Partnering News: Gilead, Merck KGaA, Novartis & Teva  

A roundup of bio/pharmaceutical partnering news from Gilead Sciences/Nurix Therapeutics, Merck KGaA/Caris Discovery, Novartis/Arvinas and Teva/mAbXience. 

* Gilead, Nurix Therapeutics Extend $1.8-Bn Research Pact
* Merck KGaA, Caris in $1.4-Bn ADC Collaboration  
* Novartis, Arvinas in $1.1-Bn Licensing Pact for Prostate Cancer Drug 
* Teva, mAbXience in Biosimilars Pact 

Gilead, Nurix Therapeutics Extend $1.8-Bn Research Pact 
Gilead Sciences and Nurix Therapeutics, a San Francisco, California-based clinical-stage bio/pharmaceutical company, have elected to extend the research terms of the companies’ ongoing collaboration, originally established in 2019, by an additional two years, in a deal worth up to $1.8 billion ($15 million upfront and $1.8 billion in milestone payments). 

Under the agreement, Nurix is deploying its proprietary drug-discovery platform to identify agents that use E3 ligases to induce degradation of specified drug targets. Gilead has an option to license drug candidates resulting from the work, and Nurix retains co-development and co-detail options on up to two programs in the US, subject to certain restrictions. For those programs that Nurix opts in to co-develop and co-detail, the parties will split development costs as well as profits and losses 50/50 for the US, and Nurix will be eligible to receive royalties on ex-US sales and reduced milestone payments.  

Upon signing the agreement in 2019, Gilead made an upfront payment of $45 million. Through Nurix’s fiscal year-end of November 30, 2023, Nurix has received an additional $70 million, including research milestones, the IRAK4 degrader license option exercise payment and additional payments. In connection with the new announcement, Nurix will receive a $15-million extension fee and remains eligible for up to $73.5 million in preclinical milestones and potential future licensing payments and up to a total of $1.7 billion in potential future development, regulatory, and sales milestones as well as royalties on future products. 

Source: Nurix Therapeutics 

Merck KGaA, Caris in $1.4-Bn ADC Collaboration 
Merck KGaA and Caris Discovery, the therapeutic research arm of Caris Life Sciences, an Irving, Texas-based bio/pharmaceutical company, have formed a multi-year strategic partnership to accelerate the discovery and development of antibody-drug conjugates (ADCs) for treating cancer, in a deal worth up to $1.4 billion. Caris Discovery applies the scale of Caris’ core molecular-profiling business to discover druggable targets that would be otherwise inaccessible through more traditional approaches. 

Under the agreement, Merck KGaA will provide Caris with an upfront payment as well as research funding. In addition, Caris will be eligible for discovery, development, regulatory and sales-based milestone payments that may total up to $1.4 billion along with tiered royalties. Merck KGaA will receive an exclusive global license to develop, manufacture and commercialize ADC therapeutics for selected targets. 

Source: Caris Life Sciences 

Novartis, Arvinas in $1.1-Bn Licensing Pact for Prostate Cancer Drug 
Novartis and Arvinas, a New Haven, Connecticut-based clinical-stage biotechnology company developing drugs based on targeted protein degradation, have entered into an exclusive strategic license agreement for the worldwide development and commercialization of ARV-766, a prostate cancer drug, in a deal worth up to $1.1 billion ($150 million upfront and $1 billion in milestone payments).  

ARV-766 is an investigational orally bioavailable protein degrader designed to selectively target and degrade the androgen receptor (AR). The androgen receptor is a protein that binds male hormones called androgens. Androgen receptors are found inside the cells of male reproductive tissue, some other types of tissue, and some cancer cells. In prostate cancer, androgens bind to androgen receptors inside the cancer cells, which causes the cancer cells to grow. Arvinas uses its proprietary Protac  discovery-engine platform to engineer proteolysis targeting chimeras, or Protac-targeted protein degraders, which are designed to use the body’s own natural protein disposal system to selectively degrade and remove disease-causing proteins. 

Under the agreement, Novartis will be responsible for worldwide clinical development and commercialization of ARV-766 and will have all research, development, manufacturing, and commercialization rights with respect to the preclinical AR-V7 program. Arvinas will receive an upfront payment of $150 million. Under the agreement, Arvinas is eligible to receive additional development, regulatory, and commercial milestones of up to $1.01 billion, as well as tiered royalties for ARV-766. The transaction also includes an asset purchase agreement for the sale of Arvinas’ preclinical AR-V7 program to Novartis. The transaction also includes an asset purchase agreement for the sale of Arvinas’ preclinical AR-V7 program to Novartis. 

Closing of the transaction is subject to the parties’ receipt of any necessary consents or approvals, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Goldman Sachs & Co. LLC is acting as the exclusive financial advisor to Arvinas.  

Source: Arvinas 

Teva, mAbXience in Biosimilars Pact 
Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries, and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, a Madrid-based pharmaceutical services firm, have entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications.  

The licensing agreement covers multiple global markets, including Europe and the US, and supports Teva’s Pivot-to -Growth strategy, announced in 2023, to expand its biosimilar pipeline through business development and strategic partnerships. 

Under the agreement, mAbxience will apply its expertise in biosimilar development and its cGMP-approved facilities in Spain and Argentina to develop and produce the biosimilar product. Teva will lead the regulatory processes and commercialization in the designated regions, to ensure access to a broader patient population. 

Source: Teva Pharmaceuticals