Valneva writes off hospital-acquired infection vaccine following PhII/III miss

Valneva (EPA:VLA) has given up on its vaccine against the hospital-acquired infection Pseudomonas aeruginosa. The vaccine was positioned to be picked up by GlaxoSmithKline ($GSK), but weak Phase II/III data torpedoed both that possibility and Valneva’s interest in forging ahead with development.

The odds of either GSK or Valneva wanting anything to do with the vaccine, VLA43, lengthened when a first look at the Phase II/III data was released in June. But, while Valneva accepted GSK was likely to walk away from the vaccine at that time, it held off on officially jettisoning the candidate from its own pipeline. Now, as expected, Valneva has decided the failure of the vaccine to improve either the number of deaths or overall survival represents a terminal blow to its prospects.

Valneva, when releasing the initial data and confirming its axing of the vaccine, has sought to shift attention to its other pipeline prospects. But, while these assets may ultimately succeed, none of them address the unmet need targeted by VLA43. The failure of VLA43 ends hopes of a prophylactic vaccine against P. aeruginosa winning approval in the foreseeable future. The bacterium is estimated to cause 51,000 healthcare-associated infections and 400 deaths a year in the U.S..


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The failure of VLA43 to establish itself as a viable option for these patients has severed another tie between GSK and Valneva, while also forcing the latter to scrap an advanced pipeline prospect. GSK acquired the relationship with Valneva through its asset swap with Novartis ($NVS), which entered into a relationship with the vaccine developer’s predecessor Intercell in 2007. That deal featured €270 million ($300 million) in upfront fees and stock purchases, but elements of it have been unpicked by GSK.

VLA43 joins Clostridium difficile vaccine VLA84 on the list of Valneva assets GSK has opted against picking up. Valneva attributed the VLA84 rejection to “strategic” considerations at GSK. Whatever the reason, Valneva finds itself on the cusp of Phase III without a partner. The vaccine player is aiming to bring a partner on board by the end of the year, at which time it will finalize the Phase III trial design and head into the end-of-Phase II meeting.

The failure of VLA43 means a lot now rests on the VLA84 partnership talks and Phase III. Valneva is working to broaden its pipeline--a Lyme disease vaccine is due to enter Phase I later this year and Valneva is seeking a partner to take its Zika vaccine candidate into the clinic--but it will be some time before it sees a notable return on these investments.

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