Aquasearch and Ancile Pharmaceuticals to Form Drug Development Collaboration.Business Editors & Health/Medical Writers BIOWIRE2K KAILUA-KONA, Hawaii--(BW HealthWire)--Sept. 25, 2001 Aquasearch, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :AQSE) today announced a Letter of Intent with Ancile Pharmaceuticals, Inc. to form a Strategic Alliance around the development of microalgae-based botanical bo·tan·i·cal also bo·tan·ic adj. 1. Of or relating to plants or plant life. 2. Of or relating to the science of botany. n. drugs. Botanical drugs, as defined by the U.S. Food and Drug Administration (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. ), are finished, labeled drug products that contain plant matter as ingredients. These products are typically derived from herbal medicines 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. and are prepared as complex mixtures. Such products have the potential to address growing consumer and practitioner demand for safer and more efficacious ef·fi·ca·cious adj. Producing or capable of producing a desired effect. See Synonyms at effective. [From Latin effic alternatives to synthetic new chemical entities ("NCEs"). Microalgae are rich sources of bioactive bi·o·ac·tive adj. Of or relating to a substance that has an effect on living tissue. bioactive having an effect on or eliciting a response from living tissue. components, and several microalgae-derived products have a long history of safe use for their beneficial health properties. The alliance will combine Aquasearch's pipeline of microalgae products and its proprietary cGMP production potential with Ancile's drug development expertise and technology platform, which consists of proprietary methods for characterizing and standardizing botanical drug substances. Together, the companies will pursue a new development pathway created by the FDA that should enable New Drug Applications for botanical drugs to be submitted several years more quickly than conventional drugs based on NCEs. Executives from both companies said the collaboration has the potential to greatly benefit consumers by bringing new and safer drugs to market. "Our combined technologies create a new business opportunity for the use of microalgae in modern medicine," said Mark E. Huntley, Ph.D., Chief Executive Officer of Aquasearch. "Under the new FDA guidelines, complex microalgae products can be developed as prescription drugs prescription drug Prescription medication Pharmacology An FDA-approved drug which must, by federal law or regulation, be dispensed only pursuant to a prescription–eg, finished dose form and active ingredients subject to the provisos of the Federal Food, Drug, for major chronic diseases with unmet medical needs. For consumers, FDA approval of these drugs will provide a meaningful validation of product quality, safety and clinical efficacy. For drug sponsors, the regulatory pathway can also result in significantly reduced time and cost to market." "The collaboration with Aquasearch enables Ancile to apply its specialized development capabilities to a broader set of drug candidates," said Janice E. Thompson, Ph.D., President and Chief Executive Officer of Ancile. "Ancile has identified several microalgae candidates for development as botanical drugs, and Aquasearch has an unparalleled capability to produce starting biomass under highly controlled conditions." About Aquasearch, Inc. Aquasearch is a biopharmaceutical company dedicated to the discovery, development, and commercialization of prescription drugs and over-the-counter nutraceuticals from microalgae. Aquasearch is a world leader in commercial photobioreactor technology, which enables large scale cGMP production of single cell plants. Although plants have proven to be the most successful source of new drugs, more than 30,000 species of single cell plants remain unexploited in health and medicine. Aquasearch's first nutraceutical nu·tra·ceu·ti·cal n. A food or naturally occurring food supplement thought to have a beneficial effect on human health. nutraceutical , The AstaFactor(TM), is a natural dietary supplement Noun 1. dietary supplement - something added to complete a diet or to make up for a dietary deficiency diet - a prescribed selection of foods vitamin pill - a pill containing one or more vitamins; taken as a dietary supplement rich in astaxanthin, a potent antioxidant antioxidant, substance that prevents or slows the breakdown of another substance by oxygen. Synthetic and natural antioxidants are used to slow the deterioration of gasoline and rubber, and such antioxidants as vitamin C (ascorbic acid), butylated hydroxytoluene with anti-inflammatory properties. The AstaFactor(TM), now at all Longs Drugs Longs Drugs (NYSE: LDG) is a pharmacy chain store located in the West Coast of the United States. It was founded in 1938 by brothers Thomas and Joseph Long (son-in-law of Marion Barton Skaggs, co-founder of Safeway Inc.), with their first store in Oakland, California. and Wal-Mart stores in Hawaii, is expected to be available at many more retail outlets retail outlet n → punto de venta retail outlet n → point m de vente retail outlet retail n → on the U.S. mainland later this year. For more information, please visit the Company's Web site at http://www.aquasearch.com. About Ancile Pharamaceuticals, Inc. Ancile Pharmaceuticals is a privately held specialty pharmaceutical company focusing on the development and commercialization of prescription botanical drugs for major chronic disease conditions. Presently, Ancile has three allowed Investigational New Drug Applications filed with the FDA and multiple human clinical programs in progress. In December 2000, Ancile successfully completed a double blind, placebo-controlled Phase 2 trial for its most advanced drug product. For more information, please visit the Company's Web site at http://www.ancile.com. "Safe-Harbor" Statement Under the 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 This press release contains forward-looking information within the meaning of Section 21E of the Securities Exchange Act of 1934, including statements regarding the potential market for botanical drugs, continued revenues, the outcome of an alliance between Ancile Pharmaceuticals and Aquasearch, the likelihood of obtaining FDA approval for any botanical drug candidate, as well as statements that include the words "believe," "expects," or similar expressions. Such forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of Aquasearch to differ materially from those implied or expressed by such forward-looking statements. Such factors include, among others, the risk factors included in Aquasearch's Annual Report on Form 10-KSB for the fiscal year ended October 31, 2000 and any subsequent reports filed with the Securities and Exchange Commission under the Exchange Act. This press release speaks as of the date first set forth above and neither Aquasearch nor Ancile Pharmaceuticals assume responsibility to update the information included herein for events occurring after the date hereof. |
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