Application sup­ported by the Phase 3 MAIA study being reviewed under the FDA Real-Time Oncology Review pilot pro­gram

Raritan, NJ (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today the sub­mission of a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) seeking approval of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (Rd) for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT).

The sBLA, based upon data from the Phase 3 MAIA (MMY3008) clin­i­cal study, is being reviewed by the FDA under the Real-Time Oncology Review (RTOR) pilot pro­gram, which for …

• Phase III COLUMBA study com­par­ing the sub­cu­tane­ous for­mu­la­tion of dara­tu­mu­mab to the in­tra­venous for­mu­la­tion in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma met both co-primary end­points
• Results show that dara­tu­mu­mab admin­istered sub­cu­tane­ously was non-inferior in ef­fi­cacy and phar­ma­co­ki­netics as com­pared to dara­tu­mu­mab admin­istered in­tra­venously
• Data will be discussed with health author­i­ties to prepare for regu­la­tory filings in sup­port of bringing con­ve­nience of sub­cu­tane­ous dara­tu­mu­mab op­tion to patients

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) an­nounced to­day top­line re­­sults from the Phase III COLUMBA study (MMY3012) of sub­cu­tane­ous (SC) versus in­tra­venous (IV) dara­tu­mu­mab for patients with re­lapsed or re­frac­tory mul­ti­ple myeloma. The re­­sults showed that SC admin­istra­tion of dara­tu­mu­mab co-formulated with recombinant human hyal­uron­i­dase PH20 is non-inferior to IV admin­istra­tion of dara­tu­mu­mab with regard to the co-primary end points of over­all re­sponse rate (ORR) and Maximum Trough con­cen­tra­tion (C_trough) of dara­tu­mu­mab on day 1 of …

Revised prod­uct label allows for new admin­istra­tion option

Horsham, PA (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today that the U.S. Food and Drug Admin­istra­tion (FDA) has approved a split-dosing regi­men for DARZALEX® (dara­tu­mu­mab), providing health­care professionals and patients with multiple myeloma an option to split the first in­fusion over two consecutive days.¹ The U.S. FDA approval is based on data from the Phase 1b EQUULEUS (MMY1001) clin­i­cal study, which dem­onstrated DARZALEX phar­ma­co­ki­netic (PK) con­cen­tra­tions were com­parable at the end of weekly dosing, re­gard­less of whether the first dose was admin­istered as a split in­fusion …

• DARZALEX split dosing regi­men approved by U.S. FDA
• Provides health­care professionals with option to split first DARZALEX in­fusion over two consecutive days
• Approval sup­ported by data from EQUULEUS (MMY1001) clin­i­cal trial

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) has approved a split dosing regi­men for DARZALEX® (dara­tu­mu­mab). The approval will be in­cluded in an update to the Prescribing Infor­ma­tion in order to provide health­care professionals the option to split the first in­fusion of DARZALEX over two consecutive days. The supple­mental Biologics License Application (sBLA) was submitted by Genmab’s licensing partner, Janssen Biotech, Inc., in July, 2018. The split dosing …

Planegg / Munich, Germany (Press Release) – MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) announced today that in its lawsuit against Janssen Biotech and Genmab A/S, the parties have settled the dispute. As a result of this, the parties to the dispute have agreed to drop the mutual claims related to this lit­i­ga­tion.

On April 4, 2016 MorphoSys had 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. In 2017, a second …

• Genmab, Janssen and MorphoSys have agreed to end the patent infringement lawsuit launched by MorphoSys AG relating to DARZALEX
• On Jan­u­ary­ 25, 2019, a summary judge­ment de­ci­sion ruled that the three MorphoSys patents were invalid
• As a result of the agree­ment, MorphoSys will not appeal the summary judge­ment of invalidity and Genmab and Janssen will not pursue their inequitable conduct claim

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the patent infringement lawsuit launched by MorphoSys relating to DARZALEX® is finally over.

As pre­vi­ously reported, on Jan­u­ary­ 25, 2019, the U.S. District Court of the District of Delaware ruled that all three patents that MorphoSys had asserted against Genmab and Janssen Biotech, Inc. (Janssen) are invalid. As noted at that time, Genmab and Janssen’s alle­ga­tions that the patents were unenforceable for inequitable conduct remained to …

Patents asserted against Janssen Biotech, Inc. & Genmab in the United States have been declared invalid by summary judg­ment

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. District Court of Delaware has declared the three U.S. patents (Nos. 8,263,746, 9,200,061, and 9,758,590), asserted by MorphoSys AG against Genmab and Genmab’s col­lab­o­ration partner Janssen Biotech, Inc. (Janssen) are invalid by summary judg­ment. The patent infringement lawsuit was ini­ti­ated by MorphoSys against Genmab and Janssen in April 2016 asserting that activ­i­ties with DARZALEX (dara­tu­mu­mab) in the United States infringe its U.S. patents, and the case has been pend­ing before the U.S. District Court of Delaware. The …