Novavax Announces Continuation of RSV Vaccine Partnership With PATH
ROCKVILLE, Md., Jan. 13, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX)
announced the continuation of their partnership with PATH to develop Novavax'
RSV (respiratory syncytial virus) vaccine for maternal immunization. Under this
amendment, PATH will provide Novavax approximately $3.5 million in funding to
support the ongoing Phase II dose-confirmatory clinical trial in women of
childbearing age, initiated in October 2013. Under this partnership, Novavax and
PATH will also initiate planning activities for clinical development of the
vaccine in low-resource countries.
Data from the ongoing Phase II clinical trial will provide additional evidence
of the vaccine candidate's safety and establish the appropriate dose to be used
in a follow-on clinical trial in pregnant women. By immunizing pregnant women,
Novavax believes that high levels of protective maternal RSV antibodies will be
transferred to their offspring through the placenta before birth, providing
protection in early infancy when RSV infection is most dangerous.
Under this partnership, PATH and Novavax may elect to continue to collaborate on
additional clinical trials to further develop Novavax' RSV vaccine for maternal
immunization in low-resource countries. Novavax retains global rights to
commercialize the product and will support PATH in its goal to make the product
affordable and available in low-resource countries.
"PATH, an internationally recognized innovative global health organization,
continues to support a key portion of the development expenses for our RSV
vaccine candidate. We are gratified by PATH's continued funding of this vaccine
development program, which has the potential to dramatically improve pediatric
health worldwide," said Stanley C. Erck, President and CEO of Novavax.
"We are pleased to be working with Novavax to support the development of a
maternal RSV vaccine that has the potential to protect infants in low-resource
countries during the critical early months of life," said Dr. John Donnelly,
director of PATH's RSV vaccine project.
Respiratory syncytial virus (RSV) is one of the most common causes of lower
respiratory tract infection among young children, both globally and in the
United States. The majority of cases of severe RSV disease occur in otherwise
healthy children. It is estimated that there are 64 million cases of RSV disease
worldwide each year, resulting in 160,000 deaths. In the U.S., RSV causes as
many as 172,000 annual hospitalizations among children younger than 5 years old,
with the vast majority of these occurring in infants less than six months of
age. Maternal immunization for the protection of young infants against
infectious diseases has been successfully employed to eliminate 92% of neonatal
tetanus cases globally, and in the U.S. is currently used to prevent whooping
cough and influenza. Currently, there is no approved vaccine against RSV.
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company
creating novel vaccines and vaccine adjuvants to address a broad range of
infectious diseases worldwide. Using innovative proprietary recombinant protein
nanoparticle vaccine technology, the company produces vaccine candidates to
efficiently and effectively respond to both known and newly emergent diseases.
Additional information about Novavax is available on the company's website,
PATH is an international nonprofit organization that transforms global health
through innovation. We take an entrepreneurial approach to developing and
delivering high-impact, low-cost solutions, from lifesaving vaccines, drugs,
diagnostics, and devices to collaborative programs with communities. Through our
work in more than 70 countries, PATH and our partners empower people to achieve
their full potential. For more information, please visit www.path.org.
Forward Looking Statements
Statements herein relating to the future of Novavax and the ongoing development
of its vaccine and adjuvant products are forward-looking statements. Novavax
cautions that these forward looking statements are subject to numerous risks and
uncertainties, which could cause actual results to differ materially from those
expressed or implied by such statements. These risks and uncertainties include
those identified under the heading "Risk Factors" in the Novavax Annual Report
on Form 10-K for the year ended December 31, 2012, and Form 10-Q for the period
ended September 30, 2013, both filed with the Securities and Exchange Commission
(SEC). We caution investors not to place considerable reliance on the forward-
looking statements contained in this press release. You are encouraged to read
our filings with the SEC, available at sec.gov, for a discussion of these and
other risks and uncertainties. The forward-looking statements in this press
release speak only as of the date of this document, and we undertake no
obligation to update or revise any of the statements. Our business is subject to
substantial risks and uncertainties, including those referenced above.
Investors, potential investors, and others should give careful consideration to
these risks and uncertainties.
CONTACT: Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Novavax, Inc. via GlobeNewswire