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Partnering News: BI, GSK, Astellas, AbbVie, Roche & More 

A roundup of bio/pharmaceutical partnering news from Boehringer Ingelheim/Ribocure Pharmaceuticals, GSK/Hansoh, Astellas/Epliscience, AbbVie/Umoja, Novartis/Voyager Therapeutics, Pfizer/Nona Bio, Roche/MediLink, Roche/Remix Therapeutics, Novo Nordisk/Omega Therapeutics/Cellarity, Daiichi Sankyo/Esperion, Otsuka Pharmaceuticals/Ionis, Eli Lilly and Company/Organon, and J&J/AbelZeta. 

* BI, Ribocure in $2-Bn siRNA NASH/MASH Drug Pact 
* GSK, Hansoh in $1.7-Bn ADC Licensing Pact 
* Astellas, Epliscience in $1.7-Bn Research Pact for Bispecific Antibodies 
* AbbVie, Umoja In $1.44-Bn CAR-T Licensing Pact  
* Novartis, Voyager Therapeutics in $1.3-Bn Gene-Therapy Pact 
* Pfizer, Nona Bio In $1.1-Bn ADC Pact 
* Roche, MediLink in $1-Bn ADC Licensing Pact 
* Roche, Remix in $1-Bn Small-Molecule RNA Drug Pact 
* Novo Nordisk In $1.1-M Small-Molecule Drug MASH Research Pacts with Omega, Cellarity 
* Daiichi Sanyko, Esperion in $125-M Settlement for Cardio Drug 
* Otsuka, Ionis in $65-M Licensing Pact for Rare-Disease Drug 
* Lilly, Organon In $50-M Pact for Migraine Drugs 
* J&J’s Janssen, AbelZeta Amend CAR-T Licensing Pact   

BI, Ribocure in $2-Bn siRNA NASH/MASH Drug Pact 
Boehringer Ingelheim, Suzhou Ribo Life Science, and its subsidiary, Ribocure Pharmaceuticals,  have entered a collaboration to develop small interfering RNA (siRNA) therapeutics for treating nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH), in a deal worth up to $2 billion.  

NASH is an inflammatory liver disease that is caused by accumulation of fat in the liver. Over time, NASH causes scar-tissue formation, which in many cases leads to liver cirrhosis and related serious complications, including liver failure or liver cancer, according to information from the companies.  

Suzhou Ribo Life Science is a Kunshan, China-based clinical-stage bio/pharma company focused on the development of nucleic acid drugs and related products based on RNA interference (RNAi) technology, and Ribocure Pharmaceuticals is its subsidiary based in Mölndal, Sweden, focused on developing siRNA drugs.  

Ribo’s RIBO-GalSTAR platform enables the development of RNAi therapeutics targeting disease-causing genes specifically in hepatocytes by silencing their messenger RNAs (mRNAs). This approach has the potential to treat diseases addressing previously inaccessible drug targets, according to the companies. 

Under the agreement, Ribo will receive an upfront payment. In this multi-target collaboration, Ribo is entitled to receive success-based milestones for clinical, regulatory, and commercial success and tiered royalties with an overall deal value that exceeds $2 billion. 

Source: Boehringer Ingelheim 

GSK, Hansoh in $1.7-Bn ADC Licensing Pact 
GlaxoSmithKline (GSK) and Hansoh Pharma, a Jiangsu, China-based bio/pharmaceutical company, have entered into an exclusive license agreement for Hansoh’s HS-20093, an antibody-drug conjugate (ADC), in a deal worth up to $1.7 billion ($185 million upfront and $1.525 billion in milestone payments).  

Under the agreement, GSK will obtain exclusive worldwide rights (excluding China’s Mainland, Hong Kong, Macau, and Taiwan) to progress clinical development and commercialization of HS-20093, which is currently being investigated in ongoing Phase I and II trials in China. GSK plans to begin Phase I trials for HS-20093 outside of China in 2024. 

Under the  agreement, GSK will pay $185 million upfront. In addition, Hansoh will be eligible to receive up to $1.525 billion in success-based milestones for HS-20093. Upon commercialization of HS-20093, GSK will pay tiered royalties on global net sales outside of China’s Mainland, Hong Kong, Macau, and Taiwan. The agreement is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the US. 

This is the second recent ADC pact between the two companies. In October 2023, GSK and Hansoh entered into an agreement for HS-20089, an ADC currently in Phase II clinical trials in China for treating ovarian and endometrial cancer with opportunities in other solid tumors. 

Source: GSK 

Astellas, Epliscience in $1.7-Bn Research Pact for Bispecific Antibodies 
Astellas and Elpiscience Biopharma, a Shanghai-based bio/pharmaceutical company, have entered a research collaboration and license agreement for bispecific macrophage engagers, ES019 and another program, in a deal worth up to $1.7 billion ($37 million upfront and $1.7 billion in milestone payments).  

The two companies will collaboratively conduct early-stage research for these two programs. Elpiscience will also grant Astellas the right to add up to two additional programs to be included in the collaboration. If Astellas exercises its option, Elpiscience will grant Astellas the exclusive right to further research, develop, manufacture, and commercialize the products for each program. 

Elpiscience will receive up to $37 million, including the upfront payment and license option fees. In addition, Elpiscience will receive research funding from Astellas to advance the programs. After Astellas exercises its option, Elpiscience is eligible to potentially receive more than $1.7 billion in payments for the achievement of future development, regulatory, and commercial milestones. Elpiscience is also eligible to receive single-digit to lower double-digit percent royalty payments on net sales for licensed products per each program. 

Source: Astellas 

AbbVie, Umoja In $1.44-Bn CAR-T Licensing Pact 
AbbVie and Umoja Biopharma, a Louisville, Colorado-based bio/pharmaceutical company, have entered two exclusive option and license agreements to develop multiple in-situ generated CAR-T cell therapy candidates in oncology using Umoja’s VivoVec platform, in deals worth up to $1.44 billion.  

Umoja’s VivoVec gene-delivery platform combines lentiviral vector gene delivery with a novel T-cell targeting and activation surface complex. This enables T cells in the body to manufacture their own cancer-fighting CAR-T cells in vivo. This has the potential to eliminate a number of challenges associated with traditional CAR-T approaches including reliance on gathering a patient’s own or donor cells that are modified externally before being delivered back to the patient, the associated time lag and manufacturing challenges of ex vivo cell modification, and the need for patient’s lymphodepletion, according to information from AbbVie.  

The first agreement provides AbbVie an exclusive option to license Umoja’s CD19-directed in-situ generated CAR-T cell therapy candidates. This includes UB-VV111, Umoja’s lead clinical program for hematologic malignancies currently at the investigational new drug-enabling phase. Under the second agreement, AbbVie and Umoja will develop up to four additional in-situ generated CAR-T cell therapy candidates for discovery targets selected by AbbVie. 

Under the two agreements, Umoja received upfront payments and an equity investment from AbbVie. Additionally, for the two agreements combined, Umoja may be eligible to receive up to $1.44 billion in aggregate for option exercise fees, development and regulatory milestones, with the potential for Umoja to earn additional sales-based milestones and tiered royalties on worldwide net sales. 

Source: AbbVie 

Novartis, Voyager Therapeutics in $1.3-Bn Gene-Therapy Pact 
Novartis and Voyager Therapeutics, a Lexington, Massachusetts-based bio/pharmaceutical company, have entered a strategic collaboration and capsid license agreement to advance potential gene therapies for Huntington’s disease (HD) and spinal muscular atrophy (SMA), in a deal worth up to $1.3 billion ($100 million upfront and $1.2 billion in milestone payments). 

Voyager will provide Novartis with a target-exclusive license to access Voyager’s Tracer capsids and other intellectual property for the respective diseases, and Voyager and Novartis will collaborate to advance a preclinical gene-therapy candidate for HD. 

Under the agreement, Novartis has agreed to pay Voyager $100 million of consideration upfront, including a $20-million purchase of newly issued equity in Voyager. Voyager is eligible to receive up to $1.2 billion in preclinical, development, regulatory, and sales milestones, as well as tiered royalties on global net sales of products incorporating Voyager’s Tracer capsids. Novartis will obtain target-exclusive access to Voyager’s Tracer capsids related to SMA for the duration of the agreement and will be responsible for all development and commercialization. Novartis will also receive worldwide rights to Voyager’s adeno-associated virus gene therapy for HD using Voyager’s capsids and proprietary payloads. Voyager will be responsible for preclinical advancement, and Novartis will be responsible for all clinical development and commercialization for the HD program. 

Novartis previously exercised options to license novel capsids generated from Voyager’s Tracer capsid discovery platform for use in gene-therapy programs against two undisclosed neurological disease targets. 

Source: Voyager Therapeutics 

Pfizer, Nona Bio In $1.1-Bn ADC Pact 
Pfizer and Nona Biosciences, a Cambridge, Massachusetts-based bio/pharmaceutical company, have entered into an exclusive license agreement for the global clinical development and commercialization of Nona Biosciences’ antibody-drug conjugate (ADC), HBM9033, in a deal worth up to $1.1 billion ($53 million upfront and $1.05 billion in milestone payments). 

HBM9033 targets MSLN, a tumor-associated antigen upregulated in various solid tumors. 

Under the agreement, Nona Biosciences will receive a total of up to $53 million in upfront and near-term payments, with the potential for additional payments of up to $1.05 billion upon achieving certain development and commercial milestones. Nona Biosciences is also eligible to receive tiered royalties on net sales ranging from high single digits to high teens. 

Source: Nona Biosciences 

Roche, MediLink in $1-Bn ADC Licensing Pact 
Roche and MediLink Therapeutics, a Suzhou, China-based bio/pharmaceutical company, have entered into a worldwide collaboration and license agreement for the development of Medilink’s antibody-drug conjugate candidate (ADC), YL211, in a deal worth up to $1 billion ($50 million upfront and $1 billion in milestone payments). 

YL211 targets c-Mesenchymal epithelial transition factor (c-Met), which belongs to the receptor tyrosine kinase family. c-Met is closely associated with formation and growth of solid tumors.  

Under the agreement, MediLink will grant Roche exclusive global rights for the development, manufacturing, and commercialization of MediLink’s YL211. MediLink will work together with Roche’s R&D unit in China to initiate the Phase I clinical trial of YL211, and Roche will then take over the further development and commercialization globally.  

Under the agreement, MediLink will receive upfront and near-term milestone payments totaling $50 million and, together with additional development, regulatory and commercial milestone payments potentially reaching a total deal value nearing $1 billion, as well as tiered royalties on future global annual net sales. 

Source: Medilink Therapeutics 

Roche, Remix in $1-Bn Small-Molecule RNA Drug Pact 
Roche and Remix Therapeutics, a Watertown, Massachusetts-based bio/pharmaceutical company developing small-molecule therapies, have entered a collaboration and license agreement for the discovery and development of small-molecule therapeutics that modulate RNA processing using Remix’s REMaster drug-discovery platform, in a deal worth up to $1 billion ($30 million upfront and $1 billion in milestone payments). 

Under the agreement, Remix will receive an upfront payment of $30 million and is eligible to receive up to $12 million in near-term milestone payments, as well as preclinical, clinical, commercial and sales milestones of up to $1 billion and tiered royalties. In exchange, Roche will have exclusive rights to specific targets. Remix will conduct discovery and preclinical activities with Roche, and Roche will be responsible for development and commercialization of any resulting products. 

Source: Remix Therapeutics 

Novo Nordisk In $1.1-M Small-Molecule Drug MASH Research Pacts with Omega, Cellarity 
Novo Nordisk has formed two separate research pacts, respectively with Omega Therapeutics, a Cambridge, Massachusetts-based bio/pharma company, and Cellarity, a Somerville, Massachusetts-based bio/pharmaceutical company, worth up to $532 million with each company (approximately $1.1 billion combined).  

These are the first two programs signed under the framework collaboration between Flagship Pioneering Medicines, an investment firm forming new bio/pharmaceutical companies, and Novo Nordisk to use Flagship’s bioplatform companies (Omega, Cellarity) to develop treatment approaches for cardiometabolic diseases. 

Under the agreement with Omega, the companies will use Omega’s platform technology to develop an epigenomic controller designed to enhance metabolic activity as a part of a potential new treatment approach for obesity management.  

Under the agreement with Cellarity, the companies will aim at biological drivers of metabolic dysfunction-associated steatohepatitis (MASH), a chronic and progressive liver disease, and will use Cellarity’s platform to develop a small-molecule therapy against this disease. 

Each company, Novo Nordisk, and Flagship Pioneering Medicines will jointly advance these respective programs through preclinical development and conduct foundational activities, after which point, Novo Nordisk could advance the programs into clinical studies. Under the terms of the respective agreements, Novo Nordisk will reimburse R&D costs. Additionally, each agreement may pay up to $532 million in upfront, development and commercial milestone payments, as well as tiered royalties on annual net sales of a licensed product, to be shared between the respective companies and Flagship’s Pioneering Medicines. 

Source: Novo Nordisk 

Daiichi Sanyko, Esperion in $125-M Settlement for Cardio Drug 
Daiichi Sankyo and Esperion Therapeutics, an Ann Arbor, Michigan-based bio/pharmaceutical company, have reached a $125-million settlement regarding the companies’ collaboration to develop bempedoic acid and related products to treat cardiovascular disease.  

Since 2019, Esperion and Daiichi have worked together in the development of bempedoic acid for treating cardiovascular disease, and Daiichi recently gained approvals for bempedoic acid in the Netherlands, Slovakia, and Spain. The settlement is an amendment to the companies’ collaboration, which includes an amicable resolution to their commercial dispute and certain other adjustments.  

Under the resolution, Daiichi has agreed to pay Esperion $100 million ahead of an anticipated Type II(a) variation approval by the European Medicines Agency (EMA) for Nilemdo (bempedoic acid) tablet and Nustendi (bempedoic acid and ezetimibe) tablet and will make an additional $25 million payment to Esperion in the calendar quarter immediately following the EMA’s decision on the pending application. The legal action pending in the United States District Court for the Southern District of New York will be dismissed. 

The parties also agreed, as part of the resolution, for Esperion to transition to Daiichi manufacturing and supply responsibilities in Europe and other territories. In addition, the companies agreed to expand their collaboration in Europe and other territories to include the potential development and commercialization of a triple formulation product comprising bempedoic acid, ezetimibe, and a statin. Lastly, under the collaboration, Daiichi will now lead all regulatory communications with the EMA regarding the pending applications. 

Source: Esperion 

Otsuka, Ionis in $65-M Licensing Pact for Rare-Disease Drug 
Otsuka Pharmaceutical and Ionis Pharmaceuticals, a Carlsbad, California-based bio/pharmaceutical company, have entered into a license agreement under which Otsuka obtains exclusive rights in Europe to commercialize Ionis’ donidalorsen, an investigational prophylactic treatment for hereditary angioedema (HAE), in a deal valued at $65 million upfront plus milestone payments.   

Ionis will maintain responsibility for the non-clinical and clinical development of donidalorsen, and Otsuka will be responsible for European regulatory filings and commercialization. Ionis plans to independently launch donidalorsen in the US if approved. 

Under the agreement, Ionis will receive a $65-million upfront payment and milestone payments based on achievement of regulatory and sales targets. Ionis is also eligible to earn tiered royalties ranging from 20% to 30% (based on aggregate annual net sales). 

Source: Ionis Pharmaceutcials 

Lilly, Organon In $50-M Pact for Migraine Drugs 
Eli Lilly and Company and Organon, a Jersey City, New Jersey-based bio/pharmaceutical company have entered an agreement under which Organon will become the sole distributor and promoter for Lilly’s migraine medicines, Emgality (galcanezumab) and Rayvow (lasmiditan), in Europe, in a deal valued at $50 million upfront and milestone payments.   

Organon was spun off from Merck & Co. as an independent, publicly traded company in 2021. The spin-off company included Merck’s women’s health, certain legacy brands and biosimilars businesses. 

Lilly’s Emgality, a humanized monoclonal antibody calcitonin gene-related peptide (CGRP) antagonist, is indicated for the prophylaxis of migraine in adults who have at least four migraine days per month. Lilly’s Rayvow is a s serotonin 5-HT1F receptor agonist approved for the acute treatment of the headache phase of migraine attacks, with or without aura in adults. 

Under the agreement, Organon will become the sole distributor and promoter of Emgality and Rayvow in Europe. Lilly will remain the marketing authorization holder and will manufacture the products for sale. 

Total consideration to be paid to Lilly includes an upfront payment of $50 million and sales-based milestone payments. The transaction is expected to close in the first quarter of 2024 upon completion of review with relevant country-specific authorities. 

Source: Organon 

J&J’s Janssen, AbelZeta Amend CAR-T Licensing Pact   
J&J’s Janssen Biotech and AbelZeta Pharma, a Rockville, Maryland-based bio/pharmaceutical company, have amended their worldwide collaboration and license agreement for certain chimeric antigen receptor T (CAR-T) therapies.  

Under the amended agreement, Janssen will have the option to obtain exclusive commercialization rights in China for CD20-directed CAR-T therapies, C-CAR039 and C-CAR066, which are being studied for the treatment of non-Hodgkin’s lymphoma. 

C-CAR039 is a bispecific CAR-T therapy targeting both CD19 and CD20 antigens and has received US Food and Drug Administration (FDA) investigational new drug (IND) clearance and regenerative medicine advanced therapy and fast-track designations from the FDA for the treatment of relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL). A Phase Ib study in the US evaluating C-CAR039 for r/r DLBCL is underway. 

C-CAR066 is a CD20-targeted CAR-T therapy that has also received US FDA IND clearance, and a Phase IIb study in patients with r/r DLBCL, including r/r to CD19 CAR-T treatment, is underway in the US. 

Under the agreement, Janssen will pay AbelZeta Pharma an option exercise fee, and AbelZeta Pharma is eligible to receive commercialization and sales milestones. 

Source: AbelZeta Pharma