Partnering News: Roche, Sanofi, AbbVie, Gilead & More 

A roundup of bio/pharmaceutical partnering news from Roche/Alnylam, Sanofi/Recludix, AbbVie/Calibr, Gilead/Cognizant, and Teva/Alvotech. 

* Roche, Alnylam In $2.8-Bn RNAI Drug Pact
* Sanofi, Recludix in $1.2-Bn Immunological Research Pact
* AbbVie, Scripps Research’s Calibr in T-Cell Research Pact   
* Gilead, Cognizant In $800-M IT Services Pact 
* BMS Takes $35-M Equity Stake in Immatics 
* Teva, Alvotech Expand Biosimilars Pact 

Roche, Alnylam In $2.8-Bn RNAi Drug Pact 
Roche and Alnylam Pharmaceuticals, a Cambridge, Massachusetts-based bio/pharmaceutical company focused on RNA interference (RNAi) therapeutics, have entered into a strategic agreement to develop and commercialize zilebesiran, Alnylam’s investigational RNAi therapeutic for treating hypertension, in a deal worth up to $2.8 billion ($310 million upfront and $2.5 billion in milestone payments). 

Zilebesiran is in Phase II development. Under the agreement, Alnylam will lead a joint clinical development plan for the first indication of zilebesiran with Roche’s participation, which includes a cardiovascular outcomes trial prior to submission of zilebesiran for regulatory approval, with all development costs shared 40% by Alnylam and 60% by Roche. Roche may lead development for additional indications in the future.   

Under the agreement, Alnylam will receive an upfront cash payment of $310 million and is eligible to receive additional near-term payments, including development milestone payments over the next few years (as reported on July 24, 2023), as well as regulatory and sales milestones, for a potential deal value of up to $2.8 billion. In addition, Alnylam is entitled to an equal profit share in the US, where Alnylam and Roche will co-commercialize zilebesiran. Roche obtained the exclusive right to commercialize zilebesiran outside the US in exchange for low double-digit royalties on net sales of zilebesiran outside of the US.  

Source: Alnylam 

Sanofi, Recludix in $1.2-Bn Immunological Research Pact   
Sanofi and Recludix Pharma, a San Diego, California-based bio/pharmaceutical company, have entered a strategic collaboration to develop and commercialize oral small-molecule signal transducer and activator of transcription 6 (STAT6) inhibitors for patients with immunological and inflammatory diseases, in a deal worth up to $1.3 billion ($125 million in near-term payments and $1.2 billion in milestone payments).  

Signal transducer and activator of transcription (STAT) proteins are both signaling proteins and transcription factors that play a role in cell growth, differentiation, and function. STAT6 is a key nodal transcription factor that selectively mediates downstream signaling of IL-4 and IL-13, dominant and central cytokines in the pathophysiology of Type 2 inflammatory diseases. A STAT6 inhibitor offers the potential for a targeted oral therapy for treating Type 2 inflammatory diseases, according to information from Recludix. 

Under the agreement, Sanofi will have global rights to Recludix’s small-molecule STAT6 inhibitors. Recludix will advance STAT6 inhibitors from preclinical research and development until the start of Phase II clinical trials. Sanofi will assume worldwide clinical development and commercialization responsibilities thereafter. Recludix has the option to participate in US profit/loss share, which includes the ability to share equally in the costs, profits and losses, and to certain co-promotion activities for the partnered product in the US. 

Recludix will receive $125 million in near-term payments, and additionally, Recludix may receive more than $1.2 billion in potential development, regulatory and sales milestones, as well as up to double-digit royalties on possible future product sales. 

Source: Recludix Pharma 

AbbVie, Scripps Research’s Calibr in T-Cell Research Pact 
AbbVie and Calibr, part of Scripps Research, have announced an expanded strategic collaboration to advance several preclinical and early-stage clinical assets across AbbVie’s core therapeutic growth areas, including immunology, oncology, neuroscience and other areas of interest. This partnership is an expansion of the collaboration AbbVie and Scripps Research formed in 2019.  

Under the agreement, AbbVie will provide Calibr with research option payments over the course of five years to obtain a first-exclusive option to develop and commercialize candidates arising from the independent preclinical research conducted by Calibr, with the goal of advancing its pipeline of therapeutic programs. Upon AbbVie’s decision to exercise its option to a specific program, Calibr is eligible to receive additional payments from AbbVie, including option exercise fees, success-based development and commercial milestone payments, as well as tiered royalties. 

Source: AbbVie 

Gilead, Cognizant In $800-M IT Services Pact 
Gilead Sciences and Cognizant, an information technology company, have formed an IT services pact, worth up to $800 million. 

Under the agreement, Cognizant will manage Gilead’s global IT infrastructure, platforms, applications and advanced analytics, and lead initiatives designed to accelerate its digital transformation. The agreement includes renewal and expansion of Cognizant services for a total expected value of $800 million over the next five years. 

Source: Cognizant  

BMS Takes $35-M Equity Stake in Immatics 
Bristol Myers Squibb has made a $35-million equity investment in Immatics, a clinical-stage bio/pharmaceutical company developing T-cell redirecting cancer immunotherapies.  

Bristol Myers Squibb purchased 2.4 million shares of Immatics in a private placement at a subscription price per share of $14.46. Additionally, Bristol Myers Squibb has the right to appoint a member to the Immatics Scientific Advisory Board.  

Source: Immatics 

Teva, Alvotech Expand Biosimilars Pact 
Teva Pharmaceuticals and Alvotech, a bio/pharmaceutical company focused on biosimilars, have agreed to expand their existing strategic partnership agreement to add exclusive commercialization in the US by Teva of two new biosimilar candidates and line extensions of two current biosimilar candidates in the partnership, to be developed, and manufactured by Alvotech. Teva will also acquire subordinated convertible bonds to be issued by Alvotech. 

The partners continue to work on matters relating to approval in the US for AVT02, an interchangeable high-concentration biosimilar candidate for AbbVie’s Humira (adalimumab). The existing strategic partnership agreement also includes four other biosimilar candidates, one of which is AVT04, a proposed biosimilar for Johnson & Johnson’s Stelara (ustekinumab), which is currently pending US Food and Drug Administration (FDA) approval. 

The new expanded agreement adds two new biosimilar candidates and line extensions of two current biosimilar candidates in the partnership. It includes milestone payments, the majority paid following product approvals and upon achieving significant sales milestones. Teva and Alvotech will share profit from the commercialization of the biosimilars. All other financial terms and product details remain confidential. 

The agreement also includes increased involvement by Teva regarding manufacturing and quality at Alvotech’s manufacturing facility. Teva is actively supporting Alvotech onsite in Iceland to be fully ready for an FDA inspection. 

Teva has agreed to acquire subordinated convertible bonds to be issued by Alvotech pursuant to a convertible bond instrument, dated December 20, 2022, for $40 million. Teva’s investment will be used by Alvotech as part of the funding for continued development of its biosimilars pipeline over the near-term. 

Source: Teva Pharmaceuticals