• First study of dara­tu­mu­mab in smoldering multiple myeloma
• Study expected to start in  2015

Copenhagen, Denmark (Press Release) - Genmab A/S (OMX: GEN) announced today that its col­lab­o­ra­tion partner, Janssen Biotech, Inc. (Janssen) plans to start a Phase II study of dara­tu­mu­mab in smol­der­ing multiple myeloma.  The study (SMM2001) will eval­u­ate three dif­fer­en­t dose schedules of dara­tu­mu­mab for the treat­ment of smol­der­ing multiple myeloma.  The study is ex­pec­ted to start enrolling patients in 2015.

"We are pleased to announce this study, which illustrates that the devel­op­ment plan for dara­tu­mu­mab encompasses all stages of multiple myeloma. Smoldering multiple myeloma is a chal­leng­ing indi­ca­tion, as physicians will eval­u­ate treating patients at an early stage of the disease, with the intent to extend the period before the disease transitions to symp­tomatic multiple myeloma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the SMM2001 study

This Phase II study will be a ran­domized, open-label, multi­center study and will enroll approx­i­mately 120 patients with high risk smol­der­ing multiple myeloma.  Patients will be ran­domized to receive one of three dose schedules of dara­tu­mu­mab.  The study will be conducted by Janssen Research & Development LLC.

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  for the treat­ment of patients with multiple myeloma who have received at least three prior lines of ther­apy in­­clud­ing a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent (IMiD) or who are double refractory to a PI and an IMiD.  In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive world­wide license to develop, manu­fac­ture 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 cur­rently has one mar­keted anti­body, Arzerra® (ofatumumab) for the treat­ment of certain chronic lym­pho­cytic leukemia indi­ca­tions and dara­tu­mu­mab in late stage clin­i­cal devel­op­ment for multiple myeloma. Additionally Genmab has a clin­i­cal pipe­line with both late and early stage pro­grams, and an inno­va­tive pre-clinical pipe­line.  Genmab's tech­nology base consists of val­i­dated and pro­pri­e­tary next generation anti­body tech­nolo­gies - the DuoBody® plat­form for generation of bispecific anti­bodies, and the HexaBody™ plat­form which creates effector function en­hanced anti­bodies. Genmab's deep anti­body expertise is ex­pec­ted to provide a stream of future prod­uct can­di­dates.  Partnering of selected 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 A/S.