A roundup of bio/pharmaceutical partnering news from Takeda/AC Immune, AbbVie/Gilgamesh Pharmaceuticals, Sanofi/Novavax, Boehringer Ingelheim/Quallent Pharmaceuticals, and Galapagos/Blood Centers of America. 

* Takeda, AC Immune in $2.2-Bn Immunotherapy Pact for Alzheimer’s Disease  
* AbbVie, Gilgamesh Pharmaceuticals in $2-Bn Licensing Pact for Psychiatric Drugs 
* Sanofi, Novavax In $1.2-Bn COVID-19 & Flu Vaccines Pact 
* BI, Quallent In Humira Biosimilar Mfg Pact 
* Galapagos, Blood Centers of America In CAR-T Mfg Pact 

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Takeda, AC Immune In $2.2-Bn Immunotherapy Pact for Alzheimer’s Disease 
Takeda and AC Immune, a Cambridge, Massachusetts-based bio/pharmaceutical company, have announced an exclusive, worldwide option and license agreement by Takeda for AC Immune’s active immunotherapies targeting toxic forms of amyloid beta, including AC Immune’s ACI-24.060 for the treatment of Alzheimer’s disease, in a deal worth up to $2.2 billion ($100 million upfront and $2.1 billion in milestone payments). 

ACI-24.060 is an anti- amyloid beta (Abeta) active immunotherapy candidate in Phase Ib/II development, designed to induce an antibody response against the toxic forms of Abeta believed to drive plaque formation and Alzheimer’s disease progression. By inducing plaque clearance and inhibiting plaque formation in the brain, ACI-24.060 has the potential to delay or slow Alzheimer’s disease progression.  

Under the agreement, AC Immune will receive an upfront payment of $100 million and will be eligible to receive an option exercise fee and additional potential development, commercial, and sales-based milestones of up to approximately $2.1 billion if all related milestones are achieved over the course of the agreement. Upon commercialization, AC Immune will be entitled to receive tiered double-digit royalties on worldwide net sales. 

Source: Takeda 

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AbbVie, Gilgamesh Pharmaceuticals in $2-Bn Licensing Pact for Psychiatric Drugs 
AbbVie and Gilgamesh Pharmaceuticals, a New York-based bio/pharmaceutical company, have announced a collaboration and option-to-license agreement to develop therapies for psychiatric disorders, in a deal worth up to $2 billion ($65 million upfront and $1.95 billion in milestone payments).  

The collaboration will use AbbVie’s expertise in psychiatry disorders and Gilgamesh’s research platform to discover neuroplastogens. 

Under the agreement, AbbVie and Gilgamesh have agreed to research and develop a portfolio of therapeutics for psychiatric disorders. Upon exercise of the option, AbbVie will lead development and commercialization activities. Gilgamesh will receive an upfront payment of $65 million from AbbVie and is eligible to receive up to $1.95 billion in aggregate option fees and milestones as well as tiered royalties from mid-single to low-double digits on net sales. 

Source: AbbVie 

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Sanofi, Novavax In $1.2-Bn COVID-19 & Flu Vaccine Pact 
Sanofi and Novavax, a Gaithersburg, Maryland-based bio/pharmaceutical company, have entered into a co-exclusive licensing agreement for Novavax’s COVID-19 vaccine and Sanofi’s flu vaccine, in a deal worth up to $1.2 billion ($500 million upfront and $700 million in milestone payments). 

The agreement includes a co-exclusive license to co-commercialize Novavax’s current stand-alone adjuvanted COVID-19 vaccine worldwide (except in countries with existing advance purchase agreements and in India, Japan, and South Korea where Novavax has existing partnership agreements); a sole license to Novavax’s adjuvanted COVID-19 vaccine for use in combination with Sanofi’s flu vaccines; and a non-exclusive license to use Novavax’s Matrix-M adjuvant in vaccine products. In addition, Sanofi will take a minority (< 5%) equity investment in Novavax. 

Under the agreement, Novavax will receive an upfront payment of $500 million and up to $700 million in development, regulatory and launch milestones, up to $1.2 billion in total. Starting in 2025, Sanofi will book sales of Novavax’s adjuvanted COVID-19 vaccine and will support certain R&D, regulatory, and commercial expenses; Novavax will receive tiered double-digit percentage royalty payments on sales by Sanofi of COVID-19 vaccines and flu-COVID-19 combination vaccines. Sanofi will be solely responsible for development and commercialization of any flu-COVID-19 combination vaccine containing a Sanofi flu vaccine. Outside of the collaboration, each party may develop and commercialize its own flu-COVID-19 vaccines and adjuvanted products at its own cost. Novavax is entitled to additional launch and sales milestones opportunities of up to $200 million plus mid-single digit royalties for each additional Sanofi vaccine product developed under a non-exclusive license with Novavax’s Matrix-M adjuvant technology. 

Source: Sanofi 

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BI, Quallent In Humira Biosimilar Mfg Pact 
Boehringer Ingelheim (BI) and Quallent Pharmaceuticals, a private-label pharmaceutical distributor, have announced an agreement in the US to citrate-free adalimumab-adbm, BI’s biosimilar to AbbVie’s Humira (adalimumab).  

Under the agreement, BI will manufacture adalimumab-adbm for Quallent. BI will continue to commercialize BI-labeled Cyltezo (adalimumab-adbm) injection and adalimumab-adbm.  

Quallent will be offering both high-concentration (40 mg/0.4 mL) and low-concentration (40 mg/0.8 mL) citrate-free formulations of adalimumab-adbm as a pre-filled syringe or pen. Adalimumab-adbm’s interchangeability designation for the low-concentration formulation will extend to Quallent’s 40 mg/0.8 mL private-labeled adalimumab-adbm. 

Source: Boehringer Ingelheim 

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Galapagos, Blood Centers of America In CAR-T Mfg Pact 
Galapagos, a Mechelen, Belgium-based bio/pharmaceutical company, and Blood Centers of America (BCA) have entered into a strategic collaboration for the decentralized manufacturing of Galapagos’ CAR-T cell therapies through BCA’s network in the US. 

Under the agreement, BCA will provide access to its network of over 50 community blood centers in 43 states for GMP-compliant manufacturing for Galapagos’ CAR-T hemato-oncology clinical program. This agreement complements existing collaborations between Galapagos and Landmark Bio and Thermo Fisher Scientific. 

Galapagos will use BCA’s network to initiate technology transfer to multiple sites in parallel for the decentralized manufacturing of its CAR-T product candidates, close to cancer treatment centers, while also accessing apheresis capacity at BCA sites when required. In addition, BCA will play a coordinating role by supporting site initiation and onboarding to accelerate Galapagos’ efforts and ensure consistent quality. 

Source: Galapagos