Global Briefs: Moderna, Jazz Pharmaceuticals, KaliVir, Orano Med & More 

A roundup of news from Moderna, Jazz Pharmaceuticals, KaliVir, Orano Med and P. Highlights below.  

Mfg News
* Moderna Updates Manufacturing Restructuring Plan 
* Biopharm Company KaliVir Opens Cleanroom for Manufacturing Oncolytic Virus Immunotherapies 
* Orano Med Breaks Ground on Radioligand Mfg Facility 
* Publix Super Markets To Build  $145-M Fill Mfg Site 
M&A News 
* Jazz Pharmaceuticals To Acquire Redx’s KRAS Inhibitor Drug Program in $880-M Deal  

Mfg News 

Moderna Updates Manufacturing Restructuring Plan 
In its full-year 2023 earnings release issued on February 22, 2024, Moderna provided an update on its manufacturing restructuring plan and related costs. Moderna had initiated the plan, announced in October 2023, primarily due to lower revenues and demand for its COVID-19 vaccine. The company reported that its cost of sales for the full year 2023 was $4.7 billion, or 70% of net product sales, inclusive of third-party royalties of $301 million, inventory write-downs of $2.2 billion, unutilized manufacturing capacity and wind-down costs of $981 million, and losses on firm purchase commitments and cancellation fees of $205 million. Cost of sales included a total of $1.6 billion, resulting from the company’s strategic initiative to resize its manufacturing cost structure that was launched in the third quarter of 2023. Cost of sales, as a percentage of net product sales, increased by 41 percentage points to 70%, from 29% in 2022. The increase in cost of sales as a percentage of net product sales was primarily due to the strategic initiative and other charges (excluding royalties) over lower net product sales, driven by a decline in product demand and increased product seasonality. 

Overall, the company reported total 2023 revenue of $6.8 billion for the full year 2023, compared to $19.3 billion in 2022. The decrease in total revenue for 2023 was mainly due to a decline in sales of the company’s COVID-19 vaccine. Net product sales for 2023 were $6.7 billion, a decrease of 64% from 2022, driven by lower vaccination rates.  

Source: Moderna 

Biopharm Company KaliVir Opens Cleanroom for Manufacturing Oncolytic Virus Immunotherapies 
KaliVir Immunotherapeutics, a Pittsburgh, Pennsylvania-based bio/pharmaceutical company developing oncolytic viral immunotherapy programs, has opened a GMP cleanroom facility to manufacture its pipeline of oncolytic viruses. 

KaliVir’s manufacturing facility includes a cleanroom spanning over 1,000 square feet. The facility is equipped with an iCellis 500 bioreactor, hyperstack, filtration, and chromatography capabilities and is supported by KaliVir’s quality, process development and analytical development capabilities. 

Source: KaliVir Immunotherapeutics 

Orano Med Breaks Ground on Radioligand Mfg Facility 
Orano Med, a Plano, Texas-based bio/pharmaceutical company, has broken ground on a EUR 29 million ($31 million) laboratory for producing lead-212 based radioligand therapies in Onnaing, France. The facility will have over 3,000 m² of floor space, and will focus on the production of lead-212 therapies developed by Orano Med and their distribution in Europe. Orano Med is due to inaugurate a similar facility this year (2024) in Indianapolis.  
This combined capacity will enable Orano Med to manufacture 10,000 doses a year as of 2025, with the aim of producing ten times that number by the end of the decade.  

Source: Orano Med  

Publix Super Markets To Build Fill Mfg Site  
Publix Super Markets has announced plans to build a pharmaceutical manufacturing facility in St. Johns County, Florida. Anticipated to be operational in 2026, the fill pharmaceutical facility will be housed in a 168,480-square-foot building. The facility will bring more than 150 new jobs initially, growing to 400 new jobs upon completion. 

Source: St. Johns County Economic Development Department 

M&A News 

Jazz Pharmaceuticals To Acquire Redx’s KRAS Inhibitor Drug Program in $880-M Deal 
Jazz Pharmaceuticals has agreed to acquire a Kirsten rat sarcoma virus (KRAS) inhibitor program from Redx Pharma, a Cheshire, UK-based bio/pharmaceutical company, in a deal worth up to $880 million ($10 million upfront and $870 million in milestone payments). 

Jazz and Redx will collaborate to advance candidates through IND-enabling studies; Jazz will be responsible for all clinical development, regulatory, manufacturing and commercialization activities. 

Under the terms of the agreement, Jazz will make an upfront payment to Redx of $10 million for all rights, patents, title, and interest relating to Redx’s proprietary KRAS inhibitor program, which includes G12D selective and pan-KRAS molecules. Redx is eligible to receive up to $870 million in development, regulatory, and commercial milestone payments from Jazz, with the next milestone being an investigational new drug (IND) clearance from this program from the US Food and Drug Administration. Redx is also eligible for tiered, mid-single digit percentage royalties based on any future net sales. 

Source: Jazz Pharmaceuticals