GTCbio, Hilton Airport/Harbor Island, San Diego, CA
May 17-18, 2004
Anti-Viral/Microbial Partnering and Dealmaking Summit
May 17-18, 2004 – Hilton Airport/Harbor Island, San Diego, CADAY ONE, 17 May 2004, Monday:
------------------------------------------------------------------------------------------------------------ 8:15 Registration, Breakfast, and Exhibiting 9:15 Chairperson’s Opening Remarks
David Palella, President, BioScience Ventures 9:30 Keynote Address
Trends Affecting the Future of Drug Development and Commercialization
Gary Cupit, Vice President, Global Business Development and Licensing, Novartis • Development of therapeutic agents for commercialization has seen greater expectations from shareholders and the financial community pressures.
• Emerging, fully integrated biotechs are competing with large pharmaceutical companies for assets.
• Decreasing competitive life cycles, more complex FDA reviews, pricing and reimbursement concerns, and the influence of consumer marketing have driven costs higher than anticipated.
• Assumptions in planning for sales productivity, marketing effectiveness, and regulatory review must be challenged.
• Global markets are evolving at differing rates influenced by economic as well as regulatory and pricing changes. 10:15 Keynote Address
A Wall Street Perspective on Capital Markets and M&A/Partnering Trends
Bob Maggiacomo, Managing Partner, Synergy Advisors, LLC This presentation will provide an update on current capital markets conditions and trends relating to biotech companies focused in the infectious disease arena. The review will also address the inter-relationship of capital markets conditions with M&A and partnership deal making trends. Major topics to be covered are current:
• investor sentiment and analysts’ perspectives
• capital raising trends and techniques
• valuation levels
• key trends in partnering and M&A deals
• implications for mergers and acquisitions and deal making activity
• effectively communicating M&A deals to the investor/financial community in the current environment. 11:00 Networking, Refreshments, and Exhibiting 11:30 Emerging Company Showcase: 11:30 Making Drugs from Biologically Active Chemicals
Presented by Kevin P. Anderson, Ph.D.
Vice President Business Development, Chimerix, Inc. Chimerix rapidly creates new, proprietary pharmaceutical products from known bioactive molecules using robust, proprietary chemistry. Existing bioactive molecules with dosing limitations are modified to mimic natural lipid metabolites resulting in enhanced intracellular delivery, improved oral availability, and broad tissue distribution. Chimerix has applied its technology to identify orally available compounds that will be developed for the treatment of smallpox infection, drug-resistant AIDS, and viral hepatitis. Chimerix is seeking partners interested in licensing or co-developing existing drug leads for these infectious disease targets, or in collaborating on the application of Chimerix technology in new therapeutic areas such as cancer, immune regulation, and metabolism. 11:45 A Tactical Approach to Preventing the Common Cold
Michele Yelmene, Executive Director, Clinical & Regulatory Affairs, Perlan Therapeutics
Perlan Therapeutics has developed a proprietary platform technology that enables the design and easy production of high-affinity biologic drugs. The company’s first product, CFY196, is an antibody-based fusion protein for the prevention and treatment of human rhinovirus infection (the common cold). The economic impact of the common cold in the U.S. is approaching $40 billion. Additionally, in at risk populations (e.g., asthmatics, elderly, immunocompromised) sequelae from the underlying rhinovirus infection can lead to significant morbidity and mortality. Currently-approved drugs treat individual symptoms of the common cold but have no impact on the underlying infection nor consequential ailment. CFY196 is a nasal spray that inhibits infection with human rhinovirus by competitively binding the major viral receptor on the nasal epithelium. The Company has demonstrated in vitro efficacy, in vivo safety, and optimized clinical-grade manufacturing processes for CFY196, and now seeks a partner to commercialize this needed and distinctive therapy.
12:00 A Human Monoclonal Antibody for the Treatment of a Gram Negative Bacterial Infecction
Mark R. ALFENITO, President, KALOBIOS
Using a proprietary platform for human therapeutic antibody discovery and engineering KaloBios has rescued a preclinical anti-infective lead, with a unique market niche, and with unique pharmacokinetic requirements. Other humanization and human antibody discovery engines did not generate effective antibodies to this target. We will present data on the disease scenario, the human idiolog selection procedure and our preclinical data. 12:15 A THERAPEUTIC RABIES VACCINE FOR THE PHILIPPINES
Scott M. Wheelwright, Co-Founder, Avianca Over 30,000 deaths occur each year from rabies in Asia. All of these deaths are preventable. Each year 60 million doses of rabies vaccine are delivered, but less than 20% are derived from high quality cell culture sources. The remainder are low quality cell culture or substandard nerve cell culture vaccines. Avianca has a low-cost, high quality manufacturing process for producing rabies vaccine. This model can be expanded to additional diseases to benefit patients in low income countries. 12:30 Broad-Spectrum Therapeutics for Influenza
Mang Yu, Founder, President & CEO, NextBio, Inc. NexBio, Inc. is a biopharmaceutical company that creates novel broad-spectrum therapeutics against life threatening human respiratory viral infections. In the recent years, outbreaks of SARS and influenza epidemics have highlighted serious threat of the respiratory viruses and inadequacy of the current therapeutic modalities. Worldwide spread of avian influenza viruses among domestic poultry, as well as small outbreaks of the avian influenza virus in human have set off the alarm for an imminent influenza pandemic. NexBio, Inc. strives to protect the public against the looming global pandemic of influenza. FludaseTM is the first drug lead in the product pipeline of NexBio, Inc.. FludaseTM targets on all strains and subtypes of influenza viruses including the potential pandemic strains. Unlike the currently available influenza vaccines, FludaseTM does not need to be updated yearly and can be readily available at the onset of annual influenza epidemics as well as future pandemics. As an enzyme-based therapeutic agent that is administered topically and locally, FludaseTM can be superior to antiviral chemical compounds owing to minimal side effects and viral drug resistance. The FludaseTM program and additional anti-influenza research programs at NexBio, Inc. are supported by the Biodefense grants from National Institute of Health. 12:45 Luncheon 2:00 Partnering Opportunities Session for Antibody/Protein Approaches to ID Drug Development
2:00 Antibodies Against Bacterial Infections – Help is on the way!
Bill Johnston, President and CEO, Inhibitex This presentation will briefly discuss the problem of hospital acquired infections which are rising dramatically throughout the world, especially those related to Staphylococcus, and a new class of drugs developed by Inhibitex that show much promise. Inhibitex has developed antibody based products which inhibit the binding of bacteria to the extra cellular matrix and act prophylactically to prevent infection. In addition, these antibodies coat the bacteria, targeting it for opsonization by the immune system so that usage of these antibodies, along with state of the art antibiotics, can clear infections faster and more efficiently, and result in reduced antibiotic usage and hospital costs related to the length of stay. 2:15 Medicinal Evolution Applied to Protein-Based Therapies for Infectious Diseases
Dr. Juan J. Estruch, Senior Director, Strategic Business Development, Diversa Corporation Diversa has assembled an integrated approach for the discovery and development of protein-based therapies, including antibodies, for infectious diseases (ID). The approach includes the identification / validation of ID targets by using a robust proteomics technology known as MudPit. This is followed by a process for generating and / or optimizing therapeutic proteins, including antibodies, which meet clinical (and commercial) needs. This process utilizes a synthetic human antibody library coupled with Diversa’s Medicinal Evolution process. Medicinal Evolution comprehensively assesses the functional contribution of every amino acid in the antibody variable domain with the potential to optimize protein / antibody performance. This comprehensive approach is currently implemented in a number of projects both internal and partnered. 2:30 Monoclonal Antibodies as Viable Therapeutics Against Antiviral and Antimicrobial Diseases
Glenn M. Kazo, General Manager & Chief Business Officer, XTL Biopharmaceuticals, LTD. 1. Identifying Novel Targets
a. What Genes are Likely to Encode the Best Targets?
b. Genes specifically induced during infection are more likely to be important to in vivo survival and pathogenesis
c. In Vivo Induced Antigen Technology (IVIAT)
d. Change Mediated Antigen Technology (CMAT)
2. Target Validation
a. In vitro models
b. Animal Models
3. Development of Neutralizing Antibodies against Hepatitis B and C
a. TrimeraTM System
b. Clinical development status 2:45 Positioning Antibody Therapies For Successful Partnering
Elizabeth G. Posillico, Vice President, Business Development, Elusys Anti-infective therapies, primarily antibiotics and vaccines, have historically been the domain of big pharma. Since the mid-eighties and the debacle over the development of antibodies to treat sepsis, biotech has largely shied away from the infectious disease market. There is a major frameshift taking place, however, that presents opportunites for companies developing antibody-based therapies. At the same time that antibiotic resistance continues to increase and nosocomial infections are a major cause of morbidity, pharma is moving away from the ID arena due to increased market pressures and low profit margins. In addition, the threat of biowarfare has become a reality for US civilians and military personnel and the US government finds itself very unprepared. This presentation will focus on the current environment and some of the opportunities for and benefits of antibody-based therapies to treat intectious disease as well as key issues to consider in developing these drug candidates to maximize their partnering potential with other companies as well as the federal government. 3:00 Human antibodies against infectious disease targets isolated from yeast
Li Zhu, President & CEO, Genetastix Genetastix Corporation has established a novel and proprietary HuMYTech platform for the screening and generation of fully human monoclonal antibodies in yeast. Genetastix has demonstrated the ability to reliably produce effective fully human antibodies against protein targets, including complex membrane-bound targets. Further, the technology provides control over the epitope specificity of the antibodies produced. Genetastix creates and develops fully human antibodies for itself and top tier pharmaceutical and biotechnology companies by providing antibodies to important biological targets. The HuMYTech system is composed of a complex library of human antibodies built into genetically engineered yeast cells, and the technology to screen for antigen-antibody interactions inside of the yeast cell, directly from any cloned antigen cDNA. Genetastix has isolated a series of functional antibody leads against HIV, entrovirus, and SARS CoV. 3:15 Networking, Refreshments and Exhibiting 4:00 VC Panel Discussion
Led by Elliot Parks, Life Sciences Managing Director of Ventana
with the following Panelists:
Vera Kallmeyer, Equity 4 Health LLC
David Coats, General Partner, Hamilton Apex Technology Ventures LP
Standish M. Fleming, Managing Member, Forward Ventures
Panel themes to include:
VC successes in ID field, e.g., Aviron acquisition by MedImmune.
Gilead acquisition of Triangle Pharma's.
Biodefense: is this a real business?
What are the hot areas for ID-related VC investment?
New business models
What are the great new VC-backed companies in this space?
5:00 The Anti-Infectives Markets: Where are the new opportunities?
John Lebbos, Senior Analyst, Decision Resources What are the main drivers and opportunities in the anti-infective markets? Which anti-infective market segments are likely to offer the highest growth in coming years? The antibiotics market has become highly competitive and will continue to become increasingly generic. Limited unmet needs and growth opportunities have caused many large pharmaceuticals to reconsider investment in this area. In contrast, the antifungal and antiviral markets have seen intense development and market activity in recent years for both large pharma and biotech. Drug resistance will continue to be a key driver in these markets in coming years. This discussion will focus on recent market trends and opportunities in drug development. 6:00 Cocktail Reception
Sponsored by Diversa Corporation DAY TWO, 18 May 2004, Tuesday:
------------------------------------------------------------------------------------------------------------ 8:15 Registration, Breakfast, and Exhibiting 9:00 Chairperson's Recap of Day One
David Palella, President, BioScience Ventures 9:15 Established Company Showcase 9:15 Major Advance in Therapeutics that Harness the Powers of the Immune System To Treat Diseases
Daniel L. Korpolinski, President & Chief Executive Officer, Stressgen Biotechnologies Heat shock proteins (Hsp) are well established as a unique class of molecules that trigger powerful immune responses. Stressgen has captured the immunostimulatory powers of Hsp in a proprietary immunization platform, referred to as CoVal fusions. CoVal fusions are recombinant proteins that consist of an Hsp and a disease-specific protein, such as a viral or cancer antigen. By combining the Hsp and the antigen into a single, covalently linked fusion protein, CoVal fusions represent a new and highly effective vaccine platform for induction of antigen-specific immune responses. This exciting concept has been validated in humans with Stressgen’s lead CoVal fusion, HspE7, for the treatment of diseases caused by chronic infection with human papillomavirus (HPV). Partnered with Roche, HspE7 is now in advanced clinical trials for multiple HPV indications. Stressgen’s CoVal fusion pipeline is focused on the development of therapeutic vaccines for other important chronic viral infections, including HBV, HSV and HCV. 9:30 Developing the Next “Franchise” Antibacterial Drugs Jeffrey Stein, Executive Vice President, Interim CEO, Quorex Pharmaceuticals
While economic and regulatory pressures have induced many large pharmaceutical companies to scale back on the discovery of new antibacterial drugs, relentless selective pressures have continued to create multi-drug resistant bacterial pathogens that pose a significant threat to the public at large and to hospitalized patients in particular. Contrary to widely held belief drugs, whose sole principle feature is activity against currently resistant pathogens, may not be sufficiently distinguished amongst the myriad “me to” compounds to earn a prominent place on hospital formularies. In reality, the full spectrum of unmet need has to be addressed by a new chemical entity in order to effectively treat patients and to capture significant market share. Quorex’s dual action GyrB/ParE directed compounds were designed to address this need and represent a potential new “franchise” in antibacterial drugs.
9:45 The Business of Biodefense
Piers Whitehead, Vice-President, Corporate and Business Development, VaxGen Inc.
VaxGen is emerging as a major player in the market for vaccines and therapeutics against bioterror agents. It has received over $100m in contracts from NIAID to support the development of a recombinant anthrax vaccine, rPA 102, and is partnered with Kaketsuken, the largest vaccine company in Japan, to develop Kaketsuken’s attenuated smallpox vaccine, LC16m8, for the US and potentially other markets. The speaker will cover the following topics:
• An overview of the market and opportunities
• Where VaxGen plays and why
• The biodefense business model: a comparison with traditional biopharmaceutical business
• Working with government
• Implications for partnering
10:00 Title TBA
Roger W. GRAHAM, VP, Corporate Development, INIMEX
10:15 Strategic Alliances: The Immusol Case Study.
Brian M. Culley, Manager, Business Development; and Scientific Liaison, Immusol In addition to luck and timing, key factors that can affect a company’s ability to strike a strategic deal include; having a unique approach or product, convincing the other party of the clinical and commercial value of the project, and conveying your firm’s ability to deliver. By leveraging a unique approach to HCV drug discovery, Immusol has attracted multiple big pharma suitors to its infectious disease program. The research program and the partnership proposal will be discussed. 10:30 Networking, Refreshments, and Exhibiting 11:15 Keynote Address
Where the Action is in the Anti-Viral/Microbial Space; the Early Stage View
Stan Yakatan, Chairman, KATAN Associates international This session is designed to provide business development professionals, biotechnology and pharmaceutical research scientists, corporate finance professionals and entrepreneurs a greater insight into how smaller, early-stage companies are created, how they evolve and how they think. This keynote will discuss practical examples of what works in early-stage deal making from the perspective of the entrepreneur, the company, the partner, and the investors. Early-stage company formation is the core of the biotechnology industry, acting as the sector’s engine. For these entities to succeed, it is imperative to build alliances to maximize expertise and resources. The recent market has not provided early stage dollars for these deals, forcing biotech business development professionals to be more creative and pioneering to develop the strategic partnerships that will sustain the growth of their companies. The speaker will cover various techniques used to create and establish credible structures for use in negotiating early stage deals. Critical success factors for success in early stage deals will be covered, outlining recently completed transactions relevant to the space. 12:00 Luncheon 1:30 Panel Discussion on Deal Terms and Trends, Business Development Pointers
Led by David Palella of BioScience, President, BioScience Ventures
With the following Panelist:
Lee R. McCracken, Senior Vice President, Diversa Corporation
Daniel L. Korpolinski, President & CEO, Stressgen
Gary Cupit, Vice President, Novartis
Stan Yakatan, Chairman, KATAN Associates international
Piers Whitehead, Vice-President, VaxGen Inc. Panel themes to include:
Recent BIG deals, their terms.
Future trends
What companies are the best partners? BIG Pharma? BIG Biotechs?
A peer/equal company in the ID space?
How to partner a biodefense program? Is it possible? 2:30 Networking, Refreshments, and Exhibiting 3:15 Partnering Opportunities for siRNA/anti-sense/oligonucleotide Approaches to ID Drug Development: 3:15 Survey Of Case Law And Pending Actions Affecting Biotech Patents
Lisa A. Haile, Partner and co-chair, Life Sciences Group at Gray Cary Ware & Freidenrich We will look at recent case law and pending actions that affect patenting of biotech inventions. We will also discuss how these cases affect patent prosecution, defense and enforcement strategies for your company. The cases that will be discussed include: Mechanism of Action cases:
University of Rochester v. G.D. Searle & Co., Inc. (2003)
Ariad Pharmaceuticals, Inc. v. Eli Lilly Co. (2002)
Pfizer Inc., v. Lilly Icos LLC, Eli Lilly & Co. and Icos Corporation (2002) Experimental Use:
Madey v. Duke University (2003) Screening Methods:
Bayer AG v. Housey Pharmacueticals (2003) Written Description:
Enzo Biochem Inc. v. Gen-Probe Inc. (2002) Infringement under 271(e)(1):
Integra Lifesciences Inc. v. Merck KgaA (2003) Inherency and Anticipation:
Schering Corp. v. Geneva Pharma Inc. (2003) Partnering-focused presentations by companies employing this specific modality. 4:00 RNAi Therapeutics: A Benchtop to Bedside Approach
Sara M. Cunningham, Co-Founder and Vice President of Intellectual Property and Business Development, Avocel, Inc. Avocel was established in 2003 to discover and develop RNAi-based therapeutics. The company has selected Hepatitis C and Hepatitis B as initial targets, and is advancing product candidates toward an IND. The company has an exclusive license from Stanford University to intellectual property developed by Professor Mark Kay relating to the expression of RNAi in vivo, and a co-exclusive license to the delivery of RNAi in vivo. The company is seeking licensees to develop commercial research applications of its intellectual property, as well as partners and licenses to broaden and strengthen its portfolio. 4:15 Rational Targets for RNAi-mediated Therapy
David Haen, Director of Business Development, CytRx Corporation CytRx has implemented a dual strategy in its RNAi program. It has a focus on using RNAi both as a therapeutic and as a drug discovery tool. To minimize the long development timelines associated with developing RNAi as a therapeutic, CytRx has focused on CMV and ALS as initial disease targets. The nature of these targets should allow us to quickly initiate clinical trials. As part of its overall strategy, CytRx expects to utilize RNAi as both a drug discovery tool (short term) and as a possible therapeutic (longer term) in the type 2 diabetes and obesity areas. By focusing on both short term and longer term applications as well as using an outsourcing model with sponsored research agreements, CytRx has positioned itself for a cost effective and a rapid drug development program.
4:30 Panel discussion and group Q&A re the business and other challenges facing this new field.
Led by Tim Riley
With the following Panelist:
Lisa A. Haile, Partner and co-chair, Life Sciences Group at Gray Cary Ware & Freidenrich
Sara M. Cunningham, Co-Founder and Vice President of Intellectual Property and Business Development, Avocel, Inc.
David Haen, Director of Business Development, CytRx Corporation
How can they avoid the long delays to market and pitfalls experienced by other new modalities like gene/cellular therapies, anti-sense, etc. 5:30 Conference Wrap-up
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