* Says can produce vaccine 11 weeks from gene sequence
* Says adhered to current good-manufacturing practices
* Plans to produce more batches for human testing
* Shares up more than 20 pct in pre-market trade
Aug 5 (Reuters) - Novavax Inc NVAX.O said it could manufacture its vaccine candidate for the new strain of H1N1 influenza virus within 11 weeks of receiving the gene sequence from the U.S. Centers for Disease Control, sending its shares up more than 20 percent in trading before the bell.
Production of the vaccine was carried out at Novavax’s new facility in Rockville, Maryland, in accordance with current good-manufacturing (GMP) practices laid down by health regulators, the company said.
“Demonstration of our ability to construct and produce GMP-quality influenza vaccine within 12 weeks under real pandemic conditions is an important and successful test of our VLP technology,” Jim Robinson, vice president of manufacturing and quality operations at Novavax, said in a statement.
The company’s virus-like particle technology uses a mimic or decoy of the virus to shorten the time to develop a vaccine for a new viral strain.
Novavax has completed a Phase I/IIa clinical study with a H5N1 influenza VLP vaccine candidate and is currently in mid-stage trials with a VLP based seasonal flu vaccine candidate.
Shares of the company were up $1.07 in pre-market trade. They closed at $4.63 Tuesday on Nasdaq. (Reporting by Anand Basu in Bangalore; Editing by Anthony Kurian)
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