Global Briefs: Novo Nordisk, Novartis, Sun Pharma & More 

A roundup of news from Novo Nordisk, Novartis, Sun Pharma, Pfizer, and the Swedish government. Highlights below.  

Manufacturing News 
* Swedish Gov’t Sets up $15-M Public-Private Consortium for Advanced Therapy Mfg 
Mergers and Acquisitions 
* Sun Pharma Proposes Acquisition of Taro Pharmaceutical 
* Novartis To Buy Cell- & Gene-Therapy from Avrobio for $87.5 M  
Partnering News 
* Novo Nordisk, Life Edit Therapeutics In $1.92-Bn Pact for Rare and Cardiometabolic Diseases 
* Pfizer’s COVID-19 Drug Paxlovid Gets Full FDA Approval 

Manufacturing News 

Swedish Gov’t Sets up $15-M Public-Private Consortium for Advanced Therapy Mfg 
The Swedish government, through Vinnova, Sweden’s innovation agency, has announced SEK 160 million ($15 million) in funding over two years for an innovation cluster to support the commercialization, development, and production of cell and gene therapies.  

The innovation cluster will be led by an industrial consortium, CCRM Nordic AB, consisting of the following companies: AstraZeneca; CombiGene, a Lund, Sweden-based bio/pharmaceutical company; Cytiva (through Cytiva Sweden and the Cytiva Testa Center); Getinge, a Gothenburg, Sweden-based medical technology company; GoCo Development, a Gothenburg, Sweden-based real estate development and investment company; Takara Bio Europe, a Saint-Germain-en-Laye, France-based biotech company; TATAA Biocenter, a Göteborg, Sweden-based contract research organization; and Verigraft, a Göteborg, Sweden-based biotech company. The cluster will be based in Mölndal outside Gothenburg, Sweden. 

The Swedish innovation cluster is to complement and tie together previous public infrastructure investments in the area, including the Cytiva Testa Center and the Innovation Hub at NorthX Biologics in Matfors.The innovation cluster is modeled from Canada’s Center for Commercialization of Regenerative Medicine in Toronto, a public-private consortium operational for 10 years.  

In total, the investment covers SEK 160 million over the next two years with businesses and the government of Sweden each contributing half. Vinnova is financing with SEK 25 million in 2023 and SEK 55 million in 2024. 

Source: Vinnova 

Mergers and Acquisitions 

Sun Pharma Proposes Acquisition of Taro Pharmaceutical 
Sun Pharmaceutical, a Mumbai, India-based bio/pharmaceutical company, has made a proposal to acquire Taro Pharmaceutical Industries, a Haifa Bay, Israel-based bio/pharmaceutical company. The offer involves acquiring the remaining percent of Tara not already owned by Sun Pharma. 

Sun Pharma already owns the majority of shares of Taro, and under the proposal, would acquire the remaining share not already owned by Sun Pharma for $38 per ordinary share. Sun Pharma has submitted the proposal to Taro’s Board of Directors, who has appointed an independent committee to evaluate the proposal. Final approval of the proposal remains subject to shareholder and regulatory approvals. 

Source: Sun Pharmaceutical 

Novartis To Buy Cell- & Gene-Therapy from Avrobio for $87.5 M 
Novartis has agreed to acquire an investigational hematopoietic stem cell (HSC) gene therapy, from Avrobio, a Cambridge, Massachusetts-based bio/pharmaceutical company, for $87.5 million.  

The agreement covers the gene therapy for the treatment of cystinosis, a genetic disorder in which the amino acid, cystine, builds up within cells and causes cell damage. Under the agreement, Avrobio retains full rights to its portfolio of HSC gene therapies for Gaucher disease (Type 1 and Type 3), Hunter syndrome, a rare inherited disorder, and Pompe disease, a genetic disorder that impacts the heart.  

Under the agreement, Novartis will pay Avrobio $87.5 million in cash at closing, in consideration for the sale and transfer of certain assets related to the cystinosis program. In addition, Avrobio has exclusively licensed to Novartis certain other assets and intellectual property related to Avriobio’s gene-therapy platform for use in cystinosis. To support the transition of the program, Avrobio also has agreed to provide, under a separate agreement, certain transition, knowledge-transfer, and other related services. 

Source: Avrobio 

Partnering News 

Novo Nordisk, Life Edit Therapeutics in $1.92-Bn Pact for Rare and Cardiometabolic Diseases    
Novo Nordisk and Life Edit Therapeutics, a Durham, North Carolina-based bio/pharmaceutical company focused on genome editing, have entered into a research and development collaboration to discover and develop gene-editing therapies against a select set of therapeutic targets, in a deal worth up to $1.92 billion (undisclosed upfront payment and equity investment and $1.92 billion in potential milestone payments). 

With a focus on advancing base-editing capabilities, Novo Nordisk will use Life Edit’s suite of gene-editing technologies to edit the genome with the aim of developing therapies for rare genetic disorders as well as more prevalent cardiometabolic diseases. 

The collaboration between the two companies allows for development of up to seven programs. Under the agreement, Life Edit will receive an upfront cash payment and is eligible to receive potential development, regulatory, and commercial milestones of $335 million for each of the first two development programs under the collaboration and up to $250 million for each of the following five development programs under the collaboration. Novo Nordisk will be responsible for all research and development costs, and Life Edit is also eligible to receive tiered royalties on future net sales of therapeutic products. In addition, Life Edit has an option to a global profit share on one program. 

Additionally, Novo Nordisk will make an equity investment in ElevateBio, Life Edit’s parent company, as part of ElevateBio’s $401-million Series D financing. 

Source: Novo Nordisk 


Pfizer’s COVID-19 Drug Paxlovid Gets Full FDA Approval 
The US Food and Drug Administration (FDA) has granted full approval to Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.  

Paxlovid has been available in the US since December 2021 under emergency use authorization.  

Source: Pfizer