Genmab Lands Experienced Partner AbbVie In Broad Bispecific Antibody Collaboration
Executive Summary
AbbVie will pay $750m up front plus up to $3.15bn in milestone fees to jointly develop and commercialize three bispecific antibody candidates for cancer and an earlier drug discovery collaboration.
Danish antibody developer Genmab AS has landed AbbVie Inc. as a big pharma partner to jointly develop and commercialize three of its next-generation bispecific antibody candidates for cancer, including epcoritamab for B-cell malignancies. The companies announced the broad collaboration on 10 June, under which AbbVie agreed to pay $750m upfront and potential milestone payments of up to $3.15bn.
"Genmab and AbbVie will be equal partners, working together to jointly make all strategy, clinical development and commercialization decisions," Genmab CEO Jan van de Winkel said during a same-day call announcing the partnership.
The centerpiece of the deal is epcoritamab (CD3xCD20) in Phase I/II clinical testing for hematological B-cell malignancies, including non-Hodgkin lymphoma. Hematological cancer is an area AbbVie has a lot of experience in from selling Imbruvica (ibrutinib) with Johnson & Johnson and Venclexta (venetoclax) with Roche.
The joint development and commercialization partnership also includes two other bispecific antibody candidates: DuoHexaBody CD37 and DuoBody CD3x5T4. DuoHexaBody CD37 entered the clinic earlier this year and has a unique mechanism of action targeting two different epitopes on CD37, which is broadly expressed in hematological cancers. The third candidate is in preclinical development in a range of cancer indications with 5T4 being expressed on multiple sold tumors.
The partnership also includes a drug discovery research component that will explore antibodies from both companies with Genmab's DuoBody technology and AbbVie's antibody-drug conjugate (ADC) technology with the goal of developing ADCs for solid tumors and blood cancers. Of the potential milestone payments, AbbVie could pay Genmab, $2bn are linked to the drug discovery collaboration. Genmab will be responsible for overseeing the programs through Phase I development.
For Genmab, the collaboration is a cornerstone of the company's 2025 vision to build out into a fully integrated biotech company. The company already has a strong cancer drug development track record, having developed Arzerra (ofatumumab), partnered with GlaxoSmithKline PLC and then sold to Novartis AG, and Darzalex (daratumumab), partnered with Johnson & Johnson.
The company's revenues are largely driven by royalties it receives on sales of Darzalex, which has grown into a hefty blockbuster, and drug discovery and development partnerships. Now with the AbbVie collaboration, Genmab is hoping to take the next step toward building a commercial organization.
"AbbVie has deep experience with 50:50 partnerships and a track record of success with ibrutinib and Venclexta," chief financial officer Anthony Pagano told the conference call.
The companies will share commercial responsibilities for epcoritamab in the US and Japan, while AbbVie will be responsible for commercialization outside of those markets. Genmab will book sales in the US and Japan and receive tiered royalties of 22%-26% on remaining global sales. Aside from the royalty-bearing sales, the partners will share pre-tax profits on sales on a 50:50 basis.
The companies are planning a broad Phase III program for epcoritamab and hope to begin an initial Phase III trial this year and multiple other studies in 2021, Winkel said, though he declined to provide details on the trials.
For other candidates developed out of the collaboration, the companies will also share development and commercialization in the US and Japan, and Genmab will retain the right to co-commercialize the products more broadly.
"For us, that's an important option, enabling us to further broaden our commercial footprint," Pagano said. "In all cases, the companies will share all development and regulatory costs for these products 50:50."
As a result of the deal, Genmab revised its 2020 revenue guidance to be in the range of DKK9.1bn-DKK9.5bn ($1.39bn-$1.45bn), an increase of DKK4.35bn ($663.16m) compared to prior guidance, reflecting the bulk of the upfront payment from AbbVie.
Genmab is one of several drug companies advancing bispecific antibodies in clinical testing, along with companies like Regeneron Pharmaceuticals Inc. and Roche's Genentech Inc. (Also see "Bispecifics Could Be A Threat To CAR-Ts, But Efficacy May Trump Convenience" - Scrip, 19 Dec, 2019.)