Pfizer Inc. and French vaccine-maker Valneva SE signed a $130 million deal to develop a preventative treatment for Lyme disease as the current coronavirus pandemic lays bare the need for new ways to fight infectious diseases.
"The power of prevention against outbreaks and the openness toward vaccination will certainly be different post-COVID than pre-COVID," Valneva CEO Thomas Lingelbach said in an interview. "Ultimately, only vaccines will bring us back to normal."
COVID-19, the respiratory illness caused by the coronavirus, has killed more than 260,000 people, according to Johns Hopkins University. The global pharmaceutical industry, including Moderna Inc., GlaxoSmithKline PLC and Johnson & Johnson, has mobilized to create vaccines on an accelerated timeline that might halt the outbreak and allow a return to normal life.
At the end of April, Pfizer agreed to pay Valneva $130 million up front, with potential for $308 million overall to bring Valneva's Lyme disease vaccine candidate VLA15 into a late-stage study. Results from a phase 2 study are expected in mid-2020. Pfizer will control commercialization of VLA15 while Valneva collects 19% in royalties.
Lyme disease has long been a difficult target for the pharmaceutical industry and Valneva has known since initiating the development of VLA15 six years ago that further investment was needed, Lingelbach said.
Valneva CEO Thomas Lingelbach
"From the beginning, we said proving the efficacy of the vaccine will require a huge investment and for a single trial would probably be higher than the entire market cap of a company like Valneva," Lingelbach said. "Manufacturing for vaccines is key — it's much more critical than in classical pharma because vaccines are complex biological components that come with their own challenges."
The creation of a new vaccine is a long process that requires massive trials, Lingelbach said.
VLA15 is a multi-valent vaccine, meaning the medicine is essentially six vaccines in one to account for different strains of the Lyme virus, often borne by ticks. The virus is widespread in North America and Europe, adding geographical challenges to an already complex development process.
Development of therapies for Lyme disease came to a halt in 1999 after a class-action lawsuit was brought against Smithkline Beecham, creators of the only Lyme disease vaccine ever approved, called Lymerix. The plaintiffs claimed the company failed to warn the public about possible reactions caused by the vaccine, including the onset of arthritis. After an investigation, the U.S. Food and Drug Administration made no changes to the product's labeling, but Lymerix was withdrawn from the market in 2002 due to falling sales, leaving no approved Lyme disease vaccines.
Lingelbach said Valneva's candidate is the only clinical-stage vaccine in development for the disease.
"Challenge number one in Lyme disease is that, with today's globalization, you need to develop a Lyme vaccine that is not just protecting people living in a certain region — you need to protect Lyme on both sides of the Atlantic," Lingelbach said.
Further incentive for vaccines
Lingelbach said the terms of the Pfizer deal are larger than usual for a single vaccine candidate, even with a predicted $1 billion market opportunity in Lyme disease. He attributed the size of the collaboration to a growing interest in preventative medicine and technological advances in the past two decades.
For many years, the number of possible vaccines was thought to have hit a limit, Lingelbach said. Technology advancements have led to vaccines in development for viruses like Ebola and herpes, spurring a renewed appetite for research — and more financial incentives for vaccine-makers and larger pharmaceutical companies. GlaxoSmithKline PLC's shingles vaccine Shingrix, for instance, brought in £647 million in the first quarter of 2020.
"Prevention is always cheaper than therapy," Lingelbach said. Complex diseases like Lyme are attractive targets for vaccines when compared to the cost of treatment down the road, he added.
With the pharmaceutical industry rushing to bring a vaccine for the coronavirus to the market, Lingelbach believes preventative medicines could come back into the spotlight once the immediate crisis wanes.
"I believe that an epidemic like COVID will certainly change the way we think about vaccination as a whole," Lingelbach said.