Gilead Sciences to Acquire Ouro Medicines to Advance First in Class T Cell Engager Program for Autoimmune Diseases
-- Acquisition Adds Clinical Stage Bispecific BCMAxCD3 T Cell Engager with Potential for Durable Immune Reset to Gilead’s Inflammation Portfolio --
-- Gilead Intends to Enter into a Strategic Collaboration with Galapagos on the Ouro Portfolio of Medicines --
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The acquisition adds OM336 (gamgertamig), a clinical‑stage BCMAxCD3 T cell engager, to Gilead’s growing inflammation portfolio. OM336 is designed to enable rapid and deep B cell depletion following a limited subcutaneously administered treatment course. In ongoing Phase 1/2 clinical studies, OM336 has demonstrated transformative efficacy and a differentiated safety profile after a single treatment cycle in severe antibody-mediated orphan diseases including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). Gamgertamig has been granted both Fast Track and Orphan Drug Designation by the
“This acquisition underscores our commitment to advancing transformative therapies for people living with serious autoimmune diseases,” said
BCMA‑targeted T cell engagers are being investigated as a precision approach for severe inflammatory and autoimmune diseases by eliminating pathogenic B cells and plasma cells. By redirecting a patient’s own T cells toward BCMA‑expressing plasma cells, clinical data suggests these agents may reduce inflammation, improve organ‑level disease, and, in some cases, enable an immune reset marked by durable, drug‑free remission without ongoing immunosuppression. T cell engagers represent an important modality for patients alongside Gilead’s portfolio of CAR-T assets.
“From the outset, we saw the potential for gamgertamig to redefine the standard of care for immune-mediated diseases,” said
Terms of the Transaction
Under the terms of the agreement Gilead will acquire all of the outstanding equity of Ouro Medicines for a total of
Strategic Collaboration with Galapagos
Gilead is currently in advanced discussions with Galapagos with respect to a potential research and development collaboration on the acquired Ouro Medicines assets. The arrangement between Gilead and Galapagos is contemplated to include the following key terms:
- Galapagos would pay 50% of the upfront consideration and 50% of any contingent milestone payments payable to Ouro Medicines’ shareholders.
- Galapagos would absorb substantially all of Ouro Medicines’ operating assets and retain its employees.
- Gilead and Galapagos would collaborate on the development of OM336, with Galapagos responsible for development costs through initiation of registrational studies. Registrational study costs would be shared equally between the parties.
- Gilead would retain sole worldwide commercialization rights (other than in Greater China where Keymed Biosciences has existing commercialization rights) and Gilead would pay Galapagos royalties of 20%-23% of net sales.
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Amended legacy Galapagos Option License and Collaboration Agreement (“OLCA”) to allow for up to
$500 million of Galapagos’ current cash to be used freely by Galapagos, including up to$150 million for potential share repurchases.
About OM336
OM336 is an investigational BCMAxCD3 bispecific T cell engager for the treatment of autoantibodies driven immune-mediated disease. OM336 has been granted Orphan Drug Designation and Fast Track Designation by the
About
About Ouro Medicines
Ouro Medicines is a clinical stage biotechnology company dedicated to developing immune reset therapeutics for people living with chronic immune-mediated diseases. Ouro’s approach is focused on leveraging T cell engagers in B cell-mediated diseases to achieve immune resets that create durable remissions without ongoing immunosuppression. Based in
Gilead Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Ouro Medicines to complete the acquisition transaction in a timely manner or at all; the possibility that various closing conditions for the acquisition transaction may not be satisfied or waived, including the possibility that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the acquisition transaction; uncertainties relating to the timing or outcome of any filings and approvals relating to the acquisition transaction; the ability of Gilead to negotiate and enter into the proposed collaboration with Galapagos, including on the terms described herein and in a timely manner or at all; difficulties or unanticipated expenses in connection with integrating the companies, including the effects of the acquisition transaction and the proposed collaboration on relationships with employees, other business partners or governmental entities; the risk that Gilead may not realize the expected benefits of this acquisition transaction; the ability of Gilead to advance their product pipeline and successfully commercialize product candidates following the acquisition; the ability of the parties to initiate and complete clinical trials involving such product candidates in the currently anticipated timelines or at all; the possibility of unfavorable results from one or more of such trials involving such product candidates; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that FDA may not approve any such product candidates in the anticipated indications or on the timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use;; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead’s Annual Report on Form 10-K for the year ended
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Gilead Contacts:
public_affairs@gilead.com
investor_relations@gilead.com
Ouro Medicines Contact:
FGS Global
ouro@fgsglobal.com
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