Novavax reports positive data from H1N1 swine flu vaccine trials; Cadila Pharma gets a booster

Cadila Pharma has a JV with Novavax – CPL Biologicals – to produce flu vaccines

India’s Cadila Pharma may get a booster dose from Novavax, Inc favorable initial results from the first stage of a two-stage pivotal Phase II study evaluating the safety and immunogenicity of its 2009 H1N1 virus-like particle (VLP) pandemic influenza vaccine.

Novavax is conducting 2009 H1N1 virus-like particle (VLP) pandemic influenza vaccine studies in collaboration with Avimex Laboratories of Mexico to support registration of the vaccine in Mexico and potentially other countries.

1,000 healthy volunteers aged 18 to 64 years old were enrolled to receive two doses of 5 mcg, 15 mcg or 45 mcg of Novavax’s 2009 H1N1 pandemic influenza VLP or a placebo to determine the safety and immunogenicity of the vaccine, in Stage A of this study.

Data and Safety Monitoring Board (DSMB) of Mexico has reviewed preliminary safety and immunogenicity data 14 days post dose one from a subset of approximately 500 subjects enrolled in this stage of the trial.

Novavax’ H1N1 vaccine was found to be well tolerated at all three dose levels and exhibited no systemic side effects in this review period.

In this subset of 500 subjects from Stage A, the hemagglutinin inhibition (HAI) antibody titers 14 days post dose one in the 15 and 45 mcg arms met the seroconversion and seroprotection criteria recommended by the U.S. and European regulatory
authorities.

Based on these findings, the DSMB recommended that the study proceed to Stage B of testing in which vaccine safety will be evaluated in 3,000 subjects with a 15 mcg single dose regimen.

The safety and immunogenicity data from all 1,000 subjects in Stage A will be available in January, 2010, Novavax said in a press release.

“We believe this is the best possible outcome for our vaccine development program because it suggests that a single 15 mcg dose of our 2009 H1N1 VLP pandemic influenza vaccine will be well tolerated,immunogenic and competitive with currently marketed H1N1 influenza vaccines which are being administered at the same dose,”stated Dr Rahul Singhvi, President and Chief Executive Officer of Novavax.

Cadila Pharma of Ahmedabad has a joint venture with Novavax, named CPL Biologicals, to develop and manufacture vaccines in India.

CPL Biologicals has already begun construction of a state-of-the-art 25,000 sq. ft manufacturing facility that will be used to produce pandemic and seasonal influenza vaccines.

In October, Cadila Pharmaceuticals and Novavax had announced that CPL Biologicals to start producing H1N1 swin flu vaccine in next four months.

The CPL Biologicals facility is expected to be be capable of producing over 60 million doses of flu vaccine annually at full capacity.

CPL Biologicals facility is being 100% supported financially by Cadila Pharmaceuticals Ltd.

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 innovative disposable manufacturing solution.

Virus-like particles (VLPs) mimic the external structure of viruses but lack the live genetic material that causes viral replication and infection. VLPs can be designed quickly to match individual viral strains and be produced efficiently using portable cell-culture technology.

Novavax’s VLP-based vaccine candidates are produced more rapidly than egg-based vaccines by using proprietary, portable, recombinant cell-culture technology.

Novavax, Inc produces potent VLP-based recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions.