DUBLIN – Shares in Valneva SE rose by as much as 32% during early trading April 30 on news that Pfizer Inc. is paying $130 million up front to in-license its Lyme disease candidate vaccine, VLA-15. Valneva could also receive a further $35 million in development milestones and $143 million in early commercial milestones, as well as tiered sales royalties starting at 19%.
The money is not flowing in just one direction, however. Valneva, of Saint Herblain, France, is on the hook for 30% of future development costs, while New-York-based Pfizer will lead late-stage development and will have sole responsibility for commercialization. The up-front payment and the development milestones should comfortably cover Valneva’s contribution. “We believe in the product. We want to have skin in the game,” CEO Thomas Lingelbach told BioWorld. The high royalty rate is the real prize. “It’s absolutely unprecedented in the vaccine space for an R&D deal.”
Participating in the commercial rollout of a Lyme disease vaccine was never an option for the company, even though it currently markets two traveler vaccines, for Japanese encephalitis virus and for cholera. “We have a specialist commercial infrastructure that is really focused on niche vaccines and defined distribution channels,” Lingelbach said. Forty to 50 sales reps can cover the entire market. Lyme disease, a tick-borne illness, represents a totally different proposition, as it necessitates a primary care sales force. About 300,000 new cases occur annually in North America, as do about 200,000 in Europe. There has been no vaccine on the market since 2002, and VLA-15 is the only program in clinical development at present. Independent assessments put its sales potential at close to $1 billion annually. “It’s probably fair to say Pfizer would see it as being north of that,” Lingelbach said.
Of course, it first has to prove its mettle in the field. Two phase II studies, which have already completed enrolment, are reading out this year. A dose-finding study, which recruited 573 participants, will read out around midyear. A second study, which is evaluating a longer dose schedule in 246 subjects, will deliver data several months later. Assuming they are positive, those data, combined with input from the FDA and the EMA, will shape the design and the timing of the phase III program. “In an ideal world, you would have one global phase III trial to support global licensure,” Lingelbach said.
Whichever dose schedule is selected – each involves three shots but they are administered over a two-month or three-month timeframe – will determine the timing of the phase III start. “It’s not entirely predictable at this point in time,” Lingelbach said. All participants will need to be fully vaccinated and to have developed an immune response in advance of the peak season for contracting Lyme disease, which extends from March to August. Pfizer is targeting 2025 for a commercial launch.
VLA-15 is a hexavalent, alum-adjuvanted, protein-based vaccine designed to protect against the six most prevalent Borrelia serotypes that cause Lyme disease. It comprises three recombinant fusion proteins, each containing the C-terminal halves of two recombinant outer surface protein A (OspA) obtained from different Borrelia serotypes. It was originally developed at Vienna-based Intercell, which was acquired by Vivalis in 2012, after which the enlarged entity was renamed Valneva.
The deal with Pfizer is a replacement for an earlier legacy deal with London-based Glaxosmithkline plc, which was laid to rest last June. GSK had inherited the Lyme disease program through its acquisition of the vaccines business of Novartis AG, as part of the large-scale asset swap the two big pharma undertook in 2015. Novartis, of Basel, Switzerland, had previously gained rights to the product as part of larger alliance it entered with Intercell back in 2007.
Rights to one other program from that deal also reverted to Valneva last year – a vaccine for Chikungunya virus, which is now slated to enter phase III development in the fourth quarter. The COVID-19 pandemic has introduced a delay of three to six months. Valneva is also working on a COVID-19 vaccine, based on an inactivated whole-virus design. “For us, it’s the simplest and fastest way to develop a vaccine,” Lingelbach said. “We are working towards clinical entry by the end of the year.” It employs beta propionilactione for inactivation, to preserve the conformation of the SARS-CoV-2 spike protein. The company has entered an agreement with Berkeley, Calif.-based Dynavax Inc., which is supplying its Toll-like receptor 9 (TLR-9) adjuvant. CpG 1018.
Shares in Valneva (Paris:VLA) peaked at €4.20 (US$4.60) during trading Thursday and closed at €4.19, up 32%.