A roundup of news from Emergent BioSolutions, Gilead Sciences and bluebird bio. Highlights below.  

Mfg News 
* Emergent BioSolutions Secures $400 M in US Gov’t Contracts for Smallpox, Mpox Vaccine   
* CSL Seqirus Receives $121-M Award From BARDA For Avian Influenza Preparedness
* Gilead Recalls One Lot of COVID-19 Antiviral Veklury 
Restructuring 
* Gene Therapy Company bluebird bio Announces 25% Workforce Cuts, Restructuring Plan 

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Mfg News 

Emergent BioSolutions Secures $400 M in US Gov’t Contracts for Mpox Vaccines 
Emergent BioSolutions, a Gaithersburg, Maryland, specialty bio/pharmaceutical and CDMO, has secured approximately $400 million in orders in 2024 and 2025 from the US government for its smallpox and mpox vaccine.  

This includes the previously disclosed US government contract modification to procure Acam2000, the company’s mpox and smallpox vaccine as well as Vigiv (vaccinia immune globulin, human) for treating vaccine complications, based on contract options exercised in 2023 and 2024. To date in 2024, customer orders of nearly $210 million have been delivered for Acam2000 and Vigiv. For the remainder of 2024 and into 2025, Emergent is confirmed to deliver an incremental $185+ million in Acam2000 and Vigiv orders. 

Source: Emergent BioSolutions  

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CSL Seqirus Receives $121-M Award From BARDA For Avian Influenza Preparedness  
CSL Seqirus, the influenza vaccines business of CSL, a Melbourne, Australia-based bio/pharmaceutical company, has received a $121.4-million award from US government for the company proprietary adjuvant, MF59, for used in the government’s avian influenza preparedness program.. 

The award is through CSL’s public–private partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services.  As part of that partnership, CSL will expand its vendor managed inventory (VMI) program for its proprietary MF59 adjuvant, CSL Seqirus will deliver its MF59 adjuvant to increase the inventory of the VMI program to 40 million equivalent doses. MF59 will be manufactured at CSL Seqirus’ Holly Springs, North Carolina, facility, which was built under a long-term public-private partnership with BARDA to provide domestic influenza pandemic preparedness. MF59 from the VMI program can be used to manufacture vaccines to protect against avian and other strains of influenza. This is the fifth award CSL Seqirus has received from BARDA in response to the US government’s avian influenza preparedness programs. 

Source: CSL Seqirus  

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Gilead Recalls One Lot of COVID-19 Antiviral Veklury 
Gilead Sciences has issued a voluntary recall to the consumer level of one lot of Veklury (remdesivir) for injection 100 mg/vial, an antiviral drug for treating COVID-19,, due to the presence of a glass particle in the vial. Gilead received a customer complaint and confirmed the presence of a glass particle in the vial during the company’s investigation. 

Veklury is indicated for the treatment of COVID-19 in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are hospitalized, or not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death. 

The product being recalled is the lyophilized form of Veklury packaged in single-dose clear-glass vials in powder form. The lot was distributed nationwide in the US beginning July 16, 2024. 

Source: The US Food and Drug Administration 

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General 

Gene Therapy Company bluebird bio Announces 25% Workforce Cuts, Restructuring Plan 
bluebird bio, a Somerville, Massachusetts-based company specializing in gene therapies, has announced a restructuring plan that would cut 25% of its workforce and reduce cash operating expenses by 20%. The plan is intended to optimize the company’s cost structure and enable quarterly cash flow break-even in the second half of 2025.  

The restructuring is expected to result in a 20% reduction in cash operating expenses when fully realized in the third quarter of 2025. The initiative further includes a reduction in the company’s workforce of approximately 25%. The company’s cash flow break-even target assumes scaling to approximately 40 drug product deliveries per quarter, realizing the 20% reduction in cash operating expenses, and obtaining additional cash resources to extend the company’s cash runway. 

As part of the restructuring, bluebird plans to further sharpen its focus on the ongoing commercial launches of it gene therapies, Lyfgenia (lovotibeglogene autotemcel), for treating sickle-cell disease, Zynteglo (betibeglogene autotemcel), for treating beta thalassemia, a rare genetic blood disorder, and Skysona (elivaldogene autotemcel), for treating cerebral adrenoleukodystrophy, a rare genetic brain disorder, to enable continued launch acceleration while the company evaluates opportunities to increase its cash resources.  

Overall, year-to-date (as of September 23, 2024), the company has had 41 patient starts across bluebird’s portfolio, up from 27 reported in mid-August (August 2024). bluebird anticipates approximately 40 patient starts in the fourth quarter of 2024. 

Source: bluebird bio