Tuesday, September 29, 2015 9:04:05 AM
Bill & Melinda Gates Foundation to Support Development of the RSV F Vaccine Program
GAITHERSBURG, Md., Sept. 29, 2015 (GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced it has been awarded a grant of up to $89 million from the Bill & Melinda Gates Foundation to support development of the RSV F Vaccine Phase 3 clinical trial in pregnant women, planned to initiate during the first quarter of 2016. This grant will also support regulatory licensing efforts, providing a path to WHO prequalification. Upon licensure, Novavax has agreed to make the RSV F Vaccine affordable and accessible to people in the developing world.
“Respiratory syncytial virus (RSV) is the leading cause of pneumonia in infants, and currently there are no affordable approaches to protecting children in the developing world from this viral disease,” said Dr. Keith Klugman, Director of the Bill & Melinda Gates Foundation’s Pneumonia Program. “Maternal immunization may provide protective antibodies to infants during the first few months of life, and we hope this vaccine will protect infants from this disease to help them live healthy, productive lives.”
“Along with today’s announcement of top-line data from the Phase 2 clinical trial of our RSV F Vaccine with the goal to protect infants via maternal immunization, we are very gratified to receive the support of the Bill & Melinda Gates Foundation to improve the health of infants throughout the world,” said Stanley C. Erck, President and CEO. “Our groundbreaking Phase 2 results in both maternal and older adult target populations, underscore the promise of our RSV F Vaccine programs. We look forward to carrying our recent momentum into the fourth quarter as we prepare to initiate two pivotal Phase 3 trials of our RSV F Vaccine.”
A fact sheet on maternal immunization is available at the Novavax website, novavax.com/download/files/pipeline/151_Novavax_FactSheet_FIN_D_9x10.pdf
About RSV
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide, with estimated annual infection and mortality rates of 64 million and 160,000, respectively1. In the US, RSV is the leading cause of hospitalization of infants2. Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common3,4. Currently, there is no approved RSV vaccine available. Palivizumab is a monoclonal antibody, licensed and sold by MedImmune as Synagis®, that targets the RSV F protein and is used for prophylaxis against RSV disease in high risk infants.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and Matrix-M™ adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Additional information about Novavax is available on the company’s website, novavax.com.
References:
Nair, H. et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet, 2010; 375: 1545-1555.
Hall, C.B. et al. Respiratory Syncytial Virus-Associated hospitalizations Among Children Less Than 24 Months of Age. Pediatrics, 2013; 132(2): E341-348.
Glezen, W.P. et al. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child, 1986; 140:543-546.
Glenn GM, et al. Modeling maternal fetal RSV F vaccine induced antibody transfer in guinea pigs. Vaccine, 2015; In press. http://dx.doi.org/10.1016/j.vaccine.2015.08.039.
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Senior Manager, Investor Relations
ir@novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull@russopartnersllc.com
todd.davenport@russopartnersllc.com
212-845-4271
Novavax, Inc.
Recent NVAX News
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 09/18/2024 08:08:16 PM
- Novavax 2024-2025 Formula COVID-19 Vaccine Available at Major Pharmacies Across the U.S. • PR Newswire (US) • 09/13/2024 01:25:00 PM
- Novavax to Participate in Upcoming September Conferences • PR Newswire (US) • 09/04/2024 01:25:00 PM
- Novavax 2024-2025 Formula COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S. • PR Newswire (US) • 08/30/2024 08:19:00 PM
- Novavax 2024-2025 Formula COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S. • PR Newswire (US) • 08/30/2024 07:46:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/21/2024 08:47:46 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/20/2024 09:06:20 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 08/08/2024 08:15:42 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/08/2024 12:04:56 PM
- Novavax Reports Second Quarter 2024 Financial Results and Operational Highlights • PR Newswire (US) • 08/08/2024 12:02:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/08/2024 11:37:07 AM
- U.S. Index Futures Drop, Signaling Ongoing Market Volatility; Oil Prices Stall • IH Market News • 08/08/2024 09:55:44 AM
- Novavax to Host Conference Call to Discuss Second Quarter 2024 Financial Results and Operational Highlights on August 8, 2024 • PR Newswire (US) • 08/01/2024 01:25:00 PM
- ASML Rises 7% on Export Waiver; Intel Plans Layoffs, HSBC $3B Buyback Announced, and More • IH Market News • 07/31/2024 09:55:50 AM
- Novavax Submits Application to Health Canada for Updated Protein-based 2024-2025 Formula COVID-19 Vaccine • PR Newswire (Canada) • 07/02/2024 12:30:00 PM
- Novavax Submits Application to European Medicines Agency for Updated Protein-based 2024-2025 Formula COVID-19 Vaccine • PR Newswire (US) • 06/24/2024 01:18:00 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/18/2024 08:09:02 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/17/2024 08:13:10 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 08:14:45 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 08:11:42 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 08:10:42 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 08:07:37 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 08:06:39 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 08:05:38 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 08:01:29 PM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM