After coming up short in COVID, Valneva focuses on chikungunya vaccine launch

After striking out in an attempt to create a niche for its COVID-19 vaccine, Valneva is taking its swings at what it does best—developing, manufacturing and commercializing vaccines for a variety of infectious diseases with unmet needs.

Previously at the top of the French company’s priority list was advancing shots that can defend against Lyme disease and the Zika virus. And now, most importantly for Valneva, is the launch of its new vaccine for the chikungunya virus.

The shot, which was endorsed by the FDA in November of last year and recommended for use by the CDC in February, is the first vaccine for the virus, which is carried by mosquitos in tropical areas of the world and can cause debilitating muscle pain, with its effects lingering for years in some who have been infected.

The arrival of the vaccine comes at a critical period as the world’s tropical regions are growing because of global warming. In recent years, the chikungunya virus has been detected in a few of the southernmost areas of the United States; and in Europe, it has turned up in Spain, Italy and France.

In launching Ixchiq, Valneva is targeting four types of customers, CEO Thomas Lingelbach said in an interview with Fierce Pharma. The company is marketing Ixchiq to people who live in areas where the virus is prevalent, to travelers who visit those areas, to military units with troops stationed in those areas and to governments stockpiling for outbreaks.

“We have four different channels requiring a different set of actions and activities,” Lingelbach said of the marketing push.

A single shot of Ixchiq is designed to protect a recipient for five or more years. An important plus for the vaccine, according to Lingelbach, is that it provides an identical level of protection and longevity of the immune response in both elderly and younger adults.

“It’s always a challenge for vaccines to perform equally well in the elderly where the immune system is not as good anymore,” Lingelbach added.

Valneva has guided its annual chikungunya sales to exceed 100 million euros ($107 million) within three years of launch, which is an exciting prospect for a company whose total product revenue totaled 145 million euros ($157 million) last year. Additionally, Valneva expects the travel market opportunity for chikungunya vaccines to eventually be valued between 300 million euros ($320 million) and 400 million euros ($427 million).

At the 24th World Vaccine Congress early this month in Washington, D.C., Ixchiq captured the Best Prophylactic Vaccine award.

“The main theme in Washington was around our general awareness building with regards to mosquito-transmitted diseases,” Lingelbach said.

Is eradication possible?

Since the virus is spread by mosquitos which contract it by biting those who are infected, it’s possible that an effective and broadly used vaccine could help eradicate chikungunya. But that’s a longshot because of the nature of mosquito-borne viruses.

Lingelbach cites the Zika virus as an example. The infection, which was seemingly tamped down less than a decade ago, remains a threat, largely because the protection afforded by vaccines and by natural infection eventually wears off.

“Much smarter people than me who do epidemiological studies, they model that through a combination [of vaccines and natural protection] you could eliminate those indications over time but it would require very high vaccination rates,” Lingelbach said.

As for its efforts to create a second-generation Zika vaccine, Valneva is the only company in the world with an asset in the clinic for the virus, according to Lingelbach. An early-stage trial, which is made up of 160 participants in the U.S., is underway for VLA1601 with data expected in the first half of next year.

“It’s a kind of a phase 1/2 combined study where we test different doses and adjuvants in healthy adults,” Lingelbach said. “It’s definitely an area where we would like to focus on now that we see the re-emergence of Zika cases in Brazil and India.”

The vaccine was developed on the same manufacturing platform as Valneva’s Japanese encephalitis vaccine Ixiaro and the company’s COVID shot.

Like the chikungunya virus, Zika is rarely fatal. Additionally, its symptoms are mild and often undetected, complicating the control of its spread. Zika’s consequences can be devastating for pregnant women and their babies as birth defects can include brain and eye disorders and neuro-development problems.

“I am personally of the belief that for any infectious disease where you have a high unmet medical need, there is by definition a market,” Lingelbach said. “Is the market big enough to justify a development that gets a positive return on investment without any support of public funding institutions? [That’s] to be seen.”

Pandemic problematic for Valneva

The emergence of the coronavirus presented vaccine specialist Valneva with a significant opportunity. Six months into the pandemic, the U.K. signed a deal to secure 100 million doses of the company’s jab which was in development.

But while other drugmakers such as Pfizer, Moderna and AstraZeneca gained approvals for their COVID vaccines by the end of 2020, Valneva did not secure a nod for its shot in the U.K. until April of 2022.

In creating the first whole-virus inactivated COVID vaccine, Valneva had something new to offer and hoped to find its niche as an answer for people who were hesitant to try unconventional mRNA vaccines. But the company was too late to the party as demand for vaccination was already in free fall.

The pandemic dealt Valneva another blow as a massive decline in travel deflated its vaccine sales. With the company’s top-selling shot, Japanese encephalitis vaccine Ixiaro, for example, sales fell from 94 million euros ($105 million) in 2019 to less than 50 million euros ($56 million) in each of the next three years, bottoming out at 41 million euros ($43 million) in 2022.

But last year saw a rebound to sales of 74 million euros ($80 million) for Ixiaro. Overall, Valneva’s product sales reached 145 million euros ($157 million) in 2023, which was a 12% increase from the pre-pandemic year of 2019. In between, product sales fell to as low as 66 million euros in 2020.

“When COVID hit, travel vaccination went almost down to zero,” Lingelbach said. “But now, sales-wise we are back to pre-COVID levels.”

The company got a boost earlier this year, selling a priority review voucher, gained with its approval for Ixchiq, for $103 million. Valneva said it would invest the funds into its R&D programs, including its Pfizer-partnered Lyme disease vaccine, which is in phase 3 testing.