Novavax begins human studies for 2009 H1N1 vaccine in Mexico; Cadila JV to run VLP flu vac clinical trials in India

Novavax, Inc.has launched a two-stage clinical study of its 2009 H1N1 flu virus-like-particle (VLP) vaccine in Mexico in collaboration with Avimex Laboratories (Avimex) and GE Healthcare.

Avimex, which distributes biological and pharmaceutical products for use in Mexico and more than 25 other countries around the world, is providing financial support for the trial and is expected to distribute the H1N1 VLP vaccine in Mexico in 2010 if it is approved for commercial sale.

GE Healthcare (a unit of General Electric Company) will support Novavax vaccine program by providing its single-use bioprocessing technologies for vaccine production. GE Healthcare and Novavax have worked together since December 2007 to develop innovative vaccine production solutions using GE Healthcare’s manufacturing technologies.

“Conducting this clinical trial during a pandemic, when the attack rate of the H1N1 virus is expected to be very high,provides the company with an invaluable opportunity to demonstrate field efficacy of its VLP-based H1N1 vaccine and the utility of the VLP vaccine platform for influenza as a whole,” said Dr Rahul Singhvi, President and CEO of Novavax.

Novavax and Avimex are initiating the blinded, placebo-controlled clinical trial in Mexico City to evaluate the safety, immunogenicity and efficacy of Novavax’s 2009 H1N1 VLP vaccine in healthy adults.

Novavax’s 2009 H1N1 VLP vaccine’s first stage will evaluate the vaccine’s safety, immunogenicity and efficacy among 1,000 subjects, including 750 VLP recipients and 250 placebo recipients.

The second stage of the study will be initiated to evaluate the safety of Novavax’s 2009 H1N1 VLP vaccine in a larger cohort of 3,000 subjects (2,000 vaccine and 1,000 placebo recipients).
The primary safety and immunogenicity results are expected within 3 months of the start of this study in January 2010.

The results will be used to seek registration of Novavax’s 2009 H1N1 pandemic flu vaccine in Mexico.

These data are also expected to support development of the company’s pandemic and seasonal flu VLP vaccines in other countries, including the United States, .

Novavax is planning to conduct a major portion of the clinical trials for 2009 H1N1 pandemic flu vaccine in India.

Indian clinical trials using 2009 H1N1 pandemic flu vaccine will be conducted from September in joint collaboration with Ahmedabad-based drug major Cadila Pharmaceuticals, Dr Singhvi had stated earlier.

Almost half of the world-wide clinical trial (phase-II) for our swine flu vaccine will be conducted in India. The trials will be conducted on the elderly population, especially on those aged above 65 years, according to him.

Novavax formed a joint venture with Ahmedabad, India-based Cadila Pharmaceuticals to develop, manufacture and market vaccines, pharmaceuticals and diagnostic products in India, in April.

Novavax is to contribute technology to the joint venture for the development of several other VLP vaccine candidates against diseases of public health concern in India, such as hepatitis E and dengue fever.

Meanwhile, Cadila is expected to contribute approximately $8 million over three years to support the joint venture operations.

The joint venture will be responsible for clinical testing and registration of products that will be marketed and sold in India by the joint venture, which will be owned 80 percent by Cadila and 20 percent by Novavax, as per the terms agreed.

This strategic alliance allows Novavax to utilize Cadila’s research, clinical development, and manufacturing expertise and infrastructure to support development of current and future vaccine candidates.

Novavax can also utize Cadila’s low-cost, high-quality infrastructure to undertake part of the development of its 2009 H1N1 pandemic flu vaccine in India.

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 significantly more quickly than egg-based
vaccines by using proprietary, portable, recombinant cell-culture technology.

Novavax is a clinical-stage biotechnology company that produces a range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like-particle (VLP) technology.