In the midst of their $500 million program to build a Covid-19 vaccine with BioNTech, Pfizer has announced a sizable deal to commercialize a vaccine for a far different disease.
Pfizer and Valneva have agreed to an up-to $308 million deal on the French biotech’s Lyme disease vaccine. The deal includes a $130 million upfront payment for Valneva, whose candidate is now in Phase II. On top of that, there are milestones and ultimately a 19% royalty on sales. Valneva will still be in charge of 30% of the commercialization costs.
Although the vaccine market has been ailing for years, Pfizer has a blockbuster in their pneumococcal vaccine, Prevnar 13, and are in late stages on a successor vaccine. The deal comes at a time of renewed interest in the field, a phenomenon the Covid-19 pandemic and the drug hunt around it have only accelerated. Earlier this month, Affinivax raised $120 million in a Series C, and in March, SutroVax raised $110 million for their attempt to rival Pfizer’s Prevnar 13 — both standard sums these days for oncology but large in the context of infectious disease research.
The hunt for a Lyme disease vaccine is decades old, dating to not long after the discovery of the tick-born illness and the bacteria that caused it in the 1970s and 80s. In 1998, SmithKline Beecham beat out Pasteur Mérieux Connaught (the Sanofi Pasteur predecessor) and got LYMErix, a recombinant DNA vaccine that required 3 shots and was about 80% effective, approved by the FDA.
The approval, though, dovetailed with the beginnings of the modern anti-vaccination movement in the United States. Growing reports of joint pain and other safety complaints with the vaccine led to a class action lawsuit against SmithKline. Although the suit was settled without compensation and an FDA review found no evidence for arthritis or other unexpected adverse effects, sales dropped precipitously. SmithKline pulled the drug off the market in 2002, citing poor commercial performance.
The controversy set back the field considerably. Pasteur Mérieux Connaught never applied for their vaccine. Today, although you can inoculate your dog against Lyme disease, you cannot inoculate yourself or your kid.
Valneva, created after the failed Austrian vaccine company Intercell merged with the French biotech Vivalis in 2012, began working on a Lyme disease vaccine shortly after its birth. They claim to have the only Lyme disease vaccine in development.
The vaccine, VLA15, targets the six most common types of Borrelia bacteria that cause Lyme disease, making it a potential candidate for use across Europe and North America. It is a protein subunit vaccine, meaning it contains only the antigens from the bacteria that the body will make antibodies against. They have fast-track designation and are expecting results from their Phase II by mid-2020. CEO Thomas Lingelbach has said he expects to bring the product to market in 4-5 years.
The number of people diagnosed with Lyme disease has expanded considerably in America and Europe in the two decades since LYMExis’s approval, potentially setting up a large market if the vaccine is approved.
Social: Thomas Lingelbach, Valneva CEO via YouTube