A new ther­apy providing an im­por­tant option for multiple myeloma patients who have received three or more prior lines of ther­apy

Toronto, Canada (Press Release) – Janssen Inc. announced today Health Canada has issued a Notice of Compliance with Conditions (NOC/c) approving DARZALEX™ (dara­tu­mu­mab) 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 refractory to both a PI and an IMiD. Health Canada approved this prod­uct on the con­di­tion that Janssen Inc. carries out con­firmatory trials to verify the clin­i­cal benefit of DARZALEX™.¹

Multiple myeloma is an incurable blood cancer that …

First-in-class CD38-directed active immuno­therapy provides new treat­ment option for MM patients who have exhausted other approved treat­ment options

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV (“Janssen”) today announced that the European Com­mis­sion (EC) has granted con­di­tional approval to DARZALEX® (dara­tu­mu­mab) for mono­therapy of adult patients with re­lapsed and refractory multiple myeloma (MM), whose prior ther­apy in­cluded a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent and who have dem­onstrated disease pro­gres­sion on the last ther­apy. Dara­tu­mu­mab was approved under an accelerated assess­ment, a process reserved for medicinal prod­ucts ex­pec­ted to be of major public health interest, particularly from the point of view of thera­peutic inno­va­tion.¹

Daratumumab is the first …

• DARZALEX (dara­tu­mu­mab) receives European con­di­tional mar­ket­ing authori­za­tion for heavily pre-treated or double refractory multiple myeloma
• First CD38 mono­clonal anti­body approved in Europe

Copenhagen, Denmark; May 23, 2016 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the European Com­mis­sion (EC) has granted a con­di­tional mar­ket­ing authori­za­tion for first-in-class CD38 anti­body DARZALEX® (dara­tu­mu­mab). The con­di­tional approval is for the use of DARZALEX® as mono­therapy for the treat­ment of adult patients with re­lapsed and refractory multiple myeloma, whose prior ther­apy in­cluded a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent and who have dem­onstrated disease pro­gres­sion on the last ther­apy. The EC approval follows a pos­i­tive opinion issued …

• Phase III POLLUX study of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone in patients with re­lapsed or refractory multiple myeloma met the pri­mary end­point at a pre-planned interim analysis
• Independent Data Monitoring Committee rec­om­mends unblinding the data
• Data will be discussed with health author­i­ties to prepare for regu­la­tory filings

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the Phase III POLLUX study (MMY3003) of dara­tu­mu­mab in combi­na­tion with lena­lido­mide and dexa­meth­a­sone versus lena­lido­mide and dexa­meth­a­sone in patients with re­lapsed or refractory multiple myeloma met the pri­mary end­point of im­prov­ing pro­gres­sion free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 0.37 (95% CI 0.27-0.52), p < 0.0001). Patients who received treat­ment with dara­tumu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone had a 63% …

First and only immunostimulatory anti­body approved in the Euro­pean Union for mul­ti­ple myeloma

Accelerated assess­ment and ap­prov­al based on long-term data from ELOQUENT-2, which eval­u­ated Empliciti in com­bi­na­tion with Revlimid® (lena­lido­mide) and dexa­meth­a­sone (Rd)

ELOQUENT-2 dem­onstrated the Empliciti com­bi­na­tion de­liv­ered a 53% rel­a­tive im­prove­ment in pro­gres­sion-free sur­vival vs. Rd alone at three years (23% vs. 15%)

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) an­nounced to­day that the Euro­pean Com­mis­sion has approved Empliciti™ (elo­tuzu­mab) for the treat­ment of mul­ti­ple myeloma as com­bi­na­tion ther­apy with Revlimid® (lena­lido­mide) and dexa­meth­a­sone in patients who have re­ceived at least one prior ther­apy. Empliciti is now the first and only immunostimulatory anti­body approved for mul­ti­ple myeloma in the Euro­pean Union (EU).

The ap­prov­al is based on data from the ran­dom­ized, open-label, Phase 3 ELOQUENT-2 study, which eval­u­ated Empliciti in …

• Oral plenary session presentation on dara­tu­mu­mab Phase III Castor study data
• Trial in progress poster presentation from Phase I study of sub­cu­tane­ous dara­tu­mu­mab

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that two dara­tu­mu­mab abstracts have been accepted for presentation at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June 3 — 7. The titles of the abstracts are avail­able on the ASCO website at www.asco.org via ASCO's iPlanner. With the exception of the dara­tu­mu­mab Phase III Castor study data, which has been designated as a late breaking abstract by ASCO, the full abstracts are scheduled to be …

Martinsried / Munich, Germany (Press Release) – MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) today announced that it filed a lawsuit in the United States (U.S.) District Court of Delaware against Janssen Biotech, and Genmab, A/S for patent infringement of U.S. Patent Number 8,263,746. This patent, which is owned by MorphoSys, describes and claims anti­bodies with particular features that bind to CD38.

By its complaint, MorphoSys seeks redress for the infringing manu­fac­ture, use and sale of Janssen's and Genmab's dara­tu­mu­mab, an anti­body targeting CD38. Janssen and Genmab recently obtained …