Message #26 From:
Jason Date: November 26, 2007 12:37:49 PM
AVANT's Partner, GlaxoSmithKline, Announces New Data Published in The Lancet Show That Rotarix(R) Provides Sustained and Broad Protection During the First Two Years of Life(1)
Note: Shares of AVAN declined amidst positive release of information on a clinical trial.
AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) today announced that new
data from a large European clinical trial, published Friday in The
Lancet, shows that AVANT’s partner,
GlaxoSmithKline’s, Rotarix®
rotavirus vaccine to be effective against the five most commonly
circulating rotavirus types (G1, G2, G3, G4 ad G9). These virus types
are responsible for more than 98% of rotavirus gastroenteritis (RVGE)
disease in Europe during the first two years of life2.
Importantly, the protection afforded by the vaccine’s
two-dose schedule in infants occurs before six months of age.
In August 2007, AVANT announced that GSK’s
Biologics License Application (BLA) for Rotarix®
had been accepted for review by the U.S. Food and Drug Administration
(FDA). 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.
About Rotarix®
Rotarix®
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®
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.
About AVANT Immunotherapeutics, Inc.
AVANT Immunotherapeutics, Inc. is a Massachusetts-based NASDAQ-listed
company discovering and developing innovative vaccines and therapeutics
that harness the human immune system to prevent and treat disease. AVANT’s
innovative bacterial vector delivery technologies with unique
manufacturing and preservation processes offer the potential for a new
generation of vaccines. AVANT has three commercialized products,
including Rotarix®
for the treatment of rotavirus and two human food safety vaccines for
reducing salmonella infection in chickens and eggs. AVANT also has four
product candidates in its development pipeline, an anti-inflammatory
agent, TP10, 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.
Additional information on AVANT Immunotherapeutics, Inc. can be obtained
through our site on the World Wide Web: http://www.avantimmune.com.
References
1. Vesikari T., et al. Human rotavirus vaccine is highly efficacious
against rotavirus gastroenteritis during the first two years of life in
European infants: results of a randomized double-blinded controlled
study. The Lance; 2007.
2. Van Damme P et al, Rotavirus Genotype Distribution in Europe. JID;
2007: 195 (Suppl 1): S 17.
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® (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® (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® (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.
AVANT Immunotherapeutics, Inc. Una S. Ryan, Ph.D., 781-433-0771 President
and CEO or AVANT Immunotherapeutics, Inc. Avery W.
Catlin, 781-433-0771 Chief Financial Officer info@avantimmune.com or For
Media: Kureczka/Martin Associates Joan Kureczka,
415-821-2413 jkureczka@comcast.net
