FDA Approves ROTARIX Rotavirus Vaccine

AVANT Immunotherapeutics, Inc. announced recently 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.