Healthcare Industry News: rotavirus vaccine
News Release - January 5, 2006
AVANT Immunotherapeutics Says Promise of Rotarix(R) Rotavirus Vaccine for Reducing Deaths, Hospitalizations Due to Rotavirus Disease Highlighted in New England Journal of MedicinePartner GSK's Global Commercialization of Rotarix Continues
NEEDHAM, Mass.--(HSMN NewsFeed)--Jan. 5, 2006--AVANT Immunotherapeutics (Nasdaq: AVAN ) today announced that data from a Phase 3 study of Rotarix®, the company's two-dose oral rotavirus vaccine being developed and commercialized globally by GlaxoSmithKline, were published today in the January 5 issue of the New England Journal of Medicine. Accompanying the publication of the clinical article, which demonstrated the safety and efficacy of the vaccine in a randomized, double-blind, Phase 3 trial, was an editorial commenting on the positive study results and the promise of Rotarix® and a second new rotavirus vaccine in development by others. The editorial noted the value of a safe and effective rotavirus vaccine both to save lives in developing nations, where rotavirus disease is a major cause of infant death, and to reduce the economic burden of the disease in industrialized countries by reducing hospitalizations and lost workdays.
"These publications clearly recognize the need for a safe and effective rotavirus vaccine like Rotarix®," said Una S. Ryan, President and Chief Executive Officer of AVANT Immunotherapeutics. "Our partner GlaxoSmithKline has undertaken a worldwide development effort that has now led to approvals for Rotarix in 25 countries and a recommendation from the European regulatory authorities for approval in Europe. Most recently it has been reported that GlaxoSmithKline is making 8 million doses for universal coverage in Brazil."
Rotarix® has been developed by GSK Biologicals since 1997 when it was in-licensed from AVANT Immunotherapeutics. Dr Richard Ward originally developed the vaccine at the Cincinnati Children's Hospital Medical Center.
Rotarix® 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. The vaccine can be co-administered with all major infant vaccines including oral polio vaccine. It is given in a two-dose schedule as of six weeks of age, allowing for an early protection.
Since Rotarix® launch in Mexico in 2004, an additional 24 licenses have been granted worldwide (12 Latin American countries including Brazil; Philippines and Singapore being the first Asian countries). Furthermore, Rotarix® has been filed in 75 countries. There are plans to file in the US where discussions are ongoing with the FDA.
Recently, Brazil and Panama included for the first time the rotavirus vaccine in their national official vaccination calendars. As part of the government's pediatric immunization program, vaccination with Rotarix® will be available free at public health clinics in Brazil and Panama.
About GlaxoSmithKline Biologicals
GSK Biologicals, one of the world's leading vaccine manufacturers, is located in Rixensart, Belgium, which is the centre of all GlaxoSmithKline's activities in the field of vaccine research, development and production. GSK Biologicals employs more than 1,000 research 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. GSK Biologicals future vaccine pipeline contains more than 20 new vaccines in clinical development.
In 2004, GSK Biologicals distributed more than 1.5 billion doses of vaccines to 168 countries in both the developed and the developing world - an average of 45 doses per second. Of those vaccine doses, approximately 140 million were doses of combination paediatric vaccines, which protect the world's children against a minimum of three - and as many as six - diseases in one vaccine. For more information, visit GlaxoSmithKline's vaccine websites at www.gsk-bio.com.
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. Six of AVANT's products are in clinical development, including a treatment to reduce complement-mediated tissue damage associated with cardiac bypass surgery and a novel vaccine for cholesterol management. AVANT is also developing a pipeline of bacteria-fighting products for biodefense, travelers' vaccines, and global health needs based on AVANT'S rapid-protecting, single-dose, oral 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 which reflect AVANT's current views with respect to future events and financial performance. These forward-looking statements are based on management's beliefs and assumptions and information currently available. The words "believe", "expect", "anticipate", "intend", "estimate", "project" and similar expressions which do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. 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 bioterrorism threats or emerging health care threats; (3) the ability to successfully complete development and commercialization of TP10, CETi-1, CholeraGarde® (Peru-15), Ty800 and other products; (4) the cost, timing, scope and results of ongoing safety and efficacy trials of TP10, CETi-1, CholeraGarde® (Peru-15), Ty800 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® (Peru-15), Ty800 and other products; (6) the ability of the Company to manage multiple late stage clinical trials for a variety of product candidates; (7) the volume and profitability of product sales of Megan®Vac 1, Megan®Egg and other future products; (8) 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; (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; (11) the timing, cost and uncertainty of obtaining regulatory approvals to use TP10, CETi-1, CholeraGarde® (Peru-15) and Ty800, among other purposes, for adults undergoing cardiac surgery, to raise serum HDL cholesterol levels and to protect travelers and people in endemic regions from diarrhea causing diseases, respectively; (12) the ability to obtain substantial additional funding; (13) the ability to develop and commercialize products before competitors; (14) the ability to retain certain members of management; and (15) other factors detailed from time to time in filings with the Securities and Exchange Commission. We expressly disclaim any responsibility to update forward-looking statements.
Source: AVANT Immunotherapeutics
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