• Genmab signs agree­ment with Janssen Biotech, Inc. to col­lab­o­rate exclusively on next-generation CD38 anti­body prod­uct, HexaBody®-CD38, incorporating Genmab’s pro­pri­e­tary HexaBody tech­nology
• New agree­ment builds on Genmab’s suc­cess­ful DARZALEX® col­lab­o­ration with Janssen
• Next-generation HexaBody-CD38 could poten­tially add to the DARZALEX multiple myeloma fran­chise and expand the poten­tial of CD38-targeted ther­a­pies in further indi­ca­tions

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copen­hagen: GEN) announced today it has entered into an exclusive world­wide license and option agree­ment with Janssen Biotech, Inc. (Janssen) to develop and com­mer­cial­ize HexaBody-CD38, a next-generation human CD38 mono­clonal anti­body prod­uct incorporating Genmab’s pro­pri­e­tary HexaBody tech­nology. Under the terms of the 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. Based on the data from these studies, Janssen may exercise its option and receive a world­wide license to develop, manu­fac­ture and com­mer­cial­ize HexaBody-CD38. Should this occur, Janssen will pay Genmab a USD 150 million option exercise fee and up to USD 125 million 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 13-20% tiered royalties on sales there­after. Should Janssen not exercise its option, the terms of the agree­ment allow Genmab to con­tinue to develop and com­mer­cial­ize 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.

The 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 leukemia models.

“With this agree­ment, we hope to build upon the suc­cess­ful and prod­uctive rela­tion­ship that we have estab­lish­ed with Janssen. As a result of our col­lab­o­ration, DARZALEX has dramatically im­proved out­comes for patients with multiple myeloma, yet there are still unmet needs for patients. We are excited that Genmab’s world-class anti­body expertise and passion for inno­va­tion has led to the novel HexaBody-CD38 prod­uct concept. Encouraging pre-clinical data suggest that HexaBody-CD38 could be superior to dara­tu­mu­mab for certain tumor cell types and may expand and extend the promise of CD38-targeted ther­a­pies for more patients with multiple myeloma, lym­phoma, leukemia, and poten­tially beyond,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Additional details of the col­lab­o­ration are not being disclosed and this news does not ma­teri­ally impact Genmab’s 2019 Financial Guidance.

About Genmab

Genmab is a publicly traded, inter­na­tional bio­technology com­pany specializing in the creation and devel­op­ment of dif­fer­en­ti­ated anti­body thera­peutics for the treat­ment of cancer. Founded in 1999, the com­pany has two approved anti­bodies, DARZALEX® (dara­tu­mu­mab) for the treat­ment of certain multiple myeloma indi­ca­tions, and Arzerra® (ofatumumab) for the treat­ment of certain chronic lym­pho­cytic leukemia indi­ca­tions. Dara­tu­mu­mab is in clin­i­cal devel­op­ment for addi­tional multiple myeloma indi­ca­tions, other blood cancers and amy­loid­osis. A sub­cu­tane­ous for­mu­la­tion of ofatumumab is in devel­op­ment for relapsing multiple sclerosis. Genmab also has a broad clin­i­cal and pre-clinical prod­uct pipe­line. Genmab's tech­nology base consists of val­i­dated and pro­pri­e­tary next generation anti­body tech­nolo­gies - the DuoBody® plat­form for generation of bispecific anti­bodies, the HexaBody® plat­form, which creates effector function en­hanced anti­bodies and the HexElect® plat­form, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing thera­peutic potency. The com­pany in­tends to leverage these tech­nolo­gies to create oppor­tu­ni­ties for full or co-ownership of future prod­ucts. Genmab has alliances with top tier pharma­ceu­tical and bio­technology com­pa­nies. For more in­for­ma­tion visit www.genmab.com.

Cautions Concerning Forward-Looking Statements

This Company Announcement con­tains for­ward looking state­ments. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar ex­pres­sions identify for­ward looking state­ments. Actual results or per­for­mance may differ ma­teri­ally from any future results or per­for­mance ex­pressed or implied by such state­ments. The im­por­tant factors that could cause our actual results or per­for­mance to differ ma­teri­ally in­clude, among others, risks asso­ci­ated with pre-clinical and clin­i­cal devel­op­ment of prod­ucts, un­cer­tain­ties related to the out­come and conduct of clin­i­cal trials in­clud­ing un­fore­seen safety issues, un­cer­tain­ties related to prod­uct manu­fac­tur­ing, the lack of mar­ket acceptance of our prod­ucts, our in­abil­ity to man­age growth, the competitive en­viron­ment in rela­tion­ to our business area and mar­kets, our in­abil­ity to attract and retain suitably qualified per­son­nel, the un­en­force­ability or lack of protection of our patents and pro­pri­e­tary rights, our rela­tion­ships with affiliated entities, changes and devel­op­ments in tech­nology which may render our prod­ucts obsolete, and other factors. For a further discussion of these risks, please refer to the risk man­agement sections in Genmab’s most recent financial reports, which are avail­able on www.genmab.com. Genmab does not under­take any obli­ga­tion to update or revise for­ward looking state­ments in this Company Announcement nor to con­firm such state­ments to reflect sub­se­quent events or cir­cum­stances after the date made or in rela­tion­ to actual results, unless required by law.

Genmab A/S and/or its sub­sid­i­aries own the fol­low­ing trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in com­bi­na­tion with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in com­bi­na­tion with the DuoBody logo®; HexaBody®; HexaBody in com­bi­na­tion with the HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Pharmaceutica NV.

Source: Genmab.