A roundup of bio/pharmaceutical partnering news from Gilead Sciences/Leo Pharma, AbbVie/Simcere Zaiming, RegenxBio/NipponShinyaku and Emergent BioSolutions/Hikma/BARDA. 

* Gilead, Leo Pharma in $1.7-Bn Small-Molecule Anti-Inflammatory Drug Pact 
* AbbVie, Simcere Zaiming in $1.06-Bn Trispecific Antibody Multiple Myeloma Drug Pact 
* RegenxBio, Nippon Shinyaku in $810-M Gene Therapy Pact 
* Emergent BioSolutions in Separate Pacts with Hikma, US Gov’t 

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Gilead, Leo Pharma in $1.7-Bn Small-Molecule Anti-Inflammatory Drug Pact 
Gilead Sciences and Leo Pharma, a Ballerup, Denmark-based bio/pharmaceutical company, have entered an agreement to accelerate the development and commercialization of Leo Pharma’s small-molecule oral programs for the potential treatment of patients with inflammatory diseases, in a deal worth up to $1.7 billion ($250 million upfront and $1.45 billion in milestone payments). 

Under the agreement, Gilead will acquire LEO Pharma’s preclinical oral STAT6 (signal transducer and activator of transcription 6) small-molecule inhibitors and targeted protein degraders. Gilead will lead further development efforts for the oral program while Leo Pharma will lead development for potential topical formulations of STAT6 inhibitors.  

STAT6 is the specific transcription factor required for IL-4 and IL-13 cytokine signaling, which are clinically validated targets for T helper 2 (Th2)-mediated inflammatory conditions such as atopic dermatitis, asthma, and chronic obstructive pulmonary disease among other diseases. Targeting STAT6 has shown potential preclinically to treat a broad population of patients and provide an oral alternative to those currently treated with injectable biologics, according to information from Gilead Sciences.  

Under the agreement, Leo Pharma is eligible to receive up to $1.7 billion in total payments, including an upfront payment of $250 million. In addition, Leo Pharma may also receive tiered royalties ranging from high single-digit to mid-teens on sales of oral STAT6 products. Gilead may receive tiered royalties ranging from high single-digit to mid-teens on sales of topical STAT6 products. 

Source: Gilead Sciences 

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AbbVie, Simcere Zaiming in $1.06-Bn Trispecific Antibody Multiple Myeloma Drug Pact 
AbbVie and Simcere Zaiming, a Haikou, China-based bio/pharmaceutical company, have entered an agreement to develop Simcere’s SIM0500, an investigational new drug candidate for treating multiple myeloma, in a deal worth up to $1.06 billion.  

SIM0500 is currently in Phase I clinical trials in patients with relapsed or refractory multiple myeloma in both China and the US. SIM0500 is a humanized trispecific antibody that targets GPRC5D, BCMA, and CD3, developed by Simcere Zaiming using its T-cell engager polyspecific antibody technology platform. SIM0500 has shown strong T cell cytotoxicity against multiple myeloma cells by leveraging a combination of various antitumor effects, according to information from the companies.  

Simcere Zaiming will receive an upfront payment from AbbVie and is eligible to receive option fees and milestone payments of up to $1.055 billion, as well as tiered royalties on net sales outside of the Greater China territory. AbbVie is eligible to receive tiered royalties on net sales in the Greater China territory. 

Source: AbbVie 

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RegenxBio, Nippon Shinyaku in $810-M Gene Therapy Pact  
RegenxBio, a Rockville, Maryland-based bio/pharmaceutical company, and Nippon Shinyaku, a Kyoto-based bio/pharmaceutical company, have entered an agreement for the development and commercialization of RGX-121 for the treatment of mucopolysaccharidosis II (MPS II), also known as Hunter syndrome, a rare genetic disorder that causes a buildup of sugar molecules in the body’s tissues, and RGX-111 for mucopolysaccharidosis I (MPS I), also known as Hurler syndrome, a rare genetic disorder that causes a buildup of toxic materials in the body’s cells, in a deal worth up to $810 million ($110 million upfront and $700 million milestone payments). 

Under the agreement, Nippon Shinyaku will commercialize both products in the US and Asia (collectively, the “Licensed Territory”) and future clinical development of RGX-121 and RGX-111 will be led by RegenxBio. RegenxBio retains all rights to, and 100% of any proceeds related to the sale of the priority review voucher (PRV) for RGX-121 received upon potential approval. 

RegenxBio will lead the manufacturing of both products for clinical and commercial supply in the Licensed Territory. RegenxBio reserves the right to develop and commercialize these products in countries outside of the Licensed Territory. 

Under the agreement, RegenxBio will receive $110 million at closing and up to an additional $700 million if certain milestones are achieved, consisting of $40 million in potential development and regulatory milestones and $660 million in potential sales milestones. RegenxBio will also receive double-digit royalties on net sales in the US and Asia. 

Source: RegenxBio  

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Emergent BioSolutions In Pacts with Hikma, Barda 
Emergent BioSolutions, a specialty pharma company and CDMO, has entered into an agreement to obtain exclusive commercial rights in the US and Canada to Hikma Pharmaceuticals’ Kloxxado (naloxone HCl) nasal spray, a spray for the emergency treatment of known or suspected opioid overdose. Separately, Emergent also has announced a contract modification with the US government for a treatment for the Zaire Ebola virus. 

Under the agreement with Hikma, Hikma will continue to manufacture Kloxxado nasal spray (8 mg) to maintain distribution and availability. Kloxxado nasal spray will soon be integrated into Emergent’s proprietary NarcanDirect online distribution network, where qualified direct purchasers, such as emergency medical services, law enforcement, fire departments, government agencies, schools/universities, and community-based naloxone distribution programs, can purchase and ship bulk quantities. 

Separately, the Biomedical Advanced Research and Development Authority (BARDA) under the US Department of Health and Human Services, has executed a contract modification for the second option period, valued at approximately $16.7 million, for the drug-product process, analytical testing validation, and long-term stability for Ebanga (ansuvimab-zykl). Ebanga is indicated for the treatment of infection caused by the Zaire Ebola virus. 

The existing 10-year contract Emergent has with BARDA consists of a base period of performance with two option periods for advanced development valued at approximately $118 million, and option periods for procurement of Ebanga treatment over five years valued at up to $583 million. Under the contract, Emergent will complete activities to advance the development of Ebanga through post-licensure commitments. These activities include manufacturing scale-up, transferring manufacturing technology, and completing stability studies, as well as the submission of a supplemental Biologics License Application to the US Food and Drug Administration. 

Source: Emergent BioSolutions (Hikma) & Emergent BioSolutions (BARDA)