CONSHOHOCKEN, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) agreed Wednesday to pay Pfizer Inc. $27 million for worldwide rights to an early-stage antibody-drug conjugate, taking control of CD228V’s development while leaving Pfizer eligible for more than $1 billion in milestones and future royalties.
Medicus paid Pfizer a $12 million nonrefundable payment when the agreement took effect and owes another $15 million on Sept. 2, 2027, according to the companies’ co-development and license agreement. Pfizer simultaneously provided Medicus with $2 million that can be used only for development of CD228V.
The transaction transfers to Medicus an exclusive, sublicensable, royalty-bearing worldwide license under specified Pfizer product patents for PF-08046031, also known as CD228V or SGN-CD228V. Medicus also receives a nonexclusive license to related Pfizer platform patents and know-how.
CD228V is an antibody-drug conjugate targeting melanotransferrin, or CD228. The compound combines a humanized antibody that binds CD228 with a cleavable linker and a microtubule-disrupting cytotoxic payload that can include monomethyl auristatin E, according to the agreement.
The license covers potential use across human diseases and disorders, while the agreement specifically identifies second-line melanoma, head and neck squamous cell carcinoma and esophageal cancer in its milestone framework.
Medicus will have sole authority over development, manufacturing, regulatory approval and commercialization and will bear those costs. Pfizer has no approval, veto or other decision-making authority over development activities, although Medicus must use commercially reasonable efforts to pursue regulatory approval in major markets.
That structure places most of the near-term development risk with Medicus. Beyond the $2 million payment, Pfizer has no obligation to finance development, manufacturing, regulatory or commercialization expenses unless the companies later sign a separate funding agreement.
Pfizer nevertheless retains an oversight role. Medicus must provide development and commercialization updates, spending information and regulatory progress reports, and Pfizer can review and comment on the development plan and budget. Medicus remains free to reject those comments and proceed at its discretion.
Pfizer also retains an option to finance all or part of CD228V development once Medicus decides to initiate the program’s first pivotal trial, or if Medicus plans a transaction in which another party would fund a material portion of post-pivotal development.
Exercising that option would not automatically commit either company to financing. The parties would have to negotiate a separate definitive agreement setting the amount, schedule, permitted uses and consideration payable to Pfizer.
Pfizer’s economic participation could become substantially larger if CD228V advances. The company is eligible for development and regulatory milestone payments across multiple indications as well as payments tied to annual and cumulative product sales.
The aggregate potential development, regulatory and sales milestones exceed $1 billion if all specified clinical, regulatory and commercial thresholds are achieved, according to Medicus’ Form 8-K.
Pfizer would additionally receive tiered royalties in the low double digits on net product sales. The agreement applies royalties by product and country during the applicable royalty term.
Under the contract, a royalty term lasts until the latest of 15 years after a product’s first commercial sale in a country, expiration of applicable regulatory or data exclusivity, or expiration of relevant licensed patent claims.
Pfizer also retains an economic interest if Medicus later sublicenses the program or enters certain strategic transactions, including a change of control. The agreement requires Medicus to pay Pfizer an undisclosed percentage of specified sublicensing income and strategic-transaction consideration; that percentage was redacted from the public filing.
Medicus can sublicense the program to its affiliates without Pfizer approval. Sublicensing to an outside company generally requires Pfizer’s prior written approval, which the agreement states cannot be unreasonably withheld or delayed.
Pfizer retains ownership of the licensed technology rather than transferring the underlying intellectual property outright. The agreement also preserves Pfizer’s ability to use CD228V internally for research and as a comparator in clinical trials involving other drugs.
The contract also provides Pfizer with significant rights if the collaboration ends under certain circumstances. If Pfizer terminates for specified causes or Medicus terminates for convenience, Pfizer can receive a perpetual, worldwide, royalty-free exclusive license to intellectual property developed by Medicus around the program through the termination date.
For Medicus, the transaction expands its clinical-development portfolio with an oncology asset originally developed within Pfizer while committing the smaller biotechnology company to both fixed licensing payments and the costs required to move the program forward.
The agreement became effective Sept. 2 between Pfizer and Medicus Pharma Inc., the wholly owned operating subsidiary of Medicus Pharma Ltd., based at 300 Conshohocken State Road in Conshohocken.
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