First Phase 3 Study Combining KYPROLIS and DARZALEX, Two Critical Mechanisms of Action in Treatment of Multiple Myeloma

Thousand Oaks, CA (Press Release) -- Amgen (NASDAQ:AMGN) today announced the Phase 3 CANDOR study eval­u­ating KYPROLIS® (car­filz­o­mib) in com­bi­na­tion with dexa­meth­a­sone and DARZALEX® (dara­tu­mu­mab) (KdD) com­pared to KYPROLIS and dexa­meth­a­sone alone (Kd) met its pri­mary end­point of pro­gres­sion-free survival (PFS). The regi­men resulted in a 37% reduction in the risk of pro­gres­sion or death in patients with re­lapsed or refractory multiple myeloma treated with KdD (HR=0.630; 95% CI: 0.464, 0.854; p=0.0014). The median PFS for patients treated with Kd alone was 15.8 months, while the median PFS for patients treated …

• Median pro­gres­sion-free sur­vival and over­all re­sponse rate doubled among patients re­ceiv­ing EPd com­pared to poma­lido­mide and low-dose dexa­meth­a­sone alone
• Second Empliciti-based com­bi­na­tion approved in Europe for patients with re­lapsed and re­frac­tory mul­ti­ple myeloma

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced that the Euro­pean Com­mis­sion (EC) has approved Empliciti (elo­tuzu­mab) plus poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with re­lapsed and re­frac­tory mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor (PI), and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. This ap­prov­al is based on data from the ELOQUENT-3 trial in which EPd doubled both median pro­gres­sion-free sur­vival (PFS) and …

• 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 …

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) to­day an­nounced that the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the Euro­pean Medicines Agency has adopted a pos­i­tive opinion on a Type-II variation appli­ca­tion for Empliciti (elo­tuzu­mab) plus poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with re­lapsed and re­frac­tory mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor (PI), and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. The CHMP recom­men­da­tion will now be reviewed by the Euro­pean Com­mis­sion, …

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 …