LGLS will also build a 30 million dose capacity manufacturing plant at its site in Osong.
LG Life Sciences (LGLS) negotiated a license to Novavax’ recombinant virus-like particle (VLP) vaccine technology for use in the development of flu vaccines. The deal gives LGLS exclusive rights to use the technology for the manufacture, development, and commercialization of relevant products in South Korea and nonexclusive rights to the technology for the development and commercialization of VLP flu vaccines in specific emerging markets.
LGLS will also construct a new 30 million dose capacity VLP vaccine manufacturing facility at its site in Osong, South Korea. The firm retains the responsibility for funding the clinical development and licensing of influenza VLP vaccines in South Korea and its other designated territories. In return, Novavax will receive an up-front fee and milestone payments plus double-digit royalties on sales of future vaccines. The firm will provide VLP technology transfer and manufacturing support for LGLS’ new vaccine production facility.
“This technology is further validation of our VLP technology,” comments Rahul Singhvi, Novavax president and CEO. “LGLS is a leading provider of vaccines to supranational health organizations such as UNICEF and the Pan American Health Organization. LGLS will help us advance our technology in Korea and other countries, consistent with our commercial strategy of developing regional partnerships and in-country manufacturing solutions with leading pharmaceutical companies around the world.”
Back in 2009, Novavax formed a joint venture with Indian firm Cadila Pharmaceuticals, focused on the development, manufacture, and marketing of vaccines, pharmaceuticals, and diagnostic products in India. In June 2010, the firms reported completion of a vaccine manufacturing facility in Dholka, India, which has the capacity to produce up to 60 million doses of novel vaccines every year.
Novavax is exploiting its VLP platform to develop vaccines against various circulating strains seasonal flu and pandemic flu strains including H1N1 and H5N1, along with respiratory syncytial virus, Varicella zoster virus, and HIV. Separately today the company won a $97 million three-year contract from BARDA to advance clinical-stage flu vaccines. The contract may be extended for an additional two years, for a total contract value of $179.1 million.
Phase II studies with both H1N1 and seasonal influenza VLP vaccines are ongoing. Final results from a Phase II trial evaluating the H1N1 VLP vaccine in over 3,000 individuals were reported just last month. The study found that the vaccine exceeded the immunogenicity criteria for seasonal influenza vaccine licensure at all dose levels. A single administration of the VLP vaccine was in addition shown to induce high levels of hemaglutinin inhibition titers in subjects without pre-existing detectable immunity to the relevant flu strain.
In January Novavax reported starting patient enrollment in a Phase I clinical trial to assess the safety, immunogenicity, and tolerability of its RSV vaccine candidate. The placebo-controlled, escalating-dose study will include 100 adult subjects.