Partnering News: Merck KGaA, Sanofi, Dr. Reddy’s & More 

A roundup of bio/pharmaceutical partnering news from Merck & Co./C4 Therapeutics, Sanofi/Maze Therapeutics, Merck KGaA/Abbisko Therapeutics, Dr. Reddy’s Laboratories/Coya Therapeutics, Sanofi/Aqemia, AstraZeneca/Absci, Daiichi Sankyo/Depixus, and Ferring Pharma/PharmaBiome. 

* Merck & Co, C4 Therapeutics in $2.1-Billion Licensing Pact for Degrader Antibody Conjugates 
* Sanofi Ends $750-M Licensing Pact with Maze Therapeutics Following FTC Review    
* Merck KGaA, Abbisko in $676-M Pact for Rare-Disease Small-Molecule Drug 
* Dr. Reddy’s, Coya Therapeutics in $733-M ALS Drug Pact 
* Sanofi, Aqemia in $140-M AI Small-Molecule Drug Pact 
* AstraZeneca, Absci in AI Oncology Drug Pact 
* Daiichi, Depixus in RNA Drug-Discovery Pact 
* Ferring Pharma, PharmaBiome in Microbiome Licensing Pact     

Merck & Co, C4 Therapeutics in $2.5-Billion Licensing Pact for Degrader Antibody Conjugates 
Merck & Co. and C4 Therapeutics, a Watertown, Massachusetts-based clinical-stage bio/pharmaceutical company, have entered into an exclusive license and collaboration agreement to develop degrader-antibody conjugates (DACs), in a deal worth up to $2.5 billion ($10 million upfront and $2.5 billion in potential milestone payments). 

DACs are an emerging modality designed to selectively target and neutralize disease-causing proteins in cancer cells. As part of the collaboration, C4 will be responsible for using its proprietary platform to develop degrader payloads in the discovery phase. Merck will be responsible for antibody conjugation to create DACs in the discovery phase and for advancing these DAC candidates through preclinical and clinical development as well as commercialization. 

Under the agreement, C4 will receive a $10-million upfront payment. C4 and Merck will collaborate to develop DACs directed to an initial undisclosed oncology target that is exclusive to the collaboration. For DACs directed to this initial target, C4 is eligible to receive milestone payments totaling approximately $600 million, as well as tiered royalties on future sales. The agreement also provides Merck with the option to extend the collaboration to include three additional targets that would be exclusive to the collaboration, which could yield option exercise payments as well as potential milestones and royalties. If Merck exercises all of its options to extend the collaboration, C4 would be eligible to receive up to approximately $2.5 billion in potential payments across the entire collaboration. 

Source: C4 Therapeutics 

Sanofi Ends $750-M Licensing Pact with Maze Therapeutics Following FTC Review   
Sanofi has ended its proposed $750-million licensing agreement with Maze Therapeutics, a South San Francisco, California-based bio/pharmaceutical company, following the US Federal Trade Commission’s (FTC) decision to take action to block the deal.  

Sanofi and Maze had agreed to a licensing pact, worth up to $750 million, earlier this year (May 2023), for Maze’s glycogen synthase 1 (GYS1) program, which includes MZE001, in Phase I development, for treating Pompe Disease, a rare, inherited disorder caused by mutations in the gene coding for acid alpha-glucosidase, which leads to the buildup of glycogen in skeletal muscle, respiratory muscle and cardiac muscle tissues resulting in progressive weakness and respiratory compromise. 

Under the agreement announced in May 2023, Maze would have received a $150-million payment consisting of both upfront cash and future equity investment for the rights to further develop and commercialize MZE001, as well as an exclusive license to related GYS1-targeting back-up programs and intellectual property. Maze would also have been eligible to receive up to an additional approximately $600 million in potential development, regulatory and sales milestones, as well as royalties on sales if MZE001 is successfully commercialized. 

Sanofi ended the proposed licensing pact, which was subject to review by the FTC, after the FTC announced that it had issued an administrative complaint and authorized a lawsuit in federal court alleging the deal would eliminate a nascent competitor to challenge Sanofi’s position in the Pompe disease therapy market. In addition to the administrative complaint, the FTC also authorized FTC staff to seek a temporary restraining order and preliminary injunction in federal district court to prevent Sanofi from acquiring MZE001, pending the agency’s administrative proceeding. The FTC’s federal court complaint will be filed in the US District Court for the District of Massachusetts. 

Source: Sanofi, Federal Trade Commission and Maze Therapeutics  

Merck KGaA, Abbisko in $676-M Pact for Rare-Disease Small-Molecule Drug 
Merck KGaA has entered an agreement with Abbisko Therapeutics, a Shanghai, China-based bio/pharmaceutical company, for Abbisko’s pimicotinib, in a deal worth up to $676 million ($70 million upfront and $606.5 million in milestone payments). 

Pimicotinibin is in a Phase III study for treating tenosynovial giant cell tumor (TGCT), a rare disease that can lead to ongoing pain and long-term joint damage. Under the agreement, Merck KGaA will receive an exclusive license to commercialize pimicotinib in mainland China, Hong Kong, Macau, and Taiwan, with an exclusive commercialization option in the rest of the world. Abbisko will continue to develop pimicotinib. In addition, Merck KGaA has the option to co-develop pimicotinib in additional indications under certain conditions. Merck KGaA will provide Abbisko with an upfront payment of $70 million and upon exercising the option, will provide Abbisko an option fee. Abbisko will receive additional payments totaling $606.5 million for the achievement of certain regulatory and commercial milestones as well as double-digit tiered royalties on net sales by Merck KGaA. 

Source: Merck KGaA and Abbisko Therapeutics   

Dr. Reddy’s, Coya Therapeutics in $733-M ALS Drug Pact 
Dr. Reddy’s Laboratories has entered into an agreement with Coya Therapeutics, a Houston, Texas-based bio/pharmaceutical company, for the development and commercialization of COYA 302, Coya’s investigational combination therapy for treating amyotrophic lateral sclerosis (ALS), in a deal worth up to $733 million ($7.5 million upfront and $725.65 million in milestone payments). 

Under the agreement, Coya has granted Dr. Reddy’s an exclusive license to commercialize COYA 302, a co-pack kit containing combination of low-dose IL-2 and CTLA-4 Ig (abatacept) in the US, Canada, the EU and the UK for ALS. This agreement is in addition to an in-licensing agreement with Dr. Reddy’s signed in early 2023. Coya retains the right to commercialize COYA 302 in Japan, Mexico, and South America. Coya will have responsibility for the clinical development of COYA 302 and for seeking regulatory approval for COYA 302 in the US. 

Dr. Reddy’s will make a $7.5 million upfront payment to Coya. Upon the first FDA acceptance of an investigational new drug (IND) application for COYA 302 for  ALS, Dr. Reddy’s will pay Coya an additional $4.2 million. Upon dosing of the first patient in the first Phase II trial of COYA 302 for the treatment of ALS in the US, Dr. Reddy’s will pay Coya an additional $4.2 million. Coya anticipates that the IND filing will be made in the first half of 2024. The agreement also includes development and regulatory milestones up to $40 million should all such development and regulatory milestones be achieved. Additionally, Coya is eligible to receive sales-based milestone payments of up to $677.25 million linked to tiers of cumulative net sales being achieved over several years (over the term of the agreement subject to product commercial exclusivity). In addition, Dr. Reddy’s will pay Coya royalties based on a percentage net sales of COYA 302 ranging from the low to middle teens. 

Source: Dr. Reddy’s Laboratories 

Sanofi, Aqemia in $140-M AI Small-Molecule Drug Pact 
Sanofi has entered an agreement with Aqemia, a Paris-based bio/pharmaceutical company using an artificial intelligence (AI)-based drug discovery platform, for small-molecule drug candidates across several therapeutic areas, in a deal worth up to $140 million (upfront and milestone payments). 

Under the agreement, Aqemia will design drug molecules using its generative AI and deep physics algorithms and platform. Aqemia will be eligible to potentially receive up to $140 million based on an upfront payment and the successful completion of research and development milestones on a number of specific therapeutic targets. Sanofi will be solely responsible for wet lab research, development, and commercialization activities. 

Source: Aqemia 

AstraZeneca, Absci in AI Oncology Drug Pact 
AstraZeneca has entered an agreement with Absci, a Vancouver, Washington-based bio/pharmaceutical company, to deliver an artificial intelligence-designed antibody against an oncology target.  

Under the agreement, Absci will contribute its generative AI technology to deliver a therapeutic candidate antibody for a specified oncology target. The agreement includes an upfront commitment, R&D funding, and milestone payments, in addition to royalties on product sales. 

Source: Absci 

Daiichi, Depixus in RNA Drug-Discovery Pact   
Daiichi Sankyo and Depixus, a life-sciences technology company, have entered a collaboration under which Daiichi will use Depixus’ Magna technology for RNA-targeted drug discovery.  

Based on magnetic force spectroscopy, Magna is a technology that enables high-throughput analysis of dynamic biomolecular interactions in real time with single-molecule resolution. Daiichi Sankyo will use Magna to explore the interactions of lead molecules with a number of undisclosed RNA targets. This data will inform hit-to-lead selection and lead optimization. 

Source: Depixus 

Ferring Pharma, PharmaBiome in Microbiome Licensing Pact  
Ferring Pharmaceuticals, a Saint-Prex, Switzerland-based bio/pharmaceutical company, and PharmaBiome, a Zürich, Switzerland-based microbiome translation company, have entered a research & development collaboration for development of new microbiome-based biotherapeutics in gastroenterology. The deal provides Ferring with exclusive rights to develop, manufacture, and commercialize microbiome-based therapeutics arising out of the collaboration. The financial details of this deal are undisclosed. 

Source: Ferring Pharmaceuticals