Both Vivotif and Vaxchora are approved and used in the US as well as more than 25 countries, representing 'two market-leading and revenue-generating' additions for the Danish vaccine company.
Meanwhile, the Chikungunya market - for which there are currently no approved vaccines - is set to be worth around $500m.
Bavarian Nordic will pay Maryland's Emergent BioSolutions up to $380m, which includes $270m in an upfront payment and a potential $110m in future conditional milestone payments.
Growth ambitions
Bavarian Nordic sets out its vision to become ‘one of the largest pure-play vaccine companies by 2025’ through organic growth and launch of new products from its R&D pipeline, combined with a selective M&A approach focused on products that fit its infectious disease portfolio. That includes ambitions to generate more than $1bn in annual revenue by this date.
While the market for travel vaccines was impacted by the COVID pandemic in both 2020 and 2021 due to extensive travel restrictions, Bavarian Nordic highlights the long-term potential of the market moving forward.
Travel vaccines are already a major part of its portfolio: with Encepur for Tick-borne encephalitis (TBE) and Rabipur/RabAvert (Rabies) - acquired from GSK in 2019.
And now the Vivotif vaccine allows Bavarian Nordic to tap into a $250m market for typhoid vaccines – with a 9% CAGR; as well as a similarly fast-growing cholera vaccine market (worth $75m and with a CAGR of 7.5%).
Furthermore, the acquisition will include a biologics facility in Bern, Switzerland: which manufacture the vaccines as well as offering the company enhanced flexibility and capabilities to insource production of future commercial products.
Meanwhile, Bavarian Nordic will also be able to expand its US commercial sales, marketing and distribution teams: as well as increased scale in additional European markets where the company is not already present.
Bavarian Nordic will acquire:
- Vivotif (Typhoid Vaccine Live Oral Ty21a), the only oral vaccine licensed by the US Food and Drug Administration (FDA) for the prevention of typhoid fever, a potentially severe and life-threatening infection caused by the bacterium Salmonella typhi. The vaccine is also approved in Europe and is marketed in more than 25 countries.
- Vaxchora (Cholera Vaccine Live Oral), the only FDA-licensed vaccine for the prevention of cholera caused by Vibrio cholerae serogroup O1, a potentially serious intestinal disease. The vaccine is also approved in Europe and is marketed in more than 25 countries.
- A Chikungunya vaccine with expected Phase 3 read-out in the second half of 2023 and projected launch in 2025.
- US-based research and development facilities related to the development of the Chikungunya vaccine, a Swiss-based biologics manufacturing facility, and EU/US-based commercial operations with a specialty salesforce.
Chikungunya potential
Bavarian Nordic also enters the promising Chikungunya vaccine market. The single-dose VLP-based vaccine, CHIV VLP, is currently being investigated in two Phase 3 trials: having received Breakthrough Therapy designation and Fast Track designation from the US FDA and PRIME designation from the EMA.
A Phase 3 read-out is expected in the second half of 2023 with a projected launch in 2025.
As a differentiated VLP vaccine, Bavarian Nordic says the candidate has a ‘highly competitive profile’ in the area: where it will take on candidates such as Valneva’s VLA1553, a live attenuated vaccine which is expected to launch in August this year if it gains regulatory approval.
New launches anticipated in coming years
Approximately 280 current Emergent employees are expected to join Bavarian Nordic as part of the transaction, which is expected to close in the first half of the year.
Bavarian Nordic’s portfolio also includes vaccines for mpox and smallpox (Jynneos/Imvanex/Imvamune) and Ebola (MVABEA); while its pipeline includes Phase 3 RSV and COVID-19 candidates.
“This acquisition adds not only to our commercial portfolio and reinforces our leading position in travel vaccines, but it also strengthens our pipeline with a promising late-stage vaccine candidate against Chikungunya, an emerging infectious disease that represents a significant unmet medical need worldwide,” said Paul Chaplin, President and CEO, Bavarian Nordic.
“Combined, these assets, together with the acquired capabilities within research and development, manufacturing, and commercial, will make a significant contribution to our vision of becoming one of the largest pure-play vaccine companies.
“Travel vaccines are seeing a rebound after the COVID-19 pandemic and the expanded portfolio allows us to further explore synergies in our commercial presence across key markets. Likewise, the addition of further manufacturing capabilities provides us with greater flexibility and scale in production, as we continue our preparations for the launch of several new products over the next few years.”
Emergent, meanwhile, says the sale of the travel health business will allow it to concentrate on its medical countermeasure products, such as ACAM2000 (Smallpox (Vaccinia) Vaccine, Live), TEMBEXA (brincidofovir), RSDL (Reactive Skin Decontamination Lotion Kit), several anthrax products, and opioid overdose reversal medicine NARCAN (naloxone HCl) Nasal Spray, as well as its contract development and manufacturing services businesses.
"Together, these actions will improve profitability and position Emergent for steady, sustainable growth over the long term," says the company.