The French biotech Valneva will collaborate with Pfizer to develop and commercialize Valneva’s phase II-stage Lyme disease vaccine candidate. The deal they signed is expected to help compensate for the impact of the Covid-19 pandemic on Valneva’s financial outlook for 2020.
The latest alliance will pool Valneva’s vaccine R&D expertise with Pfizer’s vast drug development resources. If approved, the vaccine could become the first on the market for the tick-borne Lyme disease since SmithKline Beecham’s (now GlaxoSmithKline) vaccine LYMErix was withdrawn in 2002.
According to the terms of the deal, Valneva will receive a total of €284M ($308M) in cash payments. This includes a €120M ($130M) payment upfront and €164M ($178M) in unspecified development and early commercialization milestones.
Valneva’s CEO Thomas Lingelbach told me that the upfront payment will be reinvested in the Lyme program. Pfizer will lead the late-stage development of the vaccine, with Valneva covering 30% of the development costs. Pfizer will then have full control over commercializing the vaccine, and Valneva can expect tiered royalties starting from 19%.
Lyme disease affects approximately half a million people in Europe and the US each year. Transmitted via ticks and lice, it is caused by various forms, or serotypes, of bacteria in the genus Borrelia. Early symptoms are often nonspecific, which may delay diagnosis. For those who are either left untreated or treated at an advanced stage of the disease, serious heart, neurological, and joint complications may arise.
Valneva’s product is the only Lyme disease vaccine in clinical development today. It covers six of the most important serotypes of Borrelia in Europe and the US, which represents 98% of all Borrelia species in the Northern Hemisphere. The vaccine targets OspA, which is one of the proteins most abundantly expressed by Borrelia when present in an Ixodes tick. By targeting OspA, the vaccine blocks the movement of bacteria from ticks into humans after a bite.
Valneva’s Lyme vaccine is designed for prophylactic, active immunization in adults and children from two years of age. Following positive safety and efficacy results in phase I studies, it was granted fast-track designation by the FDA in 2017. Phase II studies are now underway in 819 children and adults in North America and Europe, with results expected this summer.
While Valneva and Pfizer have the only Lyme vaccine in clinical development today, this is not the first vaccine against Lyme disease to date.
In the late ’90s, SmithKline Beecham marketed a Lyme disease vaccine called LYMErix. Like Valneva’s vaccine, LYMErix targeted OspA, but LYMErix was limited to only one Borrelia serotype. The vaccine proved effective in a phase III trial but was withdrawn voluntarily just three years after FDA approval. The reason for this was declining sales related to scientifically unfounded concerns about vaccine-related side effects, such as arthritis. Although LYMErix was officially deemed safe, lawsuits erupted and sales never recovered, likely possible in part because of a growing anti-vaccine climate at that time.
According to Thomas Lingelbach, CEO of Valneva, the link between OspA-targeting Lyme vaccines and arthritis has been thoroughly debunked.
“Even though this claim was found to be false, out of an overabundance of caution and to ensure that no further illegitimate claims were made about [our vaccine], we have modified the OspA sequence falsely associated with arthritis during the development [of our vaccine] and it is not a part of the antigen,” he told me.
Valneva expects that its vaccine candidate could become part of a standard vaccination program in badly affected areas. “Given the great threat that Lyme disease poses, we hope that our vaccine, if successful in clinical testing, is one that people living in Lyme-endemic regions strongly consider as part of a standard vaccine program,” said Lingelbach.
Valneva also has another program ongoing to develop the first potential vaccine for the mosquito-borne disease chikungunya. The vaccine has shown long-term protection in phase I and the company is preparing to launch a phase III trial as soon as the Covid-19 situation allows, expectedly in late 2020.
Valneva also just announced a new partnership with the Brazilian public research institute Instituto Butantan to make the company’s chikungunya vaccine widely available in low- and middle-income countries. The Brazilian institute will be able to develop, produce, and commercialize the vaccine in these countries, in exchange for providing certain clinical and phase IV observational studies that Valneva will use to meet regulatory requirements.
According to a recent financial report, Valneva expects that the Pfizer deal will reduce its negative earnings in 2020 by as much as €40M. The negative earnings are expected in large part due to Covid-19 driving down sales of Valneva’s approved travel vaccines, such as IXIARO/JESPECT for Japanese encephalitis and DUKORAL for the prevention of cholera diarrhea caused by E. coli.
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