IGT PHARMA INC. V:IGT
igtpharma.com
For more information, please call Jeff Murdock at 1-800-743-7444
Summary Fact Sheet June 1998
A drug discovery company targeting oncology and neurology
LISTING INFORMATION
Shares Issued: 8.3 million
Fully diluted: 9.54 million
Exchange: Vancouver
Symbol: IGT
52 Week: $0.75-1.30
Price Range (Cdn)
Cash (Cdn): $1.0 million
Monthly Burn Rate: $60,000
Approximate (Cdn)
U.S. SEC: 12g3-2(b)
Exemption
Business Objectives
ú IGT Pharma is a Canadian biopharmaceutical company that is engaged in the development and commercialization of novel therapeutic products to treat cancer and neurological disorders.
ú Oncology - Discovery and clinical development of new drugs with enhanced therapeutic properties by rational drug design and medicinal chemistry.
ú Neurological - Discovery and clinical development of novel therapeutics for the treatment of disorders of the brain through medicinal chemistry, combinatorial chemistry and molecular targeting.
Short Term Milestones
ú Start of human clinical trials for the new cancer drug Anhydrovinblastine, a patented therapy showing strong pre-clinical tumor inhibition in many cancers including lung cancer.
ú Patenting & commercial scale-up of a synthetic route to the existing cancer drug, Etoposide, one of the largest existing generic anti-cancer drugs used for the treatment of solid tumors and used in
various standard combination therapies.
ú Start of pre-clinical development of a new anti-cancer drug, which has shown unique pre-clinical results in the treatment of a range of cancers.
ú Strengthening the patent position on a portfolio of unique neurologically active molecules with therapeutic potential for disorders such as stroke, anxiety, memory loss, learning disorders and
Alzheimer's.
ú Start of pre-clinical and production development of a new class of neurologically active compounds, known as glutamate analogs, which are systematically active, potent, selective and will be able to cross the blood-brain barrier in pre-clinical models.
ú Establish IGT's biochemical division, Precision Biochemicals, to be a provider of leading edge chemicals and services to the biochemical, biotechnology and pharmaceutical industries worldwide.
With the recent media spotlight on promising drug developments in the battle against cancer, IGT's lead products and technologies are quickly tracking towards development and commercialization in an
environment of increasing awareness, enthusiasm and hope. Recent company developments include:
The assembly of the Phase I Clinical Trial team comprised of a three senior medical oncologists from the British Columbia Cancer Agency (BCCA) who will be conducting the human clinical study of the
anti-cancer drug, Anhydrovinblastine (AVLB). All pre-clinical & regulatory project team status reports indicate that the Company will submit an Investigational New Drug (IND) for regulatory approval to
begin a Phase I clinical trial in humans. The Company is dedicated to the development of AVLB into a unique therapy against cancer.
The clinical trial is a heralded event for IGT as it signals the meeting of a critical development milestone of AVLB in its progression from molecule to market and in the growth of a biotechnology
company.
IGT has acquired Precision Biochemicals Inc. (PBI), an emerging pharmaceutical development company focused in the discovery of therapeutic treatments for human neurological disorders.
Facilitated by this union, IGT has increased its depth in research, technology, products and expertise.
The Company has evolved into three operational divisions: Oncology Drug Development Division, Neurology Drug Development Division, and Custom Chemicals, which provide ongoing sales revenue.
IGT aims to advance its technology and product development through corporate partnerships with pharmaceutical companies.
The Company has established a strong intellectual property position, broadly protecting its core technologies.
IGT aims to advance its technology and product development through corporate partnerships with pharmaceutical companies. In addition, through its biochemical division PBI, a wholly owned subsidiary of IGT, is a provider of leading edge chemicals and services to the biochemical, biotechnology and pharmaceutical industries worldwide.
University of British Columbia
* Exclusive license agreement with the UBC for the patented core technology British Columbia Cancer Agency Alliances, Grants & Associations
* Collaboration and co-development with the Department of Advanced Therapeutics in the investigation of new anti-cancer drugs
* provides screening and pre-clinical evaluations National Research Council of Canada
* Industrial Research Assistance Program provides supporting grants totaling approximately $250,000 Science Council of British Columbia
* Technology BC Program has provided support of approximately $150,000 Roswell Park Cancer Institute
* Collaboration investigations with the Department of Toxicology in the investigation of new drugs British Columbia Biotechnology Alliance
* Alliance of biotechnology & pharmaceutical companies created to increase the awareness of the industry and network.
The Company's drug development approach in oncology is by building molecules exhibiting unique or enhanced anti-cancer activity. A favorable profile would constitute characteristics such as low toxicity, reversible side effects, high degree of efficacy and disease type specificity. The oncology drug development program is currently focussed on two families of anti-cancer molecules: vinca alkaloids
and lignans. The core technology in oncology is based on 15 years of pioneering research by Dr. James Kutney, Professor at Department of Chemistry, University of British Columbia (UBC) relating to
plant cyto-toxins and the translation of plant biosynthesis into commercial laboratory production. IGT is developing patented low cost methods for the production of important anti-cancer drugs. By utilizing synthetic chemistry, IGT is developing analogs or structural variations of existing anti-cancer drugs to optimize anti-cancer activity.
Cancer Market
Under an exclusive license with UBC, this technology was transferred to the Company for development and commercialization of the processes. The license covered two broad core technologies, representing a minimum of five anti-cancer drugs. The development of the technology to manufacture approved anti-cancer drugs such as Etoposide and Vincristine, go hand in hand with the development of analog versions of these compounds.
With the knowledge and expertise of how to imitate the natural chemical processes in medicinal plant, the Company's scientific staff is able to create effective analogs of these molecules. The Company is
currently engaged in the clinical and commercial development of these anti-cancer drugs and their respective synthetic processes.
Cancer: Drug Development
The World Health Organization estimates more than six million people throughout the world become ill with cancer each year. Approximately 40% of all Americans will suffer from cancer and about half of
the patients with cancer will die from this disease. The average 5-year survival rate is only 50%. For decades, cytotoxic chemotherapeutic agents have dominated the drug therapy landscape. Still today, they are the most effective arsenals in the battle against cancer. Clearly, there is an immediate demand from the oncology market for cancer therapies that are less toxic and efficacious against multi-drug-resistant cells. The National Cancer Institute expects that cancer will become the leading cause of death in the U.S. within five years. Today chemotherapy is the most effective weapon in the battle against cancer. According to IMS, the world market for anti-cancer drugs is estimated at US$9.4 billion and growing at 8% per annum.
Cancer Product Portfolio
Anhydrovinblastine (AVLB)
AVLB has shown excellent preliminary results in reducing tumors relating to human lung and cervical cancers. In comparison to a selection of other drugs used to treat cancer, AVLB has proven itself, in pre-clinical models, to be highly effective on a range of tumor types while showing generally reduced toxic side effects. Soon be entering clinical Phase l trial, AVLB's time to market is anticipated to be short due to the well-understood nature of its activity.
Etoposide
IGT has recently filed a new patent application relating to the production of the internationally marketed cancer drug, Etoposide. This novel process will provide significant financial leverage on
product costs due to the fact that only common and inexpensive starting materials will be required and therefore will completely eliminate the need for the currently used extraction from plants. Used alone and in combination with other drugs, Etoposide has proved to be one of the most effective and widely used chemotherapeutics to treat solid tumors relating to many conditions including cancers of the lung, bladder and brain as well as Kaposi's sarcoma.
New Etoposide Analog
Further upstream in our new product pipeline, IGT is developing a highly active drug with the potential to address the problem of cancers that develop multi-drug resistance. Although Etoposide is currently a blockbuster generic drug, IGT's investigation of analogs has produced a version that appears in all respects to be superior to Etoposide itself. The finalization of ongoing pre-clinical investigations will confirm the potential of this compound thus allowing for the development of a clinical trials program.
Vincristine and Vinblastine
Vincristine and Vinblastine are well known generic drugs used for various cancers such as leukemia and Hodgkin's disease as well as standards in many combination therapies. IGT has a patented
methodology, which allows for the semi-synthetic production of these two compounds from very basic starting materials.
Neurology Market
In 1995, CNS drugs were the drug industry's growth leaders with 18% growth and North American sales of US$5.8B. CNS diseases include stroke, schizophrenia, depression, obesity, anxiety and migraines. Most currently available CNS drugs are not selective in how they bind to receptors causing undesirable side effects in the process. Current CNS drug discovery methodology is part of the problem. Neuroreceptor targeting is increasingly becoming the drug discovery technology of choice and offers the possibility of discovery and development of a new generation of CNS drugs with markedly improved efficacy and safety. Given the many neurological diseases, which lack safe, effective therapies, CNS drugs appear to be the most attractive therapeutic classes going into the 21st century.
Neurology: Drug Discovery Program
The company's drug development strategy will be to use a highly targeted approach to develop drugs based on our knowledge of the structure-activity relationships of a group of eight specialized receptors, called collectively the Metabotropic Glutamate Receptors (mGluRs). These receptors have recently been cloned and experimental data shows that they have different pharmacological profiles, a feature that is crucial to the development of therapeutically specific pharmaceuticals. The research staff at PBI have access to an extensive knowledge base in this area since one of the company's principals,
Dr. Kenneth Curry, was responsible for the development of a group of chemicals (the ACPD's) that were instrumental in the initial pharmacological identification of this group of receptors. These
receptors have been implicated in a number of normal as well as pathological mechanisms in the brain and spinal cord. For example, activation of these receptors on neurons can:
* Influence levels of alertness, attention and cognition
* Influence central mechanisms in controlling movement
* Protect nerve cells from excitotoxic damage resulting from ischemia, hypoglycemia and anoxia
* Reduce sensitivity to pain
* Modulate the level of neuronal excitation
* Reduce levels of anxiety
Clinical Applications for Neurology
The consequence of designing chemicals that will interact at these receptor sites is that we will be able to develop therapeutics with the potential to target the following areas:
* Learning and Memory * Analgesics
* Stroke and Head Injuries * Anxiolytics
* Anticonvulsants * AIDS dementia
* Movement disorders associated with Parkinson's Disease and Huntington's chorea
* Alzheimer's disease
Under the company's ongoing R&D program, a number of unique first-generation metabotropic glutamate receptor agonists and antagonists have already been synthesized. The next stage will be to
develop second generation products that have increased specificity, greater bioavailabilty and greater access to the Central Nervous System.
Neurology Products & Services
PBI provides contract chemical research and custom synthesis capability that is designated to meet the outsourcing needs of the pharmaceutical and biotechnology industry. The Company has extensive
experience in multi-step organic synthesis and medicinal chemistry, and chemical design & production, asymmetric synthesis & resolution, and synthesis & separation of complex chiral molecules. PBI offers over 80 research biochemicals and about 120 fine organic chemicals. A catalog is available by request or at precisionbio.com
Management, Directors & Scientific Advisors
Bruce Schmidt, B.Sc., President & C.E.O.: Mr. Schmidt formed IGT in 1992. He has 16 years of senior management experience and has been a management consultant to high-tech and biotech companies in Canada. He is also the vice-chairman of the BC Biotechnology Alliance.
Dr. Kenneth Curry, Ph.D., VP, Research & Development and Corporate Director: Dr. Curry brings over 10 years of expertise and experience in neuropharmacology and medicinal chemistry. Dr. Curry is a
recognized pioneer in the field of neurology, holds a number of international patents and has been published 35 times in various scientific journals and books.
Dr. Martin Peet, Ph.D., MBA, VP, Business Development: Dr. Peet brings 9 years of sales & marketing experience from the biomedical industry. He has been largely responsible for the commercial success of PBI's custom chemical product line.
Daniel Bong, B.Sc., Manager, Technology Development: Mr. Bong completed his B.Sc. in cell biology from UBC and has 8 years of marketing & technology development experience in the biotechnology
industry.
Rashid Aziz, C.A., CFO & Corporate Director: Mr. Aziz was formerly the Exec. VP of InflaZyme Pharmaceuticals; VP & CFO of QLT Pharmaceuticals from 1988-1991;and Audit Manager with Deloitte & Touche from 1979 to 1987.
Brian T. Schmidt, OD, M.Sc., Corporate Director: Mr. Schmidt is the Executive Vice-President and Chief Operating Officer of the BC Cancer Agency & a Clinical Associate Professor at the University of
British Columbia.
Dr. Guy Ely, M.D., Corporate Director: Dr. Ely, as Director, will bring extensive background in clinical research and regulatory affairs relating to drug development & approvals. His current role is VP,
Clinical & Medical Affairs, Imutec Pharma. Prior roles were Assoc. Med. Dir., SmithKline Beecham, VP Clinical & Medical Affairs, BioChem Therapeutic of BioChem Pharma, Director of Clinical Research, Abbott Laboratories.
Dr. James Kutney, Ph.D., Scientific Advisor: Dr. Kutney is a professor in the Chemistry Dept. at the University of British Columbia. He is the founder of IGT's core technology and provides technical
guidance with respect to IGT's drug portfolio.
Dr. Lawrence Mayer, Ph.D. Scientific Advisor: Dr. Mayer is a senior research scientist at the Advanced Therapeutics Dept., Medical Oncology Division, BC Cancer Agency and brings to IGT over
10 years of experience in pharmaceutical formulation, preclinical and clinical testing of new anti-cancer agents. Dr. Peter Kanter, M.D. Scientific Advisor: Dr. Kanter is the Study Director, Laboratory of Preclinical Toxicology and Chairman, Department of Experimental Surgery, Division of Surgical Oncology of the Roswell Park Cancer Facility in Buffalo, New York. |
