Bavarian Nordic CEO Says Likely To Sell Imvamune Priority Review Voucher
Executive Summary
Danish group believes its smallpox vaccine will get approved, generate a transferable priority review voucher, and replace the current US-licensed replicating smallpox vaccine ACAM2000.
FDA approval for Bavarian Nordic AS's smallpox vaccine Imvamune looks highly likely after the release earlier this month of successful Phase III trial data. Approval would generate a lucrative 'priority review voucher' which the Danish biotech would probably sell to generate liquidity, rather than use to accelerate a future review for another vaccine, its CEO told Scrip.
The Phase III clinical trial was led by the US Army Medical Research Institute of Infectious Diseases (USAMRIID) and demonstrated the safety and efficacy of Bavarian Nordic's investigational, non-replicating smallpox vaccine. It's being developed as an alternative to the current US licensed replicating smallpox vaccine, ACAM2000, which cannot be used by certain populations, including people with atopic dermatitis and HIV. Imvamune is already approved in Canada and the European Union as Imvanex.
"Everything in our pipeline would in our opinion get a priority review because we're tending to go after large unmet medical needs, so our strategy would be to try to sell that priority review voucher, to give us liquidity." – Bavarian Nordic CEO Paul Chaplin
Bavarian Nordic now plans to file its US marketing application during this year's second half under US Fast Track status and, if approved, it will get a priority review voucher for accelerated review of a future application, which it can either use for another investigational vaccine - or sell to a third party.
"This was the last Phase III that we agreed with the FDA to do with our smallpox vaccine Imvamune; we believe we'll get priority review and so expect approval sometime in early 2019," Bavarian Nordic CEO Paul Chaplin told Scrip.
Bavarian Nordic CEO Paul Chaplin Bavarian Nordic A/S
Chaplin said selling in the open market an eventual priority review voucher (PRV) generated by Imvamune would make sense, given Bavarian Nordic's therapeutic focus and pipeline assets.
"Everything in our pipeline would in our opinion get a priority review because we're tending to go after large unmet medical needs, so our strategy would be to try to sell that priority review voucher, to give us liquidity," he told Scrip.
Under the US voucher program, the developer of a drug for a neglected or rare pediatric disease that is approved by the FDA receives a bonus priority review voucher for another drug.
But Bavarian Nordic doesn't need the money desperately, as it has a strong cash pile totaling some $400m.
"With our cash position, we're in no rush to sell the PRV, so we would wait for the right offer, or the right product," he said. Prices for PRV transactions have varied, "but most are settling around $130m," he added.
The US government already stockpiles Bavarian Nordic's Imvamune for emergency use for those who can't receive Emergent BioSolutions Inc.‘s ACAM2000. According to Bavarian Nordic's website, the US government wants to stockpile enough nonreplicating vaccine to protect all 66 million people who can't receive ACAM2000. Bavarian Nordic has already supplied 28 million liquid-frozen doses to the US stockpile and has newer contracts to replenish the stockpile with a yet-to-be approved freeze-dried formulation. Both vaccines have received development assistance from the government.
Chaplin expects Imvamune to eventually displace ACAM2000 as the US government licensed replicating smallpox vaccine.
That view was echoed in comments made about Imvamune in a Feb. 7 press statement by Colonel Gary Wheeler, commander of USAMRIID, who said that "if approved, this vaccine will have a direct impact on improving force health protection for US Soldiers and other service members who are required to be immunized against smallpox."
"That's not surprising; if you have a safer alternative which looks just as efficacious if not more efficacious than the current vaccine which has certain side effects, then why wouldn't you replace it?" Chaplin commented.
Bavarian Nordic's smallpox vaccine is the basis of the biotech's vaccine platforms.
"Everything we're doing in smallpox has a knock-on effect on the rest of our pipeline for infectious diseases, like our RSV (Respiratory syncytial virus) vaccine which is in Phase II, or HIV, HBV and HPV as well as cancers of the lung, prostate and bladder," the CEO said.
The vaccine uses a live virus that clinical trials shows is safe, "but one that can be manipulated to encode other antigens or other proteins from cancers or other infectious diseases, like flu and RSV, and then it becomes a vaccine carrier," he explained.
"There are many vaccine platforms out there, but our vaccine platform is already approved. We have manufacturing in place; we've manufactured 28 million doses of this vaccine for the US government, and that makes it rather unique," Chaplin concluded.
Thank you for reading this article. To improve the content and delivery of our products, we would love to speak with you about your role and content needs. Sign up here , and we will contact you to set up a 30-minute chat. As a gesture of appreciation, you can select one of 10 Pharma Intelligence special reports (valued up to $7,500) that we will send you FREE of charge.