ABT gets only U.S. patent for herbal medicine.IRVINE, Calif.--(BUSINESS WIRE)--Sept. 11, 1996-- A first-of-its-kind patent -- a pharmaceutical version of mistletoe mistletoe, common name for the Loranthaceae, a family of chiefly tropical hemiparasitic herbs and shrubs with leathery evergreen leaves and waxy white berries. They have green leaves, but they manufacture only part of the nutrients they require. to address HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. -- was announced Wednesday and two other related patents are expected before year-end, according to ABT ABT About ABT Abteilung (German: Department) ABT Abbott Laboratories (stock symbol) ABT American Ballet Theatre ABT Associação Brasileira de Telemarketing ABT Abort ABT Availability Based Tariff Global Pharmaceutical (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ABTG ABTG AquaBio Tech Group ). Until this patent, no multiple molecule herbal medicine herbal medicine, use of natural plant substances (botanicals) to treat and prevent illness. The practice has existed since prehistoric times and flourishes today as the primary form of medicine for perhaps as much as 80% of the world's population. has ever been successfully patented as a pharmaceutical. This lack of patent protection has prevented herbal medicines from applying for the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. clinical approval necessary to make them available to physicians for prescription to their patients. ABT believes that its patent opens the door for hundreds of already known and demonstrated active herbal medicines to be standardized, clinically tested and commercialized as pharmaceuticals. Specifically, the new patent is the first application of technology called "ABTG bioprinting" for the development of pharmaceutical versions of herbal medicines. The technology was developed at the University of Southern California The U.S. News & World Report ranked USC 27th among all universities in the United States in its 2008 ranking of "America's Best Colleges", also designating it as one of the "most selective universities" for admitting 8,634 of the almost 34,000 who applied for freshman admission and commercial rights are held by ABT Global Pharmaceutical Corp. First Patent The first patent (US5,547,674) was issued for successfully bioprinting and accurately replicating a mistletoe-based compound called T4GEN. Mistletoe is already used on an unregulated basis in the treatment of some cancer and AIDS patients in Europe, but previously could not be pursued as a pharmaceutical because it could not be patented, standardized, precisely dosed and clinically tested as a pharmaceutical for FDA approval. The principal scientist from the USC An abbreviation for U.S. Code. School of Medicine behind T4GEN and the underlying bioprinting technology is Dr. Tasneem A. Khwaja, now chairman and chief scientific officer of ABT. The company said it expects before year-end additional patents for a second pharmaceutical version of an herbal medicine as well as the initial patent on the bioprinting technology itself -- with a succession of subsequent patents in the future. Economics Consumer Reports magazine estimates that herbal medicines now being sold on an unregulated basis through U.S. retail stores represent a $1.5 billion market growing at more than 15 percent annually. ABT said it believes the demand outside the United States is much larger. "As herbal medicines previously could not be patented, standardized, clinically tested, FDA approved or manufactured under controlled conditions, their sale has been limited and often without professional medical direction," according to ABT President and Chief Executive Officer Elliot Friedman. "By making versions of effective herbal medicines that are pharmaceuticals which can be tested, approved and prescribed by doctors and regulated by the FDA, we believe the ultimate demand will be some multiple of present sales." Clinical Trials According to Friedman, Phase I and Phase II proof of concept clinical trials using the same mistletoe plant as the now patented T4GEN compound (IND No. 32,829) involved 50 AIDS patients in Berlin and were completed in August 1994. These trials suggest that the active lectins Lectins A class of proteins of nonimmune origin that bind carbohydrates reversibly and noncovalently without inducing any change in the carbohydrate. Lectins bind a variety of cells having cell-surface glycoproteins (carbohydrate bound proteins) or glycolipids in T4GEN will stimulate cells that function as directors of the AIDS patients immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. , although the trials did not test T4GEN per se. He said the company is seeking approval to conduct Phase I and Phase II clinical trials on T4GEN in Thailand during the fall of 1996. These would be the world's first clinical trials of a pharmaceutical version of an herbal medicine. Friedman expects ABT will seek approval for U.S. Clinical trials in the first half of 1997. In related activities, the company has entered into an agreement with the Canadian National Research Council to manufacture initial quantities of T4GEN and subsequent candidate compounds for other products, to develop standard operating procedures standard operating procedure Medtalk A technique, method or therapy performed 'by the book,' using a standard protocol meeting internally or externally defined criteria; a formal, written procedure that describes how specific lab operations are to be performed. for each of the manufacturing processes, to validate each process used in the bioprinting technology, to quantify each of the active lectins and their bioactivity bi·o·ac·tiv·i·ty n. The effect of a given agent, such as a vaccine, upon a living organism or on living tissue. , and to establish a toxicology profile for each pharmaceutical, according to Friedman. Bioprinting Product Rights Friedman said that ABT owns all rights to commercialize any proprietary products such as T4GEN emerging from the bioprinting technology via an exclusive license with the University of Southern California. USC helped found the company in 1994 and owns about 3 percent of its common stock. ABT completed a $15 million initial public offering in August underwritten by M. H. Meyerson & Co. Inc. In addition to the compounds ABT is developing with USC to address AIDS, it has entered into an agreement with the University of Miami This article is about the university in Coral Gables, Florida. For the university in Oxford, Ohio, see Miami University. The University of Miami (also known as Miami of Florida,[2] UM,[3] or just The U and Dr. Fazal Ahmad to use bioprinting to develop a pharmaceutical version of an natural medicine derived from saw palmetto saw palmetto Any of several shrubby palms chiefly of the southern U.S. and West Indies that have spiny-toothed petioles (leafstalks), especially a common palm (Serenoa repens) of the southeastern U.S., with a usually creeping stem. berry extracts presently being used on an unregulated basis to treat benign prostate enlargement. Friedman said the company is currently in discussions with other universities and principal scientists for the development of pharmaceutical versions of other natural medicines using ABT's bioprinting technology. Bioprinting ABT's proprietary bioprinting uses separation technologies such as HPLC HPLC high-performance liquid chromatography. HPLC high performance liquid chromatography. HPLC High-performance liquid chromatography Lab instrumentation A highly sensitive analytic method in which analytes are placed , gas chromatography gas chromatography (GC) Type of chromatography with a gas mixture as the mobile phase. In a packed column, the packing or solid support (held in a tube) serves as the stationary phase (vapour-phase chromatography, or VPC) or is coated with a liquid stationary phase , electrophoresis, and two-dimensional SDS 1. (company) SDS - Scientific Data Systems. 2. (tool) SDS - Schema Definition Set. PAGE and integrates these technologies with in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. bioactivity models such as L1210 cell inhibition. Through these methologies, ABT characterizes the active components of any herbal medicine. To develop pharmaceutical versions of herbal therapies, according to Friedman, bioprinting technology makes the following steps possible: -- Screen herbal medicines for indications of overall effectiveness. -- Produce standardized, precisely dosed compounds. -- Test components for bioactivity and disease-specific biologic effects. -- Establish precise standards for each active component by percent weight, bioactivity and/or biologic effect. -- Established precise toxicity standards. Other Involved Scientists In the company's prospectus dated Aug. 14, 1996, ABT announced the following members of its scientific advisory board: Dr. Ivor Ralph Edwards, professor and director of Drug Monitoring for the World Health Organization's Collaborating Center for International Drug Monitoring. Dr. Toshikazu Oki, formerly president of Bristol-Myers Research Institute, Japan, and current professor of exploratory biotechnology research, Toyama Prefectural University. Dr. Peter Schutz, a director of Ciba-Geigy Ltd. Dr. Clive R. Taylor, professor and chairman of the department of pathology and laboratory medicine at the USC School of Medicine, and president-elect of the American Association of Pathologists. Forward-Looking Statements The company notes that any forward-looking statements in this document are subject to change based on factors including without limitation changes in the trends now supporting increased demand for natural medicines, competition and technical barriers. Additional information on potential factors that could affect the company's financial results are included in the company's prospectus dated Aug. 14, 1996. ABT Global Pharmaceuticals has headquarters in Irvine, and owns commercial rights to the only patent for a pharmaceutical version of an herbal medicine and the bioprinting technology underlying that patent. The company was established in conjunction with the USC School of Medicine to develop, manufacture, test, gain FDA approval for and sell or license a growing body of pharmaceutical versions of natural medicines addressing many pathologies including cancer, heart disease and AIDS. CONTACT: ABT Global Pharmaceutical, Irvine James Burgess, 714/224-2555 or Financial Relations Board, Los Angeles, 310/442-0599 Moira Conlon (analyst contact) Steven Seiler (media contact) |
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