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 …

First-in-class mono­clonal anti­body targeting CD38 for the treat­ment of multiple myeloma

Beerse, Belgium (Press Release) – Janssen-Cilag Inter­na­tional NV ("Janssen") announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion rec­om­mending a con­di­tional mar­ket­ing authori­sa­tion for first-in-class CD38 immuno­therapy DARZALEX® (dara­tu­mu­mab) in the European Union. The rec­om­mended indi­ca­tion is 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.¹ This appli­ca­tion was reviewed under an accelerated …

PharmaMar intends to submit a Marketing Authorization Application to the European Medicines Agency during the last quarter of this year

Madrid (Press Release) – PharmaMar (MSE:PHM) today announced positive top-line results of its Phase III clin­i­cal trial -ADMYRE- with Aplidin® (plitidepsin) in combination with dexa­metha­sone versus dexa­metha­sone alone in patients with relapsed/refractory multiple myeloma (MM). Aplidin® has shown a statistically sig­nif­i­cant 35% reduction in the risk of pro­gres­sion or death over the com­parator (p=0.0054). The study has met its pri­mary end­point.

This pivotal, ran­dom­ized, open-label, inter­na­tional, multi­center Phase III clin­i­cal trial, called ADMYRE, en­rolled 255 patients in 83 medical …

Silver Spring, MD (Press Release) – The U.S. Food and Drug Admin­istra­tion today approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with addi­tional kidney or lung ab­nor­mal­i­ties after they receive a stem cell trans­plant from blood or bone marrow called hematopoietic stem cell trans­plan­ta­tion (HSCT). This is the first FDA-approved ther­apy for treat­ment of severe hepatic VOD, a rare and life-threatening liver con­di­tion.

HSCT is a procedure per­formed in some patients to treat certain blood or bone marrow cancers. Immediately before an HSCT procedure, a …

Silver Spring, MD (Press Release) – On March 30, 2016, the U. S. Food and Drug Admin­istra­tion approved Defitelio (defibrotide sodium, Jazz Pharma­ceu­ticals, Inc.) for the treat­ment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstructive syn­drome, with renal or pul­monary dysfunction fol­low­ing hematopoietic stem-cell trans­plan­ta­tion (HSCT).

The efficacy of defibrotide sodium was in­ves­ti­gated in 528 patients treated on three studies: two prospective clin­i­cal trials and an expanded access study. The patients enrolled had a diag­nosis of hepatic VOD with multi-organ dysfunction after trans­plan­ta­tion. They received …

Independent Data Monitoring Committee rec­om­mends Phase 3 trial be stopped early based on pos­i­tive results of planned interim analysis

Raritan, NJ (Press Release) – Janssen Research & Development, LLC announced today pos­i­tive results of a pre-planned interim analysis of the Phase 3 MMY3004 (CASTOR) trial eval­u­ating the efficacy and safety of dara­tu­mu­mab, a CD38-directed mono­clonal anti­body (mAb), in com­bi­na­tion with bor­tez­o­mib and dexa­metha­sone, com­pared to bor­tez­o­mib and dexa­metha­sone alone, in patients with re­lapsed or refractory multiple myeloma. The interim analysis, conducted by an Independent Data Monitoring Committee (IDMC), found that the dara­tu­mu­mab com­bi­na­tion treat­ment regi­men im­proved pro­gres­sion-free survival (PFS) com­pared with bor­tez­o­mib and dexa­metha­sone alone, achieving the pri­mary study end­point …

Lund, Sweden (Press Release) – Active Biotech (Nasdaq Stockholm: ACTI) to­day an­nounces that a pat­ent appli­ca­tion for the treat­ment of mul­ti­ple myeloma with the com­pany's com­­pound tasquinimod, to­geth­er with an inter­na­tional search report, will be pub­lic within short on WIPO's (World Intellectual Property Organi­za­tion) web site www.wipo.int. With this appli­ca­tion (WO 2016/042112), treat­ment of mul­ti­ple myeloma with tasquinimod is poten­tially pro­tected until 2035. With the aim to ex­pand the pat­ent pro­tec­tion for tasquinimod, a pre­clin­i­cal pro­gram was per­formed and very good results were achieved in models for mul­ti­ple myeloma. The existing med­i­cal …