• Study eval­u­ated the benefit of isatuximab in com­bi­na­tion with standard of care in prolonging pro­gres­sion free sur­vival as com­pared to standard of care in patients with re­lapsed / re­frac­tory multiple myeloma
• First ran­dom­ized Phase 3 trial to eval­u­ate the benefit of adding a mono­clonal anti­body to poma­lido­mide and dexa­meth­a­sone for treat­ment of re­lapsed / re­frac­tory multiple myeloma
• Multiple ongoing Phase 3 studies with isatuximab, an inves­ti­ga­tional agent, in com­bi­na­tion with standard of care ther­a­pies in newly diag­nosed and re­lapsed / re­frac­tory multiple myeloma

Paris, France (Press Release) – The pivotal Phase 3 trial of isatuximab in patients with re­lapsed / re­frac­tory multiple myeloma met the pri­mary end­point of prolonging pro­gres­sion free sur­vival in patients treated with isatuximab in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone versus poma­lido­mide and low-dose dexa­meth­a­sone alone (standard of care).

Results will be sub­mitted to an upcoming medical meeting and are antic­i­pated to form the basis of regu­la­tory sub­missions planned for later this year.

"We are ex­cited by these results, …

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 …

Planegg / Munich, Germany (Press Release) – MorphoSys AG (FSE: MOR; Prime Standard Seg­ment, MDAX & TecDAX; NASDAQ: MOR) announces that it was informed today that in its lawsuit against Janssen Biotech and Genmab A/S, the United States (U.S.) District Court of Delaware, based on a hearing held No­vem­ber 27, 2018, has ruled in a Court Order on Jan­u­ary­ 25, 2019, that the asserted claims of three MorphoSys patents with U.S. Patent Numbers 8,263,746; 9,200,061 and 9,758,590 are invalid. The Court thus granted a motion for Summary Judgement of invalidity filed by Janssen Biotech …

• First part of regu­la­tory package submitted to the U.S. FDA for label expansion of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for patients with newly diag­nosed multiple myeloma who are not can­di­dates for high dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant
• The U.S. FDA plan to review the sub­mission under their Real-Time Oncology Review Pilot Program
• Application based on data from Phase III MAIA (MMY3008) study

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its licensing partner, Janssen Biotech, Inc. (Janssen), has submitted the first part of a regu­la­tory sub­mission to the U.S. Food and Drug Admin­istra­tion (U.S. FDA) for a label expansion to in­clude the use of dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of patients with newly diag­nosed multiple myeloma who are not can­di­dates for high dose chemo­ther­apy and au­tol­o­gous stem cell trans­plant (ASCT).  The U.S. FDA plans to …

Beerse, Belgium (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson today announced that the European Com­mis­sion has granted mar­ket­ing authori­sa­tion to provide health­care professionals with the option to split the first in­fusion of Darzalex® (dara­tu­mu­mab) over two consecutive days.

“We are committed to the devel­op­ment of new treat­ments, com­bi­na­tions, and for­mu­la­tions that will sup­port people living with multiple myeloma across the full disease spectrum,” said Dr Catherine Taylor, Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead, Janssen. “This is an im­por­tant de­ci­sion for health­care professionals and patients, as …