Navigation Links
NOVAVAX Achieves Pandemic H1N1 Influenza Production Milestone

ROCKVILLE, Md., Aug. 5 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced today it has manufactured a virus-like particle (VLP) vaccine candidate against the H1N1 pandemic influenza virus under current good-manufacturing practices (cGMP) at its new vaccine manufacturing facility in Rockville, MD. This milestone was accomplished in only 11 weeks after receiving the gene sequence for the H1N1 strain from the U.S. Centers for Disease Control. The Company was able to reach this manufacturing goal by employing proprietary, novel production technology which is not dependent on growing influenza virus in eggs. Chicken eggs are used to produce almost all of the world's influenza vaccine supply. In addition, Novavax has produced essential reagents for measuring vaccine potency. The Company also has plans to produce additional batches of the pandemic H1N1 VLP vaccine to support human clinical studies and stands ready to assist with additional public health needs in the US as well as foreign countries.

A detailed timeline describing the process from gene sequence to cGMP manufacturing is available on the Novavax website (

Mr. Jim Robinson, Vice President of Manufacturing and Quality Operations at Novavax, commented, "Demonstration of our ability to construct and produce GMP-quality influenza vaccine within 12 weeks under real pandemic conditions is an important and successful test of our VLP technology. With further scale up, recombinant influenza VLP vaccine technology has the potential to expand vaccine surge capacity and significantly reduce the timeline for vaccine release. We are proud of our staff who worked tirelessly to achieve this important milestone while working concurrently to produce materials for a clinical study in the elderly population with our Seasonal Flu vaccine."

"The accomplishments announced today further validate our strategy to create a rapid, in-border influenza vaccine solution for governments around the world by addressing gaps in currently available vaccine technologies," added Dr. Rahul Singhvi, President and CEO of Novavax, Inc.

Novavax, Inc has successfully completed a Phase I/IIa clinical study with a candidate H5N1 influenza VLP vaccine and is currently in Phase II trials with a VLP based seasonal flu vaccine candidate. The Company plans to initiate a Phase II study with its Seasonal Flu vaccine candidate in the elderly population during Q4, 2009.

About Novavax

Novavax, Inc. is a clinical-stage biotechnology company creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like particle (VLP) technology. The company produces these VLP-based, potent, recombinant vaccines utilizing new and efficient manufacturing approaches. Additional information about Novavax is available at and in the company's various filings with the Securities and Exchange Commission.

Forward Looking Statements

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding revenues, operating expenses, cash burn, and clinical developments and anticipated milestones are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the Company's ability to progress any product candidates in preclinical or clinical trials; the scope, initiation, rate and progress of its preclinical studies and clinical trials and other research and development activities; clinical trial results; even if the data from preclinical studies or clinical trials is positive, the product may not prove to be safe and efficacious; regulatory approval is needed before any vaccines can be sold in or outside the US; Novavax's pilot plant facility is subject to extensive validation and FDA inspections, which may result in delays and increased costs; the success of the Company's foreign joint venture and licensing agreements; the Company's ability to enter into future collaborations with industry partners and governments and the terms, timing and success of any such collaboration; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; our ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; our ability to obtain adequate financing in the future through product licensing, public or private equity or debt financing or otherwise; general business conditions; competition; business abilities and judgment of personnel; and the availability of qualified personnel. Further information on the factors and risks that could affect Novavax's business, financial conditions and results of operations, is contained in Novavax's filings with the U.S. Securities and Exchange Commission, which are available at These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.

SOURCE Novavax, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Novavax Completes Enrollment of Its Second Phase II Seasonal Influenza VLP Vaccine Clinical Trial
2. Novavax Reports Positive Preclinical Results for a Novel, Broadly Cross-Protective H5N1 Pandemic Influenza Virus-like Particle (VLP) Vaccine Candidate
3. Novavax Presents Favorable Results from Phase I/IIa Pandemic Influenza Vaccine Program at World Health Organization Conference
4. Novavax Announces Top Line Results of Phase IIa Clinical Trial for Its Seasonal Influenza VLP (Trivalent) Vaccine Candidate
5. Novavax Announces Preclinical Data for Respiratory Syncytial Virus Vaccine Candidate
6. NOVAVAX Featured at Clinton Global Initiative 2008 Annual Meeting
7. NOVAVAX CEO to Present at 2008 UBS Global Life Sciences Conference
8. Novavax Announces Favorable Results from Phase I/IIa Pandemic Influenza Vaccine Program
9. Novavax to Present Phase I/IIa Trial Data Results in an Investor Conference Call on August 26, 2008
10. Novavax Announces Proprietary Method to Create SARS Vaccine and Renewal of NIH Funding for SARS Vaccine Development
11. Novavax Completes Enrollment in Phase I/IIa Pandemic Influenza Vaccine Clinical Trial
Post Your Comments:
(Date:10/12/2015)... Given the intricacy of the anatomy and physiology of ... drug effectively to a specific ocular site. Several barriers have ... include dilution of a drug by tears, clearance of a ... issues with respect to the cornea, sclera and choroid. Approximately ... due to the aforementioned barriers. --> Given ...
(Date:10/12/2015)... 12, 2015  Former White House Spokesman, and Drug Czar ... House Narcotics Committee, Robert Weiner , and Policy Analyst ... two emphasize that this is now a potential bipartisan campaign ... Jeb Bush , Carly Fiorina to Rand ... federal statistics, which they call "a shocker: 23 million need ...
(Date:10/12/2015)... 2015  Luminex Corporation (NASDAQ: LMNX ) today announced ... ended September 30, 2015 on Monday, November 2, 2015. A ... the close of trading. --> ... discuss the operating highlights and financial results for the third ... 4:30 p.m. Eastern time. . Simply ...
Breaking Medicine Technology:
(Date:10/13/2015)... CA (PRWEB) , ... October 13, 2015 , ... According ... Care, a recent study has shown that women who successfully lose weight with a ... in the United States each year. The article notes that anywhere from 40 to ...
(Date:10/13/2015)... ... 13, 2015 , ... Altec Products, Inc., the leader in ... Dynamics AXUG, GPUG and NAVUG Summits to take place the week of October ... user conferences designed and led by users to provide attendees with a unique ...
(Date:10/13/2015)... ... 13, 2015 , ... Element Blue ™, a leading ... company, RightSensor™ LLC, an Internet of Things (IoT) hardware supplier that delivers custom ... approach for customers requiring sensor hardware for critical data environments. , RightSensor™, working ...
(Date:10/13/2015)... ... October 13, 2015 , ... ... private messaging application, announced today a significant contract that will provide its award-winning ... plans to build on the growing success of its Relay program, IBX Wire™, ...
(Date:10/13/2015)... (PRWEB) , ... October 13, 2015 , ... e-con Systems ... solutions, today announced See3CAM_CU40, the industry’s first RGB-IR pixel format camera with ... a new member of e-con’s See3CAM family of UVC USB 3.0 cameras, is based ...
Breaking Medicine News(10 mins):