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 …

• Split dosing regi­men approved by European Com­mis­sion
• 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 European Com­mis­sion (EC) has granted mar­ket­ing authori­za­tion for a split dosing regi­men for DARZALEX® (dara­tu­mu­mab). The approval will be in­cluded in an update of the Summary of Product Characteristics in order to provide health care professionals the option to split the first in­fusion of DARZALEX over two consecutive days. The EC approval follows a pos­i­tive opinion issued for DARZALEX by the European Committee for Medicinal Products for …

DARZALEX® com­bi­na­tion ther­apy sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death com­pared to a preferred regi­men alone.^1,2

Toronto, ON (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today that Health Canada has approved DARZA­LEX® (dara­tu­mu­mab), in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone (VMP), for the treat­ment of patients newly diag­nosed with multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plan­ta­tion.³ DARZA­LEX® is the first mono­clonal anti­body to be approved for newly diag­nosed patients in Canada.

Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow un­con­trol­lably in the bone marrow.^4,5 The dis­ease can be very complex to treat as most patients …

• Supplemental new drug appli­ca­tion submitted in Japan for dara­tu­mu­mab in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma in­eli­gible for au­tol­o­gous stem cell trans­plant
• Submission based on data from Phase III ALCYONE study
• Genmab to receive USD 2 million mile­stone pay­ment from Janssen

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Janssen Pharma­ceu­tical K.K. has submitted a supple­mental new drug appli­ca­tion (sNDA) to the Ministry of Health, Labor and Welfare (MHLW) in Japan, for the use of dara­tu­mu­mab (DAR­ZALEX®) 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). The appli­ca­tion will receive a priority review. The sub­mission of the appli­ca­tion triggers …

• CHMP issued pos­i­tive opinion on split dosing regi­men for DARZALEX
• Final de­ci­sion from European Com­mis­sion ex­pec­ted in the coming months
• Opinion sup­ported by data from EQUULEUS (MMY1001) clin­i­cal trial

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a pos­i­tive opinion rec­om­mending updating the existing mar­ket­ing authori­za­tion for DARZALEX® (dara­tu­mu­mab) in the European Union. The recom­men­da­tion is to update the Summary of Product Characteristics in order to provide health care professionals the option to split the first in­fusion of DARZALEX over two consecutive days. The Type II variation …