A roundup of manufacturing news from Merck & Co., Daiichi Sanyko, Moderna, Roche, J&J, and Emergent BioSolutions. Highlights below.

* Merck & Co., Daiichi Sankyo Receive CRL from FDA for Mfg Issues for ADC Drug Candidate
* Moderna, US Gov’t in $176-M Pact for Avian Flu Vaccine
* Roche To Re-Launch Eye-Drug Implant Following Two-Year Recall
* US Gov’t Awards Emergent BioSolutions $250 M in Contracts for Medical Countermeasures
* Emergent BioSolutions, J&J Settle $50-M Contract Dispute Over COVID-19 Vaccine

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Merck & Co., Daiichi Sankyo Receive CRL from FDA for Mfg Issues for ADC Drug Candidate
Merck & Co. and Daiichi Sankyo have received a Complete Response Letter from the US Food and Drug Administration (FDA) for their biologics license application for patritumab deruxtecan, an antibody drug conjugate (ADC) for treating several cancers due to findings pertaining to an inspection of a third-party manufacturing facility. The CRL did not identify any issues with the efficacy or safety data submitted. The companies said that they will work with FDA and its third-party manufacturer to resolve the issues.

The companies had formed a $22-billion global development and commercialization agreement last October (October 2023) for three of Daiichi Sankyo’s ADC oncology drug candidates against solid tumors: patritumab deruxtecan, ifinatamab deruxtecan, and raludotatug deruxtecan. Under the deal, Merck agreed to pay Daiichi Sankyo a $4-billion upfront payment in addition to $1.5 billion in continuation payments over the next 24 months (as reported in October 2023), and potential additional payments of up to $16.5 billion contingent upon the achievement of future sales milestones, for a total potential consideration of up to $22 billion.

Source: Merck & Co. and Daiichi Sankyo

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Moderna, US Gov’t in $176-M Pact for Avian Flu Vaccine
Moderna has announced a project award of $176 million through the Rapid Response Partnership Vehicle (RRPV) of the US government to accelerate the development of mRNA-based pandemic influenza vaccines. The RRPV is a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS).

The project award will support late-stage development for an mRNA-based vaccine to enable the licensure of a pre-pandemic vaccine against H5 influenza virus. This subtype of influenza virus causes a highly infectious, severe disease in birds called avian influenza and poses a risk for spillover into the human population. The agreement also includes additional options to prepare and accelerate aresponse to future public health threats.

In 2023, Moderna initiated a Phase I/II study to generate safety and immunogenicity data of an investigational pandemic influenza vaccine (mRNA-1018) in healthy adults 18 years of age and older. The study includes vaccine candidates against H5 and H7 avian influenza viruses. Results from the study are expected in 2024 and will inform Phase III development plans.

Source: Moderna

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Roche To Re-Launch Eye-Drug Implant Following Two-Year Recall
Roche has announced the reintroduction of Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant in the US for treating neovascular or wet age-related macular degeneration (nAMD), following the end of a voluntary recall that was first inititated in 2022.

Susvimo was recalled in 2022, following some concerns from the the US Food and Drug Administration (FDA) regarding manufacturing issues. Since then, FDA has approved a post-approval supplement to the biologics license application for Susvimo, reflecting component-level updates made to the ocular implant and refill needle.

Source: Roche and Genentech

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US Gov’t Awards Emergent BioSolutions $250 M in Contracts for Medical Countermeasures
Emergent BioSolutions, a Gaithersburg, Maryland-based specialty bio/pharmaceutical company and contract manufacturer, has announced it has received more than $250 million in contract modifications with the US government in supplying millions of doses of four medical countermeasures to address biological threats and emergencies against anthrax, smallpox, and botulism. The four awards include:

• A contract modification valued at $30 million to supply Cyfendus (anthrax vaccine adsorbed, adjuvanted) this year (2024). Previously known as AV7909, Cyfendus is a two-dose anthrax vaccine for post-exposure prophylaxis use in individuals 18 years of age and older. This new procurement funding is from Emergent’s existing 10-year contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS).
• A contract modification valued at $99.9 million to supply Acam2000 (smallpox vaccine, live) this year (2024). Acam2000 is licensed for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection. This is under Emergent’s existing 10-year contract with the Administration for Strategic Preparedness and Response (ASPR) at HHS.
• Two new contract options totaling $122.9 million have been awarded to supply ASPR with Vigiv [vaccinia immune globulin intravenous (human)] drug product, and Bat [botulism antitoxin heptavalent (A, B, C, D, E, F, G) – (equine)] drug substance and delivery of drug production this year (2024) and into early 2025. Vigiv is used for treatment of complications to smallpox vaccination, and Bat is indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients. Both are under Emergent’s existing 10-year contracts with ASPR.

Source: Emergent BioSolutions

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Emergent BioSolutions, J&J Settle $50-M Contract Dispute Over COVID-19 vaccine
Emergent BioSolutions, a Gaithersburg, Maryland-based specialty bio/pharmaceutical company and contract manufacturer, and Johnson & Johnson have settled a contract dispute between the companies for large-scale drug-substance manufacturing of Johnson & Johnson’s investigational COVID-19 vaccine. Under the settlement, J&J will pay Emergent $50 million.

The companies had formed a supply pact in 2020 under which Emergent was to produce J&J’s investigational SARS-CoV-2 vaccine, a viral vector recombinant based on J&J’s AdVac technology platform. Emergent had been awarded contracts with the US government to produce the vaccine. J&J terminated the agreement in 2022 following quality issues at Emergent’s manufacturing facility in Maryland.

Under the agreement, J&J will pay Emergent $50 million on or before the later of (1) July 31, 2024 and (2) 28 calendar days following the effective date of the agreement. In addition, the agreement contains broad releases of the parties, their affiliates and subsidiaries, representatives, officers, directors, and shareholders, including releases of all claims related to the manufacture of the product or any agreement or understanding between the parties concerning the product, and the matters at issue in the arbitration.

Source: Emergent BioSolutions