Clinical Pfizer to back Valneva with €91M investment for phase...

Pfizer to back Valneva with €91M investment for phase 3 Lyme disease vaccine trial

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Pfizer has Valneva’s back in support of the late-phase development of a vaccine for Lyme disease. Pfizer has agreed to invest €90.5M or $95.6M as a part of an updated deal that initiated an 81% increase in Valneva’s premarket stock price.

Valneva is a biotech company that operates out of Saint-Herblain, France. They are known to develop and commercialize vaccines for contagious diseases. The company has manufacturing facilities in three major locations, namely Vienna, Austria; Livingston, Scotland and Solna, Sweden. Pfizer is an American multinational biotech and pharmaceutical giant operating out of Manhattan, New York City.

The two companies have made the case for the multivalent protein subunit vaccine VLA15 over a series of data points, which enables them to aim for a phase 3 clinical trial in the third quarter of the year. The partners revisited their deal before the launch of the study and agreed on revised terms. According to the initial deal that was signed in April of 2020, Pfizer paid Valneva $130M upfront.

The new deal states that Valneva is to fund 40% of the remaining shared development costs, which is an increase from the original deal of 30%. Pfizer will take an 8.1% stake in Valneva to aid the company in the phase 3 trial without denting its cash situation. At the end of the month of March, Valneva had €311.3M in the bank.

Thomas Lingelbach, CEO of Valneva, said, “Pfizer’s investment in Valneva highlights the quality of the work that we’ve done together over the past two years and is a strong recognition of Valneva’s vaccine expertise. We are looking forward to further investigating our VLA15 candidate in Phase III, which will take us a step closer to potentially help protect both adults and children from this devastating disease.”

The future paydays for Valneva have also been revised under the new deal. Tiered royalties to be paid by Pfizer have been increased from the original deal of 19%, to the new range of 14% to 22%. An additional $100M has been added to be paid based on sales milestones. Valneva is yet to receive $100M in early commercialization and development milestones which include $25M set for the initiation of phase 3.

Pfizer’s investment has caused the Valneva stock to rise, after it had taken additional beating courtesy of the pandemic, its aftermath, and the setbacks to its Covid vaccine, following the general uneasiness of the biotech bear market. Valneva’s stock was dipping late on Friday in the US stock market and with the market closed on Monday, Tuesday saw aggressive premarket trading since the disclosure of Pfizer’s investment news. This caused the stock price to rise an incredible 81% to a per-share price of $25.

Spotlight is now on phase 3 clinical trial that would enlighten the long-inactive Lyme disease market. The last activity in that market was when SmithKline Beecham got the approval for their Lyme disease vaccine in the late 90s. However, a few years later SmithKline Beecham pulled the product from the market. That was the last activity in the market. The reported Lyme disease cases in the US have since been on the rise and there have been no valuable attempts to counter it. Pfizer’s partnership with French company Valneva will be the first lyme disease activity since the exit of SmithKline Beecham from the market in the late 90s.

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