Genmab, de Deense parel

1. [verwijderd] 10 maart 2016 22:07

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   globenewswire.com/news-release/2016/0...
2. [verwijderd] 16 maart 2016 08:48

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   Na indiening bij EU nu dus ook indiening bij FDA (USA). Novartis is op stoom met Azerra voor patienten met chronische leukemie. Op naar een goedkeuring....
3. sheriff Grover 22 maart 2016 11:16

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   Genmab Announces Studies of Daratumumab in Combination with Atezolizumab in a Solid Tumor and Multiple Myeloma
   
   Company Announcement
   • Phase Ib studies of daratumumab in combination with Roche's immune checkpoint inhibitor atezolizumab in a solid tumor and multiple myeloma to be started
   • Studies conducted under a clinical trial collaboration agreement between Janssen and Roche
   
   Copenhagen, Denmark; March 21, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that daratumumab will be investigated in early stage clinical studies in combination with atezolizumab (anti-PD-L1 antibody), in a solid tumor and multiple myeloma. The studies will be conducted under a clinical trial collaboration agreement between Genmab's licensing partner for daratumumab, Janssen Biotech, Inc., and Genentech, a member of the Roche Group. Atezolizumab is an investigational monoclonal antibody designed to bind to a protein called PD-L1, which is expressed on tumor cells and tumor-infiltrating immune cells. Janssen will conduct a Phase Ib study of daratumumab in combination with atezolizumab to treat a solid tumor. Genentech will amend an ongoing Phase Ib study to assess atezolizumab in combination with daratumumab, with daratumumab and lenalidomide, and with daratumumab and pomalidomide in relapsed/refractory multiple myeloma (NCT02431208). The studies are expected to start enrolling patients later this year and information about the studies will be posted on www.clinicaltrials.gov.
   
   "We are very excited about the start of the first study to investigate daratumumab in a solid tumor, potentially expanding its clinical utility beyond hematological cancers. We are equally excited about testing daratumumab in combination with an immune checkpoint inhibitor, such as Roche's anti-PDL1, atezolizumab, in multiple myeloma. Both studies mark a key next step in the expansive clinical development of daratumumab in the hope to find even more effective treatment options for cancer patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
   
   Mooi nieuws nu dus ook Darzalex studie voor solide tumoren (een veel grotere markt!)ism Roche / Genetech
   
   Sheriif Grover
4. Fredk 22 maart 2016 11:57

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   quote:

   sheriff Grover schreef op 22 maart 2016 11:16:

   Genmab Announces Studies of Daratumumab in Combination with Atezolizumab in a Solid Tumor and Multiple Myeloma
   
   Company Announcement
   
   Mooi nieuws nu dus ook Darzalex studie voor solide tumoren (een veel grotere markt!)ism Roche / Genetech
   
   Sheriif Grover
   

   Dank voor posting Sheriff! Mooie ontwikkeling voor dit prachtbedrijf .......
5. [verwijderd] 22 maart 2016 12:15

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   Mooi bericht, dank Sheriff. Dit zou Genmab product portfolio weer een bredere basis geven. Dus aandeel nog wat langer op de plank laten en helaas af en toe even doorbijten bij -vaak tijdelijke- grotere of kleinere (neergaande) koersbewegingen. Genmab is en blijft een bijzonder bedrijf met nog heel veel (te benutten) potentieel.
6. sheriff Grover 30 maart 2016 20:16

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   Genmab Announces Positive Interim Result in Phase III Castor Study of Daratumumab in Relapsed or Refractory Multiple Myeloma
   
   Company Announcement
   
   Phase III Castor study of daratumumab in combination with bortezomib and dexamethasone in relapsed or refractory multiple myeloma met primary endpoint at pre-planned interim analysis
   IDMC recommended to stop the clinical trial early
   Data will be discussed with authorities to prepare for regulatory filings
   Copenhagen, Denmark; March 30, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the Phase III Castor study (MMY3004) of daratumumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma met the primary endpoint of improving progression free survival (PFS) in an interim analysis (p =< 0.0001). The planned interim analysis was conducted by an Independent Data Monitoring Committee (IDMC).
   
   Daratumumab showed a tolerable safety profile in the interim analysis. Based on the IDMC's recommendation, the study will be stopped early. Patients originally assigned to the bortezomib plus dexamethasone treatment group will be offered the option of receiving daratumumab following confirmed disease progression. Patients will continue to be monitored for safety and overall survival. Further analysis of the safety and efficacy data is underway. Based on the interim data, Janssen Biotech, Inc., who licensed daratumumab from Genmab in 2012, will engage in a dialogue with health authorities about the potential for these data to serve as the basis for a regulatory submission for daratumumab in this indication.
   
   "We are very pleased with the positive interim result in this study, which documents the therapeutic potential of daratumumab in combination with bortezomib and dexamethasone. We look forward to having the data presented at a future major medical conference," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab
   
   Weer een belangrijke stap ! Data zijn klaarblijkelijk zo goed dat ze eerder met de studie mogen stoppen en dus nu versneld kunnen indienen voor 2e lijn goedkeuring !
   
   Sheriff Grover
7. Fredk 30 maart 2016 20:42

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   quote:

   sheriff Grover schreef op 30 maart 2016 20:16:

   Genmab Announces Positive Interim Result in Phase III Castor Study of Daratumumab in Relapsed or Refractory Multiple Myeloma
   
   Company Announcement
   
   Weer een belangrijke stap ! Data zijn klaarblijkelijk zo goed dat ze eerder met de studie mogen stoppen en dus nu versneld kunnen indienen voor 2e lijn goedkeuring !
   
   Sheriff Grover
   

   Dank je S. Grover .. Mooie ontwikkeling! 't Wordt steeds spannnender!
   
   Fredk.
8. [verwijderd] 1 april 2016 18:05

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   En weer een stap voor Daratumumab....
   
   CHMP issued positive opinion for DARZALEX for relapsed and refractory multiple myeloma
   Final decision from European Commission expected in the coming months
   Copenhagen, Denmark; April 1, 2016 — 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 the grant of a conditional marketing authorization for DARZALEX® (daratumumab) in the European Union. The recommendation is for the use of DARZALEX as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
   The positive opinion of the CHMP was predominantly based on data from the Phase II study (SIRIUS MMY2002, published in The Lancet in January 2016) of daratumumab in multiple myeloma patients who have received at least three prior lines of therapy including both a PI and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent. Additional data from four other studies, including the Phase I/II GEN501 monotherapy study (published in The New England Journal of Medicine in August 2015) support the opinion. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
9. Fredk 1 april 2016 20:30

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   Dank je Jeroen! ... Spannend(er) ontwikkeling! ....
10. sheriff Grover 5 april 2016 07:17

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    Patent Infringement Lawsuit Filed Against Genmab and Janssen in the United States Regarding DARZALEX®
    
    Company Announcement
    • Morphosys AG files patent infringement complaint against Genmab and Janssen Biotech, Inc. with the US District Court of Delaware
    • Complaint is under US patent no. 8,263,746
    
    Copenhagen, Denmark; April 4, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Morphosys apparently has filed a complaint at the US District Court of Delaware against Genmab and Genmab's collaboration partner Janssen Biotech, Inc. for patent infringement under US patent no. 8,263,746 based on activities relating to manufacture, use and sale of DARZALEX (daratumumab) in the United States. The US patent relates to CD38 antibodies defined by functional features.
    
    DARZALEX is approved in the US for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent and a marketing application has been submitted in the EU for daratumumab for use in patients with relapsed and refractory multiple myeloma by Janssen.
    
    Janssen will in consultation with Genmab determine the appropriate action in response to the complaint.
    
    About DARZALEX® (daratumumab)
    
    Waarschijnlijk niet meer dan een wanhopige actie om een graantje mee te pikken maar vervelend kan weer maanden zo niet jaren duren in het slechtste geval . Kans dat de koers een tikje krijgt vandaag ..
    
    Never a dull moment @ Genmab !
11. [verwijderd] 5 april 2016 08:52

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    Nu Darzalex gaat lopen wordt deze zaak aanhangig gemaakt. Tja, timing....gaat om grote belangen. Jammer, want leidt af van de focus van Genmab en kost altijd extra tijd en energie. Hoort wellicht helaas ook bij een sterk groeiende biotech, die steeds meer in de spotlights staat. Dus positief gezien markeert dit ook het succes van de het bedrijf, in de USA en daarbuiten. Vooralsnog een kleine tegenslag op de weg omhoog...
12. Fredk 5 april 2016 09:44

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    quote:

    jeroengp01 schreef op 5 april 2016 08:52:

    Nu Darzalex gaat lopen wordt deze zaak aanhangig gemaakt. Tja, timing... Dus positief gezien markeert dit ook het succes van de het bedrijf, in de USA en daarbuiten. Vooralsnog een kleine tegenslag op de weg omhoog...
    

    Wat een vertrouwen wordt hier uitgesproken! (ook door S. Grover) .....Dank daarvoor!
13. Fredk 5 april 2016 23:25

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    Koers heeft redelijk standgehouden ondanks deze juridische aanval ......
14. sheriff Grover 20 april 2016 09:01

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    Genmab Updates Financial Guidance for 2016
    
    Company Announcement
    • Genmab improves financial guidance for 2016
    • Improvement driven by DARZALEX® sales
    • Rapid uptake of the product since launch
    
    Copenhagen, Denmark; April 20, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that it is improving its financial guidance published on February 17, 2016. The improvement is driven by the anticipation of increased royalty income related to the sales of DARZALEX by Genmab's collaboration partner Janssen Biotech, Inc. and the rapid uptake of the product since launch.
    
    "We are pleased to improve our 2016 financial guidance based on the robust level of DARZALEX sales that we have seen since the product's launch in November 2015," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
    
    Outlook 2016
    
    MDKK Revised Guidance Original Guidance
    Revenue 925 — 975 825 — 875
    Operating expenses (775) — (825) (775) — (825)
    Operating income 125 — 175 25 — 75
    Cash position at end of year* 3,400 — 3,500 3,300 — 3,400
    *Cash, cash equivalents, and marketable securities
    
    We expect our 2016 revenue to be in the range of DKK 925 — 975 million, an increase of DKK 100 million compared to the previous guidance. Our projected revenue for 2016 consists primarily of daratumumab milestones of DKK 400 million and DARZALEX royalties of DKK 300 — 350 million (previously DKK 200 — 250 million) that are based on an estimated USD 400 — 450 million of DARZALEX sales in 2016 (previously USD 250 — 300 million). The remainder of the revenue mainly consists of Arzerra® royalties, DuoBody® milestones, and non-cash amortization of deferred revenue.
    
    We anticipate that our 2016 operating expenses will remain in the range of DKK 775 — 825 million. The increased expense level from previous years is driven by the additional investment in our pipeline of products, including the advancement of tisotumab vedotin as well as HuMax®-AXL-ADC, HexaBody®-DR5/DR5, DuoBody-CD3xCD20, and our other pre-clinical programs.
    
    We expect the operating income for 2016 to be approximately DKK 125 - 175 million, an improvement of DKK 100 million, compared to the previous guidance of DKK 25 - 75 million.
    
    We are projecting a cash position at the end of 2016 of DKK 3,400 — 3,500 million, an improvement of DKK 100 million, compared to the previous guidance of DKK 3,300 — 3,400 million.
    
    In addition to factors already mentioned, the estimates above are subject to change due to numerous reasons, including but not limited to the achievement of certain milestones associated with our collaboration agreements; the timing and variation of development activities (including activities carried out by our collaboration partners) and related income and costs; Arzerra and DARZALEX sales and corresponding royalties to Genmab; fluctuations in the value of our marketable securities; and currency exchange rates. The financial guidance does not include any potential proceeds from future warrant exercises and also assumes that no significant agreements are entered into during 2016 that could materially affect the results.
    
    
15. [verwijderd] 20 april 2016 09:19

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    Dank Sheriff voor plaatsen bericht. Niet geheel onverwacht, dit bericht. Genmab aandeel kruipt ook al met gezwinde spoed naar all time high. Daaruit spreekt veel vertrouwen van de markt. Er staan nog diverse andere potjes op het vuur. Genmab komt ook steeds meer in the picture als gestaag groeiende biotech. De takeover geruchten zullen vroeg of laat weer aanzwellen, maar zelfstandig koers houden lijkt mij vooralsnog een prima groeiconcept. En ja, ook 2016 zal ongetwijfeld weer onverwachte verrassingen in petto hebben. Dat zijn we in biotech wel gewend. Ook wat betreft aandelenkoersen. Na de dip vroeg in het jaar is de koers weer helemaal terug en dus in enkele maanden met ca 60% gestegen. Wat een onderliggende kracht.
16. sheriff Grover 20 april 2016 11:16

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    Hi Jeroen ja dat is de grote vraag wat gaat J&J doen ... ik denk dat ze na een goedkeuring in Europa en positieve Pollux data niet anders kunnen ... Doen ze het dan niet dan doen ze het nooit meer naar mijn mening . De CFO van J&J zijn antwoord op de laatste vraag : www.cnbc.com/2016/04/19/
17. [verwijderd] 20 april 2016 15:05

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    Interessant interview Sheriff. De CFO van J&J noemt Darzalex specfiek als voorbeeld van veelbelovend medicijn. En de vraag over M&A bij deze in transcript: As for possible M&A opportunities with biotech valuations coming down, Caruso said J&J is "obviously looking very closely at the field."
    
    "[But] I'm not sure the owners of those companies agree the current valuations are at the right place. So we'll continue to work through various acquisition proposals," he added. "We want to do the right deal, at the right time, with the right partner, at the right valuation."
    
    Kortom, to be continued.
    
18. Fredk 20 april 2016 15:26

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    Je hebt gelijk gekregen Sheriff wat betreft de behoudende vooruitzichten voor 2016. Na een kwartaal werden ze dus alweer bijgesteld. ...... Wél had 'k vandaag een sterkere koersreactie verwacht vandaag
19. sheriff Grover 21 april 2016 08:29

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    Hoi Fredk , nou koersreactie is waardeloos ... zweedse bank dumpte zo'n 75000 stukken .. nou ja maar hopen dat het weer over is en op naar de 4 cijfers ! Sheriff Grover
    
    
20. sheriff Grover 21 april 2016 08:30

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    Genmab Announces Daratumumab Data to be Presented at 2016 ASCO Annual Meeting
    
    Oral plenary session presentation on daratumumab Phase III Castor study data
    • Trial in progress poster presentation from Phase I study of subcutaneous daratumumab
    
    Copenhagen, Denmark; April 20, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that two daratumumab abstracts have been accepted for presentation at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June 3 — 7. The titles of the abstracts are available on the ASCO website at www.asco.org via ASCO's iPlanner. With the exception of the daratumumab Phase III Castor study data, which has been designated as a late breaking abstract by ASCO, the full abstracts are scheduled to be published on the ASCO website on May 18 at 5:00PM EDT.
    
    Daratumumab Phase III Castor Study Data
    Safety and efficacy data from the Phase III study of daratumumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma will be presented in the Plenary Session at the ASCO meeting on June 5. A total of 498 patients with relapsed or refractory multiple myeloma were enrolled in the study. The study met the primary endpoint of improving progression free survival (PFS); Hazard Ratio (HR) = 0.39, p<0.0001. The median PFS for patients treated with daratumumab has not been reached, compared to median PFS of 7.2 months for patients who did not receive daratumumab.
    
    Daratumumab showed a manageable safety profile in the study consistent with the reported safety profile of monotherapy and background bortezomib/dexamethasone therapy.
    
    As announced on March 30, 2016 an Independent Data Monitoring Committee recommended stopping the study as the primary endpoint had been reached at the time of the pre-specified interim analysis. Patients originally assigned to the bortezomib plus dexamethasone treatment group will be offered the option of receiving daratumumab following confirmed disease progression. Patients continue to be monitored for safety and overall survival.
    
    Abstract details: Phase 3 randomized controlled study of daratumumab, bortezomib and dexamethasone (DVd) vs bortezomib and dexamethasone (Vd) in patients (pts) with relapsed or refractory multiple myeloma (RRMM): CASTOR study— Abstract # LBA4, Oral presentation, Sunday, June 5 at 3:10PM-3:25PM CDT
    
    This abstract has been designated a late breaking abstract and the embargo will be lifted on Sunday, June 5 at 6:30AM CDT.
    
    "ASCO is one of the premier medical conferences of the year and we are very pleased that highly impressive data with one of our key programs, daratumumab, will be presented again this year," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
    
    
    List of Further Abstracts to Be Presented
    
    Daratumumab
    An open-label, dose-escalation Phase 1b study of subcutaneous daratumumab with recombinant human hyaluronidase in patients with relapsed or refractory multiple myeloma (PAVO) — Abstract # 333b, Trials in progress poster presentation, Monday, June 6 at 8:00AM -11.30AM CDT
    The study described in this abstract is ongoing.