Application for Rotarix by AVANT's Partner, GlaxoSmithKline, is Accepted for Review by the FDA
AVANT Immunotherapeutics 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."
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.
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.
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 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 development and commercialization of TP10, CETi-1, CholeraGarde(R) (Peru-15), Ty800, ETEC E. coli 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 TP10, CETi-1, CholeraGarde(R) (Peru-15), Ty800, ETEC E. coli vaccine 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 TP10, CETi-1, CholeraGarde(R) (Peru-15), Ty800, ETEC E. coli vaccine and other products; (6) the ability of AVANT to manage multiple late stage clinical trials for a variety of product candidates; (7) our expectations regarding our technological capabilities and expanding our focus to broader markets for vaccines; (8) our expectations regarding the cost of funding our 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 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 Glaxo), revenues and expenses, including infrastructure expenses; (16) our belief regarding the validity of our patents and potential litigation; and (17) certain other factors that might cause AVANT's actual results to differ materially from those in the forward-looking statements include 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 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 we do not promise to update any forward-looking statements to reflect changes in underlying assumptions or factors, new information, future events or other changes.