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Are we going down??


27796 dheena 2/4 2010 12:29
Oversigt

Salget af fabrikken trækker ud.
Arzerra giver formodentlig ikke de store indtægter i år.

Kapitaltilførsel hvornår og hvad koster det på kursen?

Mon Lisa vil faldbyde GEN til GSK for spotpris?

Det er fandme svært at bevare optimismen.



2/4 2010 14:17 troldmanden 027804



Hej Dheena

Akademikeren, stinker, Collersten og undertegnede sad og snakkede lidt om genmab casen sidste fredag. Det er ikke meget positivt sentiment omkring selskabet i denne tid. Langsigtet er der bestemt store muligheder. Men her og nu mangler de positive nyheder for at bryde den negative spiral.

Som du selv er inden på så kommer Arzerra salg som sådan ikke til at betyde det store for Genmab i år. Det bliver først de kommende år det begynder at blive sjovt. Derfor er jeg måske også lidt mere tilbageholdende med udsigten på positive momento ovenpå Q1 salgs tal. Jeg tror mere vi skal frem til Q3 hvor der kommer vigtige fase 3 data fra Arzerra. Så derfor tror jeg også man vilo kunne samle aktien op i nivveau 65 i løbet af den kommende periode. Og når vi det nivau så er der nok også en pæn mulighed for jeg bliver Genmab aktionær igen

Vh
T.



2/4 2010 15:13 akademikeren 027805



Det er altid svært at spå om kursen. Men siger man ned på Genmab har man jo odds med sig. Jeg er meget interesseret i salgstal Q1 og det af mange grunde som er nævnt før.

Uptake hastighed interesserer mig utroligt meget. Der virker til at være et stort marked i cll for arzerra. Og det er de ved at bryde ind på. Selv positive analytikere er egentligt konservative med uptake. Men igen virker det som om Lisa har oversolgt alt i alle henseender. Men hvis vi kam skimte 1000 patienter i horisonten, så er det bullish. Jeg leder efter 18 mill royalty og så skal vi huske på at arzerra ikke er indregnet i budget 2010. Q1 salg vil sikkert endnu udløse diskussion om lageropbygning, men måske også løfte sløret for sammensætning af salget, selvom jeg tvivler.

Når GSK fyrer tallene af vil de også komme med en kommentar. Og mon ikke de vil kommenterer hvis de ser en blockbuster under opsejling.

Dette kvartal og de følgende er præget af opstart og usikkerhed, men bringer Genmab mange år foran resten af dansk biotek. Vi kan nu begynde at slå streger på det regneark der i sidste ende betyder noget. Omsætning og indtjenning. Og jeg synes ikke jeg vil undlade at nævne at royalties's klasker ned på bundlinien.

sent from iPhone



2/4 2010 20:19 dheena 027813



Men kommer de ikke i problemer, rent økonomisk, i år hvis ikke de får solgt fabrikken?
Arzerra giver vel max. 100 mil i år.



2/4 2010 20:49 akademikeren 027814



Ja det er det store spørgsmål.....Hvis de brænder 450 mill, så mener jeg det bliver lige på grænsen, men i så fald de skal kunne klare den uden fabrikssalg, så må de kigge lidt på fyringer i organisationen. For hvis de hverken skal lave Arzerra eller Zalutumumab hvad skal de så lave?



5/4 2010 16:34 gentogen 127874



Decision Resources, one of the world?s leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that GlaxoSmithKline?s ofatumumab will become Decision Resources? proprietary clinical gold-standard treatment for relapsed/refractory chronic lymphocytic leukemia (CLL) by 2012. This shift is due to ofatumumab?s competitive advantages over the current gold standard?Bayer Schering Pharma?s Campath/MabCampath?in efficacy (overall response rate), safety and tolerability (hematological toxicities and infections) and delivery (frequency).

The new report entitled Relapsed/Refractory Chronic Lymphocytic Leukemia: Physicians Are Eager for Increasingly Efficacious Therapies in the Refractory Setting finds that an agent showing improvement in overall response rate, compared to Campath/MabCampath, for high-risk, relapsed/refractory patients would earn a higher patient share in the U.S. (50 percent) than in Europe (40 percent). This is because European oncologists are more cost-conscious than U.S. physicians and such a drug would bear a slight price increase.

?The European market is more sensitive to increases in price than the U.S. market, and the price of Campath/MabCampath is already very high in both markets. Even though European oncologists forecast a more conservative patient share for such an agent, a patient share of 40 percent is considerable in the relapsed/refractory CLL market,? stated Andrew Merron, Ph.D., analyst at Decision Resources.



5/4 2010 16:44 gentogen 027875



Undskyld. Teksten er et år gammel. Det overså jeg i farten. Beklager meget.



5/4 2010 16:49 akademikeren 027876



Hej Gentogen, lige præcis i den setting der er nævnt her er den stadig MEGET relevant, for her er der jo intet sket. Og jo jeg tror også at Arzerra bliver guld standarden i refrac CLL.




6/4 2010 11:43 gentogen 427899



Ja, noget kunne tyde på det. Se blot denne opdaterede analyse. Og denne gang er den altså helt ny (selv om det selvfølgelig er de "gamle" data, så er der flere detaljer end jeg har set før i denne nye version). Og det ser ganske fornuftigt ud.

Se:
Journal of Clinical Oncology, Vol 28, No 10 (April 1), 2010: pp. 1749-1755
© 2010 American Society of Clinical Oncology.

på: http://jco.ascopubs.org/cgi/content/full/28/10/1749

Citat:Outcomes for patients with FA-ref or BF-ref CLL are poor with available salvage regimens, including intensive chemoimmunotherapy, with low response rates (23% ORR), short time to treatment failure (median, 2 to 3 months), and short survival (median, 9 months)7; new treatment options are needed for these patients. Comparisons with available historical data are limited; however, an ORR of 47% to 58% and a median PFS time of approximately 6 months with ofatumumab, as assessed by an IRC, clearly demonstrate clinical activity and are significant given outcomes reported with current salvage therapies.7 Furthermore, the activity with single-agent ofatumumab is remarkable, given the ORR of 0% in 14 patients with FA-ref or BF-ref CLL treated with other types of mAb therapy in the retrospective report.7 The median OS time with ofatumumab treatment was 14 to 15 months, and a significant survival benefit was observed in responding patients in both patient groups. The landmark method was used to minimize the survival bias in responders, which would otherwise occur when using a direct comparison of survival among all responders versus nonresponders.

In this study, treatment with ofatumumab was associated with considerable relief of disease-related constitutional symptoms and improvements in performance status, even among patients who did not qualify as responders strictly based on NCI-WG criteria. Complete resolution of splenomegaly and hepatomegaly and/or substantial reduction in lymphadenopathy were observed in a large proportion of patients (Table 3), and patients with thrombocytopenia or anemia at baseline experienced improvements in hematologic parameters.

Response to ofatumumab was consistent across various subgroups based on pretreatment characteristics, except for 17p deletion, which was associated with lower ORR in the BF-ref group. This study was not powered to identify subgroup differences; however, it is encouraging to appreciate responses in patients who may be considered higher risk, such as those with advanced disease stage, age 70 years, 11q deletion, poor performance status, or large palpable lymph nodes (> 5 cm). The dose of corticosteroid premedication used in this study has not been reported to have efficacy in refractory patients with CLL and was not likely to significantly affect the ORR.

With median response duration of 6 to 7 months, some patients experienced relapse soon after completing treatment. One possible explanation for this is the proliferative nature of disease in these refractory patients. Because all but one responder achieved PR, responders had residual disease that progressed after completion of ofatumumab treatment. The median number of malignant B cells in peripheral blood decreased rapidly with ofatumumab and remained depleted during the course of treatment (Appendix Fig A2, online only). The gradual disappearance of the tumor bulk during continued therapy was followed by a gradual return of the malignant clone after discontinuation of treatment (data not shown). Thus, loss of response did not seem to be a result of resistance to ofatumumab during active treatment; detailed pharmacokinetic and pharmacodynamic analyses may provide further insights.

Ofatumumab was well tolerated, there were no unexpected toxicities, and no formation of HAHAs was detected. The most common AEs were infusion reactions and infections, which were primarily grade 1 or 2 events; infusion reactions were common during the first two doses, as expected with this type of therapy, but largely subsided with subsequent infusions. The incidence of grade 3 or 4 infections was at an expected level, considering prior treatment, extent of disease, and immunosuppression among these patients.28 One case of PML (resulting in death 63 days after last dose of ofatumumab) occurred in a patient with FA-ref disease who had received eight prior treatments and had a low CD4 count at baseline (data not shown). PML has been reported in patients with B-cell malignancies treated with rituximab-containing regimens.29?31 The incidence of major infections (as previously defined by Tam et al7) in our patients with FA-ref and BF-ref CLL (32% and 23%, respectively; data not shown) compared favorably with that of similar patients treated with various other salvage regimens (60% and 45%, respectively)7; the incidence of early death in our patients with FA-ref and BF-ref CLL (7% and 3%, respectively) was also lower than that reported in the historical data (16% and 10%, respectively).7 Although median neutrophil counts in our patient population decreased during the first 4 to 8 weeks of treatment, they remained greater than 1.5 x 109/L and were stable during the course of treatment (Appendix Fig A3A, online only). Median platelet and hemoglobin values rapidly improved during the study for patients who stayed on the study (Appendix Figs A3B and A3C, online only), including patients with baseline thrombocytopenia and anemia, as a result of continued treatment and responses. These outcomes in hematologic parameters are notable considering the extent of disease in this patient population and the lack of blood count limits for trial enrollment.

Ofatumumab demonstrates significant activity and a favorable safety profile, providing meaningful clinical improvements in poor-risk patients with heavily pretreated FA-ref and BF-ref CLL. Results are especially encouraging for a single-agent mAb used in such heavily pretreated patients as in this salvage setting. Importantly, similar response rates were seen irrespective of prior exposure to rituximab-containing treatments and irrespective of refractoriness to fludarabine combined with cyclophosphamide and rituximab, a standard regimen in earlier lines of CLL therapy. Phase III trials are needed to confirm therapeutic efficacy in patients with CLL. Further investigation of ofatumumab is warranted in earlier disease settings.





12/4 2010 23:22 gentogen 028138



Jeg har søgt en del på nettet efter statistik for antallet af DR patienter. Uden det store held. Men har dog fundet dette på cafepharma, der er et forum for sælgere.

"The indication is great. With app 10.000 Americans being DR each year and at an annual price of almost USD100.000 we will all get rich."



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