Generex Biotechnology has been engaged primarily in the research and development of drug delivery systems and technologies. Our primary focus has been our proprietary technology for the administration of formulations of large molecule drugs to the oral (buccal) cavity using a handheld aerosol applicator.
Generex Biotechnology has a two business focuses: 1) implementing an acquisition strategy and 2) financing sponsored clinical trials. We are positioning ourselves as a diversified holding company involved in increasing our “pipeline” of compounds, therapies, treatments, diagnostics, and technologies in all stages in the FDA process through accretive acquisitions. We are also strategically aligning ourselves with the global biopharmaceutical companies by providing a financing solution to them as sponsors of clinical trials, which are conducted by patient care providers (PCPs) such as hospitals, medical research institutes, centers, and clinics.
We are Dedicated to Biopharmaceutical Research & Advancement
Generex Biotechnology Corp., is a biopharmaceutical company that is actively involved in discovery, research, development, and financing of new compounds, therapies, diagnostics, delivery systems, and medical technologies.
Generex Biotechnology Corp. is developing innovative technologies for reliable, convenient, pain-free delivery of both small and large-molecule drugs. To date we have focused on creating a unique liquid formulation that can be administered directly into the mouth as an aerosol spray for absorption through the buccal mucosa, the mucous membranes that line the inner walls of the cheek.
The buccal mucosa offers a near ideal, non-invasive portal through which large-molecule drugs might enter the body. The large surface area of the buccal mucosa provides direct access to a rich network of blood vessels, offering the potential of rapid absorption of medications into the circulatory system. Using this route, drugs avoid the gastrointestinal system and other hostile environments.
Medications based on large molecules (also called macromolecules) are increasingly crucial to the treatment of many diseases and conditions. In fact, large-molecule biopharmaceutical products – including proteins, peptides, and nucleic acids-are sometimes referred to as “next generation” medicines. Unfortunately, large molecules have some challenging properties. They are:
Large-molecule drugs are therefore usually introduced into the body via injection and that is a problem. Injections are painful, inconvenient, and often must be delivered by trained medical staff. For these reasons, injection is not a user-friendly drug delivery system.
The discomfort of a daily regimen of injections increases patient anxiety, which clearly is an undesirable outcome in itself. Moreover, as anxiety increases, compliance decreases, and that has serious repercussions. For the individual patient, decreased compliance with a medication schedule often leads to a serious deterioration in health. For the health care system as a whole, decreased compliance is extremely costly – in the US alone, hospital and physician visits attributable to noncompliance have an estimated price tag of $8.5 billion.
Scientists in academic and commercial laboratories have attempted to find less invasive alternatives to injection of large-molecule drugs, but so far most of the results have not been useful. That is why the preliminary success of the Generex approach – buccal delivery of large-molecule drugs – is so exciting.
Generex Oral-lyn, is an insulin spray for the treatment of Type I and Type II diabetes. Generex Oral-lyn; is a safe, simple, fast, effective, and pain-free alternative to subcutaneous injections of prandial insulin and is conveniently delivered to the membranes of the oral cavity by a simple asthma-like device with no pulmonary (lung) deposition.
As a pain-free and convenient method of insulin delivery, Generex Oral-lyn will allow individual patients to “fine tune” and then maintain their metabolism resulting in an improved quality of life. Accordingly, Generex Oral-lyn provides the opportunity for the establishment of a new and more effective diabetes treatment paradigm.
RapidMist an advanced buccal drug delivery technology, is comprised of a proprietary formulation and a proprietary device design that is able to deliver drugs through the buccal mucosa safely, thereby eliminating the pain from and need for multiple injections. RapidMist has been shown to have a rapid onset of action with no lung deposition, precise dosage control, easy use and handling, and improved patient compliance.
The formulation involves the preparation of a proprietary process in which an active pharmaceutical agent is placed in a solution with a combination of absorption enhancers and other excipients classified generally recognized as safe (“GRAS”) by the Food and Drug Administration (“FDA”) when used in accordance with specified quantity and other limitations. The formulation is a liquid that contains a medication plus a number of enhancers. The enhancers are the key. They help the medication penetrate the epithelial membrane of the buccal mucosa, and they also promote rapid absorption of the drug into the circulatory system.
Enhancers are surface-active compounds, called surfactants. A surfactant is an organic chemical that contains both hydrophilic and hydrophobic ends. Because one end of a surfactant resists water and the other end embraces it, a surfactant has some unique characteristics. For example, under certain conditions, a surfactant assumes a micelle structure. In a micelle, the ‘water-loving’ ends of the surfactant form a protective shell around the ‘water-hating’ ends. Micelles are critical to drug delivery, because the protective shell of a micelle can be used to surround a large molecule. The micelle then carries the target molecule through cell membranes and even through cell walls.
A relatively small concentration of surfactant not only allows a drug to traverse mucous membranes rapidly, but it also increases both the solubility and the stability of the drug, which makes it possible to achieve therapeutic levels of the drug in blood plasma. After years of research and tests, our scientists have succeeded in identifying a unique combination of enhancers that makes it possible to deliver a large-molecule drug – insulin – as an oral spray that is absorbed through the buccal mucosa.
Management & Directors
Joseph Moscato – President & Chief Executive Officer
Mr. Moscato over 30 years of experience in healthcare, sales, marketing, and finance.
Terry Thompson – Chief Operating Officer
Mr. Thompson brings a wealth of experience and expertise in healthcare, providing executive leadership in pharmacy benefits management, network administration, claims processing, and distribution & logistics for drugs, durable medical equipment (DME), and infusion therapy, as illustrated by his impressive 35-year career.
Mark Fletcher, Esq. – Company’s Executive Vice-President,
General Counsel, and Secretary
Mr. Fletcher served as the Company’s President & Chief Executive Officer from September 2010 through January 2017 and as a member of the Board of Directors from March 2011 through January 2017. He served as the Company’s Executive Vice-President and General Counsel from April 2003 through September 2010. Prior to joining Generex, Mr. Fletcher was engaged in the private practice of corporate/commercial and securities law as a partner at Goodman and Carr LLP, a leading Toronto law firm. Mr. Fletcher received his LL.B. from the University of Western Ontario and is a member of the Law Society of Upper Canada, the Canadian Bar Association, and the Association of Corporate Counsel.
Andrew Ro – Chief Investment Officer, Senior VP of Investments, Director
Mr. Ro over 20 years of experience in the financial markets. He is a partner with an investment fund.
Mark Corrao – Chief Financial Officer, Treasurer
Mr. Corrao over 20 years of experience in financial management. He is also involved in the initial registration of numerous public companies and subsequent SEC quarterly and annual reporting. He is the CFO and a Director for a pharmaceutical company specializing in research and development, as well as novel and new therapeutic agents as immune modulators and neuroprotectants.
Jacob Dagan, Ph.D. – VP Business Development, Director
Dr. Dagan over 25 years of proven success in healthcare management, corporate and product development, operations, marketing, sales, and hospital management. He also has strong biomedical scientific skills.
Craig Eagle, MD – Director
Dr. Eagle Head of Pfizer European, Head of Pfizer Canada, and Senior Director, Global Oncology Pfizer Global Pharmaceuticals.
Gary Lyman, MD, MPH -Director
Dr. Lyman is co-director of the Fred Hutchinson Institute for Cancer Outcomes Research, as well as Professor of Medicine and Professor in the Schools of Public Health & Pharmacy at the University of Washington.
Jason B. Terrell, MD – Director, Chief Medical and Scientific Officer
Dr. Terrell is currently Chief Medical Officer and Head of U.S. Operations for a NYSE-traded international medical diagnostic company.
Richard Purcell – Senior Vice President Research & New Drug Development, Director
Mr. Purcell is a consultant and advisor for emerging biopharmaceutical and technology companies on new business strategy, operations management, clinical development of novel compounds, data solutions for clinical and medical applications, and patient engagement and communication, as well as medical education for professionals, consumers, and data analytics for outcomes research.
Lawrence Salvo – Director
Mr. Salvo is the founder of rapid diagnostic tests for infectious diseases. He is involved in the management of international distribution, sales, and design and has developed and maintained substantial and long-term relationships within China, South and Central America, and the African Continent.
Generex Biotechnology Corp. (OTCMKTS:GNBT) is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Our company creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure.
The company goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) to ultimately generate our revenue.
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