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BioNTech SE (NASDAQ:BNTX) and Bristol Myers Squibb & Co. (NYSE:BMY) entered into a co-development and co-commercialization agreement.
The pact focuses on BioNTech’s investigational bispecific antibody BNT327 across numerous solid tumor types.
Under the agreement, BioNTech and Bristol Myers Squibb will work jointly to broaden and accelerate the development of this clinical candidate.
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BioNTech’s BNT327 is currently under extensive evaluation in multiple ongoing clinical trials, with over 1,000 patients having received the treatment to date.
These evaluations include global Phase 3 trials with registrational potential, investigating BNT327 as a first-line treatment for both extensive-stage small cell lung cancer (ES-SCLC) and non-small cell lung cancer (NSCLC).
Furthermore, BioNTech plans to initiate an additional global Phase 3 trial by the end of 2025 to assess the candidate’s efficacy in treating triple-negative breast cancer (TNBC).
Under the terms of the agreement, the companies will jointly develop and commercialize BNT327, including the development of BNT327 as monotherapy and in combination with other products.
Both companies have the right to independently develop BNT327 in further indications and combinations, including combinations of BNT327 with proprietary pipeline assets.
Bristol Myers Squibb will pay BioNTech $1.5 billion in an upfront payment and $2 billion in non-contingent anniversary payments through 2028.
These tax-deductible charges will be recorded as Acquired IPR&D Expense when incurred, with the $1.5 billion being incurred in Q2.
In addition, BioNTech will be eligible to receive up to $7.6 billion in additional development, regulatory and commercial milestones.
BioNTech and Bristol Myers Squibb will share joint development and manufacturing costs on a 50:50 basis, subject to certain exceptions. Global profits/losses will be equally shared between BioNTech and Bristol-Myers Squibb.
In May, Bristol-Myers Squibb agreed to pay $350 million to the State of Hawaii to settle claims related to the prescription drug Plavix, an antiplatelet drug that prevents blood clots by keeping platelets in the blood from coming together and making clots.
The agreement resolves a lawsuit filed by the state that alleged the pharmaceutical company engaged in deceptive practices surrounding the development, labeling, and marketing of the drug.
Price Action: BNTX stock is trading higher by 14.8% to $109.95, and BMY stock is trading lower by 0.62% to $47.98 at last check Monday.