AVANT Immunotherapeutics Announces New CholeraGarde Manufacturer.Business Editors/Health/Medical Writers BIOWIRE2K NEEDHAM, Mass.--(BUSINESS WIRE)--June 19, 2003 AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) announced today the termination of its manufacturing contract with Bio Sidus, S.A., of Buenos Aires, Argentina, for the manufacture of its CholeraGarde(TM) vaccine. Simultaneously, AVANT has commenced arbitration proceedings in the State of New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of to reconcile contractual issues between the two companies. AVANT's partner, the International Vaccine Institute (IVI IVI Intelligent Vehicle Initiative IVI International Vaccine Institute IVI Interchangeable Virtual Instrument IVI Intravenous Infusion IVI Interactive Video Instruction IVI Intra Venous Injection IVI Institute for Vision Improvement IVI Interactive Video Initiative ), is currently conducting a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of the CholeraGarde(TM) vaccine in approximately 70 adult and 280 pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. subjects in Bangladesh. The study is assessing the safety and immunogenicity immunogenicity /im·mu·no·ge·nic·i·ty/ (-je-nis´it-e) the property enabling a substance to provoke an immune response, or the degree to which a substance possesses this property. of the vaccine in a population where cholera is endemic. Clinical material for the trial previously has been manufactured by the Walter Reed Army Institute of Research This article is about the U.S. Army medical research institute (not the hospital). Otherwise, see Walter Reed (disambiguation). The Walter Reed Army Institute of Research (WRAIR) is the largest biomedical research facility administered by the U.S. (WRAIR WRAIR Walter Reed Army Institute of Research ), and AVANT and WRAIR have entered into a manufacturing agreement to supply CholeraGarde(TM). "We already have sufficient clinical material to satisfy IVI's Phase II trial needs, and so we do not anticipate any slowdown or changes in the clinical timelines for CholeraGarde(TM) as a result of this event," said Una Ryan, President and Chief Executive Officer of AVANT Immunotherapeutics. "At the same time, we will be working to identify a manufacturer for the production of Phase III clinical materials, as well as future commercialization needs." AVANT Immunotherapeutics, Inc. is engaged in the discovery, development and commercialization of products that harness the human 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. to prevent and treat disease. The company is developing a broad portfolio of vaccines addressing a wide range of applications including bacterial and viral diseases, chronic human disease, biodefense and food safety. These include single-dose, oral vaccines that protect against important disease-causing agents and a novel, proprietary vaccine candidate for cholesterol management. AVANT's goal is to demonstrate proof-of-concept for its products before leveraging their value through partnerships. Current collaborations encompass the development of an oral human rotavirus rotavirus /ro·ta·vi·rus/ (ro´tah-vi?rus) any member of the genus Rotavirus. ro´taviral Rotavirus /Ro·ta·vi·rus/ (ro´tah-vi?rus vaccine, vaccines to combat threats of biological warfare biological warfare, employment in war of microorganisms to injure or destroy people, animals, or crops; also called germ or bacteriological warfare. Limited attempts have been made in the past to spread disease among the enemy; e.g. , and vaccines addressed to human food safety and animal health. Additional information on AVANT Immunotherapeutics, Inc. can be obtained through our site on the World Wide Web: http://www.avantimmune.com. 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. 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 release includes forward-looking statements which reflect AVANT's current views with respect to future events and financial performance. These forward-looking statements are based on management's beliefs and assumptions and information currently available. The words "believe", "expect", "anticipate", "intend", "estimate", "project" and similar expressions which do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to: (1) the proposed acquisition of UPT UPT Universal Personal Telecommunications UPT Universidade Portucalense UPT Uptown (New Orleans, LA) UPT Undergraduate Pilot Training UPT Units Per Transaction UPT Urine Pregnancy Test UPT Union Pacific Technologies and related transactions may not be consummated on the terms currently anticipated or at all; (2) the ability to adapt AVANT's vectoring systems to develop new, safe and effective orally administered vaccines against anthrax and plague or any other microbes used as bioweapons; (3) the ability to successfully complete development and commercialization of CholeraGarde(TM) (Peru-15), Ty800 and of other products; (4) the cost, timing, scope and results of ongoing safety and efficacy trials of CholeraGarde(TM) (Peru-15), Ty800 and other preclinical and clinical testing; (5) the ability to successfully complete product research and further development, including animal, pre-clinical and clinical studies of CholeraGarde(TM) (Peru-15), Ty800 and other products; (6) the ability of the Company to manage multiple late stage clinical trials for a variety of product candidates; (7) the volume and profitability of product sales of Megan(R)Vac 1 and other future products; (8) changes in existing and potential relationships with corporate collaborators; (9) the cost, delivery and quality of clinical and commercial grade materials supplied by contract manufacturers (10) the timing, cost and uncertainty of obtaining regulatory approvals to use CholeraGarde(TM) (Peru-15) and Ty800, among other purposes, to protect travelers and people in endemic regions from diarrhea causing diseases and for other products; (11) the ability to obtain substantial additional funding; (12) the ability to develop and commercialize products before competitors; (13) the ability to retain certain members of management; and (14) other factors detailed from time to time in filings with the Securities and Exchange Commission. We expressly disclaim any responsibility to update forward-looking statements. |
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