COMPANY FACT SHEET
| Company Overview | Visible Genetics Inc. (VGI) is a leading international manufacturer of unique, high performance, automated DNA sequencing systems and tests for the analysis of genes linked to disease including HIV, hepatitis B, hepatitis C, other infectious diseases and cancer.Founded in 1993, VGI is a leader in the rapidly emerging field of pharmacogenomics, the science of individualizing therapy based on patients’ or infectious agents’ genetic differences. VGI sells its products through a combination of a direct sales force and distributors. VGI currently has over 300 employees with comprehensive experience in the areas of genetic research and product development, engineering, manufacturing, software development, sales and marketing, medical and regulatory affairs, clinical research and finance. Since 1993, VGI has been granted over 40 U.S. patents covering various aspects of the OpenGene™ System. | ||||||||
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| Products and Services | VGI has developed an automated, integrated DNA sequencing system — OpenGene. The system employs proprietary instrumentation and CLIP™ single-tube sequencing technology which effectively reduces the time and cost involved in identifying genetic information. The OpenGene System is the hardware and software platform used with TRUGENE™ test kits. The OpenGene System consists of the Long-Read Tower™ automated DNA sequencer; the disposable MicroCel™ Cassettes; the Gel Toaster™ polymerizing unit; the SureFill™ disposable gel cartridge and the GeneObjects™ DNA analysis software. The OpenGene System is used to run tests, such as the TRUGENE HIV-1 Genotyping Test, and to perform generic laboratory-developed DNA sequencing assays.The TRUGENE HIV-1 Genotyping Test is the first standardized complete system cleared by the FDA and available for HIV-1 genotyping for drug resistance. TRUGENE HIV-1 incorporates GuideLines™ rules-based interpretation software to generate the easy to interpret TRUGENE HIV-1 Resistance Report. These rules and algorithms are developed and updated by an international expert panel of HIV clinicians and researchers. This report incorporates interpretation of mutations by drug based on both in vitro phenotypic and in vivo virological response data. Genotyping assays for HBV and HCV are also currently in development. | ||||||||
| Clinical Milestones | The clinical utility of genotyping has been established in four studies. The first study, VIRADAPT, was conducted by researchers from the Centre Hospitalier at the Universitaire de Nice. Six-month data from VIRADAPT demonstrated that drug selection based on genotyping was effective in producing a statistically significant benefit in lowering the viral loads of HIV patients who were failing triple drug combination therapy. Six-month data were published in the June 26, 1999 issue of The Lancet; 12-month data were presented at the 3rd International Workshop on Drug Resistance and Treatment Outcomes in June 1999.Results from the second prospective study, sponsored by the CPCRA extramural program of the NIH, Genotypic Antiretroviral Resistance Testing (GART), demonstrated the clinical utility of genotyping in the treatment and management of HIV/AIDS patients. Data were presented at the 6th Conference on Retroviruses and Opportunistic Infections in February 1999 and were published in the June 2000 issue of AIDS.
In the NARVAL study, the largest prospective resistance testing study presented to date, HIV-infected patients who received HIV drug resistance genotype testing achieved a better long term virologic benefit versus those patients who received standard of care (SOC) treatment or phenotypic testing. The NARVAL study was originally presented at the 4th International Workshop on HIV Drug Resistance and Treatment Strategies (June 2000, Sitges, Spain), and updated data was presented during the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC, September 2000, Toronto, Canada). The 24-week data involved a total of 541 HIV-positive patients. The HAVANNA study was a six-month, randomized, prospective, multi-center study. Results from the 274 HIV-positive patient study were also presented at the September 2000 ICAAC conference. The HAVANNA study involved heavily pre-treated HIV patients and reported that genotypic testing was of significant benefit as compared to SOC treatment. On September 5, 2000, the company submitted an application to the FDA for market clearance of the TRUGENE HIV-1 Genotyping Kit and the OpenGene System. On June 28, 2001, VGI announced that the FDA completed its review of the company’s 501(k) and responded to VGI’s submission suggesting the product performance and safety, quality systems and manufacturing appear to be passing the FDA’s rigorous review. In addition VGI filed a petition under the Modernization Act to reclassify this product as a Class II device. On September 26, 2001, the FDA granted market clearance of the TRUGENE HIV-1 Genotyping Kit and the OpenGene DNA Sequencing System for routine clinical use. |
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| Key Executives |
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| Company Facilities | Corporate headquarters are located in Toronto, with facilities in North America and Europe for instrument and kit manufacturing, sales, and support. In June 2000, VGI opened its new U.S. headquarters in Atlanta, GA. The VGI Atlanta site is the company’s center of commercial operations; the Toronto site is VGI’s center for research, instrument manufacturing and software development. | ||||||||
VISIBLE GENETICS’ EXECUTIVE COMMITTEE BIOS
President and Chief Executive Officer
Richard Daly is president and chief executive officer of Visible Genetics Inc. (VGI). VGI is an international manufacturer of unique, high-performance automated DNA sequencing systems and tests for the analysis of genes linked to disease. Mr. Daly is also a member of the company’s board of directors, a post he has held since June 1998.
Prior to joining VGI in 1999, Mr. Daly founded and served as Chairman and CEO of Clinical Partners Inc., the largest HIV disease management company in North America with more than 6,000 patients and covering 6,000,000 lives. While at Clinical Partners, Mr. Daly negotiated and managed a collaborative initiative with VGI to perform clinical trials aimed at assessing the benefits of HIV genotyping in the diagnosis and treatment of HIV and AIDS patients.
Mr. Daly has spent more than 23 years in the healthcare industry with several companies in a variety of executive positions in sales, marketing and general management, including serving as the president of Baxter Canada, general manager of Baxter’s Latin American Subsidiaries, and president of The Health Data Institute, a pioneer company in outcome and health data analysis.
Mr. Daly holds an MBA from Harvard Business School.
Tim Ellis is chief operating officer of Visible Genetics Inc. He is responsible for all commercial activities in North and South America as well as worldwide manufacturing.
Prior to joining VGI in 1999, Mr. Ellis held a variety of positions with a number of companies including serving as general manager of Abbott Laboratories’ Clinical Chemistry Business Unit, president of Dynex Technologies and president of Genetic Systems Corp. He has more than 25 years of experience in the diagnostics business.
Mr. Ellis holds a Bachelor of Science and Master of Science degrees from Bradley University.
Chief Financial Officer
Tom Clarke is chief financial officer of Visible Genetics Inc. He is responsible for all financial and accounting matters for the company.
Mr. Clarke brings to VGI more than 20 years of financial experience gained in a variety of private and public companies. Prior to joining VGI in 2000, Clarke was employed by CCS Trexcom, a communications software company, where he served as chief operating officer from July 1997 to January 2000 and as chief financial officer from 1991. Prior to that, he held senior financial positions at a number of companies including Medaphis Corp., a medical transaction-processing company, Days Inn Corp., Quadram Corp., Contel Corp. and Arthur Andersen, LLP.
Mr. Clarke holds a Bachelor’s degree in business administration from the University of Central Florida and is a Certified Public Accountant.
President, VGI Europe
Arthur Cole, Ph.D. is president of Visible Genetics Inc. Europe. He is responsible for managing all European operations for the company.
Dr. Cole brings 19 years of international biotech/diagnostic market experience to Visible Genetics. Prior to joining VGI in 1996, he held a variety of positions at Pharmacia Biotech. Most recently (1994), Dr. Cole was vice president of new business development for their merger and acquisition projects and executive vice president of international business operations (1992-1994) where he was responsible for the business of five profit centers as well as strategic planning for the company.
Dr. Cole holds a Bachelor of Science degree in biological sciences from Heriot Watt University, Edinburgh and earned his Ph.D. at Charing Cross Hospital Medical School, University of London.
Vice President and General Counsel
Marguerite Ethier is the vice president and general counsel of Visible Genetics Inc. She is responsible for all Visible Genetics legal matters, including intellectual property.
Prior to joining VGI, Ms. Ethier was a partner in the law firm of McCarthy Tetrault, where she practiced technology and intellectual property litigation. She is qualified as a United States patent attorney, a registered Canadian Patent Agent, and is also a member of the bars of California and Ontario.
Ms Ethier holds a Bachelor of Science degree in genetics from the University of Alberta, a Master of Science degree in medical genetics from the University of Toronto, and an LL.B. from Osgoode Hall Law School.
Vice President, Regulatory Affairs and Clinical Research
Dean Winslow, M.D., is vice president of regulatory affairs and clinical research, and medical director for Visible Genetics Inc. He is responsible for VGI’s clinical trials and all submissions to the Food and Drug Administration for TRUGENE™ HIV-1 Genotyping Kit, as well as hepatitis kits and other infectious disease resistance assays.
Winslow brings to VGI more than 20 years of experience as a medical professional within the pharmaceutical, healthcare and academic arenas. Prior to joining VGI in 1999, Dr.Winslow served as director of the AIDS Clinic and head of the Section of Infectious Diseases at The Medical Center of Delaware and later as Director of Oncology and Viral Diseases at DuPont Pharmaceutical Company.
Throughout his career, Dr.Winslow has served on the boards of several healthcare organizations, including the American Red Cross, the Arthritis Foundation and the Blood Bank of Delaware. Additionally, Winslow served on the Governor’s AIDS Task Force for Delaware and as chairman of the Virology Subcommittee for the Inter-Company Collaboration for AIDS Drug Development. He is also the author or co-author of more than 80 scientific abstracts and 50 peer-reviewed articles. He currently holds an appointment as a Clinical Professor of Medicine at Stanford University School of Medicine.
Dr.Winslow holds a Bachelor of Science degree from Pennsylvania State University and earned his M.D. from Jefferson Medical College, Philadelphia and is board-certified in internal medicine and infectious diseases.
Brendan Larder, Ph.D., is Chief Scientific Officer for Visible Genetics Inc. He is responsible for all research activities in the company, including programs involving both existing and new assays, advanced technology platforms for genetics and mutational analysis and bioinformatic interpretation systems.
Dr. Larder obtained his bachelors and doctorate degrees at Cambridge University in the UK. His Ph.D. thesis in 1983, focused on the study of biochemical mechanisms of herpes simplex virus drug resistance. Subsequently, he spent two years as a post-doctoral research fellow in the Virology Division of the Pathology Department at Cambridge. His research emphasis shifted to the genetic characterization of herpes virus drug resistance. This research theme was continued in 1985 when he joined the Wellcome Research Laboratories in London, as a research scientist. In 1986, he initiated research work with HIV, with particular emphasis on the mode of action of antiretroviral inhibitors such as AZT.
Dr. Larder has been at the forefront of HIV drug resistance for over 15 years and has numerous seminal publications in this field. His achievements include the first identification of HIV drug resistance with the description of AZT resistance in 1989 and the subsequent elucidation of the genetic basis of this resistance. This research program was extended to include the description of resistance to many other antiretrovirals, in particular, ddI, d4T, 3TC and abacavir. In 1997, Dr. Larder joined Virco to become the Chief Scientific Officer for the company. During this period he pioneered the development of phenotyping and genotyping assay technologies. More recently, this work culminated in novel pharmacogenomic developments facilitating interrogation of large clinical databases. The applications are used to generate information about patient specific drug resistance and are one of the first practical examples of pharmacogenomics. In addition, Dr. Larder has recently been involved in developing assays for hepatitis C, hepatitis B and oncology-related tests.