Biotechnology Company With Two Potential Blockbuster Drugs Approved for Phase III Human Clinical Trials Announces Major Increase in Revenues.Business Editors & Health/Medical Writers MONTGOMERY, Texas--(BUSINESS WIRE)--Sept. 30, 2002 Endovasc Ltd. Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :ENVC) announced today it has filed its annual report (10K) with the Securities and Exchange Commission. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the annual report, Endovasc's sales revenues increased by 571%, to $671,000, even though the company has not yet entered the main revenue-generating phase of its business model. Endovasc is the company behind ANGIOGENIX(TM) -- the revolutionary new treatment that has shown to recruit the body's own stem cells stem cells, unspecialized human or animal cells that can produce mature specialized body cells and at the same time replicate themselves. Embryonic stem cells are derived from a blastocyst (the blastula typical of placental mammals; see embryo), which is very young that help grow new heart vessels to relieve chest pain and improve heart function -- and Liprostin(tm), a liposomal prostaglandin-based treatment that studies suggest will prevent restenosis (re-blockage of arteries), increase circulation and reduce leg pain due to poor blood flow. Both of these cardiovascular drugs have been approved for final 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. Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA human clinical trials. This makes Endovasc the only OTCBB-listed biotech company with two potential blockbuster drugs approved for Phase III trials. According to the company's 10K filing with the SEC, Endovasc's revenues for the fiscal year ending June 30, 2002 increased to $671,000 from $100,000 for the previous fiscal year. The company's net loss decreased from $2.84 million to $2.4 million, or from $6.90 per share to only $1.34 per share. "We are very satisfied with our financial performance, as we have not yet entered the revenue-generating phase of our business model. Most of the revenue came from grants and services to others, which we are very proud to have carried out. Biotech is a very research-and-development-intensive industry. Bringing new treatments to market typically requires millions of dollars of available capital and takes several years. We are proud that we have been able to bring two potential major breakthrough drugs from the discovery phase all the way through to Phase III without incurring any significant debt," says David P. Summers, chairman and chief executive officer of Endovasc Ltd. Inc. Endovasc's business model is based on taking on promising drug candidates at the end of the discovery phase and then conducting a fast-track program for the technical and early clinical development phases, covering Phases I and II of the compound. At that point, Endovasc creates a separate subsidiary for each one of its drugs, spins them off and issues a stock dividend to its existing shareholders of record. This model enables Endovasc to receive licensing revenues from its technologies without incurring additional expense or dilution. The fact that the company has been able to get two potential blockbuster drugs all the way to Phase III trials without incurring any significant debt, in near record time, proves this model shows tremendous potential. There are several factors that may dramatically increase Endovasc's profitability in the future. First, upon entering Phase III trials, biotech companies can start making money even though their drugs are not yet on the market. When the first positive results from their human trials start to come in, companies can start selling sub-licensing agreements and rights to their drugs to major pharmaceutical companies. These upfront fees can be significant, from millions to literally billions of dollars. Biotech companies can also sell distribution rights for their products. In Endovasc's case, the upfront fees could be significant because the company's drugs focus on the vast cardiovascular and metabolic markets, accounting for more than $69 billion in sales volume per year -- 25% of the entire pharmaceutical market. Cardiovascular diseases are the number one cause of death in the western world today. They account for 50% of deaths worldwide, nearly double of those caused by cancer, the second most prevalent cause of death. It is estimated that in the United States alone, the economic cost of cardiovascular diseases is over $250 billion per year. Secondly, Endovasc has recently created a new subsidiary called Nutraceutical Development Corporation (NDC NDC National Drug Code NDC NATO Defense College NDC National Documentation Centre (National Hellenic Research Foundation, Athens, Greece) NDC National Dairy Council NDC National Democratic Congress ). The company believes that its ANGIOGENIX(TM)-based nutraceuticals, which combined with high protein complexes, could become blockbuster nonprescription non·pre·scrip·tion adj. Sold legally without a physician's prescription; over-the-counter. products, producing positive cash flow even sooner than its later stage drugs because they are not subject to the FDA approval process. The current U.S. market size for nutraceuticals is estimated to be approximately $28 billion annually. Endovasc's products include ANGIOGENIX(TM) -- the revolutionary new treatment that has shown to recruit the body's own stem cells that help grow new heart vessels to relieve chest pain and improve heart function; Liprostin(TM), a liposomal prostaglandin-based treatment that studies suggest will prevent restenosis (re-blockage of arteries), increase circulation and reduce leg pain due to poor blood flow; biodegradable stents; drug-delivery stents; and newly discovered nutraceutical stem cell stem cell In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult. recruiter, natural products of nature, may accelerate development of muscle mass in subjects who either due to disease or for esthetic es·thet·ic adj. Variant of aesthetic. reasons wish to add muscle. Its dietary gamma linoleic acid linoleic acid /lin·o·le·ic ac·id/ (lin?o-le´ik) a polyunsaturated fatty acid, occurring as a major constituent of many vegetable oils; it is used in the biosynthesis of prostaglandins and cell membranes. (GLA) PGE-1 natural precursors, combined with various essential amino acids essential amino acid n. An alpha-amino acid that is required for protein synthesis but cannot be synthesized by humans and must be obtained in the diet. and omega-3 fatty acids This is a list of omega-3 fatty acids. Common name Lipid name Chemical name α-Linolenic acid (ALA) 18:3 (n-3) octadeca-9,12,15-trienoic acid Stearidonic acid 18:4 (n-3) octadeca-6,9,12,15-tetraenoic acid supplements, are targets to weight loss and prostaglandin prostaglandin (prŏs'təglăn`dən), any of a group of about a dozen compounds synthesized from fatty acids in mammals as well as in lower animals. balance, which may provide a natural reduction of insulin and reduce weight in overweight diabetic women. Endovasc believes that its nutriceutical nicotine-based drinks, fitness bars or capsules (which, according to the company, will contain nicotine levels too low to be habituating or to cause the typical euphoria effects from smoking) combined with high protein complexes could become blockbuster nonprescription products, producing positive cash flow even sooner than its later stage drugs because they are not subject to the FDA approval process. Endovasc Ltd. Inc., established in 1996, is a biotechnology company focused in the area of cardiovascular disease, pioneering drug delivery technology designed to deliver and release drugs to their intended targets in an efficient and controlled manner. The company's pipeline of products and processes include: Liprostin(TM), ANGIOGENIX(TM), PROStent(TM) stent-coating technology and a biodegradable stent prosthesis prosthesis (prŏs`thĭsĭs): see artificial limb. prosthesis Artificial substitute for a missing part of the body, usually an arm or leg. . The foregoing statements are made under the "Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 and may contain forward-looking statements that involve risks and uncertainties that may not be evident at the time of this release. For more information about Endovasc, please visit www.endovasc.com. (Investor questions and requests for materials can be submitted online.) |
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