AVANT's Partner, GlaxoSmithKline, Files Rotarix(R) Application for U.S. Marketing Approval with the FDA.NEEDHAM, Mass. -- AVANT Immunotherapeutics (Nasdaq: AVAN) today announced that its partner, GlaxoSmithKline (GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) ) Biologicals, has filed a marketing application for the Rotarix([R]) vaccine with the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (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. ). Rotarix([R]) is a two-dose 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 given to children for the prevention of gastroenteritis gastroenteritis: see enteritis. gastroenteritis Acute infectious syndrome of the stomach lining and intestines. Symptoms include diarrhea, vomiting, and abdominal cramps. caused by rotavirus. "We are delighted that our partner GSK has filed for approval of Rotarix([R]) in the United States," said Una S. Ryan, Ph.D., President and Chief Executive Officer of AVANT Immunotherapeutics. "The FDA filing marks a significant milestone towards the global commercialization of Rotarix([R]), which has already been approved for commercial use in over 90 countries worldwide, including the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community ." In May 2005, AVANT entered into an agreement whereby an affiliate of Paul Royalty Fund (PRF PRF abbr. prolactin-releasing factor ) purchased an interest in the net royalties AVANT will receive on worldwide sales of Rotarix([R]). The terms of the agreement with PRF include a $10 million milestone payment on product launch in 2008 in the United States. Under the PRF agreement, AVANT retains 50% of the GSK milestone payment triggered by U.S. approval of Rotarix([R]), with the balance payable to PRF and Cincinnati Children's Hospital Medical Center Cincinnati Children's Hospital Medical Center is a hospital in Cincinnati, Ohio. In June of 1883, a meeting of women from parish communities around Cincinnati established a mission to create a Diocesan Hospital for Children. . About Rotarix([R]) Rotarix([R]) is an oral, two-dose, live attenuated vaccine live attenuated vaccine A vaccine that induces an immune response, which more closely resembles that of a natural infection, than that elicited by killed vaccines, as the organisms contained therein actively reproduce until held in check by the recipient's own against rotavirus disease in infants that was licensed in 1997 by AVANT Immunotherapeutics to GSK for worldwide commercialization. The vaccine was originally developed at Cincinnati Children's Hospital Medical Center. Rotarix([R]) is the first human rotavirus vaccine derived from a human virus strain available in the market. The vaccine, which is given orally, confers significant protection against rotavirus diarrhea. Clinical trials have shown high efficacy against the most prevalent rotavirus strains. It is given in a two-dose schedule as of six weeks of age, allowing for early protection. About AVANT Immunotherapeutics, Inc. AVANT Immunotherapeutics, Inc. discovers and develops innovative vaccines and therapeutics 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. AVANT has three products on the market and four of AVANT's products are in clinical development. AVANT's pipeline includes products for travelers' vaccines and global health needs based on AVANT's oral, rapid-protecting, single-dose and temperature-stable vaccine technology. 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 that are subject to a variety of risks and uncertainties and reflect AVANT's current views with respect to future events and financial performance. There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by AVANT. These factors include, but are not limited to: (1) the integration of multiple technologies and programs; (2) the ability to adapt AVANT's vectoring systems to develop new, safe and effective orally administered vaccines against anthrax and plague or other any other microbes used as bioweapons and other disease causing agents; (3) the ability to successfully complete product research and further development, including animal, pre-clinical and clinical studies, and commercialization of CholeraGarde[R] (Peru-15), Ty800, ETEC ETEC enterotoxigenic Escherichia coli. ETEC Enterotoxic Escherichia coli, see there E. coli E. coli: see Escherichia coli. E. coli in full Escherichia coli Species of bacterium that inhabits the stomach and intestines. E. coli can be transmitted by water, milk, food, or flies and other insects. vaccine, VLPs and other products and AVANT's expectations regarding market growth; (4) the cost, timing, scope and results of ongoing safety and efficacy trials of CholeraGarde[R] (Peru-15), Ty800, ETEC E. coli vaccine and other preclinical and clinical testing; (5) the ability to negotiate strategic partnerships or other disposition transactions for AVANT's cardiovascular programs, including TP10 and CETi; (6) the ability of AVANT to manage multiple clinical trials for a variety of product candidates; (7) AVANT's expectations regarding its technological capabilities and expanding its focus to broader markets for vaccines; (8) the Company's expectations regarding the cost of funding its development partnership with Select Vaccines Limited for the influenza vaccine, the opportunity to extend to other disease targets, and AVANT's ability to develop products through this collaboration; (9) changes in existing and potential relationships with corporate collaborators; (10) the availability, cost, delivery and quality of clinical and commercial grade materials produced at AVANT's own Manufacturing facility or supplied by contract manufacturers and partners; (11) the timing, cost and uncertainty of obtaining regulatory approvals; (12) the ability to develop and commercialize products before competitors that are superior to the alternatives developed by competitors; (13) the ability to retain certain members of management;(14) AVANT's expectations regarding research and development expenses and general and administrative expenses; (15) AVANT's expectations regarding cash balances, capital requirements, anticipated royalty payments (including those from Paul Royalty Fund), revenues and expenses, including infrastructure expenses; (16) our belief regarding the validity of our patents and potential litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. ; and (17) certain other factors that might cause AVANT's actual results to differ materially from those in the forward-looking statements including those set forth under the headings "Business," "Risk Factors" and Management's Discussion and Analysis Management's discussion and analysis (MD&A) A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial of Financial Condition and Results of Operations" in each of AVANT's Annual Report on Form 10-K, its Quarterly Reports on Form 8-K, as well as those described in AVANT's other press releases and filings with the Securities and Exchange Commission, from time to time. You should carefully review all of these factors, and you should be aware that there may be other factors that could cause these differences. These forward-looking statements were based on information, plans and estimates at the date of this press release, and AVANT does not promise to update any forward-looking statements to reflect changes in underlying assumptions or factors, new information, future events or other changes. |
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