- Israeli drugmaker BiondVax Pharmaceuticals intends to ramp up production of its lead candidate, a universal flu vaccine, with a new manufacturing facility.
- Located in Jerusalem BioPark, the 1,800-square-meter (about 20,000-square-foot) site is still in a planning and design phase, according to a Tuesday statement from BiondVax. Once operational, however, the pharma expects the plant to be capable of crafting at least 20 million doses — through single-dose syringes or in bulk — of its drug, M-001.
- The company's shares ticked up about 7% to $9.87 apiece on Wednesday from their close-of-market value the day prior.
BiondVax is financing the new facility with a grant from Israel's Ministry of Economy and Industry worth a little more than $1 million, as well as a €20 million (about $22 million at the time) loan received in June from the European Investment Bank.
The company now holds a 10-year lease for the plant that it can extend to 15 years. Terms of the lease require BiondVax to start submitting payments in October 2018.
"BiondVax’s previous manufacturing accomplishments include achieving GMP certification, twice passing European QP audits, and an ongoing collaboration with a U.S.-based CMO for upscaling for Phase 3 clinical batches," the company's Chief Operating Officer Shimon Hassin said in the Tuesday statement.
"We expect our new facility will optimize production timelines and significantly reduce production costs," he added. "This new planned mid-size commercial manufacturing facility will mark the culmination of BiondVax’s transformation into a fully integrated pharmaceutical company operating under international GMP standards."
The Jerusalem BioPark facility represents yet another example of a small and large drugmakers working to expand their vaccine manufacturing capabilities. Since just the beginning of 2016, Gilead, Sanofi and Pfizer have all expanded, rolled out or broke ground on new vaccine production sites.
And late last year, the Bill & Melinda Gates Foundation granted $12 million to Belgium-based Univercells to create a breakthrough vaccine manufacturing platform.
BiondVax's investment comes at a time when a large portion of the world's population need protection against influenza. According to the World Health Organization, seasonal epidemics lead to as many as five million severe cases of the illness every year, and up to half a million deaths.
As such, the global influenza market has reached northwards of $5.5 billion, according to a report from market intelligence firm Renub Research published a few months ago. Additionally, a MarketsandMarkets study from last year projected the worldwide vaccines market to have a compound annual growth rate of 8.3% from 2016 to 2021, with the market reaching $48 billion by that latter date.
BiondVax is currently working to usher M-001 into Phase 3 testing. The drug is currently being investigated in several early- and mid-stage studies, including one evaluating it as a primer to pandemic influenza A/H7N9 and another as a primer to pandemic influenza H5N1 in adults 18 to 60 years of age.