AVAN Avant Immunotherapeutics (MM)

AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) announced today that its partner, GlaxoSmithKline (GSK), has received approval from the U.S. Food and Drug Administration (FDA) for ROTARIX� for the prevention of rotavirus gastroenteritis in infants. With only two doses, ROTARIX will offer protection against the most commonly circulating rotavirus types in the U.S. and allow infants to complete the vaccination series by four months of age. The U.S. Centers for Disease Control and Prevention (CDC) currently recommends that children complete the rotavirus immunization series by six months of age. Rotavirus infects virtually every child in the United States by age five and is the leading cause of severe gastroenteritis in infants and young children worldwide. ROTARIX may help prevent many of the 55,000 � 70,000 hospitalizations by young children that result from rotavirus in the U.S. each year. Not only does ROTARIX confer protection at an early age, but clinical trials have shown that protection is broad and sustained. ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a two-dose series in infants and children. Clinical data published on the two-dose series of ROTARIX show that protection was sustained through the first two years of life and was highly efficacious against rotavirus hospitalizations (96%) and severe rotavirus gastroenteritis (90%). In addition, ROTARIX was effective against rotavirus gastroenteritis of any severity (79%). Specifically, significant protection was demonstrated against severe rotavirus gastroenteritis during two rotavirus seasons caused by types G1 (96%), G2 (86%), G3 (94%), G4 (95%), and G9 (85%), the most commonly circulating rotavirus types in the U.S. �We are delighted that our partner GSK has received approval of ROTARIX in the United States,� said Una S. Ryan, Ph.D., President and Chief Executive Officer of AVANT Immunotherapeutics. �With only two doses, ROTARIX will allow infants to complete the vaccination series against rotavirus earlier than ever before. We have great expectations for GSK to launch ROTARIX prior to the upcoming rotavirus season.� AVANT licensed the technology for ROTARIX to GSK in 1997 for worldwide commercialization. The vaccine was originally developed at Cincinnati Children�s Hospital Medical Center. The FDA's approval of ROTARIX was based on one of the largest clinical development plans undertaken by a vaccine manufacturer and includes data from nearly 75,000 infants. These clinical trials were conducted in the Americas, Europe, Asia and Africa and reflect an ethnically diverse population. About ROTARIX� ROTARIX is an oral live-attenuated human rotavirus vaccine licensed in more than 100 countries around the world. More than 25 million doses of ROTARIX have been distributed worldwide. The vaccine was developed for the prevention of rotavirus gastroenteritis by mimicking the protective effects of natural human rotavirus infection. Naturally occurring human rotavirus infection provides significant protection against subsequent moderate to severe rotavirus gastroenteritis regardless of the infecting serotype(s). Five Phase 3 clinical trials were conducted worldwide to assess the safety and efficacy of ROTARIX in support of U.S. licensure. The clinical trials conducted in support of U.S. licensure demonstrated efficacy against rotavirus gastroenteritis of any severity due to the most common currently circulating rotavirus types in the U.S. In clinical studies, common adverse events were fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting. ROTARIX is contraindicated in certain individuals with a history of uncorrected congenital malformation of the gastrointestinal tract. About Rotavirus Rotavirus infects virtually every child worldwide by age five and is the leading cause of severe gastroenteritis in infants and young children in the U.S. and worldwide. Severe, dehydrating gastroenteritis can occur as young as three months of age. In the U.S. each year, 2.7 million children younger than five years of age suffer from rotavirus disease, resulting in 410,000 clinic visits and up to 272,000 emergency department visits. In addition, between 55,000 and 70,000 children are hospitalized and 20 to 60 die each year. In the U.S., the rotavirus season typically begins in the southwest during November-December and spreads to the northeast by April-May. About GlaxoSmithKline: A Leader in Vaccines GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research Triangle Park, NC, is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. GlaxoSmithKline Biologicals (GSK Biologicals) is a global vaccine company which has shown to be a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development. Headquartered in Belgium, GSK Biologicals has 14 manufacturing sites strategically positioned around the globe. In 2007 GSK Biologicals distributed 1.1 billion doses of vaccines to 169 countries in both developed and the developing world -- an average of 3 million doses a day. GSK Biologicals employs over 9,000 people worldwide including more than 1,600 passionate scientists engaged in research aimed at discovering innovative vaccines that contribute to the health and well-being of people of all generations around the world. About AVANT Immunotherapeutics, Inc. AVANT Immunotherapeutics, Inc. is a NASDAQ-listed company discovering and developing innovative vaccines and targeted immunotherapeutics for the treatment of cancer, infectious and inflammatory diseases. AVANT focuses on the use of tumor-specific targets and human monoclonal antibodies (mAbs) to precisely deliver therapeutic agents through its novel �targeted immunization� approach. AVANT also possesses innovative bacterial vector delivery technologies with unique manufacturing and preservation processes that offer the potential for a new generation of infectious disease vaccines. AVANT�s deep product pipeline consists of products in varying stages of development, with its lead candidate, CDX-110, currently undergoing evaluation in a Phase 2/3 clinical trial in newly diagnosed glioblastoma multiforme, one of the most aggressive forms of brain cancer. AVANT also has five product candidates in its development pipeline including: CDX-1307, a product based on its proprietary APC Targeting Technology�, which is in two Phase 1 clinical trials for patients with advanced pancreatic, bladder, breast and colon cancer; a complement inhibitor, TP10, in development for transplantation and other indications; and three candidates based on its oral, rapidly-protecting, single-dose and temperature-stable vaccine technology, including combination vaccines for travelers, the military and global health needs. AVANT has three commercialized products, including ROTARIX for the prevention of rotavirus infection and two human food safety vaccines for reducing salmonella infection in chickens and eggs. Additional information on AVANT Immunotherapeutics, Inc. can be obtained through its site on the World Wide Web: http://www.avantimmune.com. Safe Harbor Statement Under the Private Securities Litigation Reform Act 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 successful integration of the business post-merger, multiple technologies and programs; (2) the ability to adopt AVANT�s APC Targeting TechnologyTM to develop new, safe and effective vaccines against oncology and infectious disease indications; (3) the ability to adapt AVANT�s vectoring systems to develop new, safe and effective orally administered vaccines against disease causing agents; (4) the ability to successfully complete product research and further development, including animal, pre-clinical and clinical studies, and commercialization of CDX-110, CDX-1307, CholeraGarde� (Peru-15), Ty800, ETEC E. coli vaccine, and other products and AVANT�s expectations regarding market growth; (5) the cost, timing, scope and results of ongoing safety and efficacy trials of CDX-110, CDX-1307, CholeraGarde� (Peru-15), Ty800, ETEC E. coli vaccine and other preclinical and clinical testing; (6) the ability to negotiate strategic partnerships or other disposition transactions for AVANT�s cardiovascular programs, including TP10 and CETi; (7) the ability of AVANT to manage multiple clinical trials for a variety of product candidates; (8)�the volume and profitability of product sales of Megan�Vac 1, Megan�Egg and other future products; (9)�the process of obtaining regulatory approval for the sale of Rotarix� in major commercial markets, as well as the timing and success of worldwide commercialization of Rotarix� by our partner, GlaxoSmithKline or Glaxo; (10)�Glaxo�s strategy and business plans to launch and supply Rotarix� worldwide, including in the U.S. and other major markets and its payment of royalties to AVANT; (11) AVANT�s expectations regarding its technological capabilities and expanding its focus to broader markets for vaccines; (12) changes in existing and potential relationships with corporate collaborators; (13) 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; (14) the timing, cost and uncertainty of obtaining regulatory approvals; (15) AVANT�s ability to develop and commercialize products before competitors that are superior to the alternatives developed by such competitors; (16) AVANT�s ability to retain certain members of management;(17) AVANT�s expectations regarding research and development expenses and general and administrative expenses; (18) AVANT�s expectations regarding cash balances, capital requirements, anticipated royalty payments (including those from Paul Royalty Fund), revenues and expenses, including infrastructure expenses; (19)�the ability to obtain substantial additional funding; (20) AVANT�s belief regarding the validity of our patents and potential litigation; and (21) 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 of Financial Condition and Results of Operations� in each of AVANT�s Annual Report on Form 10-K, its current 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.