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Genmab, de Deense parel

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  1. flosz 10 juni 2009 15:12
    RECRUITMENT COMPLETED IN ZALUTUMUMAB HEAD AND NECK CANCER PIVOTAL STUDY
    Copenhagen, Denmark; June 10, 2009 - Genmab A/S (OMX: GEN) announced today it has completed enrollment of 273 patients in the zalutumumab pivotal Phase III study in refractory head and neck cancer. Genmab expects to report final results from the study by the end of 2009.
    www.genmab.com/upload/20_zalutumumab_...
  2. [verwijderd] 17 juli 2009 07:16
    GENMAB ANNOUNCES LIFT OF ZALUTUMUMAB PARTIAL CLINICAL HOLD

    Copenhagen, Denmark; July 16, 2009 - Genmab A/S (OMX: GEN) announced today that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on zalutumumab studies being conducted under an US Investigational New Drug application. Enrolment of patients can now resume in the Phase II study in patients with head and neck cancer considered incurable with standard treatment and the Phase I/II front line study of zalutumumab in combination with chemo-radiation.

    "We have worked diligently to meet the FDA's request for additional zalutumumab safety information and are pleased that enrolment in the studies can be resumed so quickly," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We continue to believe zalutumumab could provide an important new treatment option for head and neck cancer patients with unmet medical needs."

    www.genmab.com/PressCentre/RecentNews...
  3. [verwijderd] 13 augustus 2009 16:29
    GLAXOSMITHKLINE AND GENMAB ANNOUNCE TOP-LINE RESULTS FOR OFATUMUMAB IN RHEUMATOID ARTHRITIS

    London, UK and Copenhagen, Denmark; July 29, 2009 - GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced today preliminary top-line results from a Phase III study of ofatumumab administered intravenously for the treatment of rheumatoid arthritis (RA) in patients who had an inadequate response to methotrexate. The study met the primary endpoint, ACR20 at 24 weeks, which indicates a 20 percent or greater improvement in the number of swollen and tender joints, as well as improvements in other disease-activity measures.

    In the study, 260 patients were treated and included in the analysis. At week 24, the ACR20 response rate was significantly greater for RA patients on ofatumumab (n=129) than on placebo (n=131) with a 50 percent response rate in the patients receiving ofatumumab, compared to 27 percent for patients on placebo (p-value less than 0.001). All key secondary endpoints were significant (p-value less than or equal to 0.001).

    There were no unexpected safety findings. The most common adverse events in the ofatumumab treated patients (greater than 5 percent) were rash, urticaria, nasopharyngitis, pruritus, throat irritation and hypersensitivity. Other than nasopharyngitis, these events generally occurred within 24 hours of the first infusion. One death, judged by the investigator as unrelated to ofatumumab, was reported in the study during the 24-week study period.

    "We have always believed in ofatumumab's potential to make a difference in patients' lives. We are pleased with the results of this study, supporting the further investigation of this antibody's promise in the treatment of RA," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.

    "RA can be a highly debilitating disease. It is encouraging to see the reduction in disease symptoms achieved with intravenous ofatumumab, and we look forward to presenting the full study results," said Carlo Russo, M.D., Senior Vice President, Biopharm Development, GSK.

    About the study

    In this 24 week double-blind study, patients with active RA were randomized to receive two 700 mg doses of intravenous ofatumumab or placebo two weeks apart in addition to background methotrexate. Disease status was measured every 4 weeks. Patients for this non-IND study were recruited from Europe, South America and Australia.

    The primary objective of the study was to determine the efficacy of intravenous ofatumumab in reducing the clinical signs and symptoms in RA patients after two 700 mg doses of ofatumumab compared to placebo. The primary endpoint of the study was ACR20 at 24 weeks. Other key secondary objectives included safety, patient reported outcomes, biomarkers and ACR 50 and ACR 70.

    ACR Response

    The ACR 20 response is defined as a 20 percent or greater improvement from baseline in tender and swollen joint counts, and 20percent or greater improvement in 3 of the 5 following assessments: patient and physician global assessments, pain, disability, and an acute phase reactant (ESR or CRP).

    About ofatumumab

    Ofatumumab is a novel, investigational, fully human monoclonal antibody that targets a membrane-proximal (close to the cell surface) small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule of B-cells. This epitope is different from the binding sites targeted by other CD20 antibodies currently available.

    Ofatumumab is being developed for other indications under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.

    www.genmab.com/PressCentre/RecentNews...
  4. [verwijderd] 13 augustus 2009 16:30
    GENMAB ANNOUNCES PRELIMINARY TOP-LINE RESULTS FOR ARZERRA™ IN FRONT LINE CLL

    Copenhagen, Denmark; August 11, 2009 - Genmab A/S (OMX: GEN) announced today top-line results from the Phase II study of Arzerra™ (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) to treat chronic lymphocytic leukemia (CLL) in previously untreated patients.



    A total of 61 patients were treated in the study. Treatment response was assessed using the 1996 National Cancer Institute Guidelines. The complete remission rate was 32% in patients who received 500 mg of ofatumumab (n=31) and 50% in patients who received 1000 mg of ofatumumab (n=30). The overall response rate was 77% in the 500 mg treatment group and 73% in the 1000 mg treatment group.



    There were no unexpected safety findings reported during treatment and within 30 days after last infusion. The most common adverse event reported was neutropenia at 48%. Other common adverse events (greater that 15 percent) were nausea, leukopenia, rash, vomiting, pyrexia, headache and thrombocytopenia. The number of patients, who experienced adverse events, including serious adverse events, was similar between the two dose groups. One death was reported and was judged by the investigator as unrelated to ofatumumab.



    "We are pleased to see the positive results of this first study investigating ofatumumab for the treatment of front line CLL," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We look forward to presenting the full data at a future medical meeting."



    About the study

    Patients in this open label study were randomized into two treatment groups. Each patient was to receive one infusion of 300 mg of ofatumumab in combination with FC followed by 5 monthly infusions of either 500 or 1000 mg of ofatumumab in combination with FC. Disease status was measured every 4 weeks until week 24 and every 3 months thereafter until disease progression or 24 months. Treatment response was assessed according to the 1996 National Cancer Institute Working Group guidelines by an Independent endpoints Review Committee. Patients not having progressed on their disease at 24 months will be followed for disease progression at 6 month intervals until 60 months.



    The objective of the study was to determine the efficacy of ofatumumab in combination with FC in previously untreated CLL patients. The primary endpoint was complete remission rate from start of treatment until 3 months after last infusion.



    About ofatumumab

    Ofatumumab is a novel, investigational, fully human monoclonal antibody that targets a membrane-proximal (close to the cell surface) small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule of B-cells. This epitope is different from the binding sites targeted by other CD20 antibodies currently available. The CD20 molecule is a key target in CLL therapy because it is expressed on most B-cells in CLL patients.



    Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.


    www.genmab.com/PressCentre/RecentNews...
  5. [verwijderd] 18 augustus 2009 07:35
    GLAXOSMITHKLINE AND GENMAB ANNOUNCE RESULTS FROM A STUDY OF ARZERRA IN RITUXIMAB REFRACTORY FOLLICULAR NHL

    London, UK and Copenhagen, Denmark; August 17, 2009 – GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced today top-line results from an international multi-center study of Arzerra™ (ofatumumab) in rituximab refractory follicular non-Hodgkin’s lymphoma (NHL).



    A total of 116 patients were treated in the study, including 30 patients treated with 500 mg ofatumumab and 86 patients treated with 1000 mg of ofatumumab. The patients in the study were highly refractory. Forty-nine percent of patients were refractory to their last chemotherapy treatment. Patients in the study had previously received a median of 4 prior treatment regimens. The primary endpoint was objective response (International Working Group Criteria) over six months from the start of treatment in the 1000 mg dose population.



    The overall response rate (ORR) in the 1000 mg treatment arm was 10%, including one complete response and 8 partial responses. In addition, 50% (43) of patients in the 1000 mg treatment arm had stable disease. The overall response rate in the total population was 11%.



    The ORR among patients who were refractory to prior rituximab monotherapy (n=27) was 22%. For patients considered refractory to rituximab in combination with chemotherapy the response rate was 7% and among patients considered refractory to rituximab maintenance the response rate was 9%. The median duration of response in the 1000 mg treatment arm was 6 months and the progression free survival was 6 months.



    There were no unexpected safety findings reported during treatment and within 30 days after last infusion. The most common adverse events (greater than 10%) were rash, urticaria, pruritus, fatigue, nausea, pyrexia and cough.



    “The results of this study demonstrate the activity of ofatumumab in patients who had not responded to prior treatment with a CD20 antibody. The response rate in patients refractory to rituximab monotherapy is of interest and warrants further study. We are committed to the further development of ofatumumab in NHL,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.



    “Clearly, this is a challenging patient population to treat with a single agent CD20 antibody. We are committed to evaluating ofatumumab in combination with other agents in this patient population to develop new treatment options for these difficult to treat patients,” said Kathy Rouan, Ph.D., Vice President and Medicines Development Leader at GSK.



    GSK and Genmab continue to review the study results and discuss the development strategy for ofatumumab in NHL.

    www.genmab.com/PressCentre/RecentNews...
  6. [verwijderd] 18 augustus 2009 07:37
    GENMAB REVISES FINANCIAL GUIDANCE

    Copenhagen, Denmark; August 17, 2009 – Genmab A/S (OMX: GEN) announced today it is revising its 2009 financial guidance. We now expect our 2009 revenue to be approximately DKK 750 million compared to the previous estimate of DKK 1.2 billion. The reduction in revenue is primarily due to the exclusion of a milestone payment under the Arzerra™ (ofatumumab) collaboration with GlaxoSmithKline.



    With a continued focus on cost control we now anticipate that our operating expenses will be approximately DKK 1.4 billion, DKK 200 million below our previous guidance of DKK 1.6 billion. This will result in a revised operating loss of approximately DKK 650 million, as compared to our previous guidance of DKK 400 million.



    We now expect the cash burn for 2009 to be approximately DKK 700 million compared to previous guidance of DKK 500 million. Therefore we project a cash balance at the end of the year of approximately DKK 1,050 million, DKK 200 million below our previous guidance.

    www.genmab.com/PressCentre/RecentNews...
  7. [verwijderd] 19 augustus 2009 06:25
    Genmab Punished as Arzerra Stumbles in Pivotal Trial - Glaxo Also Affected

    Genmab (GNMSF.PK) and GlaxoSmithKline (GSK) were always going to have a hard task establishing a significant foothold for their anti-CD20 antibody Arzerra in the face of entrenched competition from Roche’s (RHHBY.PK) similar product Rituxan, which generated sales of $5.7bn last year and has been on the market for 12 years.

    Data announced late last night suggest the new drug still has much to prove. A pivotal trial in Rituxan refractory patients with non-Hodgkins lymphoma (NHL) generated a disappointing overall response rate of 10%; the company was banking on at least 20% whilst many analysts were hoping to see 30% or 40%. With plenty of data still to come on Arzerra an accurate picture of its efficacy has yet to be painted, but investors are becoming increasingly nervous. Shares in Genmab plunged 32% to a three-and-a-half year low today on concerns about lost milestone payments, slower sales and the ultimate value of the drug.

    The results announced yesterday do not look good enough to win approval in NHL, even in this refractory setting where patients are very ill. This is disappointing in itself, however adding to that disappointment is that the read out has dashed hopes of early off-label sales in NHL.

    Missed opportunity

    Arzerra is not on the market yet; the companies are waiting to hear on FDA approval by October 31 in chronic lymphocytic leukaemia (CLL), again in a refractory setting. Once on the market, doctors may have been tempted to try the drug with refractory NHL patients, had the trial shown encouraging response rates.

    Many analysts believed that refractory NHL, in a second or third line setting, was likely to be a key revenue generator for Arzerra. Consensus data from EvaluatePharma has Glaxo booking sales of $536m in 2014, a figure that might now creep down.

    For Glaxo this is not a huge concern, but for Genmab the set back in NHL has a tangible impact, and not just because of lost royalties. The Danish company lowered full-year revenue guidance by Dkr450m to Dkr750m ($142m) today mainly due to the exclusion of a milestone payment that would have been received had the trial succeeded. This implies a chunky payment, much higher than many analysts were anticipating, and highlighting how valuable the companies saw this opportunity.

    Larger and longer

    It seems likely that a much larger pivotal trial will now be needed in NHL before a filing can be made to regulators, suggesting a significant delay. Lisa Drakeman, chief executive of Genmab, told EP Vantage this afternoon that talks with Glaxo about further development are underway and plans should be announced “in the near future”.

    Ms Drakeman agreed that the results do not look adequate to support a filing, but said she does not expect a read through to other NHL studies. A phase II trial in front line NHL patients is due to report this quarter.

    “These patients were extraordinarily refractory. We were very encouraged by the activity in patients refractory to prior rituximab monotherapy, where the response rate was 22%,” she said.

    Head-to-head

    The impending phase II front line study will now be watched with added interest. However, the results today prompted many analysts to reiterate a belief that a head-to-head trial between the two drugs might be required.

    Ms. Drakeman said there is a plan to look at such a trial in NHL, but neither Glaxo nor Genmab has yet committed to such a move. This would be a bold and expensive step, not to say high risk, but ultimately might be needed if Arzerra is to grab a significant foothold in front line NHL. The partners need to prove that the drug has at least the same efficacy as Rituxan if doctors are to be persuaded to give the drug a go.

    There is a raft of data due on Arzerra over the next few months, in both NHL and RA, and much more promising results are going to be needed to reinject some confidence into this project. The ultimate question for Arzerra has always been, will the product be a bio-better, or a bio-similar, to Rituxan? Investors appear to be taking the position that the latter now looks more likely.

    seekingalpha.com/article/156887-genma...
  8. [verwijderd] 25 augustus 2009 18:14
    " Een absurde reactie "

    De koers van het aandeel van biotechbedrijf Genmab, dat in Kopenhagen noteert, staat al een jaar onder druk.

    Het bedrijf, dat 550 onderzoekers huisvest in Utrecht, zag de koers sinds augustus vorig jaar dalen van 325 Deense kronen naar DKr 210. Vorige week ging het aandeel plots naar DKr 130.

    Genmab ontwikkelt Arzerra, een medicijn gebaseerd op menselijke antistoffen tegen chronisch lymfatische leukemie en non-Hodgkin lymfeklierkanker (NHL). Arzerra moet het opnemen tegen Rituxan van Genentech, dat jaarlijks $ 5,5 mrd omzet.

    Onderzoeken geven aan dat Arzerra veel beter scoort dan Rituxan. GlaxoSmithKline (GSK) heeft eind 2006 voor circa $ 2 mrd aan mijlpaalbetalingen toegezegd in ruil voor de helft van de toekomstige inkomsten uit Arzerra en een belang van 10%. Verwacht wordt dat de Europese en Amerikaanse autoriteiten in oktober de marktintroductie van Arzerra goedkeuren en dat GSK dan met een overnamebod komt.

    Vorige week maandag publiceerde Genmab studieresultaten naar de werking van Arzerra bij patiënten met non-Hodgkin lymfeklierkanker die niet reageerden op Rituxan. De responsgraad was laag: 10%. Genmab maakte verder bekend dat een mijlpaalbetaling van $ 85 mln is uitgesteld en dat de inkomsten lager uitvallen.

    Voor beleggers was dit reden om uit te stappen. De koers kelderde ruim 30% naar het laagste punt in drieënhalf jaar tijd.

    Volgens Jan Mellegers van Biotech Turnaround Fund (BTF) in Haarlem, dat circa 4,3% in Genmab houdt, is er 'niets aan de hand'. 'Het ging hier om een kleine groep van 116 dood- en doodzieke patiënten bij wie niets meer hielp en Rituxan al helemaal niet. De kans op succes was zeer klein.'

    Mellegers noemt de koersreactie 'een vloedgolf aan debiliteit, een absurde reactie.' Hij benadrukt dat Genmab nog 14 onderzoeken heeft lopen met Arzerra als middel tegen NHL, dat de werking van het middel allang vaststaat en dat niets goedkeuring in de weg staat.

    Ook Marcel Wijma, analist gespecialiseerd in biotech, verwacht dat Genmab binnenkort met meer positieve resultaten komt, onder meer van twee groepen patiënten met NHL.

    Ook hij acht de koersreactie zwaar overtrokken. Die zou zijn 'ingegeven door analisten die zich laten leiden door emoties en nog eens worden versneld doordat banken als RBS turbo's uitgeven op het aandeel Genmab.' Dat versterkt koersdalingen en - stijgingen. 'Het is pure manipulatie.'

    Wijma verklaart de koersdruk verder uit hooggespannen overnameverwachtingen. 'Allemaal ongeduld, met als risico dat een overnamekoers straks heel laag ligt en andere kapers dan GSk zich aandienen.

    25 augustus 2009 , Het Financieele Dagblad
  9. [verwijderd] 26 augustus 2009 18:52
    GENMAB ANNOUNCES POSITIVE TOP-LINE RESULTS FOR ARZERRA™ IN FRONT LINE NHL

    Copenhagen, Denmark; August 26, 2009 – Genmab A/S (OMX: GEN) announced today positive top-line results from the Phase II study of Arzerra™ (ofatumumab) in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) in patients with previously untreated follicular non-Hodgkin’s lymphoma (NHL).

    A total of 58 patients were treated in the study. The overall response rate (ORR) in patients treated with 500 mg of ofatumumab (n=29) was 90%, including 24% complete remissions (CR), and 45% complete remissions/unconfirmed (CRu). In patients treated with 1000 mg of ofatumumab (n=29), the ORR was 100% including 38% CR, and 17% CRu.

    There were no unexpected safety findings reported during treatment and within 30 days after last infusion. The most common adverse events of grade 3 or 4 (greater than 10 percent) were leucopenia and neutropenia. No events of sepsis or pneumonia were observed, and no deaths reported in the trial.

    “We are pleased with the positive results shown in this study and believe they are indicative of the potential of ofatumumab in the treatment of front line follicular non-Hodgkin’s lymphoma,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.

    Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.

    About the study
    Patients in this open label study were randomized into two dose groups of 29 patients each. Patients were to receive 300 mg of ofatumumab at the first infusion, followed by 5 infusions of either 500 or 1000 mg of ofatumumab every 3 weeks in combination with 6 cycles of CHOP. Disease status is measured prior to the fourth cycle, at three months following the last treatment and then every three months until month 12, and every six months thereafter until 24 months or initiation of alternative treatment. Treatment response was assessed according to the 1999 standardized response criteria for NHL by an Independent endpoints Review Committee.

    The objective of the study is to determine the efficacy of two dose regimens of ofatumumab in combination with CHOP in previously untreated follicular NHL patients. The primary endpoint in the study was objective response from start of treatment until 3 months after last administration of ofatumumab.

    About ofatumumab
    Ofatumumab is an investigational, fully human monoclonal antibody that binds specifically to the small and large extracellular loops of the CD20 molecule proximal to the cell membrane. The CD20 molecule is a key target in B-cell malignancy therapy because it is expressed on most B-cells.

    Ofatumumab is not yet approved in any country.

    www.genmab.com/PressCentre/RecentNews...
  10. [verwijderd] 28 augustus 2009 06:51
    Koopje Genmab

    Marcel Wijma - 27 augustus 2009, 15:30

    In mijn Top 3 Europese biotech staan naast Antisoma en MediGene, het Deens-Nederlandse Genmab. De afgelopen weken is de koers fors onderuit gezakt naar een dieptepunt van DKK 130. Reden om haar uit mijn top 3 te halen?
    Daar zie ik nu geen enkele reden voor. Integendeel, ik ben alleen maar gesterkt in mijn mening dat Genmab tot de top van de Europese biotech behoort en alles in zich heeft om uit te groeien tot een van de grotere in de wereld.

    Op het huidige niveau, het laagste in ruim drie jaar, is het aandeel een koopje. De daling heeft weinig te maken met de fundamentele ontwikkeling van het bedrijf en meer met korte termijn sentimenten van handelaren en ondeskundigheid van analisten, die beter zouden moeten weten.

    Een fundamenteel analist moeten zich niet laten leiden door sentiment en de waan van de dag.

    100% positief
    Hij of zij moet zich bezighouden met fundamentele analyse van het bedrijf en de omgeving waarin ze opereert. Wat dat betreft worden de analyses van te veel analisten ingegeven door andere belangen, maar dat is ander verhaal. Terug naar Genmab. Ook nu dient zich de situatie aan dat veel handelaren short-posities hebben ingenomen.

    Dit is naar aanleiding van de negatieve berichtgeving vorige week. De kans is groot dat die posities snel teruggedraaid worden. Zeker nu uit de laatste fase II studie in Non Hodgkin Lymfoom (NHL) bleek, dat 100% (!) positief reageerde op Arzerra en dat meer dan de helft van de patiënten met de hoogste dosering een complete response heeft.

    Dat betekent dat de tumoren volledig zijn verdwenen. Hiermee zet Arzerra de huidige golden standard Rituxan overtuigend in de hoek. Rituxan verkoopt jaarlijks miljarden in NHL. Genmab daalde omdat een andere studie duidelijk maakte dat Arzerra een lager dan verwachte response liet zien in patiënten met refractoir Non Hodgkin Lymfoom (NHL).
    Teleurstelling
    Dat is een ernstige vorm van lymfklierkanker: 11% van de patiënten in de geteste groep zag de tumoren sterk afnemen en bij de helft van alle patiënten werd tumorgroei gestabiliseerd gedurende therapie met Arzerra. Het percentage van 11% is te laag om Arzerra al te kunnen voordragen voor goedkeuring tegen refractoir NHL.
    Dat is inderdaad een teleurstelling, omdat hiermee het middel later op de markt komt tegen NHL. Ook mistte Genmab hierdoor voorlopig een tussentijdse betaling van Glaxosmithkline van ruim 80 miljoen dollar. Mede hierdoor moest Genmab haar verwachte kaspositie 2009 naar beneden bijstellen met 27 miljoen euro.

    Bedacht moet worden dat het bij die resultaten gaat om een groep van de meest zieke patiënten, die al vele andere behandelingen en chemokuren achter de rug hadden. Geen van hen had enige baat meer bij Rituxan. Dat een aantal patiënten toch aan de beterende hand was, laat zien dat Arzerra superieur is aan Rituxan.

    16 onderzoeken
    Zeker als ook de resultaten van deze week worden meegenomen. Iets wat ook al eerder bleek in de resultaten van Arzerra tegen chronische leukemie (CLL). Verschillende analisten hebben op basis van de uitslag een groot deel (of zelfs helemaal) van de toekomstige omzet van Arzerra uit hun rekenmodellen gehaald.

    Het is inderdaad zo dat NHL een miljardenmarkt is die ook voor Genmab vele honderden miljoenen kan opleveren. Dat analisten Arzerra in NHL vorige week op basis van één testresultaat volledig hadden afgeschreven, is erg voorbarig. In totaal lopen er 16 klinische onderzoeken met Arzerra met in totaal honderden patiënten.

    Verder werd er door beleggers en analisten gevreesd dat dit ook consequenties heeft voor de goedkeuring van Arzerra in CLL. Deze goedkeuring verleent de FDA waarschijnlijk oktober. De negatieve uitslag in de groep van refractoire NHL patiënten kan niet worden gekoppeld aan het toelatingsdossier van Arzerra in CLL.

    Trots
    Op basis van de sterke werking van het middel Arzerra bij deze patiënten ligt een goedkeuring voor de hand. Dat werd ook nog eens bevestigd door een panel van deskundigen, ingesteld door de FDA. Die liet onlangs via een stemming zien ook positief te zijn over de werking van het middel Arzerra in CLL.

    Kortom, de koersreactie op de berichten is zwaar overtrokken en biedt instapmogelijkheden. Dat sommige partijen zich voor het karretje laten spannen van handelaren en zich laten leiden door korte termijn sentimenten is niet professioneel en heeft weinig te maken met de fundamentele gang van zaken bij Genmab.

    Een onderneming die wat dat betreft zeker tot de wereldtop in nieuwe kankerbehandelingen behoort. Nederland zou wat dat betreft trots mogen zijn om zo’n bedrijf binnen haar landsgrenzen te hebben.

    Teleurstelling
    Dat is een ernstige vorm van lymfklierkanker: 11% van de patiënten in de geteste groep zag de tumoren sterk afnemen en bij de helft van alle patiënten werd tumorgroei gestabiliseerd gedurende therapie met Arzerra. Het percentage van 11% is te laag om Arzerra al te kunnen voordragen voor goedkeuring tegen refractoir NHL.
    Dat is inderdaad een teleurstelling, omdat hiermee het middel later op de markt komt tegen NHL. Ook mistte Genmab hierdoor voorlopig een tussentijdse betaling van Glaxosmithkline van ruim 80 miljoen dollar. Mede hierdoor moest Genmab haar verwachte kaspositie 2009 naar beneden bijstellen met 27 miljoen euro.

    Bedacht moet worden dat het bij die resultaten gaat om een groep van de meest zieke patiënten, die al vele andere behandelingen en chemokuren achter de rug hadden. Geen van hen had enige baat meer bij Rituxan. Dat een aantal patiënten toch aan de beterende hand was, laat zien dat Arzerra superieur is aan Rituxan.

    16 onderzoeken
    Zeker als ook de resultaten van deze week worden meegenomen. Iets wat ook al eerder bleek in de resultaten van Arzerra tegen chronische leukemie (CLL). Verschillende analisten hebben op basis van de uitslag een groot deel (of zelfs helemaal) van de toekomstige omzet van Arzerra uit hun rekenmodellen gehaald.

    Het is inderdaad zo dat NHL een miljardenmarkt is die ook voor Genmab vele honderden miljoenen kan opleveren. Dat analisten Arzerra in NHL vorige week op basis van één testresultaat volledig hadden afgeschreven, is erg voorbarig. In totaal lopen er 16 klinische onderzoeken met Arzerra met in totaal honderden patiënten.

    Verder werd er door beleggers en analisten gevreesd dat dit ook consequenties heeft voor de goedkeuring van Arzerra in CLL. Deze goedkeuring verleent de FDA waarschijnlijk oktober. De negatieve uitslag in de groep van refractoire NHL patiënten kan niet worden gekoppeld aan het toelatingsdossier van Arzerra in CLL.

    Trots
    Op basis van de sterke werking van het middel Arzerra bij deze patiënten ligt een goedkeuring voor de hand. Dat werd ook nog eens bevestigd door een panel van deskundigen, ingesteld door de FDA. Die liet onlangs via een stemming zien ook positief te zijn over de werking van het middel Arzerra in CLL.

    Kortom, de koersreactie op de berichten is zwaar overtrokken en biedt instapmogelijkheden. Dat sommige partijen zich voor het karretje laten spannen van handelaren en zich laten leiden door korte termijn sentimenten is niet professioneel en heeft weinig te maken met de fundamentele gang van zaken bij Genmab.

    Een onderneming die wat dat betreft zeker tot de wereldtop in nieuwe kankerbehandelingen behoort. Nederland zou wat dat betreft trots mogen zijn om zo’n bedrijf binnen haar landsgrenzen te hebben.

    www.iex.nl/columns
  11. [verwijderd] 2 september 2009 13:41
    GENMAB TO ATTEND FOUR SEPTEMBER INVESTOR CONFERENCES

    Copenhagen, Denmark; September 2, 2009 – Genmab A/S (OMX: GEN) announced today its management will attend the following investor conferences in September 2009:



    September 4 - President, Research & Development, Prof. Jan van de Winkel, Ph.D. will attend the Goldman Sachs 3rd Biotech
    Symposium in London, UK.

    September 15 - CEO Lisa N. Drakeman, Ph.D. will present at the 2009 Morgan Stanley Global Healthcare Unplugged Conference in New York, NY at 2:45PM local time.

    September 16 – Senior Vice President, Medical Affairs, Ole Baadsgaard, M.D., Dr.MSci., will present at the Nordea Healthcare Seminar in Stockholm, Sweden at 11:30AM local time.

    September 23 - CEO Lisa N. Drakeman, Ph.D. will present at the UBS Global Life Sciences Conference in New York, NY at 9:30AM local time.

    www.genmab.com/PressCentre/RecentNews...
  12. [verwijderd] 4 september 2009 16:01
    quote:

    gocrucellgo schreef:

    Equity Research • Health Care • 3 September 2009 • Jyske Markets

    Genmab ACCUMULATE Frank Hørning Andersen

    jyskebank.com
    Nu 140,75 ...

    17.06.2009 12:10
    Goldman Sachs streicht Genmab von 'Conviction Buy List'
    Goldman Sachs hat Genmab von der "Conviction Buy List" gestrichen. Die Einstufung belasse er aber auf "Buy" und das Kursziel auf 593,00 dänischen Kronen, schrieb Analyst Mick Reade in einer Studie am Mittwoch. Die Papiere des Pharmakonzerns näherten sich dem Stop-Loss-Niveau. Er geht zwar weiter von einer Zulassung des Leukämie-Mittels Arzerra in den USA aus. Seine Ergebnisprognosen berücksichtigten aber auch Verzögerungen und das Risiko eines Scheiterns bei der Marktzulassung.

    www.finanznachrichten.de/nachrichten-...


  13. [verwijderd] 9 september 2009 10:03
    Goldman Sachs heef gisteren van een groot aantal biopharma bedrijven de Buy/Hold/Sell rating ingetrokken met de mededeling dat eerdere aanbevelingen niet meer geldig zijn. GenMab behoort ook tot deze groep.
  14. [verwijderd] 8 oktober 2009 19:20
    DECLARATORY JUDGMENT ACTION FILED BY GSK
    Copenhagen, Denmark; October 8, 2009 -

    Genmab A/S (OMX: GEN) announced today that in connection with Genmab's collaboration agreement with GSK regarding ofatumumab (ArzerraTM) GSK has today filed a declaratory judgment action at the United States District Court for the Southern District of Florida seeking a declaration that U.S. Patent 6,331,415 (the "Cabilly" patent) owned by Genentech, Inc. and City of Hope, is invalid, unenforceable and not infringed by Arzerra. The filing of this action is not expected to affect Genmab's financial guidelines for 2009.

    www.genmab.com/PressCentre/RecentNews...
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AB InBev 2 5.529
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