Novavax, Inc., a Pennsylvania-based specialty biopharmaceutical company engaged in the research, development and commercialization of proprietary products focused on drug delivery and biological technologies, is working on a seasonal flu vaccine. The company is planning to develop and manufacture the vaccine on its own. It is hoping to initiate clinical trials by the end of 2006, Dr Rahul Singhvi, president and CEO, Novavax, told Pharmabiz.
The company has multiple projects in its drug delivery and biologicals pipelines which are based upon proprietary technologies. Androsorb, for female sexual dysfunction, is the most advanced candidate in the drug delivery pipeline, having completed two Phase I studies. The pipeline also includes a large number of compounds which have completed preclinical evaluation.
The majority of company's biological projects are in vaccines which utilize its virus-like particle (VLP) and proprietary insect cell production technology. E-selectin tolerogen is in early testing as a preventative for secondary stroke. Melanoma Vaccine is in Phase I stage, whereas Hepatitis E Virus Vaccine is in Phase III.
The company is focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies. These include the company's virus-like particle (VLP) manufacturing technology utilizing the baculovirus expression system in insect cells, as well as novel vaccine adjuvants based on Novasomes and dendrimer technologies, he added.
Novavax's drug delivery technologies include the micellar nanoparticle (MNP) technology which is the basis for the development of its first FDA-approved product, ESTRASORB, a prescription product for menopausal symptom relief. In addition to MNP, the company's drug delivery technologies include Novasomes (paucillamellar non- phospholipid liposomes) and Sterisomes (subcutaneous depot injection).
It has formed a strategic alliance with Wave Biotech on the development of a commercial scale manufacturing and production process for vaccines during September 2005. The partners will collaborate on the development of a commercial scale production process for Novavax's pandemic influenza virus (avian flu) vaccine and other biological products. Initially, the companies will focus on Novavax's H9N2 avian flu Virus-Like Particle (VLP) vaccine that has shown promising results in preclinical studies.
During mid-October 2005, the company entered into License and Supply Agreement with Esprit Pharma, a private specialty pharmaceutical company based in East Brunswick, NJ, for its primary product, ESTRASORB. It has entered into a collaborative research agreement with researchers at the University of Pittsburgh School of Medicine to evaluate the efficacy of virus-like particle (VLP) influenza vaccines as well as Novasomes, a proprietary adjuvant, during mid February 2006. On February 28, 2006, Novavax, Inc. and PacificGMP, LLC have formed a strategic alliance to collaborate on the development of a commercial scale production process for Novavax's experimental pandemic influenza virus (avian flu) vaccine and other biological products.
A similar tie up has been announced with Bharat Biotech International Limited (BBIL), on March 6, 2006, to pursue the rapid development of pandemic influenza vaccine for India and certain other south Asian markets. Under the terms of the agreement, BBIL will fund 100 per cent of the pre-clinical and clinical studies for these markets and assist in developing an efficient manufacturing process for the Virus-Like Particle (VLP) based influenza vaccine. BBIL will be responsible for the sale and distribution of the vaccine in India and other surrounding countries. Novavax will receive unrestricted access to all pre-clinical and clinical data generated by BBIL and will receive a double digit royalty on all future sales located within BBIL's geographic territories, Singhvi informed.