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Genmab nog niet te duur

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Auteur: Mark Leenards

Mark Leenards is strategieontwikkelaar voor beleggingsfondsen en vanaf zeer jonge leeftijd actief belegger voor eigen rekening. Leenards selecteert aandelen op basis van een zelf ontwikkeld kwantitatief screeningmodel dat toegepast kan worden op ruim 50.000 aandelen wereldwijd. Naast aandelenselectie houdt hij zich bezig met ...

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8 Posts
| Omlaag ↓
  4. sheriff Grover 5 juni 2015 20:20
    Genmab Announces Start of Rolling Submission of Biologics License Application for Daratumumab for Double Refractory Multiple Myeloma to the FDA

    COPENHAGEN, Denmark, June 5, 2015 (GLOBE NEWSWIRE) -- Genmab A/S (GEN.CO) announced today its licensing partner Janssen Biotech, Inc. has initiated a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for daratumumab. The submission is for daratumumab as a treatment for patients with multiple myeloma who have received at least three different lines of therapy including both a proteasome inhibitor and an immunomodulatory agent (IMiD) or who are double refractory to a proteasome inhibitor and an IMiD. A rolling submission allows completed portions of the application to be submitted to the FDA on an ongoing basis. The FDA grants this type of review if the agency determines after a preliminary evaluation of clinical data that the breakthrough therapy may be effective and therefore, will consider reviewing portions of an application before the submission is complete. In August 2012, Genmab and Janssen Biotech, Inc. entered an agreement which granted Janssen a worldwide exclusive license to develop, manufacture and commercialize daratumumab. Janssen is currently the sponsor of all but one study globally.

    The submission includes data from the Phase II study (Sirius MMY2002) of daratumumab in multiple myeloma patients who have received at least three prior lines of therapy including both a proteasome inhibitor and an IMiD or who are double refractory to a proteasome inhibitor and an IMiD. However, safety and efficacy data from the Phase I/II study (GEN501) and safety data from three other studies, have also been included in the BLA submission. Daratumumab received a Breakthrough Therapy Designation (BTD) for this indication from the FDA in May 2013.

    "Daratumumab is a highly innovative antibody that holds promise for patients with multiple myeloma, a disease for which there is currently no cure. Today, patients that are double refractory have run out of treatment options and we are very pleased that daratumumab offers the potential to help this group of patients. The initiation of this rolling BLA submission is a landmark in the development of daratumumab and we are working together with Janssen to bring this new treatment option to patients as quickly as we can," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

    About multiple myeloma

    Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the United States (U.S.), following only leukemia and lymphoma.2 Approximately 26,850 new patients will be diagnosed with multiple myeloma and approximately 11,240 people will die from the disease in the U.S. in 2015.3 Globally, it is estimated that 114,251 people will be diagnosed and 80,019 will die from the disease.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

    About daratumumab

    Daratumumab is an investigational human IgG1k monoclonal antibody (mAb) that binds with high affinity to the transmembrane ectoenzyme, CD38, on the surface of multiple myeloma cells. It induces rapid tumor cell death through diverse mechanisms of action. Five Phase III clinical studies with daratumumab in relapsed and frontline settings are currently ongoing. Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma and non-Hodgkin's lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the US FDA.

  6. sheriff Grover 9 juli 2015 22:06
    Genmab Announces Completion of Rolling Submission of Biologics License Application for Daratumumab in Multiple Myeloma and Achievement of a USD 15 Million Milestone

    Company Announcement
    • Submission of rolling BLA to US FDA for daratumumab in multiple myeloma completed by Janssen Biotech, Inc.
    • Completion of submission triggers USD 15 million milestone payment to Genmab

    Copenhagen, Denmark; July 9, 2015 — Genmab A/S (OMX: GEN) announced its licensing partner Janssen Biotech, Inc. has completed the rolling submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for daratumumab. The submission is for daratumumab as a treatment for patients with multiple myeloma who have received at least three prior lines of therapy including both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD. In May, 2013, daratumumab was granted a Breakthrough Therapy Designation (BTD) in this population. The completion of the submission triggers a milestone payment of USD 15 million to Genmab from Janssen. The milestone was included in Genmab's financial guidance for 2015, which was updated on May 20, 2015. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

    A request for Priority Review has been submitted by Janssen with this BLA. The FDA will inform Janssen whether a Priority Review has been granted by calendar day 60 of their review starting today. If the FDA grants Priority Review the review period may not exceed 6 months from that date.

    If daratumumab receives FDA approval, Genmab will receive a milestone payment from Janssen of USD 45 million associated with the first commercial sale of the product in the United States. However, it is not possible to precisely predict the timing of a potential marketing approval and first commercial sale; therefore, this milestone has not been included in the 2015 financial guidance at this time.
    The rapid completion of the BLA submission brings us a significant step closer to the potential regulatory approval of daratumumab," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Daratumumab received Breakthrough Therapy Designation from the FDA for this indication for multiple myeloma patients who have no other treatment options available, and we are proud that our partner Janssen has completed the submission in record time."

    The submission includes data from the Phase II study (Sirius MMY2002) of daratumumab in multiple myeloma patients who have received at least three prior lines of therapy including both a PI and an IMiD, or who are double refractory to a PI and an IMiD. However, safety and efficacy data from the Phase I/II study (GEN501) and safety data from three other studies have also been included in the BLA submission.

    About multiple myeloma
    Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the United States (U.S.), following only leukemia and lymphoma.2 Approximately 26,850 new patients will be diagnosed with multiple myeloma and approximately 11,240 people will die from the disease in the U.S. in 2015.3 Globally, it is estimated that 114,251 people will be diagnosed and 80,019 will die from the disease.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

    About daratumumab
    Daratumumab is an investigational human IgG1k monoclonal antibody (mAb) that binds with high affinity to the transmembrane ectoenzyme, CD38, on the surface of multiple myeloma cells. It induces rapid tumor cell death through diverse mechanisms of action. Five Phase III clinical studies with daratumumab in relapsed and frontline settings are currently ongoing. Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma and non-Hodgkin's lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the US FDA.

    Weer een belangrijke stap op weg naar goedkeuring !

    Sheriff Grover
8 Posts
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