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Application for Rotarix(R) by AVANT's partner, GlaxoSmithKline, is accepted for review by the FDA |
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15 Aug 2007 |
AVANT Immunotherapeutics, Inc. today announced that GlaxoSmithKline's Biologics License Application (BLA) for Rotarix(R) has been accepted for review by the U.S. Food and Drug Administration (FDA)
NEEDHAM, MA, USA | August 14, 2007 | AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) today announced that GlaxoSmithKline's Biologics License Application (BLA) for Rotarix(R), an oral candidate vaccine for infants to prevent rotavirus gastroenteritis, has been accepted for review by the U.S. Food and Drug Administration (FDA). Severe, dehydrating gastroenteritis occurs primarily among children aged three to 35 months. Of children hospitalized with rotavirus, approximately 17 percent are younger than six months old. If approved, the GSK candidate vaccine could offer completion of the rotavirus vaccination series by four months of age. The rotavirus candidate vaccine is a live-attenuated vaccine derived from the most common human rotavirus strain. Published data show that immunity resulting from natural human rotavirus infection provides significant protection against moderate to severe disease, regardless of rotavirus strain.
The BLA for the GSK rotavirus candidate vaccine is 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.
"We are delighted that our partner GSK's application for Rotarix(R) has been accepted for review," said Una S. Ryan, Ph.D., President and Chief Executive Officer of AVANT Immunotherapeutics. "The FDA review 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."
About Rotarix(R)
Rotarix(R) is an oral, two-dose, live attenuated vaccine 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 beginning at six weeks of age, allowing for early protection.
About GlaxoSmithKline
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. GSK Biologicals (GSK Bio), one of the world's leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline's activities in the field of vaccine research, development and production are conducted. GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world - an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination pediatric vaccines which protect the world's children from up to six diseases in one vaccine.
About AVANT Immunotherapeutics, Inc.
AVANT Immunotherapeutics, Inc. discovers and develops innovative vaccines and therapeutics that harness the human immune system 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, global health, and pandemic flu 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.
SOURCE: AVANT IMMUNOTHERAPEUTICS |
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