Global Briefs: Pfizer, AstraZeneca, Novo Nordisk & More 

The latest news on mergers and acquisitions featuring Pfizer/AstraZeneca’s Alexion, Novo Nordisk/Inversago Pharma, BioNTech/InstaDeep, Regeneron/Decibel Therapeutics and partnering news from from Emergent BioSolutions/US Government, Astellas/Poseida Therapeutics, and SK biosciences/Novavax. Highlights below.  

Mergers and Acquisitions 
* AstraZeneca’s Alexion To Acquire Portfolio of Preclinical Rare Disease Gene Therapies from Pfizer for up to $1 Bn 
* Novo Nordisk To Acquire Inversago Pharma in $1-Bn Deal 
* BioNTech Acquires AI Company InstaDeep for $548 M 
* Regeneron To Acquire Decibel Therapeutics in $214-M Deal  
Partnering News 
* US Gov’t, Emergent BioSolutions In $704-M Pact for Ebola Drug 
* Astellas Takes $50-M Stake in Poseida Therapeutics
* SK biosciences Takes Equity Stake in Vaccine Maker Novavax  

Mergers & Acquisitions

AstraZeneca’s Alexion To Acquire Portfolio of Preclinical Rare Disease Gene Therapies from Pfizer for up to $1 Bn 
Alexion, AstraZeneca’s rare-disease business, and Pfizer have entered a definitive purchase and license agreement under which Alexion will acquire a portfolio of preclinical gene therapy programs and enabling technologies from Pfizer in a deal worth up to $1 billion.  

Under the agreement, the transaction will bring to Alexion a number of adeno-associated virus (AAV) capsids. The portfolio includes preclinical gene-therapy programs and enabling technologies with potential across several therapeutic areas. Additionally, Alexion will seek to welcome talent from Pfizer associated with the portfolio. 

Under the agreement, Alexion will purchase and license the assets of Pfizer’s early-stage rare-disease gene-therapy portfolio for a total consideration of up to $1 billion, plus tiered royalties on sales. Alexion plans to close the transaction in the third quarter of 2023, subject to the satisfaction of closing conditions. 

Source: AstraZeneca 

Novo Nordisk To Acquire Inversago Pharma in $1-Bn Deal 
Novo Nordisk has agreed to acquire Inversago Pharma, a Montreal, Canada-based bio/pharmaceutical company, for up to $1.08 billion if certain development and commercial milestones are achieved.  

Inversago’s lead candidate is INV-202, which demonstrated weight-loss potential in a Phase Ib trial and is currently in a Phase II trial for diabetic kidney disease. Additional pipeline assets are also being developed for metabolic and fibrotic disorders. Novo Nordisk intends to investigate the potential of INV-202 for obesity and obesity-related complications. 

The closing of the acquisition is subject to receipt of applicable regulatory approvals and other customary conditions and is expected to close before the end of 2023. 

Source: Novo Nordisk 

BioNTech Acquires AI Company InstaDeep for $548 M 
BioNTech, a Mainz, Germany-based bio/pharmaceutical company, has completed its EUR-500 million ($548 million) acquisition of InstaDeep, a technology company specializing in artificial intelligence (AI) and machine learning. The acquisition was announced in January 2023. 

InstaDeep will operate as a UK-based global subsidiary of BioNTech. The acquisition adds approximately 290 employees to BioNTech’s workforce, including teams in AI, machine learning, bioengineering, data science, and software development. 

The total consideration to acquire the remaining InstaDeep shares, excluding the shares already owned by BioNTech, amounted to approximately EUR 500 million ($548 million) in cash, BioNTech shares, and performance-based future milestone payments. 

Source: BioNTech 

Regeneron To Acquire Decibel Therapeutics in $214-M Deal   
Regeneron Pharmaceuticals, a Tarrytown, New York-based bio/pharmaceutical company  has agreed to acquire Decibel Therapeutics, a clinical-stage bio/pharmaceutical company, for $214 million. 

Decibel has a proprietary platform that integrates single-cell genomics and bioinformatic analyses, gene-therapy technologies and inner-ear biology. Decibel is using its platform to advance gene therapies designed to selectively replace genes for the treatment of congenital, monogenic hearing loss and to regenerate inner-ear hair cells for the treatment of acquired hearing and balance disorders. Decibel’s lead gene-therapy candidate, DB-OTO, is for the treatment of congenital, monogenic hearing loss.   

Under the agreement, Regeneron will acquire Decibel at a price of $4.00 per share of Decibel common stock payable in cash at closing, with an additional non-tradeable contingent value right (CVR) up to $3.50 per share in cash upon achievement of certain clinical development and regulatory milestones for Decibel’s lead investigational candidate, DB-OTO, within specified time periods. The proposed acquisition values Decibel at a total equity value of approximately $109 million based on the amount payable at closing, and a total equity value of up to approximately $213 million if the CVR milestones are achieved. 

Source: Regeneron Pharmaceuticals  

Partnering News 

US Gov’t, Emergent BioSolutions In $704-M Pact for Ebola Drug   
The US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority has granted a 10-year contract to Emergent BioSolutions, a Gaithersburg, Maryland-based specialty bio/pharmaceutical company and contract manufacturer, valued at up to a maximum of $704 million, for development, manufacturing scale-up, and procurement of Ebanga (ansuvimab-zykl), a licensed drug for Ebola virus disease (EVD). 

The contract consists of a base period of performance with two option periods for advanced development valued at approximately $121 million, and option periods for procurement of Ebanga over five years valued at up to $583 million. If all option periods are exercised, the total contract value will be valued at approximately $704 million.  

Under the agreement, Emergent will complete activities to advance the development of Ebanga through post-licensure commitments, including the transfer of technology as part of manufacturing scale-up, submission of a supplemental biologics license application to the US Food and Drug Administration, and completion stability studies. 

Source: Emergent BioSolutions 

Astellas Takes $50-M Stake in Poseida Therapeutics 
Astellas Pharma has taken a $50-million stake in Poseida Therapeutics, a San Diego, California-based bio/pharmaceutical company specializing in cancer cell therapies. 

Under the agreement, Astellas will invest a total of $50 million, including $25 million to acquire 8.3 million shares of common stock of Poseida (approximately 8.8% of the outstanding common stock of Poseida) at $3.00 per share in a private placement and a one-time-$25 million payment for a right of exclusive negotiation and first refusal to license one of Poseida’s clinical-stage programs: P-MUC1C-ALLO1, an allogeneic CAR-T cell therapy in development for multiple solid tumor indications.  

Additionally, Poseida has granted Astellas a board observer seat, which includes the ability to attend Poseida’s scientific advisory board meetings and for certain notice rights related to any potential change of control of Poseida. 

Source: Astellas 

SK biosciences Takes Equity Stake in Vaccine Maker Novavax 
SK bioscience, a Seongnam, South Korea-based vaccines company, has agreed to make an  equity investment in Novavax, a Gaithersburg, Maryland-based vaccines company, for 6.5 million shares of Novavax common stock through a private placement. 

The companies say that the investment comes at a time when the two companies aim to transition from a CMO/CDMO partnership formed during the pandemic to a long-term relationship in the endemic era. 

Additionally, SK bioscience and Novavax have extended their current license agreement, adding Novavax’s updated COVID-19 vaccine, which is currently under development for annual vaccination. The agreement serves as a strategic shift of partnership from the pandemic period to the endemic phase, in which SK bioscience will obtain exclusive rights to Novavax’s COVID-19 variant vaccine in South Korea and non-exclusive rights in Thailand and Vietnam to supply and commercialize the vaccine. SK bioscience also will manufacture and commercialize drug substance and vaccine products (including pre-filled syringe products) utilizing Novavax´ proprietary variant strain antigens and Matrix-M adjuvant. 

Source: SK bioscience