Key Developments For Novavax Inc
Novavax Inc (NVAX.O) (Consolidated Issue listed on NASDAQ Global Market)
Novavax, Inc. Announces Public Offering Of Common Stock
Novavax, Inc. announced that it intends to offer shares of its common stock in an underwritten public offering. Piper Jaffray & Co. and Lazard Capital Markets LLC are acting as joint book running managers.
Novavax, Inc. Begins Phase IIa Study of Seasonal Influenza Vaccine In Older Adults
Novavax, Inc. announced that it has begun a Phase IIa clinical study of its trivalent seasonal influenza VLP vaccine candidate in healthy adults 60 years of age or older. This randomized, double-blind, active-controlled study is evaluating the safety, tolerability and immunogenicity of two different doses of Novavax's trivalent seasonal influenza VLP vaccine compared with that of a commercially available trivalent inactivated vaccine (TIV, Fluzone). Novavax's vaccine contains VLPs made up of the hemagglutinin (HA), neuraminidase (NA), and matrix 1 (M1) proteins against the H3N2, H1N1, and B strains recommended for 2009-2010 influenza vaccines. A total of 480 subjects will be enrolled, in a 1:1:1 randomization schedule (160 subjects in each of the three arms) at approximately six sites in the United States and one site in India. In addition to evaluating hemagglutinin inhibition (HAI) responses, anti-neuraminidase and cell-mediated immune responses will also be examined.
Novavax, Inc. Reports Positive Data For Its Trivalent Seasonal Influenza (VLP) Vaccine Candidate In Second Phase II Study
Novavax, Inc. announced data from a study of Novavax's trivalent seasonal influenza VLP vaccine that began in May of this year among healthy adults 18 to 49 years of age. The vaccine contained VLPs matched to the influenza strains recommended for the 2008-2009 influenza vaccine including H1N1 A/Brisbane/59/2007, H3N2 A/Brisbane/10/2007, and B/Florida/04/2006. The study enrolled 241 subjects in total, including 221 who were randomized to receive either VLP vaccine at 15 mcg or 60 mcg or a placebo and 20 subjects who received an inactivated influenza vaccine (TIV). The trivalent seasonal influenza VLP vaccine was well tolerated and immunogenic. The incidence of adverse events was comparable in the VLP vaccine groups (10.6%) and the placebo group (11.8%). No serious vaccine-related adverse events have been reported to date. The VLP vaccine induced robust hemagglutination inhibition (HAI) antibody responses against all three strains in the vaccine and a drifted strain. Seroconversion (greater than or equal to 4-fold rise in titer from baseline) rates met the suggested FDA criteria for licensure of seasonal influenza vaccines for all three strains. For subjects in the 15 mcg group, seroconversion rates (95% CIs) were 57% (44, 68), 86% (75,93), and 62% (50,74) against the H1N1, H3N2, and B strains, respectively. Seroprotection (titer greater than or equal to 1:40) rates met the FDA criteria for licensure for all strains except the H1N1 strain.
Novavax, Inc. And CPL Biologicals Break Ground On New Influenza Vaccine Manufacturing Facility In India
Novavax, Inc. announced that CPL Biologicals Pvt. Ltd., the new joint venture between Cadila Pharmaceuticals in India, has begun construction of a manufacturing facility that will be used to produce pandemic and seasonal influenza vaccines. CPL Biologicals will utilize Novavax's virus-like particle (VLP) vaccine technology to produce commercial-scale quantities of VLP-based influenza vaccines using Novavax's disposable manufacturing solution. The CPL Biologicals facility is expected to be operational within four months and should be capable of producing over 60 million doses annually at full capacity. This facility will also be used to produce other vaccines being developed by CPL Biologicals, based on Novavax's VLP vaccine technology. CPL Biologicals is a newly formed company evolved from a joint venture by Cadila Pharmaceuticals Ltd and Novavax, Inc.
Novavax, Inc. And Xcellerex, Inc. Announce Collaboration To Develop Large Scale Manufacturing Process For 2009 H1N1 Influenza VLP Vaccine
Novavax, Inc. and Xcellerex, Inc. announced that they have entered into a strategic collaboration to accelerate the development of Novavax's vaccine manufacturing process to commercial scale and begin immediate production of Novavax's 2009 H1N1 influenza vaccine for potential commercial sale. Xcellerex will provide development expertise and product manufacturing in exchange for manufacturing supply fees from Novavax.
