stage Terms 1 Date Pfizer Idun Pharmaceuticals Preclinical USD 300m 02/2005 Roche Glycart Preclinical CHF 235m 06/2005 AstraZeneca Kudos (PARP) Phase I USD 210m 12/2005 Biogen Idec Conforma Phase I EUR 192m 05/2006 Pharmion Cabrelis Phase II USD 59m 11/2006 GSK Domantis Preclinical EUR 347m 12/2006 Partnering Deals Buying Selling Stage Terms 2 Upfront 3 Date Novartis Astex (Kinases Phase I USD 520m 12/2005 Inhib.) Genentech Piramed Preclinical USD 230m 12/2005 Merck & Co Agensys Phase I USD ,5m 10/2005 Genentech Curis Research USD 140m 04/2005 Pharmion Methylgene (Hdac Phase I USD 245m 25m 02/2006 Inhib.) Novartis Infinity (BCL-2 Preclinical USD 370m 03/2006 Inhib.) Medimmune Infinity (HSP90 Phase I USD 430m 70m 09/2006 Inhib.) Roche Plexxicon (BRAF) Preclinical USD 660m 40m 10/2006 Genentech Exelixis (MEK Preclinical USD 40m 01/2007 Inhib.) Kyowa ArQules Phase I USD m 04/2007 Genentech Seattle Genetics Phase I\II USD 860m 60m 01/2007 Figure 2: Benchmark Valuations for Trade Sales and Partnering Deals on Validated Targets ( 1 In cash, 2 Headline value, excluding royalties and upfront;.source Biocentury 3 where available, source PharmaDeals) 7

8 Smart Selection of Good Projects Selection Criteria Focus on hot targets in Oncology creating first/best-inclass low molecular weight agents well credentialed but not well trodden Ideal targets are those where forerunners have: convincing preclinical validation in cellular and animal models tolerability/efficacy profiles encouraging but still not optimal suboptimal scheduling or administration forms scaffolds with sub-optimal pharmaceutical characteristics that suggest room for improvement through chemical modifications 8

9 Smart Selection of Good Projects Selection Process: Broad scouting with comprehensive screening of the biopharmaceutical, biotech and academia milieu Deeper evaluation of ~100 opportunities Due diligence on 10 programs performed Initial portfolio finalized on 5 projects covering multiple and different pathways/mechanisms Further pipeline boosting: Active options under discussion from biotech in the field of kinase inhibitors and novel anti-proliferative mechanisms Open dialogue with several big-pharma and biotech 9

10 EOS Business Model EOS partnering vision is to: source early projects and lead them until value inflexion (POC), assume the investment risk form alliances for later stage development and marketing EOS is an attractive partner for: Bio-pharmaceutical companies: Partnering preclinical projects, to keep them off balance sheet until POC, with the option to take over late stage development and marketing Small, highly innovative biotech companies: Advancing preclinical projects to human studies without reducing key investment in own technology platforms or core programs Academia discovery, lacking resources and industrial know-how: Advancing lead development programs until IND or beyond, sharing the value generated while remaining actively involved 10

11 Smart Selection of Good Projects Pipeline Overview ANTIPROLIFERATIVE SIGNALING WNT Pathway Inhibitors RTK & INTRA-CELLULAR TRANSDUCTION PATHWAYS Several approaches under evaluation Proteasome MODULATING GENE EXPRESSION By interfering with protein homeostasis and histone acetylation HDAC Hsp90 RESTORING APOPTOSIS Inhibition of Bcl-2 Proteins Family 11

12 Project Pipeline: Summary CEP Proteasome Inhibitor Second Generation Phase I Cephalon Development License June 07 Success Milestones Option for Phase II Licensing-in Option HDAC Inhibitors Class selective Innovative & Unique Approach Lead Optimiz. Karus Co-develop. License Sep. 07 Majority of economics Bcl-2 Proteins Family Inhibitors Pro-apoptotic LMW Lead Optimiz. Acquired July 07 All rights retained Wnt Pathway Inhibitors Very Hot Area Innovative Approaches Lead Selection Acquisition under finalization Exp. Jan 18, 2008 All rights retained HSP-90 Inhibitors Protein Homeostasis In silico screening New leads Lead Selection In House - All rights retained 12

13 EOS: present Resources LEAD GENERATION TRANSLATIONAL MEDICINE Hit-2-Lead Lead Optimization Clinical Candidate Selection EIH Enabling Early Clinical Development (to clinical PoC) Medicinal Chemistry & IP CMC & QA 1 IP & Lead Generation Manager; 2 FTE s at EOS lab. at CISI; 6 FTE s Strategic Partneship with ChemPartner; Coop. with Bioarc. 1 FTE outsourced by CMC&QS Pharmacology Toxicity & ADME Biomarker Development Clinical & DRA 1 Pharmacology Manager; 3 FTE s by the Mario Negri Institute Strategic Partneship for in vivo studies, biomarker implementation and IND enabling activities with Accelera (under finalization) FTEs at Mario Negri Institute for pre-clinical and clinical PK/PD Ad hoc cooperations with CROs 1 Clinical Project Manager; Regulatory outsourced; Strategic partnership with SENDO for Phase I and IIa Bold Font: EOS personnel 13

14 Value Creation Paradigm Mi Red Font: Company s Value Black Font: Cumulative Costs Mi 55 9 Lead Dev. To 2 Clinical Candidates Preclinical Development To 2 IND s 2 Clinical Studies to Biomarker- Driven POC

15 EOS: Solid Foundation for Growth In its first 12 months of operations EOS has: Selected an initial portfolio in the lead optimisation stage 4 projects with solid IP and first or best in class potential Development activities up and running two clinical candidates will emerge by the end of 2008 Validated later stage development capabilities through an agreement with Cephalon One phase I trial activated and recruiting Set up a lean and robust infrastructure Minimum number of permanent employees securing strategic know how and management of outsourced activities Reliable network of strategic partnerships and scientific collaborations 16

16 EOS: Partnering/Acquisition Target by 2010 Sustainable Portfolio in unmet Medical Need Indications Robust Data Approvable Solid IP First/Best in Class Projects in Molecular Oncology o Work in Progress o Work in Progress Achieved No Cumbersome Infrastructure Semi-virtual Infrastructure 17