- First Phase III study of dara­tu­mu­mab
- Patient recruitment to start in the coming months

Copenhagen (Press Release) - Genmab A/S (OMX: GEN) announced today that its partner, Janssen Biotech, Inc. ("Janssen") will start a Phase III study of dara­tu­mu­mab in re­lapsed or refractory multiple myeloma.  The study will compare dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­metha­sone to lena­lido­mide and dexa­metha­sone alone.

"The dara­tu­mu­mab devel­op­ment pro­gram is progressing very well.  We are extremely pleased to be able to announce that this study eval­u­ating dara­tu­mu­mab in com­bi­na­tion with a core multiple myeloma treat­ment regime will ini­ti­ate patient recruitment in the coming months," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the study
This Phase III study will in­clude approx­i­mately 500 patients who have re­lapsed or refractory multiple myeloma.  Patients will be ran­domized to receive either dara­tu­mu­mab com­bined with lena­lido­mide and dexa­metha­sone, or lena­lido­mide and dexa­metha­sone alone.  The pri­mary end­point of the study is pro­gres­sion free survival (PFS).

About dara­tu­mu­mab
Daratumumab is a human CD38 mono­clonal anti­body with broad-spectrum killing activity. Dara­tu­mu­mab is in clin­i­cal devel­op­ment for multiple myeloma (MM). Dara­tu­mu­mab targets the CD38 molecule which is highly ex­pressed on the surface of multiple myeloma cells. Dara­tu­mu­mab may also have poten­tial in other cancers on which CD38 is ex­pressed, in­­clud­ing diffuse large B-cell lym­pho­ma, chronic lym­pho­cytic leu­ke­mia, acute lymphoblastic leu­ke­mia, plasma cell leu­ke­mia, acute myeloid leu­ke­mia, follicular lym­phoma and mantle cell lym­phoma.  Dara­tu­mu­mab has been granted Break­through Therapy Desig­na­tion from the US FDA.  In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive world­wide license to develop and com­mer­cial­ize dara­tu­mu­mab.

About Genmab A/S
Genmab is a publicly traded, inter­na­tional bio­technology com­pa­ny specializing in the creation and develop­ment of dif­fer­en­ti­ated human anti­body thera­peutics for the treat­ment of cancer.  Founded in 1999, the com­pa­ny's first mar­keted anti­body, ofatumumab (Arzerra^®), was approved to treat chronic lym­pho­cytic leu­ke­mia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in devel­op­ment.  Genmab's val­i­dated and next generation anti­body tech­nolo­gies are ex­pec­ted to provide a steady stream of future prod­uct can­di­dates.  Partnering of inno­va­tive prod­uct can­di­dates and tech­nolo­gies is a key focus of Genmab's strategy and the com­pa­ny has alliances with top tier pharma­ceu­tical and bio­technology com­panies.  For more in­­for­ma­tion visit www.genmab.com.

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 in rela­tion­ to actual results, unless required by law. 

Genmab A/S and its sub­sid­i­aries own the fol­low­ing trademarks: Genmab^®; the Y-shaped Genmab logo^®; Genmab in com­bi­na­tion with the Y-shaped Genmab logo™; the DuoBody logo™; the HexaBody logo™; HuMax^®; HuMax-CD20^®; DuoBody^®; HexaBody™ and UniBody^®. Arzerra^® is a registered trademark of the GSK group of com­pa­nies.

Source: Genmab.