Global Briefs: AstraZeneca, Roche, Teva, Merck & Co. & More
A roundup of news from AstraZeneca, Teva Pharmaceuticals, Roche/Manifold Bio, Merck & Co./Blackstone Life Sciences, Boehringer Ingelheim/CDR-Life, Eli Lilly and Company/Ailux and Merck & Co./Dr Falk Pharma. Highlights below.
Mfg News
* AstraZeneca Investing $136 M in Mfg Site in China for Inhaled Aerosols
* Teva Recalls 500,000 Bottles of Blood Pressure Drug for Nitrosamine Impurity
Partnering News
* Roche, Manifold Bio in $2-Bn Neurological Drug Development Deal
* Merck & Co., Blackstone Life Sciences in $700-M ADC Development Pact
* BI, CDR-Life in $570-M Deal for Trispecific Antibody
* Lilly, Ailux Partner for Bispecific Antibodies in $345-M Deal
* Merck & Co., Dr Falk Pharma Update Drug Licensing Pact
Mfg News
AstraZeneca Investing $136 M in Mfg Site in China for Inhaled Aerosols
AstraZeneca has signed a cooperation agreement with China’s Qingdao High-tech Industrial Development Zone Management Committee, announcing an additional investment of approximately $136 million to expand the production capacity of its Qingdao production and supply base. This expansion will further increase AstraZeneca’s production capacity of inhaled aerosols.
Source: AstraZeneca
Teva Recalls 500,000 Bottles of Blood Pressure Drug for Nitrosamine Impurity
Teva Pharmaceuticals has issued a voluntary recall of over 500,000 bottles of prazosin hydrochloride, capsules, an oral blood-pressure drug, for nitrosamine impurities above acceptable levels. The recall applies to three types of capsules: 1 mg (181,659 bottles recalled), 2 mg (291,512 bottles recalled), and 5 mg (107,673 bottles recalled).
The voluntary recall, which was issued nationwide in the US on October 7, 2025, is a result of GMP deviations-test results for N-nitroso prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit. The CPCA is a methodology developed by the US Food and Drug Administration and international regulators in assessing the risk from a nitrosamine impurity.
Source: US Food and Drug Administration
Partnering News
Roche, Manifold Bio in $2-Bn Neurological Drug Development Deal
Roche and Manifold Bio, a platform therapeutics company focused on AI, have entered an agreement that will apply Manifold’s proprietary tissue-targeting shuttle portfolio and mDesign AI-driven in vivo discovery engine to create multiple next-generation blood-brain barrier (BBB) shuttles for the treatment of neurological and neurodegenerative diseases, in a deal worth up to $2 billion ($55 million upfront and $2 billion in milestone payments).
Unlike traditional approaches that rely heavily on in-vitro assays, Manifold’s mDesign platform can be used to measure thousands to millions of biologic variants directly in vivo, according to the company and can be applied to antibodies, oligonucleotides, and other modalities.
Under the agreement, Manifold will lead research and discovery activities to identify and develop novel BBB shuttles tailored to select Roche therapeutic payloads. Roche will then lead preclinical, clinical, and commercialization efforts. Roche will pay Manifold an upfront fee of $55 million. In addition, Manifold is eligible to receive research, discovery, and preclinical milestones as well as clinical and sales milestones totaling over $2 billion, along with tiered royalties. Manifold also retains the right to co-fund development of one program in exchange for enhanced royalties, as well as the right to apply its BBB shuttles to therapeutic payloads outside of Roche’s licensed targets.
Source: Manifold Bio
Merck & Co., Blackstone Life Sciences in $700-M ADC Development Pact
Merck & Co. has entered an agreement to receive funds managed by Blackstone Life Sciences for sacituzumab tirumotecan (sac-TMT), an investigational antibody-drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), a protein found on the surface of various cancer cells, in a deal worth $700 million. Merck is currently evaluating sac-TMT in 15 global Phase III clinical trials spanning six tumor types, including breast, endometrial, and lung cancers.
Under the agreement, Blackstone will pay Merck $700 million to fund a portion of the development costs for sac-TMT expected to be incurred throughout 2026. In return, Blackstone is eligible to receive low-to-mid single-digit royalties on net sales of sac-TMT across all approved indications in Merck’s marketing territories contingent upon receipt of regulatory approval in the US for first-line treatment of triple-negative-breast cancer based on findings of the TroFuse-011 clinical trial.
Source: Merck & Co.
BI, CDR-Life in $570-M Deal for Trispecific Antibody
Boehringer Ingelheim (BI) and CDR-Life, a bio/pharmaceutical company focused on T cell engagers, have entered an agreement to develop CDR-Life’s antibody-based molecule CDR111 for autoimmune diseases, in a deal worth up to $570 million ($48 million upfront and $522 million in milestone payments).
CDR111 is a trispecific M-gager, an antibody-based T-cell engager designed to selectively target and deplete B cells, with the goal of achieving immune system reset.
The agreement builds on the companies’ successful collaboration on an investigational antibody fragment. BI has developed this molecule with technology licensed from CDR-Life, with the goal of preserving vision in people living with geographic atrophy, a late stage of dry age-related macular degeneration. It is currently being investigated in a Phase II trial.
Under the agreement, CDR-Life is eligible for up to a total of CHF 456 million (approximately $570 million) in payments, including CHF 38 million (approximately $48 million) in upfront and near-term payments, plus tiered royalties on future sales.
Source: CDR-Life
Lilly, Ailux Partner for Bispecific Antibodies in $345-M Deal
Eli Lilly and Company and Ailux, a platform technology company using AI for antbody-based drug development, has entered an agreement to accelerate the discovery and development of bispecific antibodies for the treatment of various diseases, in a deal worth up to $345 million.
Through this collaboration, Lilly will gain access to Ailux’s AI-powered bispecific antibody engineering platform, which integrates advanced structural modeling, generative design, and developability analytics to deliver therapeutic constructs.
Under the agreement, Lilly may nominate an undisclosed number of target pairs for bispecific antibody design and may also obtain a license to Ailux’s proprietary platform for internal use. The agreement includes upfront and near-term payments totaling a double-digit million-dollar amount, including a platform license option. The total potential value of the deal, which includes development, regulatory, and commercial milestone payments, is up to $345 million.
Source: Ailux
Merck & Co., Dr Falk Pharma Update Drug Licensing Pact
Merck & Co., through a Merck subsidiary (Prometheus BioSciences), has entered an agreement with Dr. Falk Pharma GmbH, a Freiburg, Germany-based bio/pharmaceutical company, to discontinue an existing contract concerning co-development and co-commercialization rights in certain territories for MK-8690 (formerly PRA-052), an anti-CD30 ligand monoclonal antibody being evaluated by Merck in an early-stage clinical trial, and for Merck to assume full responsibility for the development program going forward.
Falk and Prometheus have discontinued their collaboration based on their existing co-development contract resulting in Prometheus having secured global rights to MK-8690. In exchange, Falk will receive a $150-million upfront payment and is eligible to receive a payment associated with a development milestone as well as royalties on sales in certain territories. The original contract between Falk and Prometheus was signed in 2020. Merck later acquired Prometheus in 2023.
Source: Merck & Co.
