DGAP-News: Novavax to Initiate Seasonal and Pandemic

New Post Public Reply Private Reply Replies (0) Message Board

News Desk 2018

Sep 24, 2013 at 8:15 AM

DGAP-News: Novavax to Initiate Seasonal and Pandemic Influenza Trials in Collaboration With BARDA

Novavax, Inc. 24.09.2013 14:00 --------------------------------------------------------------------------- -- Quadrivalent Seasonal Influenza Clinical Trial to start in 1Q2014 -- Pandemic Influenza Clinical Trial to start in the U.S. in 1H2014 -- Proprietary Adjuvant Matrix-M to be used in the Pandemic Clinical Trial ROCKVILLE, Md., 2013-09-24 14:00 CEST (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) a clinical-stage vaccine company, announced today that it is finalizing details on costs and timelines for their next round of clinical studies with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) following successful completion of process improvement studies. Novavax is preparing to move forward with these next clinical trials for its quadrivalent seasonal influenza vaccine candidate and its pandemic influenza vaccine candidate, both under U.S. INDs. The pandemic study will include the use of Novavax' proprietary saponin-based adjuvant, Matrix-M(tm). 'Novavax is committed to moving these two vaccine candidates through to licensure. The clinical trials we have planned for 2014 are important steps in the completion of that goal,' said Stanley C. Erck, President and Chief Executive Officer, 'Given the shift in the global disease focus from the H5N1 avian influenza strain to the H7N9 avian influenza strain we have expanded our pandemic program to include H7N9. We are especially pleased with BARDA's interest in the development of both of our pandemic vaccine candidates with the Matrix-M adjuvant, along with our seasonal vaccine program.' About the Novavax BARDA Contract In February 2011, Novavax was awarded a contract valued at up to $179 million by BARDA for the advanced development of recombinant influenza vaccine products and manufacturing capabilities for pandemic preparedness. Throughout the contract's 3-year base period, valued at $97 million, Novavax has been developing and testing its novel recombinant virus-like particle (VLP) influenza vaccines to address BARDA's commitment to advancing recombinant-based technology as a component of pandemic preparedness. Upon satisfaction of established milestones, the contract can expect to be extended for an additional 24 months, upon execution by BARDA of an Option One period, valued at $79 million in additional funding. The milestones under the Option One period would focus on completion of the pathway to product licensures from the U.S. Food and Drug Administration (FDA), including support for manufacturing scale-up. There is an additional contract option for vaccine production ($3 million). About Novavax 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. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea, PATH and recently acquired Isconova AB, a leading vaccine adjuvant company located in Sweden. Together, Novavax' network supports its global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. Additional information about Novavax is available on the company's website, novavax.com. 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 June 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 Phillips SVP, Chief Financial Officer and Treasurer Novavax, Inc. 240-268-2000 News Source: NASDAQ OMX 24.09.2013 Dissemination of a Corporate News, transmitted by DGAP - a company of EQS Group AG. The issuer is solely responsible for the content of this announcement. DGAP's Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------------- Language: English Company: Novavax, Inc. United States Phone: Fax: E-mail: Internet: ISIN: US6700021040 WKN: End of Announcement DGAP News-Service ---------------------------------------------------------------------------

Newer

Older

Scroll down for more posts ▼

Top 10 Most Recent News Articles

Young Visionaries Win Junior Medals at STARMUS VIII

Fresh from the Canary Islands' shores, STARMUS VIII has lifted the veil on two young powerhouses shaping tomorrow—Valeria Corrales and Aneeshwar Kunchala. These two have snagged coveted honors, crowning them as champions of their generation. Igniting Passion for Science and the Environment Valeria Corrales isn't just another face in the crowd; she’s the force behind a...

Retail Trading Platforms Report Record Growth in 2026

A Boom in Self-Directed Investing Times are changing, folks. More people than ever are taking finance into their own hands, wielding smartphones like fiscal swords in the name of self-directed investment. No middlemen, no fancy office, just straight-up trading from wherever you might be perched. Four major platforms now boast over 41 million funded accounts combined, each...

Phase I of 2026 Hong Kong Trade Shows Highlights Innovation

Hong Kong Takes Center Stage in Global Commerce Flip through the economic landscape today, and you’ll spot Hong Kong, decked out in its best as a trade linchpin—with over 2,100 suppliers gathered under one roof. AsiaWorld-Expo is buzzing with the commencement of Phase I of the October 2026 Global Sources Hong Kong Shows. The theme's all about 'Connecting Global...

AI Revenue Missteps Shake Semiconductor Stocks

Nervous Times for Semiconductor Stocks When the semiconductor sector started October like a high-speed train, I thought we might sail through this month without hitting turbulence. But then, in trotted some shaky AI revenue numbers, and bam, the whole sector took a hit off its October highs. The semiconductor stocks, led by giants like Taiwan Semiconductor Manufacturing...

AI Drives Major Time Savings in Endoscopy Tech

AI in Endoscopy: Game-Changer or Gimmick? Stumbling across AnX Robotica's latest pitch about their NaviCam ProScan AI workflow, one can't help but feel a mix of curiosity and skepticism. With the stakes in medical tech sky-high, they've fired off some impressive stats that grab attention. We're talking about cutting small-bowel capsule review times by a whopping...

Emdoor’s Rugged Devices Fuel Industry Growth Globally

Emdoor Information: A Sturdy Path in Rugged Computing Dive into the heart of the rugged computing terrain, and you may very well run into Emdoor Information—an 18-year-old titan from Shenzhen that’s carved its niche on the backs of rugged tablets, laptops, and handhelds. Publicly listed since 2023 on China’s A-share main board, Emdoor isn't just any player in this...

AI in Music: CITY JAM Focuses on Human Creativity

Breaking Down the AI Music Race In the wild world of music production, AI's making waves. Here's the thing though—it's all about how fast and how much it can churn out. Now, won't lie to you, that's impressive, but not the full picture. Pat Villaceran, the brain behind CITY JAM, is adamant that the real gold isn't just speed. It's the unique sound each artist brings to...

Kailas Campaign Binds Climbers with Gear, Trust

Embracing the Spirit of Climbing Connections Alright, so when's the last time you saw a brand digging into the human side of one rugged sport like climbing? That's where Kailas steps in, pulling us beyond gear talk into the trust and camaraderie that defines climbing. Their latest effort—dubbed “Stay Warm, Stay Together”—goes beyond mere technical prowess by...

KAPSARC Drives Energy Dialogue at WPC in Riyadh

Defining Energy Horizons in Riyadh Mark those calendars, because as the global energy crowd descends on Riyadh from October 11 to 15, 2026, KAPSARC steps into the spotlight. As the National Partner at the 25th World Petroleum Congress (WPC), they're not just warming the bench—they're playing every position, shaking up the field of energy. Paving the Pathways with...

New Docs Spotlight Psychiatry on World Mental Health Day

Unmasking Mental Health on the Global Stage Hold onto your hats, folks. The Scientology Network is cranking up the heat this World Mental Health Day. On October 10, they’re rolling out a program that puts the spotlight on CCHR’s crusade against what they see as dark forces in the psychiatric industry. It’s a marathon of documentaries that dives into allegations of...