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Genmab — September 2020

Planlagt Fastgjort Låst Flyttet Genmab
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  • BulderB Offline
    BulderB Offline
    Bulder
    wrote on sidst redigeret af
    #545

    Yes, but I would prefer a large Janssen-led study in RA.

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    0
    • E Offline
      E Offline
      E_L
      wrote on sidst redigeret af
      #546

      offcourse, so would I. However, I am wondering more and more if maybe JNJ will wait for early efficacy of HexabodyCD38 before deciding what they will do with any new CD38 trials...
      ?

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      0
      • G Offline
        G Offline
        gentogen
        wrote on sidst redigeret af
        #547

        From previous link: If the Parties mutually agree on a Term Sheet by 31 August 2020, the Parties shall negotiate in good faith a license agreement in accordance with the Term Sheet for a period of sixty (60) calendar days starting on 1 September 2020, which sixty (60) calendar day period may be extended by prior mutual written agreement by the Parties (the “Negotiation Period”).

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        • G Offline
          G Offline
          gentogen
          wrote on sidst redigeret af
          #548

          If we fail to agree on the key financial terms or if no license agreement has been entered into during the specified time period to do so, a defined process to facilitate the divestment of Cami will be initiated. This process includes the opportunity for both parties to bid for the license rights alongside third parties

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          0
          • DarvinD Offline
            DarvinD Offline
            Darvin
            wrote on sidst redigeret af
            #549

            Præcis

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            0
            • E Offline
              E Offline
              E_L
              wrote on sidst redigeret af
              #550

              i don't think that stops the divestment process of the 25%? and then there is still the Genmab antibody they will want royalties/licence payments on

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              0
              • K Offline
                K Offline
                KWC
                wrote on sidst redigeret af
                #551

                FDA Accepts BLA for bluebird and BMS' Multiple Myeloma CAR-T Treatment

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                0
                • K Offline
                  K Offline
                  KWC
                  wrote on sidst redigeret af
                  #552

                  https://www.biospace.com/article/fda-accepts-bla-for-bms-and-bluebird-s-bla-for-multiple-myeloma-car-t-under-priority-review/?utm_campaign=Daily Article&utm_content=140594344&utm_medium=social&utm_source=facebook&hss_channel=fbp-10530620221

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                  • B Offline
                    B Offline
                    BioShare
                    wrote on sidst redigeret af
                    #553

                    Der var så ikke helt enighed om aftalen og betalingen til HALO for SC 😞 https://finance.yahoo.com/news/genmab-commences-bindin
                    g-arbitration-two-210400349.html

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                    • B Offline
                      B Offline
                      BioShare
                      wrote on sidst redigeret af
                      #554

                      Link Preview Image
                      Genmab Commences Binding Arbitration of Two Matters Under License Agreement with Janssen

                      Company AnnouncementCopenhagen, Denmark; September 22, 2020 – Genmab A/S (Nasdaq: GMAB) announced today that it has commenced binding arbitration of two matters arising under its license agreement with Janssen Biotech, Inc. (Janssen) relating to daratumumab. Under the license agreement, Genmab is, among other things, entitled to royalties from Janssen on sales of daratumumab (marketed as DARZALEX® for intravenous administration and, in the United States, as DARZALEX FASPRO™ for subcutaneous administration).The arbitration first is to settle whether Genmab is required to share in Janssen’s royalty payments to Halozyme Therapeutics, Inc. for the Halozyme enzyme technology used in the subcutaneous formulation of daratumumab. The royalties Janssen pays to Halozyme represent a mid-single digit percentage rate of subcutaneous daratumumab sales. Janssen has started reducing its royalty payments to Genmab by what it claims to be Genmab’s share of Janssen’s royalty payments to Halozyme for the second quarter of 2020.The arbitration is also to settle whether Janssen’s obligation to pay royalties on sales of licensed product extends, in each applicable country, until the expiration or invalidation of the last-to-expire relevant Genmab-owned patent or the last-to-expire relevant Janssen-owned patent covering the product, as further defined and described in the license agreement. The relevant Genmab-owned issued U.S., European and Japanese patents will expire in the late 2020s and early 2030s. The relevant Janssen-owned issued patents and patent applications (if granted) covering the subcutaneous formulation of daratumumab would expire in the mid-2030s.Under the agreement, the arbitration will be conducted in New York pursuant to the rules of the CPR Institute for Dispute Resolution for Non-Administered Arbitration before a panel of three arbitrators. While Genmab intends to vigorously protect its rights under the agreement, the outcome of any arbitration proceeding, as well as its duration, is inherently uncertain. The arbitration will be confidential, subject to the parties’ disclosure obligations under applicable law. Other than pursuant to these obligations, Genmab does not intend to comment or provide additional information regarding the arbitration until an order on the merits or other material order is issued in the arbitration or the arbitration is otherwise concluded. While the arbitration is pending, Genmab’s collaborations with Janssen on daratumumab and HexaBody®-CD38 will continue.Based on currently available information, Genmab does not expect these matters to materially affect its 2020 financial guidance.About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of the following approved antibodies: DARZALEX® (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Kesimpta® (subcutaneous ofatumumab, under agreement with Novartis AG), for the treatment of adults with relapsing forms of multiple sclerosis in the U.S. and TEPEZZA® (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, known as DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in the U.S., has been approved in the U.S. and Europe for the treatment of adult patients with certain multiple myeloma indications. The first approved Genmab created therapy, Arzerra® (ofatumumab, under agreement with Novartis AG), approved for the treatment of certain chronic lymphocytic leukemia indications, is available in Japan and is also available in other territories via compassionate use or oncology access programs. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody® platform for generation of bispecific antibodies, the HexaBody® platform, which creates effector function enhanced antibodies, the HexElect® platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody® platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. Contact:           Marisol Peron, Corporate Vice President, Communications & Investor Relations T: +1 609 524 0065; E: [email protected] Investor Relations: Andrew Carlsen, Senior Director, Investor Relations T: +45 3377 9558; E: [email protected] This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. Arzerra® and Kesimpta® are trademarks of Novartis AG or its affiliates. DARZALEX® and DARZALEX FASPRO™ are trademarks of Janssen Pharmaceutica NV. TEPEZZA® is a trademark of Horizon Therapeutics plc. Company Announcement no. 39 CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122Genmab A/S Kalvebod Brygge 43 1560 Copenhagen V Denmark Attachment * 220920_CA39_Arbitration

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                      • B Offline
                        B Offline
                        BioShare
                        wrote on sidst redigeret af
                        #555

                        Link Preview Image
                        Genmab Commences Binding Arbitration of Two Matters Under License Agreement with Janssen

                        Company AnnouncementCopenhagen, Denmark; September 22, 2020 – Genmab A/S (Nasdaq: GMAB) announced today that it has commenced binding arbitration of two matters arising under its license agreement with Janssen Biotech, Inc. (Janssen) relating to daratumumab. Under the license agreement, Genmab is, among other things, entitled to royalties from Janssen on sales of daratumumab (marketed as DARZALEX® for intravenous administration and, in the United States, as DARZALEX FASPRO™ for subcutaneous administration).The arbitration first is to settle whether Genmab is required to share in Janssen’s royalty payments to Halozyme Therapeutics, Inc. for the Halozyme enzyme technology used in the subcutaneous formulation of daratumumab. The royalties Janssen pays to Halozyme represent a mid-single digit percentage rate of subcutaneous daratumumab sales. Janssen has started reducing its royalty payments to Genmab by what it claims to be Genmab’s share of Janssen’s royalty payments to Halozyme for the second quarter of 2020.The arbitration is also to settle whether Janssen’s obligation to pay royalties on sales of licensed product extends, in each applicable country, until the expiration or invalidation of the last-to-expire relevant Genmab-owned patent or the last-to-expire relevant Janssen-owned patent covering the product, as further defined and described in the license agreement. The relevant Genmab-owned issued U.S., European and Japanese patents will expire in the late 2020s and early 2030s. The relevant Janssen-owned issued patents and patent applications (if granted) covering the subcutaneous formulation of daratumumab would expire in the mid-2030s.Under the agreement, the arbitration will be conducted in New York pursuant to the rules of the CPR Institute for Dispute Resolution for Non-Administered Arbitration before a panel of three arbitrators. While Genmab intends to vigorously protect its rights under the agreement, the outcome of any arbitration proceeding, as well as its duration, is inherently uncertain. The arbitration will be confidential, subject to the parties’ disclosure obligations under applicable law. Other than pursuant to these obligations, Genmab does not intend to comment or provide additional information regarding the arbitration until an order on the merits or other material order is issued in the arbitration or the arbitration is otherwise concluded. While the arbitration is pending, Genmab’s collaborations with Janssen on daratumumab and HexaBody®-CD38 will continue.Based on currently available information, Genmab does not expect these matters to materially affect its 2020 financial guidance.About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of the following approved antibodies: DARZALEX® (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Kesimpta® (subcutaneous ofatumumab, under agreement with Novartis AG), for the treatment of adults with relapsing forms of multiple sclerosis in the U.S. and TEPEZZA® (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, known as DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in the U.S., has been approved in the U.S. and Europe for the treatment of adult patients with certain multiple myeloma indications. The first approved Genmab created therapy, Arzerra® (ofatumumab, under agreement with Novartis AG), approved for the treatment of certain chronic lymphocytic leukemia indications, is available in Japan and is also available in other territories via compassionate use or oncology access programs. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody® platform for generation of bispecific antibodies, the HexaBody® platform, which creates effector function enhanced antibodies, the HexElect® platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody® platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. Contact:           Marisol Peron, Corporate Vice President, Communications & Investor Relations T: +1 609 524 0065; E: [email protected] Investor Relations: Andrew Carlsen, Senior Director, Investor Relations T: +45 3377 9558; E: [email protected] This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. Arzerra® and Kesimpta® are trademarks of Novartis AG or its affiliates. DARZALEX® and DARZALEX FASPRO™ are trademarks of Janssen Pharmaceutica NV. TEPEZZA® is a trademark of Horizon Therapeutics plc. Company Announcement no. 39 CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122Genmab A/S Kalvebod Brygge 43 1560 Copenhagen V Denmark Attachment * 220920_CA39_Arbitration

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                        • HenryASH Offline
                          HenryASH Offline
                          HenryAS
                          wrote on sidst redigeret af
                          #556

                          Min Agro idag: Genmab kan snart gå i køb igen igen 😉 kursmål 3.000-3.500

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                          0
                          • K Offline
                            K Offline
                            Klarussen
                            wrote on sidst redigeret af
                            #557

                            22 sep, 23:51
                            Ritzau
                            Genmab: I royalty-slagsmål med Jannsen
                            Den danske biotekkoncern Genmab er røget i totterne på sin meget vigtige amerikanske partner Janssen omkring royalty-betalinger forbundet med blockbuster-kræftmidlet Daratumumab, også kendt som Darzalex.
                            Det fremgår af en fondsbørsmeddelelse tirsdag aften.
                            De to selskaber har derfor indledt en bindende voldgiftssag i New York ved CPR Institute for Dispute Resolution for Non-Administered Arbitration… https://borsen.dk/investor/live/2247

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                            0
                            • K Offline
                              K Offline
                              Klarussen
                              wrote on sidst redigeret af
                              #558

                              Koster vel noget på kursen?

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                              0
                              • Helge_LarsenPI-redaktørH Offline
                                Helge_LarsenPI-redaktørH Offline
                                Helge_LarsenPI-redaktør
                                wrote on sidst redigeret af
                                #559

                                God morgen. 🙂

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                                0
                                • Helge_LarsenPI-redaktørH Offline
                                  Helge_LarsenPI-redaktørH Offline
                                  Helge_LarsenPI-redaktør
                                  wrote on sidst redigeret af
                                  #560

                                  At tage en voldgiftssag i forbindelse med en uenighed omkring kontraktlige forhold er nu meget almindeligt to parter i mellem.

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                                  0
                                  • Helge_LarsenPI-redaktørH Offline
                                    Helge_LarsenPI-redaktørH Offline
                                    Helge_LarsenPI-redaktør
                                    wrote on sidst redigeret af
                                    #561

                                    Muligheden indskrives stort set i alle forretningsmæssige kontrakter.

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                                    0
                                    • T Offline
                                      T Offline
                                      transalp
                                      wrote on sidst redigeret af
                                      #562

                                      Go morgen.. 🙂

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                                      0
                                      • Helge_LarsenPI-redaktørH Offline
                                        Helge_LarsenPI-redaktørH Offline
                                        Helge_LarsenPI-redaktør
                                        wrote on sidst redigeret af
                                        #563

                                        Meddelelsen er her: https://www.proinvestor.com/index.php?p=debat_1&postid=86970

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                                        0
                                        • L Offline
                                          L Offline
                                          lahn1
                                          wrote on sidst redigeret af
                                          #564

                                          Uha, tænker at patent spørgsmålet potentielt kan koste os meget mere end en andel af 5% til Halo. Er der nogen som har overblik over dara patenter og udløbs datoer som holdes af hhv Gmab og Jansen. Hvad er risikoen ?

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