Valneva Receives Funding From Pfizer to Develop World’s Only Lyme Disease Vaccine

While updating the terms of their partnership, Pfizer vows to buy 8.1% of Valneva’s shares, equating to €90.5 million ($95.3 million), to help the specialized vaccine company support its Phase 3 clinical trial developing the world’s only current Lyme disease vaccine, VLA15. Valneva’s Lyme disease vaccine will be the first since LYMERix was pulled off the shelves in 2002 after it was publicly available for just four years.

Redeeming Lyme Disease Vaccine’s Reputation

Lyme disease is a vector-borne disease meaning it is transmitted through the bite of an arthropod, a cold-blooded insect. Black-legged ticks are the arthropods responsible for transmitting Lyme disease. It is one of the most common vector-borne diseases in the northern hemisphere, affecting people of all ages exposed to ticks that carry the disease. 

According to the CDC, antibiotics can typically treat Lyme disease within a few weeks. However, the disease can spread to the joints, heart, and nervous system if left untreated. 

Valneva’s VLA15 shows promising results so far, but it will have to follow in the fateful footsteps of the only other Lyme disease ever brought to market, LYMERix. 

The FDA approved LYMERix in 1998 based on positive results from Phase 3 clinical trials, and the public initially accepted it well. The vaccine had some issues, including only an 80% efficacy rate after three doses. Still, it proved safe overall, and the FDA considered it a cost-effective vaccine relative to healthcare costs associated with Lyme disease treatment. 

LYMERix saw success until reports came in that some people developed arthritis after receiving the vaccine. Despite several independent studies confirming a vaccinated population was at no higher risk of developing arthritis than an unvaccinated population, the damage was done to LYMERix’s reputation. A few short years after it was commercialized, GlaxoSmithKline, the vaccine’s manufacturer, pulled the product from the shelves in 2002, citing insufficient consumer demand. 

With the reputation of Lyme disease vaccines effectively tarnished, Valneva will have to work hard to prove its worth to both European and North American markets to differentiate itself from the LYMERix catastrophe that preceded VLA15. 

The Environmental Protection Agency claims that Lyme disease cases have nearly doubled since 1991, but the number of cases reported by the CDC varies drastically. The CDC says that healthcare systems report about 30,000 Lyme disease cases each year, but because the effects of Lyme disease are often minimal, many cases go unreported. So many cases go unreported that the CDC says, based on insurance claim data, that upwards of 400,000 people may contract Lyme disease each year in the US. 

With the potential for such high case numbers, Valneva certainly has a market to go after with VLA15. With Pfizer’s support and positive results in clinical trials, VLA15 might have a shot at vindicating the public opinion on Lyme disease vaccines. 

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Updates on the Collaboration’s Terms

The original 2020 partnership agreement secured $130 million upfront for the potential of an additional $178 million in development and early commercialization milestones. Since then, Valneva has continued pushing VLA15 through a Phase 2 clinical trial, reporting positive results a few times a year. 

Pfizer’s equity investment comes when Valneva is looking to initiate Phase 3 clinical trials for VLA15. Valneva will now cover 40% of the remaining development costs instead of 30% in the initial agreement. 

Additional changes include tiered royalty payments ranging from 14% to 22% compared to the original agreement, which stated royalties would start at 19%. Accompanying the percentage of royalties will be $100 million based on an undisclosed amount of cumulative sales. 

Valneva has $168 million potentially available to it from the original partnership terms. Pfizer will make $25 million available to Valneva upon initiating the upcoming Phase 3 clinical trial. 

Even with the past criticisms of Lyme disease vaccines, Valneva seems to be on a good track to commercializing VLA15. The needs for a vaccine appear to be increasing year over year, and with Pfizer’s economic support, VLA15 looks like it has a shot to make it to market in the next few years.

Author

Reed Slater