• DARZALEX® approved in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma in­eli­gible for au­tol­o­gous stem cell trans­plant in Japan
• Genmab to receive USD 7 million mile­stone pay­ment
• Approval based on data from Phase III ALCYONE study

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq: GMAB) announced today that the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the use of DARZALEX (dara­tu­mu­mab) in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). DARZALEX is being devel­oped under an August 2012 agree­ment in which Genmab granted Janssen Biotech, Inc. (Janssen) an exclusive world­wide license to develop, manu­fac­ture and …

San Diego, CA (Press Release) – Halozyme Thera­peutics, Inc. (NASDAQ: HALO), a bio­technology com­pany devel­op­ing novel on­col­ogy and drug-delivery ther­a­pies, to­day an­nounced that Janssen-Cilag Inter­na­tional NV (Janssen) has sub­mitted an extension appli­ca­tion to the Euro­pean Medicines Agency (EMA) for the sub­cu­tane­ous de­livery of DAR­ZA­LEX® (dara­tu­mu­mab) for patients with mul­ti­ple myeloma.

"We are pleased that Janssen's filing follows quickly after its filing last week of a Biologics License Appli­ca­tion (BLA) with the U.S. Food and Drug Admin­istra­tion," said Dr. Helen Torley, Pres­i­dent and CEO. "We are par­tic­u­larly ex­cited that, pend­ing ap­­prov­al by the EMA, …

Data sup­porting the appli­ca­tion dem­onstrated that the inves­ti­ga­tional sub­cu­tane­ous for­mu­la­tion im­proved quality of life, reduced admin­istra­tion time, lowered rates of in­fusion-related reac­tions, and was non-inferior com­pared to in­tra­venous admin­istra­tion¹

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of John­son & John­son to­day an­nounced the sub­mission of an extension appli­ca­tion to the Euro­pean Medicines Agency (EMA) for sub­cu­tane­ous (under the skin) use of DAR­ZA­LEX® (dara­tu­mu­mab) for the treat­ment of patients with mul­ti­ple myeloma. This sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab is co-formulated with recombinant human hyal­uron­i­dase PH20 (rHuPH20) [Halozyme's ENHANZE® drug de­livery tech­nology]. Dara­tu­mu­mab is cur­rently only approved for in­tra­venous (IV) use.

“This new for­mu­la­tion is an example of our unwavering com­mitment to pur­sue inno­va­tive treat­ment op­tions to sup­port people living with mul­ti­ple myeloma,” …

• Extension of mar­ket­ing authori­za­tion sub­mitted to Euro­pean Medicines Agency for sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab
• Submission based on data from Phase III COLUMBA and Phase II PLEIADES stud­ies

Copenhagen, Denmark (Press Release) – Genmab A/S (CSE:GEN, Nasdaq:GMAB) an­nounced to­day that its licensing part­ner, Janssen Biotech, Inc., has sub­mitted an appli­ca­tion for the extension of the DAR­ZA­LEX® mar­ket­ing authori­za­tion to the Euro­pean Medicines Agency (EMA). This appli­ca­tion seeks ap­­prov­al for the use of the sub­cu­tane­ous (SubQ) for­mu­la­tion of dara­tu­mu­mab in mul­ti­ple myeloma indi­ca­tions where the in­tra­venous for­mu­la­tion of dara­tu­mu­mab is cur­rently approved. In August 2012, Genmab granted Janssen an ex­clu­sive world­wide license to de­vel­op, manu­fac­ture and com­mer­cial­ize dara­tu­mu­mab.

“Janssen has now sub­mitted appli­ca­tions …

San Diego, CA (Press Release) – Halozyme Thera­peutics, Inc. (NASDAQ: HALO), a bio­technology com­pany devel­op­ing novel on­col­ogy and drug-delivery ther­a­pies, to­day an­nounced that its col­lab­o­rator Janssen Biotech, Inc. (Janssen) has sub­mitted a Biologics License Appli­ca­tion (BLA) to the U.S. Food and Drug Admin­istra­tion for the sub­cu­tane­ous de­livery of DAR­ZA­LEX® (dara­tu­mu­mab) for patients with mul­ti­ple myeloma.

"Janssen's BLA sub­mission for sub­cu­tane­ous DAR­ZA­LEX® rep­re­sents an im­por­tant devel­op­ment for our ENHANZE® drug de­livery tech­nology business," said Dr. Helen Torley, pres­i­dent and chief exec­u­tive of­fi­cer. "We are delighted that an ap­­prov­al of the sub­cu­tane­ous for­mu­la­tion may soon …

• BLA sub­mitted to U.S. FDA for sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab
• Submission based on data from Phase III COLUMBA and Phase II PLEIADES stud­ies

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copenhagen: GEN) an­nounced to­day that its licensing part­ner, Janssen Biotech, Inc., has sub­mitted a Biologics License Appli­ca­tion (BLA) to the U.S. Food and Drug Admin­istra­tion (U.S. FDA) for the use of the sub­cu­tane­ous (SubQ) for­mu­la­tion of dara­tu­mu­mab in mul­ti­ple myeloma indi­ca­tions where the in­tra­venous for­mu­la­tion of dara­tu­mu­mab is cur­rently approved. In August 2012, Genmab granted Janssen an ex­clu­sive world­wide license to de­vel­op, manu­fac­ture and com­mer­cial­ize dara­tu­mu­mab.

“Should this sub­mission lead to an ap­­prov­al, it would provide patients …

Topline data from the ran­dom­ized Phase II GRIFFIN study in trans­plant eli­gible, newly diag­nosed patients with multiple myeloma treated with dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone met the study’s pri­mary end­point with a higher per­cent­age of stringent com­plete response in the dara­tu­mu­mab arm as com­pared with patients who received lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone alone

Copenhagen, Denmark (Company Announcement) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that topline data from the Phase II GRIFFIN (MMY2004) study of newly diag­nosed patients with multiple myeloma eli­gible for high-dose chemo­ther­apy and au­tol­o­gous stem cell trans­plan­ta­tion (ASCT), who were treated with dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide, bor­tez­o­mib, and dexa­meth­a­sone (VRd), met its pri­mary end­point, demonstrating a higher per­cent­age of stringent com­plete responses (sCR) than patients who received VRd alone. Specifically, the topline data showed that 42.4% of patients treated with dara­tu­mu­mab in com­bi­na­tion with VRd achieved a sCR, com­pared to 32.0% …