• After initial data read-out in Part 1, study may possibly be expanded and continued in Part 2 for use as a potential registration study
• Patient recruitment expected to start soon

Copenhagen (Press Release) - Genmab A/S (OMX: GEN) announced today that its partner, Janssen Bio­tech, Inc. ("Janssen") will start a new Phase II study of dara­tu­mu­mab in multiple myeloma.  The Phase II study is designed in 2 parts in multiple myeloma patients who have received at least three dif­fer­en­t lines of ther­apy in­­clud­ing both a pro­te­a­some inhibitor and an immuno­modu­la­tory agent (IMiD) or who are double refractory to a pro­te­a­some inhibitor and an IMiD.  This is the same indi­ca­tion for which dara­tu­mu­mab was granted Break­through Therapy Desig­na­tion from the FDA in May 2013.

"We con­tinue to be excited by the pros­pect­s for dara­tu­mu­mab, which has the poten­tial to offer a sig­nif­i­cant thera­peutic alter­na­tive for multiple myeloma patients who desperately seek new treat­ment options," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.  "We look for­ward to the initiation of this trial with dara­tu­mu­mab in multiple myeloma patients, and we believe this study has the poten­tial to be used for regis­tration in the United States."

About the Study
This two-part study will enroll up to a maximum of 110 patients who have received at least three prior lines of ther­apy, in­­clud­ing both a pro­te­a­some inhibitor and an IMiD or who are double refractory to a pro­te­a­some inhibitor and an IMiD. Examples of pro­te­a­some inhibitors are bor­tez­o­mib or car­filz­o­mib and examples of IMiD agents are poma­lido­mide or lena­lido­mide.  Part 1 will define an optimal dara­tu­mu­mab regi­men going for­ward, while part 2 is an expansion based on the optimal regi­men de­ter­mined in Part 1.  The pri­mary objective of the study is to define the optimal dose and dosing schedule, to de­ter­mine the efficacy of two treat­ment regi­mens of dara­tu­mu­mab as measured by over­all response rate, and to further char­ac­ter­ize the safety of dara­tu­mu­mab as a single agent.

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 could 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^TM; the DuoBody™ logo; HuMax^®; HuMax-CD20^®; DuoBody^®, HexaBody^TM and UniBody^®. Arzerra^® is a registered trademark of GlaxoSmithKline.

Source: Genmab A/S.