Policy & Regulation
Genmab enters into exclusive, collaboration agreement with Janssen for HexaBody-CD38
12 June 2019 -

Genmab A/S (CPH:GEN), a biotechnology company specialising in the creation and development of differentiated antibody therapeutics for the treatment of cancer, announced on Tuesday the entering into an exclusive worldwide license and option agreement with Janssen Biotech Inc (Janssen) to develop and commercialise HexaBody-CD38, a next-generation human CD38 monoclonal antibody product incorporating Genmab's proprietary HexaBody technology.

Under the terms of this agreement, Genmab will collaborate exclusively with Janssen on HexaBody-CD38, with Genmab funding research and development activities until completion of clinical proof of concept studies in multiple myeloma and diffuse large B-cell lymphoma.

Also, based on the data from these studies, Janssen may exercise its option and receive a worldwide license to develop, manufacture and commercialise HexaBody-CD38.

In the event this occurs, Janssen will pay Genmab a USD150m option exercise fee and up to USD125m in development milestones, as well as a flat royalty rate of 20% on sales of HexaBody-CD38 until a specified time in 2031, followed by 13% to 20% tiered royalties on sales thereafter.

Should Janssen not exercise its option, the terms of the agreement allow Genmab to continue to develop and commercialise HexaBody-CD38 for DARZALEX-resistant patients and in all other indications, except those multiple myeloma or amyloidosis indications where DARZALEX is either approved or is being actively developed.

Reportedly, this agreement is the outcome of pre-clinical research on novel CD38 targeting concepts conducted by Genmab. For HexaBody-CD38, Genmab obtained promising pre-clinical data in a panel of multiple myeloma, lymphoma and leukaemia models.

Additional details of the collaboration are not being disclosed and Genmab added that this agreement does not materially impact its 2019 financial guidance.