Global Briefs: Gilead, Roche, Hikma & More
A roundup of news from the large and mid-sized bio/pharmaceutical companies featuring Gilead Sciences, Roche, Hikma Pharmaceuticals, Alynylam, Novartis, GSK, Servier and Sanofi. Highlights below.
For the latest news roundup on small and Emerging Pharma companies, see Biotech Briefs.
Mfg News
* Hikma To Invest $267 M in US Mfg Facilities
M&A News
* Gilead Sciences and Lakefront Complete Acquisition of Ouro Medicines
Partnering News
* Roche, Nurix Therapeutics in $2.3-Bn Oncology Drug Pact
* Alynylam, Inceptive Nucleics in $2-Bn RNAi Pact
* Novartis, Orionis Biosciences in $1.4-Bn Pact for Molecular Glue Medicines
* GSK, Engitix in $216-M Liver Drug Pact
* Servier, n-Lorem Foundation in Rare Disease Antisense Oligonucleotide Drug Pact
* Sanofi, Owkin Expand AI Drug-Discovery Pact
Mfg News
Hikma To Invest $267 M in US Mfg Facilities
Hikma Pharmaceuticals, a generic-drug company, has announced plans for a $267-million expansion of its manufacturing operations in Columbus and Bedford ,Ohio.
The Bedford project will create up to 300 new jobs as part of a $51-million investment to expand injectable pharmaceutical manufacturing capabilities, including advanced aseptic vial filling and lyophilization, in addition to IV bag production, warehousing, and distribution. In Columbus, Hikma will invest $216 million to expand its oral solid dose and nasal inhalation manufacturing operations, which is expected to create 50 new jobs.
Source: Hikma Pharmaceuticals
M&A News
Gilead Sciences and Lakefront Complete Acquisition of Ouro Medicines
Gilead Sciences and Lakefront Biotherapeutics, a Mechelen, Belgium-based bio/pharmaceutical company, have completed their acquisition of Ouro Medicines, a privately held biotechnology company focused on developing T cell engager therapies for autoimmune diseases, in a deal worth up to $2.2 billion ($1.7 billion upfront and $500 million in milestone payments).
The acquisition adds OM336 (gamgertamig), a clinical‑stage BCMAxCD3 T cell engager, to Gilead’s inflammation drug portfolio. OM336 is designed to enable B cell depletion following a limited subcutaneously administered treatment course. In ongoing Phase I/II clinical studies, OM336 has demonstrated 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), according to information from Gilead Sciences. Gamgertamig has been granted both fast-track and orphan drug designation by the US Food and Drug Administration for the treatment of AIHA and ITP and is expected to enter registrational studies in 2027. Gamgertamig is in-licensed from Keymed Biosciences, which owns the rights to develop the program in Greater China.
With this transaction, Lakefront has acquired substantially all of Ouro Medicines’ team and operational assets in connection with Gilead’s acquisition of Ouro Medicines and will collaborate with Gilead on the development of gamgertamig. As part of the collaboration, Lakefront is responsible for the ongoing and future Phase I/II clinical studies of gamgertamig, with Gilead leading the registrational and later-stage studies. Gilead will retain sole worldwide commercialization rights, including all related costs, globally outside of Keymed’s territories. Lakefront will receive tiered royalties of 20%–23% on net sales of gamgertamig from Gilead.
Lakefront has also in-licensed a preclinical portfolio of three additional autoimmune-focused programs originally from Ouro with an opt-in for Gilead for a 50/50 profit split post clinical proof-of-concept for $75 million per program.
Under the agreement, Gilead acquired all the outstanding equity of Ouro Medicines for $1.675 billion and up to $500 million in contingent milestone payments. Lakefront and Gilead will equally split the upfront payment, subject to customary adjustments, and contingent milestone payments of up to $500 million.
Source: Gilead Sciences
Partnering News
Roche, Nurix Therapeutics in $2.3-Bn Oncology Drug Pact
Roche has entered into an agreement with Nurix Therapeutics, a Brisbane, California-based bio/pharmaceutical company, in a deal worth up to $2.3 billion ($700 million upfront and $1.6 billion in milestone payments).
Under the agreement, the two companies will collaborate to co-develop and co-commercialize bexobrutideg (NX-5948), Nurix’s investigational Bruton’s tyrosine kinase (BTK) degrader. The collaboration encompasses a clinical development plan spanning B-cell malignancies, immunology, and neurology. The addition of bexobrutideg complements Roche’s existing strengths in hematology and provides a cross-therapeutic opportunity to extend the pipeline’s reach in immunology and neurology.
Bexobrutideg, an oral targeted BTK degrader, is planned for Phase III clinical trial initiation in the summer of 2026 for the second-line treatment of chronic lymphocytic leukemia.
Under the agreement, Nurix will receive an upfront cash payment of $700 million and is eligible to receive development, regulatory and sales milestones for a potential total deal value of up to $2.3 billion. Development costs will be shared 40% by Nurix and 60% by Roche. The parties will equally split the profits and losses from US commercialization. Nurix and Roche will co-commercialize bexobrutideg in the US across all indications. Outside of the US, Roche will be responsible for commercialization, with Nurix receiving royalties ranging from the low- to high-teens.
The transaction is subject to customary closing conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The parties expect the transaction to close in the third quarter of 2026.
Source: Roche
Alynylam, Inceptive Nucleics in $2-Bn RNAi Pact
Alnylam Pharmaceuticals and Inceptive Nucleics, a Palo Alto, California-based company specializing in AI-based drug design and optimization, have announced a strategic collaboration in RNAi therapeutics, in a deal worth up to $2 billion ($30 million upfront, including Inceptive equity and additional payments based on the achievement of preclinical, regulatory, and commercial sales milestones).
Founded in 2021, Inceptive Nucleics partners with pharma companies to customize molecule-design models for discovery of sequence-based medicines such as small interfering RNA (siRNA) medicines antisense oligonucleotides, peptides, and messenger RNA (mRNA) medicines for applications such as in-vivo cell therapies.
The collaboration seeks to advance siRNA design by modeling target mRNAs and jointly exploring sequence space and chemical modifications to enhance potency and efficacy and to predict top-performing therapeutic candidates in preclinical models for further development by Alnylam. The goal is to help Alnylam prioritize the most promising molecules and improve experimental productivity.
Source: Alnylam Pharmaceuticals
Novartis, Orionis Biosciences in $1.4-Bn Pact for Molecular Glue Medicines
Novartis and Orionis Biosciences, a privately held, clinical-stage bio/pharmaceutical company, have announced a multi-year collaboration to discover and design molecular glue medicines for therapeutic targets across multiple disease areas, in a deal worth up to $1.4 billion ($40 million upfront and $1.4 billion in milestone payments).
Molecular glues represent a specific class of small molecules that modulate protein–protein interactions by inducing or stabilizing non-native contacts between proteins. Orionis has a proprietary platform for discovering and designing molecule glue medicines, Allo-Glue, which produces small-molecule monovalent glues that induce or enhance specific protein-protein interactions by reprogramming protein functions and impacting disease targets through either proximal or distal allosteric mechanisms, including targets once considered “undruggable.” Outcomes of induced proximity include target protein degradation, inhibition, modulation, or stabilization, according to company information.
Under the agreement, Novartis and Orionis will use Orionis’s Allo-Glue platform, together with its AI-driven discovery engine, to accelerate target and ligase profiling and molecular glue optimization. These integrated capabilities enable the systematic discovery of small molecule glues that modulate therapeutic targets through induced proximity mechanisms.
Orionis will receive an upfront payment of $40 million and is eligible to receive research, development, and commercial milestone payments of up to $1.4 billion, in addition to tiered royalties on net sales of collaboration products.
Source: Orionis Bioscience
Lilly, Alzecure Pharma in $1-Bn Alzheimer’s Drug Pact
Eli Lilly and Company and AlzeCure Pharma, a Hälsovägen, Sweden-based bio/pharmaceutical company developing small-molecule drug candidates for central nervous system diseases with a focus on Alzheimer’s disease and pain, have entered into a collaboration and out-licensing agreement for the global rights to AlzeCure’s ACD680, a preclinical drug candidate for treating Alzheimer’s disease, in a deal worth up to $1 billion ($10 million upfront and $1 billion in milestone payments).
AlzeCure has developed a proprietary research platform in Alzheimer’s diseas, Alzstatin. ACD680 is a gamma-secretase modulator that aims to reduce the production of the amyloid-beta (Aβ) protein, Aβ42, which forms the building blocks of the amyloid plaques found in the brains of Alzheimer’s patients. In addition, ACD680 is designed to increase the production of shorter, benign Aβ proteins, Aβ37 and Aβ38, which may reduce the aggregation of Aβ42, thereby also reducing the build-up of plaques in the brain.
Under the agreement, AlzeCure will receive an upfront payment of $10 million, development and commercial milestones, and tiered mid-single digit royalties on sales. The total deal value, excluding royalty payments, may exceed $1 billion.
Source: AlzeCure Pharma
GSK, Engitix in $216-M Liver Drug Pact
GSK and Engitix, a bio/pharmaceutical company focused on extracellular matrix (ECM)-based drug discovery, have announced a strategic research collaboration and option agreement to identify and validate novel therapeutic targets driving liver fibrosis regression, in a deal worth up to $216 million ($59 million upfront and $157 million in milestone payments).
This alliance brings together Engitix’s human ECM Platform and multi-omics datasets with GSK’s drug-development capabilities, to focus on mechanisms of liver fibrosis regression.
Under the agreement, Engitix is eligible to receive up to £44.5 million ($59 million) in upfront and near-term payments, as well as up to £118 million ($157 million) per target in downstream milestone payments, in addition to tiered low-single digit royalties on future product sales. Engitix will develop human ECM-based disease models and generate high-resolution translational multi-omics datasets, to uncover targets associated with fibrosis resolution in liver disease. GSK will have the option to license assays, datasets, and targets arising from the collaboration, and GSK will lead any further research, development and commercialization activities on targets discovered and validated in the collaboration.
Source: Engitix
Servier, n-Lorem Foundation in Rare Disease Antisense Oligonucleotide Drug Pact
Servier, a French bio/pharmaceutical company, and n-Lorem Foundation, a non-profit reasearch organization, have entered into a multi-target research collaboration to develop antisense oligonucleotide (ASO) therapeutic approaches to address rare neurodevelopmental disorders. ASOs are designed to target disease-causing RNA and may enable highly personalized approaches to treating genetic disorders. Under the agreement, n-Lorem research teams will apply ASO technology platform to engineer preclinical candidates, which Servier will advance into clinical development.
Source: Servier
Sanofi, Owkin Expand AI Drug-Discovery Pact
Sanofi and Owkin, a New York-based agentic AI company in drug discovery and development, have formed a multi-year collaboration that includes a five-year license for Owkin’s K Pro platform, an AI platform designed to enhance drug discovery.
During the five-year collaboration, Owkin will lead the end-to-end development of AI-driven biopharma agents for Sanofi, which will work like intelligent assistants by autonomously performing tasks in drug research and development. They will be deployed through Owkin’s K Pro platform, with the aim of complementing and reinforcing Sanofi’s existing agentic AI capabilities.
Owkin and Sanofi have collaborated since 2021 through a EUR 90-million ($104-million) strategic partnership focused on target identification in oncology and patient subgrouping. The collaboration was later expanded to include drug positioning for Sanofi’s immunology pipeline.
Source: Owkin
