Monkeypox Vaccine Approval A Shot In The Arm For Bavarian
Executive Summary
Nigeria's monkeypox outbreak represents opportunity for Danish company still looking to overcome cancer vaccine setback.
Bavarian Nordic AS has gained US Food and Drug Administration approval for Jynneos, making it the first approved non-replicating smallpox vaccine in the US and the only approved monkeypox vaccine anywhere in the world.
Jynneos (MVA-BN, liquid-frozen) is a live, non-replicating vaccine, which means it can be administered to people who are at high risk of adverse reaction to traditional, replicating smallpox vaccines because of weakened immune systems.
While smallpox is eradicated globally, cases of monkeypox are increasing and spreading globally, driven by an ongoing outbreak in Nigeria.
The approval is a shot in the arm for the Copenhagen, Denmark headquartered firm, which spies a potentially lucrative business in providing the vaccine to international travelers.
Bavarian Nordic is trying to rebuild its business after the September 2017 failure of its Prostvac prostate cancer vaccine in Phase III.
That late-stage failure saw the company’s share price halve overnight and then continue to decline in 2018. Investors were unconvinced by its R&D strategy, which is split between infectious diseases and cancer immunotherapy. (Also see "PROSPECTs Futile For Bavarian Nordic's Prostvac Cancer Vaccine" - Scrip, 15 Sep, 2017.)
While the jury is still out on its cancer immunotherapy pipeline, this year has seen the infectious diseases side beginning to yield wins. Earlier this month, Merck & Co. Inc. filed the ebola vaccine it has co-developed with Bavarian with the FDA.
The vaccine was given a priority review, and if the FDA gives a positive verdict in March, it will be the first ever ebola vaccine to reach the market, ahead of rival candidates from GSK.
Paul Chaplin
The FDA approval of Jynneos, as expected, will help boost confidence in the firm’s growth prospects. Paul Chaplin, president and CEO of Bavarian Nordic called the Jynneos approval a “tremendous milestone” for the company and the US Department of Health and Human Services.
The development of the vaccine has only been possible thanks to a long-term partnership between the firm and US government agencies, who have bankrolled the research since 2004.
“Jynneos is the culmination of a fifteen-year partnership that started with a call from the NIH for a safer smallpox vaccine, successfully transitioned to BARDA and was delivered to the Strategic National Stockpile for use in an emergency,” Chaplin added.
The additional indication to protect against monkeypox creates new commercial opportunities for Jynneos.
Monkeypox Threat Is An Opportunity
Monkeypox is naturally occurring in central and western Africa, and until recently cases in humans were mostly limited to the region. However, an ongoing outbreak of the disease in Nigeria has seen an increased number of human-to-human transmission, with cases spread into urban centres.
Infected individuals have been identified as far afield as the UK, Israel and Singapore, all originating from Nigeria, raising fears that the virus could follow Ebola and Zika in spreading globally if unchecked.
Nigeria’s booming oil and gas industry employs a significant number of local and foreign workers, and Bavarian Nordic says more than 5 million people travel to countries affected by monkeypox in central Africa each year. It believes it can tap into this travellers’ market for a monkeypox vaccine.
The approval also brings with it an FDA priority review voucher (PRV) under the Material Threat Medical Countermeasure PRV program.
Bavarian has confirmed that it intends to sell on the PRV to a third party, which will be another boost for its balance sheet, though prices fetched for these fast-track tickets have fallen in recent times. (Also see "AstraZeneca Buys Priority Review Voucher With Two Big Filings On The Horizon" - Scrip, 22 Aug, 2019.)
The company says it is still on track to record a loss before interest and tax (EBIT) of around DKK360m ($55m) in 2019. Its revenues are expected to rise to DKK600m ($92m) this year, and has set its sights on becoming profitable by 2023.
Among its brightest pipeline hopes are a collaboration with Janssen Inc. on a therapeutic HPV vaccine regimen (currently in Phase I/II) and an in-house program to develop a vaccine for respiratory syncytial virus (RSV), set to enter Phase III in 2020.
One of the most common causes for hospitalisation of children, analysts at Datamonitor Healthcare forecast new vaccine products for RSV will see the market grow in value to $3.1bn in the 2025/26 season. (Also see "Bavarian Nordic CEO 'Seeking Big Pharma partner' For RSV Vaccine Program" - Scrip, 10 May, 2018.)