US-based Novavax will double its current good manufacturing practice (cGMP) vaccine production capacity when the 74,000 sq ft of leased manufacturing, laboratory and office space comes online.
“We anticipate that it will enable us to supply our vaccines, most immediately our seasonal and pandemic VLP (virus-like particle) influenza vaccines, to meet our projected clinical- and commercial-supply requirements for the foreseeable future”, Stanley Erck, president and CEO of Novavax, said.
Novavax is modifying the two facilities and expects to complete work by mid-2012. As well as giving Novavax production capacity the site in Gaithersburg, Maryland will also meet its clinical, research and development, and administrative needs.
Once the site is ready Novavax will move its headquarters from Rockville, Maryland to the new campus in Gaithersburg. The Rockville site includes a pilot plant but its future is unclear.
“The company is assessing its long-term needs for the pilot-scale facility, however, I am delighted to report that the very favourable terms of this new lease would allow us to operate both this new facility and our pilot-scale facility at no additional expense over the next several years”, Erck said.
Opening the plant will equip Novavax to handle an anticipated uptick in demand. In the third quarter Novavax posted revenues of $5.0m (€3.7m), up from $175,000 a year earlier, as the contract with the US Office of Biomedical Advanced Research and Development Authority (BARDA) ramped up.
BARDA is funding Novavax’ seasonal influenza vaccine through Phase III and its pandemic product through early stage clinical trials. It is these products that Novavax expects to account for the bulk of initial production at its new plant.
The BARDA-driven uptick in business helped Novavax slash its operating loss, although it still posted a $4.0m deficit. In the first nine months of the year Novavax came close to halving its losses but was still down $17.3m.