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Genentechs Patent no. 7,682,612


27572 akademikeren 25/3 2010 13:31
Oversigt

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&..


What is claimed is:

1. A method of treating chronic lymphocytic leukemia in a human patient, comprising administering an anti-CD20 antibody to the patient in an amount effective to treat the chronic lymphocytic leukemia, wherein the method does not include treatment with a radiolabeled anti-CD20 antibody.

2. A method according to claim 1, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 0.001 to about 30 mg/kg.

3. A method according to claim 1, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 0.01 to about 25 mg/kg.

4. A method according to claim 1, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 0.1 to about 20 mg/kg.

5. A method according to claim 1, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 375 mg/m.sup.2.

6. A method of treating chronic lymphocytic leukemia in a human patient, comprising administering an anti-CD20 antibody to the patient in an amount effective to treat the chronic lymphocytic leukemia, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 500 to about 1500 mg/m.sup.2, wherein the method does not include treatment with a radiolabeled anti-CD20 antibody.

7. A method according to claim 6, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 500 mg/m.sup.2.

8. A method according to claim 1 or 6, wherein the patient has relapsed following previous treatment for the chronic lymphocytic leukemia.

9. A method according to claim 1 or 6, wherein the patient is refractory to a treatment previously administered for the chronic lymphocytic leukemia.

10. A method according to claim 9, wherein the patient is refractory to fludarabine.

11. A method according to claim 1 or 6, wherein the anti-CD20 antibody is a chimeric antibody.

12. A method according to claim 11, wherein the anti-CD20 antibody is rituximab.

13. A method according to claim 1 or 6, wherein the anti-CD20 antibody is a humanized antibody.

14. A method according to claim 1 or 6, wherein the anti-CD20 antibody is a human antibody.

15. A method according to claim 1 or 6, wherein the anti-CD20 antibody comprises a CD20-binding fragment of a chimeric, humanized, or human antibody.

16. A method according to claim 1 or 6, wherein the anti-CD20 antibody is administered to the patient repeatedly.

17. A method according to claim 16, wherein the anti-CD20 antibody is administered to the patient weekly.

18. A method according to claim 16, wherein the anti-CD20 antibody is administered to the patient weekly for about 2 to 10 weeks.

19. A method according to claim 16, wherein the anti-CD20 antibody is administered to the patient biweekly.

20. A method according to claim 16, wherein the anti-CD20 antibody is administered to the patient monthly.

21. A method according to claim 1 or 6, wherein the anti-CD20 antibody is administered to the patient parenterally.

22. A method according to claim 21, wherein the anti-CD20 antibody is administered to the patient by intravenous infusion.

23. A method of treating chronic lymphocytic leukemia in a human patient, comprising administering an anti-CD20 antibody to the patient in an amount effective to treat the chronic lymphocytic leukemia, wherein the anti-CD20 antibody therapy is combined with chemotherapy, wherein the method does not include treatment with a radiolabeled anti-CD20 antibody.

24. A method according to claim 23, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 0.001 to about 30 mg/kg.

25. A method according to claim 23, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 0.01 to about 25 mg/kg.

26. A method according to claim 23, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 0.1 to about 20 mg/kg.

27. A method according to claim 23, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 375 mg/m.sup.2.

28. A method of treating chronic lymphocytic leukemia in a human patient, comprising administering an anti-CD20 antibody to the patient in an amount effective to treat the chronic lymphocytic leukemia, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 500 to about 1500 mg/m.sup.2, wherein the anti-CD20 antibody therapy is combined with chemotherapy, and wherein the method does not include treatment with a radiolabeled anti-CD20 antibody.

29. A method according to claim 28, wherein the anti-CD20 antibody is administered to the patient at a dosage of about 500 mg/m.sup.2.

30. A method according to claim 23 or 28, wherein the patient has relapsed following previous treatment for the chronic lymphocytic leukemia.

31. A method according to claim 23 or 28, wherein the patient is refractory to a treatment previously administered for the chronic lymphocytic leukemia.

32. A method according to claim 31, wherein the patient is refractory to fludarabine.

33. A method according to claim 23 or 28, wherein the anti-CD20 antibody is a chimeric antibody.

34. A method according to claim 33, wherein the anti-CD20 antibody is rituximab.

35. A method according to claim 23 or 28, wherein the anti-CD20 antibody is a humanized antibody.

36. A method according to claim 23 or 28, wherein the anti-CD20 antibody is a human antibody.

37. A method according to claim 23 or 28, wherein the anti-CD20 antibody comprises a CD20-binding fragment of a chimeric, humanized, or human antibody.

38. A method according to claim 23 or 28, wherein the anti-CD20 antibody is administered to the patient repeatedly.

39. A method according to claim 38, wherein the anti-CD20 antibody is administered to the patient weekly.

40. A method according to claim 38, wherein the anti-CD20 antibody is administered to the patient weekly for about 2 to 10 weeks.

41. A method according to claim 38, wherein the anti-CD20 antibody is administered to the patient biweekly.

42. A method according to claim 38, wherein the anti-CD20 antibody is administered to the patient monthly.

43. A method according to claim 23 or 28, wherein the anti-CD20 antibody is administered to the patient parenterally.

44. A method according to claim 43, wherein the anti-CD20 antibody is administered to the patient by intravenous infusion.

45. A method according to claim 23 or 28, wherein the anti-CD20 antibody therapy and the chemotherapy are administered to the patient concurrently.

46. A method according to claim 23 or 28, wherein the chemotherapy comprises chlorambucil.

47. A method according to claim 23 or 28, wherein the chemotherapy comprises cyclophosphamide.

48. A method according to claim 47, wherein the chemotherapy comprises cyclophosphamide, vincristine, and prednisone (COP).

49. A method according to claim 47, wherein the chemotherapy comprises cyclophosphamide, vincristine, prednisone, and doxorubicin (CHOP).

50. A method according to claim 23 or 28, wherein the chemotherapy comprises vincristine.

51. A method according to claim 23 or 28, wherein the chemotherapy comprises prednisone.

52. A method according to claim 23 or 28, wherein the chemotherapy comprises doxorubicin.

53. A method according to claim 23 or 28, wherein the chemotherapy comprises fludarabine.

54. A method according to claim 23 or 28, wherein the chemotherapy comprises methotrexate.

55. A method according to claim 23 or 28, wherein the chemotherapy comprises cisplatin.

56. A method according to claim 23 or 28, wherein the chemotherapy comprises toremifene.

57. A method according to claim 23 or 28, wherein the chemotherapy comprises tamoxifen.

58. A method of treating chronic lymphocytic leukemia in a human patient, comprising administering an anti-CD20 antibody to the patient in an amount effective to treat the chronic lymphocytic leukemia, wherein the patient is refractory to fludarabine previously administered for the chronic lymphocytic leukemia, and wherein the method does not include treatment with a radiolabeled anti-CD20 antibody.

59. A method according to claim 6, 28, or 58, wherein radiation is not used in conjunction with the anti-CD20 antibody.

60. A method of treating chronic lymphocytic leukemia in a human patient, comprising administering a therapeutic non-radiolabeled anti-CD20 antibody to the patient in an amount effective to treat the chronic lymphocytic leukemia, wherein radiation is not used in conjunction with said anti-CD20 antibody.



25/3 2010 15:41 akademikeren 027576



Patent complaint filed against Glaxo, Genmab drug
Thu Mar 25, 2010 9:32am EDT
Stocks

GlaxoSmithKline PLC
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2:22pm GMT+0100

Genmab A/S
GEN.CO
kr.72.10
-0.45-0.62%
2:22pm GMT+0100

Biogen Idec Inc.
BIIB.O
$58.70
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2:24pm GMT+0100
COPENHAGEN/LONDON, March 25 (Reuters) - GlaxoSmithKline (GSK.L) and Genmab (GEN.CO) said on Thursday that two rival drugmakers had filed a patent infringement related complaint with a Californian district court over leukaemia drug Arzerra.

STOCKS | FINANCIALS | HEALTHCARE

U.S.-based Biogen Idec Inc (BIIB.O) and Swiss Roche (ROG.VX) filed the complaint "based on GSK's manufacture, marketing and sale of Arzerra in the U.S. for the treatment of fludarabine and alemtuzumab refractory chronic lymphocytic leukemia (CLL)", Genmab said in a statement.

Arzerra became Genmab's first drug to the market when it was launched in the Unites States in November. It is produced and marketed by Glaxo, which was the subject of the complaint.

A Glaxo spokeswoman confirmed the move, which follows granting of a patent to Biogen and Roche on March 23 -- but she said the British company did not believe the claims were valid or enforceable.

The action by Biogen and Roche is not aimed at seeking an injunction to stop sales of Arzerra, she added.

"U.S. patent No 7,682,612 was issued to Genentech, Inc. and Biogen Idec, Inc. on March 23, 2010 and contains a claim to a method of treating CLL with anti-CD20 antibodies, wherein the method does not comprise treatment with radiolabeled anti-CD20 antibodies," Genmab said in a statement.

Genmab and Glaxo said they would assess the claim and determine how to respond.

Shares in Genmab were down 1 percent at 1325 GMT. Glaxo shares were up 0.3 percent. (Reporting by Anna Ringstrom and Ben Hirschler; Editing by Hans Peters)



25/3 2010 16:01 collersteen 027579



Lad os lige få meddelelsen ind også som det hele handler om:

Genmab A/S (OMX: GEN) offentliggjorde i
dag, at Genentech, Inc. og Biogen Idec, Inc. den 23. marts 2010 indleverede
stævning til US District Court, Southern District of California mod Genmabs
samarbejdspartner GlaxoSmithKline (GSK) med påstand om anerkendelse af
patentkrænkelse (declaratory relief complaint) af parternes amerikanske patent
US patentnr. 7,682,612 som følge af GSK's fremstilling, markedsføring og salg
af Arzerra? i USA til behandling af patienter med kronisk lymfatisk leukæmi
(CLL), som er refraktære over for fludarabin og alemtuzumab.

US patentnr. 7,682,612 blev udstedt til Genentech, Inc. og Biogen Idec, Inc.
den 23. marts 2010 og indeholder krav omhandlende en metode til behandling af
CLL med anti-CD20 antistoffer, hvori metoden ikke omfatter behandling med
radioaktivt mærkede anti-CD20 antistoffer.

Genmab vil i samarbejde med GSK vurdere og analysere de i sagen nedlagte
påstande og træffe beslutning om det mest hensigtsmæssige svar på søgsmålet.

http://www.proinvestor.com/news/472204/Anerkendelsess..



25/3 2010 16:52 JensH 027580



Hmmm... Gad vide hvad det næste der rammer genmab som et tog bliver :( Utroligt at der bliver ved med at komme trælse beskeder.



25/3 2010 17:34 akademikeren 027584



sent from iphone?



25/3 2010 19:39 Solsen 327585



Som ses af kursreaktionen - intet uentet.

Genmab skal ikke betale sagsomkostninger, idet de har aftale med gsk om, at de afholder alle omkostninger forbundet med IP.

Arzerras hæftning på den lille "loop" på CD20 gør, at Genmab/GSK mener at Roche intet har at komme efter.....

Zevalin og Bexxar er begge cd20 stoffer, men med radioaktive virkestoffer - forskellig fra Arzerra.

Der er så mange penge på spil, at Roche skal forsøge dette.

pdfArzerra_binding_site.pdf



26/3 2010 07:53 gentogen 227604



Jeg opfatter det også som ret forudsigeligt, da GSK i efteråret jo anlagde den modsatte sag, men som lægmand må jeg hellere tilføje, at jeg egentlig ikke fatter ret meget....

Nå, men man bliver jo nysgerrig, så jeg læste teksten alligevel

Så vidt jeg kan læse mig til, påstår de, at de efter at have set effekten af Rituxan i NHL, nu har gjort den opfindelse (invention), at anti CD 20 MÅSKE kan anvendes i andre indikationer. Selve opfindelsen af produktet har de ganske vist ikke gjort, men hævder patent på ethvert fremtidigt anti CD20 antigen(uanset dosis, uanset administrationsform, uanset type, uanset kombinationsbehandlinger, uanset indikation etc.). Patentet går således ud på, at de håber at kunne udvikle et produkt. Så de er da tydeligvis rigtig ærgerlige over, at Genmab kom først...Det er da fint, at Roche mener at have et problem.

De tager (får)med andre ord patent på noget, som de strengt taget ikke ved, hvordan virker, i hvilke doser, i hvilke patienter, i hvilke sugdomme, etc. etc. Som lægmand må jeg antage, at Genmab har en ret god sag.

Citat:(mine fremhævelser)
However, while anti-CD20 antibodies and, in particular, RITUXAN.RTM. (rituximab) have been reported to be effective for treatment of B-cell lymphomas, such as non-Hodgkin's lymphoma, it WOULD BE beneficial IF effective antibody treatments for other malignancies could be developed. More specifically, it WOULD BE beneficial IF anti-CD20 antibodies could be used for treating other types of malignancies.

BRIEF DESCRIPTION OF THE INVENTION

Toward that end, the present inventors HAVE DEVELOPED (det passer jo ikke, GtG) a novel treatment for hematologic malignancies characterized by a high number of tumor cells in the blood involving the administration of a therapeutically effective amount of an anti-CD20 antibody. In the preferred embodiments, such anti-CD20 antibody will comprise a chimeric, humanized, or human anti-human CD20 antibody. Examples of such hematologic malignancies include B-pro-lymphocytic leukemia (B-PLL), chronic lymphocyte leukemia (CLL), and transformed non-Hodgkin's lymphoma.

Thus, it is AN OBJECT of the invention to provide a novel treatment (det er deres mål, men de har jo netop IKKE udviklet det, GtG) for hematologic malignancies comprising the administration of an anti-CD20 antibody.".

Men den type patent er måske almindeligt??????



27/3 2010 11:35 Solsen 127636



http://clldiary.blogspot.com/

Lidt omkring Arzerra / Revlidmid studiet som forfatteren er igang med - men også rystende læsning omkring ameriakernerne i almindelighed !



29/3 2010 10:12 MammaMia 127660



Jeg undskylder på forhånd at jeg blot har valgt den nyeste GEN-tråd:

KØBENHAVN (Direkt) Skæbnen for Genmabs lægemiddelhåb Zalutumumab hænger i det uvisse, efter skuffende fase 3 resultater tidligere i marts. Et af de lignende produkter, Erbitux fra Merck KGaA, har til gengæld anderledes medvind.

Erbitux har fået udvidet godkendelsen i Japan til også at omfatte førstelinjebehandling af tarmkræft.

- Brugen af Erbitux som førstelinjebehandling af tarmkræft er et vigtigt skridt i udvidelsen af behandlingsmulighederne for japanske patienter, udtaler dr. Wolfgang Wein, der er chef for kræftmidler i divisionen Merck Serono, i en meddelelse.

Erbitux er desuden godkendt som behandling af hoved- og halskræft, hvilket var den sygdom, Genmab i første omgang havde ventet at søge Zalutumumab godkendt til. De skuffende studier har fået mange analytikere til at fraskrive Zalutumumab værdi, mens Genmab dog fortsat mener, at der er håb for, at Zalutumumab på et tidspunkt kan nå markedet.



Jakob Ussing +45 33 300 600

Nyhedsbureauet Direkt



29/3 2010 13:38 gentogen 027663



Med alle mulige forbehold for urimeælige sammenligninger etc. , så kan jeg altså ikke lade være med at undre mig lidt over, at Genmabs resultater hele tiden skal omtales som nærmest katastrofale, mens dette hos Erbitux omvendt er nærmest mirakuløst:

Median OS was 23.5 months compared to 20.0 months in those receiving chemotherapy alone (Hazard Ratio [HR] 0.796; p=0.0093)

The risk of disease progression was reduced by 30.4% (HR 0.696; p=0.0012)

The likelihood of achieving a tumor response doubled overall (Odds Ratio [OR] 2.0693; ORR 57.3% vs. 39.7%; p



29/3 2010 17:12 fistandanti 027665



Men zalut viste jo ikke nogen signifikant forbedring af OS i forhold til BSC armen, måske ikke katastrofalt når man ser på patientpopulationen, men alligevel katastrofalt for zaluts videre skæbne.

Lisa har udtalt, før de skuffende fase 3 vel at mærke, at man ikke søger H2H med zalutumumab, da der er mange mulige indikationer inden for EGFr inhibitors. Men jvnf. Mammamias tråd, indtager erbitux gradvist flere og flere indikationer og spørgsmålet er om ikke H2Hs er uundgåelige, hvis zalut skal have en blockbuster fremtid?




29/3 2010 17:47 Solsen 027667



Set i bakspejlet ville en H2H strategi i Arzerra og Zalutumumab have været mindst lige så god som den strategi Genmab valgte med at behandle dødsyge patienter - med umet medical need.

Zalutumumab kan vise sig bedre end Erbitux, der har stor frekvens af alvorlige bivirkninger.....MEN HVEM SKAL BETALE FOR DISSE STUDIER.

De kan være heldige, at et selskab vil køre studierne men der kommer ikke mange penge ud af det på den korte bane.




29/3 2010 19:47 akademikeren 027673



tjaaa. CLL strategien lykkedes til fulde synes jeg. Men jo der må nogen h2h studier til i arzerra ihvertfald, men kan vel i EGFR godt forfølge en almindelig fornuftig gennemrulning af firstline studier, men når Genmab nu har talt om at Zalut var et EGFR stof i særklasse, så er det lidt ærgeligt at stå her med håret i postkassen.



29/3 2010 20:12 gentogen 027674



Ja OK. Det er da rigtigt, at Genmab ikke kunne påvise, at de 30% forbedret OS var statistisk signifikant, mens Erbitux åbenbart kan påvise, at deres 17,5% forbedring er signifikant. Sådan kan det gå.



25/3 2010 16:53 Sibelius 027581



Hmmm, en ulykke (endsige tre) kommer sjældent alene.

Skal man se noget positivt i det må det være at Roche tager Arzerra meget alvorligt.



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