Risk Sharing in Drug Development BIOCOM CRO Committee

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Risk Sharing in Drug Development BIOCOM CRO Committee Workshop 15 September 2011 Athanasios (Thanos) Risk Sharing in Drug Development BIOCOM CRO Committee Workshop 15 September 2011 Athanasios (Thanos) Maroglou, Ph. D. Chief Business Officer, Cato Bioventures Bringing your projects to a higher level Copyright 2010 Cato Research

Risk Sharing in Drug Development Presentation Objective: Examine successful venture-supported models in building viable Risk Sharing in Drug Development Presentation Objective: Examine successful venture-supported models in building viable companies from promising strategic assets Bringing your projects to a higher level Copyright 2010 Cato Research

Biopharma market dynamics • 545 first round financings • more mega-mergers and big acquisitions Biopharma market dynamics • 545 first round financings • more mega-mergers and big acquisitions • Shrinking returns Bringing your projects to a higher level http: //lifescivc. com Copyright 2010 Cato Research

Cato Research • Integrated Clinical Research and Development Organization – Private, international, mid-size company Cato Research • Integrated Clinical Research and Development Organization – Private, international, mid-size company – Founded in 1988 – Approximately 300 employees Bringing your projects to a higher level Copyright 2010 Cato Research

Strategic Locations RTP Rockville Boston San Diego South San Francisco Montréal, Canada Tel Aviv, Strategic Locations RTP Rockville Boston San Diego South San Francisco Montréal, Canada Tel Aviv, Israel Cologne, Germany Graz, Austria Johannesburg, South Africa Hyderabad, India Strategic Alliances: Netherlands, Italy, Spain, Poland, Russia, Ukraine, Korea, France, Japan, China Bringing your projects to a higher level Copyright 2010 Cato Research

CATO Involvement Adds Value • CATO is effective at identifying companies with technologies that CATO Involvement Adds Value • CATO is effective at identifying companies with technologies that have a high probability of success • Through its involvement, CATO is able to identify and streamline the pathway to approval Bringing your projects to a higher level Copyright 2010 Cato Research

Cato Research – History of Impact • Pivotal role in approval of multiple sponsors’ Cato Research – History of Impact • Pivotal role in approval of multiple sponsors’ compounds and therapeutic products – Involved in 3 of the 22 FDA new product approvals in 2008, and 3 approved in 2010 • 13 approved marketing applications have been submitted in e. CTD format – One of the first companies to perform electronic submissions Bringing your projects to a higher level Copyright 2010 Cato Research

CATO Involvement Leading to Marketing Approval Sponsor Product Indication Year of MA 2010 Photocure CATO Involvement Leading to Marketing Approval Sponsor Product Indication Year of MA 2010 Photocure Cysview™ Cystoscopic detection of invasive papillary bladder cancer Vanda Pharmaceucticals Fanapt™ Acute Schizophrenia 2009 Regeneron Arcalyst™ Cryopyrin-Associated Periodic Syndromes (CAPS) 2008 Prestwick Tetrabenazine Chorea of Huntington’s Disease 2008 Photocure Metvixia™ Actinic Keratosis 2008 Astellas Vaprisol® (Conivaptan) Euvolemic hyponatremia 2007 Bringing your projects to a higher level Quality People Quality Data Quality Service Copyright 2010 Cato Research

CATO Involvement Leading to Marketing Approval Indication Year of Marketing Approval Sponsor Product United CATO Involvement Leading to Marketing Approval Indication Year of Marketing Approval Sponsor Product United Therapeutics Remodulin ® Pulmonary arterial (Treprostinil) hypertension 2006 CV Therapeutics Renaxa™ Chronic angina 2006 TEVA Azilect(Rasagi line) Parkinson's disease 2006 Cryo. Cath Technologies, Inc. Freezor Max ® Cardiac arrhythmias Freezor XTRA Astellas VESIcare ® 2006 ® Bladder and urinary tract 2004 muscle spasms Bringing your projects to a higher level Quality People Quality Data Quality Service Copyright 2010 Cato Research

CATO Involvement Leading to Marketing Approval Sponsor Product Indication Year of Marketing Approval Serono CATO Involvement Leading to Marketing Approval Sponsor Product Indication Year of Marketing Approval Serono Nutre. Store™ Zorbtive™ (somatopin) Short bowel syndrome 2004 Schering Plough Doxie/Caclyx (liposomal doxorubicin) Metastatic breast cancer 2004 Eli Lilly Humalog ® (Insulin Lispro) Diabetes mellitus 2004 California Department of Health Services Baby. BIG ® Infant Botulism types A 2003 and B Merz/Forrest Nameda (Memantine) Dementia of Alzheimer 2003 type Bringing your projects to a higher level Quality People Quality Data Quality Service Copyright 2010 Cato Research

Cato Bioventures • • • Venture capital affiliate of Cato Research Internally funded for Cato Bioventures • • • Venture capital affiliate of Cato Research Internally funded for over 20 years Broad investment focus Multiple investment models Leverage Cato Research “CRO Service Capital®” – – Strategic Scientific development partnerships Extensive development and regulatory expertise Unique portfolio management model Proven track record Bringing your projects to a higher level Copyright 2010 Cato Research

Wholly Owned Model • Technology New. Co Model – Acquire technology – Advance the Wholly Owned Model • Technology New. Co Model – Acquire technology – Advance the technology for 24 to 36 months in a majority-owned portfolio company by leveraging CRO Service Capital® and modest internal funding – Exit through M&A or out-licensing Bringing your projects to a higher level Copyright 2010 Cato Research

Example • Intellectual property – Patent covering a • combination therapy for obesity-related hypertension Example • Intellectual property – Patent covering a • combination therapy for obesity-related hypertension • Scientific Expertise • • • Drug Development Resources – Nonclinical – CMC Regulatory Expertise Startup Capital Management Bringing your projects to a higher level Copyright 2010 Cato Research

Portfolio Companies Cato Holding Company (Founded 1988) Cato Bioventures Cato Research Ltd (CBV) (Outsourcing Portfolio Companies Cato Holding Company (Founded 1988) Cato Bioventures Cato Research Ltd (CBV) (Outsourcing Partner) Advanced Pain Remedies Hemodynamic Therapeutics Indication: Pain Pre-IND opportunity Indication: Hypertension Phase 2 b opportunity Cancer Advances Indication: Oncology Phase 3 opportunity Bringing your projects to a higher level Copyright 2010 Cato Research

Technology New. Co Exits St Elizabeth’s Hospital, CBV, Human Genome Sciences VEGF-2 gene therapy Technology New. Co Exits St Elizabeth’s Hospital, CBV, Human Genome Sciences VEGF-2 gene therapy for cardiovascular disease Exit = Pubco M&A (VGI) Univ. of Miami and CBV Drug-delivery technology for insoluble drugs Exit = Pubco M&A Skye Pharma (SKYE) Topical penetration enhancer for dermatologic applications FDA approvable letter for lead compound Exit = Pubco M&A Echo Therapeutics (ECTE. OB) NRP NRC, Brigham and Women’s Hospital, Serono and CBV Proprietary combination therapy for the treatment of short bowel syndrome Obtained FDA approval Exit = License to Pharma Emmaus Medical Bringing your projects to a higher level Copyright 2010 Cato Research

Risk Sharing Model • Strategic Scientific Development Partnership – Strategic Master Services Agreement – Risk Sharing Model • Strategic Scientific Development Partnership – Strategic Master Services Agreement – CRO Service Capital® for minority equity – Immediate access to milestone-enabling CRO services – Start-up & Special Warrant structure – Typical investment covers up to 20% of partner’s projected development and regulatory needs Bringing your projects to a higher level Copyright 2010 Cato Research

Portfolio of Active Investments Partial list: Bringing your projects to a higher level Copyright Portfolio of Active Investments Partial list: Bringing your projects to a higher level Copyright 2010 Cato Research

PIPE Model • PIPE – Private Investment in a Public Entity – Immunovaccine, Inc. PIPE Model • PIPE – Private Investment in a Public Entity – Immunovaccine, Inc. – Neuren Pharmaceuticals Bringing your projects to a higher level Copyright 2010 Cato Research

Summary • Flexible venture financing models • Product/technology validating due-diligence process smoothes venture capital Summary • Flexible venture financing models • Product/technology validating due-diligence process smoothes venture capital funding • Fast and efficient IND filing • Design and run market focused POC clinical studies • Excellent regulatory agency interaction • Support from fund raising all the way to a profitable exit Bringing your projects to a higher level Copyright 2010 Cato Research




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