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Genmab, de Deense parel

1. [verwijderd] 2 april 2008 06:46

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   GENMAB ANNOUNCES YEAR END 2007 FINANCIAL RESULTS
   
   www.genmab.com/upload/11_ar2007_31030...
2. Edjes1 4 april 2008 11:16

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   Is er wat aan het handje vandaag bij Genmab? +6,6%
3. [verwijderd] 7 april 2008 18:09

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   GENMAB A/S SUMMONS ANNUAL GENERAL MEETING
   
   Copenhagen, Denmark; April 7, 2008 – Genmab A/S (OMX: GEN) summon the Annual General Meeting on Wednesday April 23, 2008 at 3:00 pm CEST at the Radisson SAS Scandinavia Hotel, Amager Boulevard 70, 2300 Copenhagen S, Denmark.
   
   Agenda:
   
   1. Report of the Board of Directors on the Company’s activities during the year.
   
   2. Presentation of the audited Annual Report 2007 for approval and the discharge of the Board of Directors and the Management.
   
   3. Decision as to the settlement of loss according to the approved Annual Report.
   
   4. Election of members of the Board of Directors.
   
   5. Election of auditor.
   
   6. Proposals from the Board of Directors and/or the shareholders.
   
   www.genmab.com/PressCentre/RecentNews...
4. [verwijderd] 16 april 2008 06:53

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   NOVEL INSIGHTS INTO HUMAX-EGFr MECHANISMS OF ACTION PUBLISHED IN PNAS
   
   Copenhagen, Denmark; April 15, 2008 – Genmab A/S (OMX: GEN) announced today new insights showing that HuMax-EGFr™ (zalutumumab) locks epidermal growth factor receptor (EGFr) molecules into a very compact, inactive conformation. The flexibility of the EGFr is central to its role in signaling, and binding of HuMax-EGFr (zalutumumab) results in effective inhibition of cancer cell growth. As EGFr activity plays an important role in many cancers, targeting it with HuMax-EGFr (zalutumumab) should make it especially difficult for cancer cells to grow, multiply, and survive.
   
   
   
   By using an electron microscope based technique, called protein tomography, the structural rearrangement accompanying inhibition of individual EGFr molecules was studied. Biochemical analyses showed that HuMax-EGFr binds bivalently to the EGFr and, furthermore, was shown to prevent receptor dimerization and to severely limit intermolecular flexibility of EGFr molecules.
   
   
   
   “These new insights point out that HuMax-EGFr may employ at least three distinct mechanisms of action leading to inhibition of cancer cell growth. HuMax-EGFr is able to induce potent immune system defense activity known as ADCC, block growth factor binding to EGF receptors, and we now established that HuMax-EGFr inhibits EGFR activation by limiting receptor flexibility. This new data further underlines the potential of HuMax-EGFr for treatment of solid cancers.” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
   
   
   
   These new findings will be published in the journal Proceedings of the National Academy of Sciences of the United States of America (PNAS) in the edition published on April 15, 2008.
   
   www.genmab.com/PressCentre/RecentNews...
5. [verwijderd] 24 april 2008 16:13

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   PASSING OF GENMAB A/S' ANNUAL GENERAL MEETING
   
   Copenhagen, Denmark; April 23, 2008 - Genmab A/S (OMX: GEN) held its Annual General Meeting, today April 23, 2008 at 3:00 pm at Radisson SAS Scandinavia Hotel, Amager Boulevard 70, 2300 Copenhagen S, Denmark.
   
   At the meeting Chairman of the Board Dr. Michael B. Widmer gave - on behalf of the Board - a report on the Company's activities during the past year. Chief Executive Officer and member of the Board, Lisa N. Drakeman presented plans for the year ahead, and Chief Financial Officer Bo Kruse presented the Annual Report for 2007 endorsed by the auditors. The report was approved and discharge was given to the Board and the Management.
   
   It was decided that the year's loss of DKK 373 million be carried forward by transfer to accumulated deficit, as stated in the Annual Report.
   
   Michael B. Widmer and Karsten Havkrog Pedersen were re-elected to the Board for a further three year period.
   
   PricewaterhouseCoopers, Statsautoriseret Revisionsaktieselskab A/S was reelected as the Company's auditor.
   
   The General Meeting adopted the proposals from the Board to change the Company's Articles of Association, as follows:
   
   * The proposals to remove the current Article 5, Article 6 and Schedule A and to make the consequent amendments to the Articles of Association.
   * The proposal to amend Article 5 (previously Article 6A) to authorize the Board of Directors to issue additional warrants - without pre-emption rights for the existing shareholders - that give the right to subscribe up to nominally DKK 1,500,000 shares in the Company to members of the Company's Board of Directors, the Company's employees and consultants as well as employees and consultants of the Company's subsidiaries and to implement the corresponding capital increases related to the warrants issued.
   * The proposal to adopt a new Article 5A to the Articles of Association under which the Board of Directors shall be authorized, until April 23, 2013, by one or more issues to raise loans against bonds or other financial instruments up to a maximum amount of DKK 2 billion, or the equivalent amount in USD or EUR, with a right for the lender to convert his claim to new shares in the Company.
   * The proposal to amend Article 8 (previously Article 9) so that the requirement of publishing the notice for the General Meeting in a Danish nationwide newspaper is discontinued and the notification is instead published in the computer information system of the Danish Commerce and Companies Agency, by notification to OMX The Nordic Exchange Copenhagen and by posting on the Company's website.
   * The proposal to amend Article 12 (previously Article 13) to simplify the staggered board election provisions to a more simple election principle so that the members of the Board of Directors elected by the General Meeting shall be elected for a period which expires at the Annual General Meeting in the Company in the third year after the year of their election.
   * The proposal to adopt a new Article 14 to reflect the adoption of general guidelines for incentive-based remuneration for the Board of Directors and Executive Management.
   
   Finally the Board of Directors were authorized according to Section 48 of the Danish Companies Act so that until the next Annual General Meeting the Company may purchase own shares in connection with the buy-back of shares subscribed by employees etc. pursuant to the Company's employee warrant programmes to the extent of up to 2 percent of the Company's share capital and so that the consideration for such shares shall be equal to the exercise price paid for the shares in question.
   
   [URL="http://www.genmab.com/PressCentre/RecentNewsReleases/16PassingofGenmabA,-s-,S%27AnnualGeneralMeeting/Language/English.aspx"]Bron[/URL]
6. flosz 19 mei 2008 12:49

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   SNS Securities
   
   The Fantastic Five in Biotech Europe
   19 May 2008
   
   Introduction
   Within the ESN Biotech Universe we have selected five companies that we think will show a
   better performance than the sector as a whole. In making our selection we specifically looked
   at important fundamentals for biotechnology companies like:
   Pipeline development: preferably late stage products in which near term mile stones are
   to be reached
   Partnerships: The validation of a pipeline/technology is often underscored if a biotech
   company managed to sign one or more partnerships with large pharmaceutical or
   biotechnology companies. It also reduces the risk profile of a company as it often secures
   the current financial position of a biotech company as well as the financing of future cash
   burn (milestone payments)
   Cash position: Most biotech companies in development do not have a steady growing
   income from revenues. The development of a product is costly and time consuming, which
   means that a sufficient cash position provides the company with the financial space to
   finance the development of its pipeline. A low cash position often leads to forced strategic
   her orientations and weak negotiation power in making partnerships with big pharma.
   Management: Especially in fast growing companies like biotechs, it is important to have a
   well experienced management that has the knowledge of business development, closing
   deals with pharma and commercial experience.
   However, next to these fundamentals, in the short to medium term it is vital for the share
   price performance of biotechs to have enough news flow. This, above all things drives the
   share price. Contrary to most other sectors, the performance of most biotechs is not driven
   by quarterly figures and the development of the bottom line result. News items that are of
   importance are usually announcements of partnerships with big pharma, data of clinical
   trials (Phase I, II, III) and approval/disapprovals of products by the FDA and/or EMEA.
   In selecting our top picks for this quarter we looked at the news flow that is to be expected
   in the short to medium term which can drive the share price in the short to medium term.
   Our top picks for 2008Q2 are:
   Crucell (NL)
   Genmab (DK)
   Intercell (AV)
   Morphosys (Ger)
   Transgene (F)
   Furthermore, per company covered by ESN in European biotech, we have included the news items
   we can expect in the next few quarters.
   
7. flosz 19 mei 2008 12:50

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   Closing in on HuMax-CD20 CLL ph3 data
   
   Like the majority of the biotech companies, Genmab has taken some
   hits during the last 12 months, now trading one-third down from its
   peak after the record-breaking partner agreement with GSK on the
   HuMax CD20 programme. We view the current share price as a great
   opportunity to Buy on anticipation of a positive outcome on the pivotal
   phase III data from four trials expected before year-end. Based on the
   previous data presented and the validated technology and targets, we
   believe the chances of a positive outcome of these trials are good.
   We believe Genmab is on track to become a profitable biopharmaceutical
   company, with its very impressive strong late-stage
   pipeline for the treatment of cancerous and inflammatory diseases. The
   next 12 months could change the company dramatically, with data
   expected from four out of the six different phase III studies. The HuMax-
   CD20 CLL study is expected next month, and data from HuMax-CD20 in
   NHL, HuMax-EGFr in SCCHN and HuMax-CD4 in CTCL before yearend.
   The next key event for Genmab is the pivotal data from the HuMax CD20
   CLL phase III trial. The previous phase 1/2 “proof of concept” study
   showed a 50% response in refractory CLL patients and Genmab has
   indicated that a response of 25% would be enough to get approval. Also
   keep in mind that the total exposure of the antibody in the phase III study
   is much higher than in the previous study, which we believe will further
   increase the odds for a successful outcome. If positive, it could lead to
   filing for approval in mid-2008 and a possible launch of HuMax CD20 in
   CLL early 2009.
   Genmab anticipates ramping up its R&D significantly during 2008. Aside
   from the HuMax-CD20 development, it clearly looks as if Genmab wants
   to maximise the value of the still-not-partnered HuMax-EGFr programme.
   With 17 announced new clinical programmes expected in 2008, five of
   these are focused on HuMax-EGFr. We expect that a significant partner
   agreement could see daylight during 2009.
   Financial guidance for 2008: Revenues of DKK 1.0 billion and a net loss
   of DKK 800-900 million. Cash position at year-end in the range of DKK
   1.7-1.8 billion.
   Thomas Bowers/ Martin Parkhøi
   Danske Markets Equities
   +45 45 12 80 44/+45 45 12 80 46
   THBO@danskebank.dk/ MPAR@danskebank.com
   
8. flosz 19 mei 2008 13:09

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   quote:

   flosz schreef:

   SNS Securities
   
   The Fantastic Five in Biotech Europe
   19 May 2008
   
   Our top picks for 2008Q2 are:
   Crucell (NL)
   Genmab (DK)
   Intercell (AV)
   Morphosys (Ger)
   Transgene (F)
   Furthermore, per company covered by ESN in European biotech, we have included the news items
   we can expect in the next few quarters.
   
   

   Upcoming corporate calendar Top Picks
   
   Genmab (GEN DC, DKK 261)
   
   Date Product Event Impact
   June 2008 HuMax CD20 Clinical Phase III data CLL Very important
   Mid 2008 HuMax EGFr Clinical Phase II data SCCHN front line Important
   2008H2 HuMax EGFr Clinical Phase II data NSCLC Very important
   2008H2 HuMax CD4 Initiate front line studies Not so important
   2008H2 HuMax CD4 Clinical Phase III data CTCL Very important
   2008H2 AMG714 Initiate proof of concept Phase II studies Not so important
   2008H2 HuMax CD20 Clinical Phase III data NHL Very important
   2008H2 HuMax EGFr Initiate Phase III NSCLC front line combined with CRT and RT Important
   2008H2 HuMax EGFr Initiate Phase I/II study in colorectal cancer Not so important
   2008H2 HuMax CD20 BLA filing CLL Important
   2008H2 HuMax EGFr Clinical Phase III data SCCHN Very important
   2008H2 HuMax HepC Initiate Phase I/II liver transplants (Hep C) Not important
   
9. [verwijderd] 19 mei 2008 13:10

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   Flosz, je maakt mijn dag weer goed:
   
   Our top picks for 2008Q2 are:
   Crucell (NL)
   Crucell (NL)
   Crucell (NL)
   Crucell (NL)
   Genmab (DK)
   Intercell (AV)
   Morphosys (Ger)
   Transgene (F)
   
   Psycho
   
10. flosz 23 mei 2008 15:15

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    Uit nieuwsbrief biofarmind:
    
    Eerste Educatieve Sessie over
    Monoclonale Antilichamen bijzonder
    Succesvol
    O.a. incl. keynote speaker, Jan vd Winkel (Genmab).
    
    www.biofarmind.nl/biofarmind/content/...
    
11. flosz 25 juni 2008 08:20

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    GENMAB INITIATES STUDY OF ZALUTUMUMAB WITH RADIOTHERAPY IN HEAD AND NECK CANCER
    
    Copenhagen, Denmark; June 24, 2008 - Genmab A/S (OMX: GEN) announced today it has initiated a Phase I/II study of zalutumumab (HuMax-EGFr™) in combination with radiotherapy for the treatment of advanced head and neck cancer. The study will include a maximum of 36 patients who are ineligible for platinum based chemotherapy.
    
    "Platinum based chemotherapy is currently considered to be the best available standard treatment for advanced head and neck cancer. We hope zalutumumab may some day provide a treatment option for patients who are in need of less toxic therapies," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
    
    About the trial
    In the dose-escalation part of the study, 6 to 24 patients will be enrolled in cohorts of 3 patients per dose level of zalutumumab. The dose level for each successive cohort will be determined by the aggregate safety data observed in the prior cohorts. When the maximum tolerated dose of zalutumumab is established, an additional cohort of 12 patients will be enrolled and treated at this level.
    
    Patients in the study will receive 8 weekly infusions of zalutumumab with the first cohort receiving an initial dose of 12 mg/kg of zalutumumab followed by 7 maintenance doses of 8 mg/kg of zalutumumab in addition to radiotherapy. Patients will be evaluated at 4 weeks following the last dose of zalutumumab and will be followed for a total of 2 years.
    
    The objective of the study is to evaluate the safety of repeat dosing and establish the maximum tolerated dose of zalutumumab in combination with radiotherapy in patients with advanced head and neck cancer who are ineligible for platinum based chemotherapy. The primary endpoint of the study is adverse events.
    www.genmab.com/upload/31_humax-egfr_p...
    
12. [verwijderd] 25 juni 2008 15:15

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    Waarom wordt er zo negatief gereageerd op dit nieuws? Nu 8,46 % in de min (15:14)
13. op&neer 30 juni 2008 16:17

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    Inmmiddels staat de koers 50% lager dan 12 maanden geleden. Zoals altijd binnen de biophama duurt het allemaal wat langer dan verwacht, maar ik heb de indruk dat er toch geen echte tegenvallers zijn te verwachten. Daarbij zijn de komende maanden cruciaal voor Genmab.
    
    Het gaat wel weer erg hard de afgelopen weken. Kan iemand dat verklaren of is dat de verkoopclimax aan het einde van een LT dalende trend (verkopende scheefzittende hedgefunds als GO Capital??)
    
    De resultaten van HuMax CD20 kunnen nu ieder moment naar buiten komen. Een positieve uitslag en er komt een shortsqueeze op gang. Dan staan we zo weer op DKK 250+.
    
    Ik heb in ieder geval gekocht vandaag op DKK 181,-.
14. flosz 30 juni 2008 20:19

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    GENMAB REACHES MILESTONE IN OFATUMUMAB COLLABORATION
    Copenhagen, Denmark; June 30, 2008 – Genmab A/S (OMX: GEN) announced today it has reached a development milestone for ofatumumab (HuMax-CD20®) under the terms of its collaboration with GlaxoSmithKline (GSK). A milestone payment of approximately DKK 29 million (approximately USD 6 million) was triggered by treatment of the first patient participating in the Phase II study of ofatumumab for the treatment of relapsing remitting multiple sclerosis (RRMS).
    
    
    
    “Our collaboration with GSK continues to progress as both companies work towards providing new treatment options for patients,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “We are pleased to begin treating patients in the first study of ofatumumab in RRMS, an unpredictable and debilitating disease.”
    
    
    
    Ofatumumab is an investigational, fully human, next generation monoclonal antibody that targets a distinct small loop epitope on the CD20 receptor on the surface of B-cells. This epitope is different from the other anti-CD20 antibodies currently available or in development. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GSK.
    
15. flosz 7 juli 2008 17:47

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    Europe's biotech firms need to think big if they are to prosper, says Lisa Drakeman of Genmab
    www.economist.com/people/displaystory...
    
16. [verwijderd] 10 juli 2008 15:53

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    RECRUITMENT COMPLETED IN OFATUMUMAB CLL FRONT LINE STUDY
    
    Copenhagen, Denmark; July 9, 2008 - Genmab A/S (OMX: GEN) announced today it has completed recruitment of 56 patients in the Phase II study of ofatumumab (HuMax-CD20®) in combination with fludarabine and cyclophosphamide (FC) to treat chronic lymphocytic leukemia (CLL) in previously untreated patients.
    
    "We are pleased to complete patient enrollment in the first front line study of ofatumumab and hope to see a positive outcome for the CLL patients in this trial," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
    
    Ofatumumab is an investigational fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 molecule on the surface of B-cells. Other anti-CD20 antibodies currently available or in development bind to a different epitope on the CD20 molecule. Ofatumumab is being developed to treat CLL, follicular non-Hodgkin's lymphoma, diffuse large B-cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any country.
    
    About the trial
    
    Patients in this open label study will be randomized into two treatment groups of 28 patients each. Each patient will receive 6 monthly infusions of either 500 or 1000 mg of ofatumumab in combination with FC. Disease status will be measured every 4 weeks until week 24 according to National Cancer Institute Working Group Guidelines and every 3 months thereafter until disease progression or 24 months. Patients not having progressed on their disease at 24 months will be followed for disease progression at 6 month intervals until 48 months.
    
    The objective of the study is to determine the efficacy of ofatumumab in combination with FC in previously untreated CLL patients. The primary endpoint is complete remission measured at any time during the treatment period.
    
    Bron: Genmab website
    
    (15:22 198DK +9.09%)
17. [verwijderd] 1 augustus 2008 09:54

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    Genmab surges on successful drug study with Glaxo
    Fri Aug 1, 2008 3:28am EDT
    
    COPENHAGEN, Aug 1 (Reuters) - Shares in Danish biotech firm Genmab (GEN.CO: Quote, Profile, Research, Stock Buzz) rose by as much as a third on Friday after an experimental treatment for leukaemia it developed with GlaxoSmithKline (GSK.L: Quote, Profile, Research, Stock Buzz) proved effective in a pivotal trial.
    
    The companies said late on Thursday the antibody drug met its goal in the study of difficult-to-treat patients with chronic lymphocytic leukaemia (LCC), producing a response rate well in excess of the 25 percent minimum needed.
    
    By 0725 GMT, Genmab traded up 26 percent at 324 crowns, after a high of 345, while Glaxo, for which the drug is just one of many in development, added 1.5 percent to 11.93 pounds.
    
    Analysts at Lehman Brothers said the results for what would be Genmab's first commercial product were well ahead of expectations and strongly supported a regulatory filing in the fourth quarter of 2008, with potential U.S. launch by mid-2009.
    
    The positive results were likely to trigger an estimated $60 million payment to Genmab from Glaxo from the more than $1.1 billion of outstanding milestone payments, they added.
18. flosz 25 augustus 2008 09:00

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    GENMAB ANNOUNCES UPCOMING OFATUMUMAB STUDIES
    Front Line CLL, NHL and CLL Retreatment and Japanese Development Studies Planned
    
    Copenhagen, Denmark; August 25, 2008 - Genmab A/S (OMX: GEN) announced today plans to begin four studies of ofatumumab in chronic lymphocytic leukemia (CLL) and follicular non-Hodgkin's lymphoma (NHL) this year.
    
    "Genmab and GSK have worked diligently to expand the ofatumumab development program to maximize the value of the antibody for patients and shareholders since our collaboration began," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "The new studies we are initiating this year will examine the potential of ofatumumab in Japan as well as a number of new treatment settings - retreatment, maintenance and front line with chlorambucil."
    www.genmab.com/upload/36_upcoming_ofa...
    
19. flosz 3 september 2008 20:09

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    GENMAB ANNOUNCES CHANGE IN MANAGEMENT
    Copenhagen, Denmark; September 3, 2008 - Genmab A/S (OMX: GEN) announced today that Claus Møller, M.D., Ph.D. has informed the Board of Directors of his intention to step down from his position as Executive Vice President, Chief Operating Officer of Genmab. Dr. Møller's decision reflects his desire to concentrate on his role as Chairman of the board of IPC-International, Plc and to spend more time with his family having achieved his main career goals within Genmab.
    
    Dr. Møller will remain available to Genmab as Development Advisor during a transitional period for the remainder of 2008. The Chief Operating Officer position at Genmab will be discontinued and Dr. Møller's responsibilities will be folded into the research and development department which has already been consolidated under the direction of Prof. Jan G. J. van de Winkel, Ph.D., President, Research and Development and Chief Scientific Officer, in conjunction with an earlier expansion of the company's senior management team which now includes eight members.
    
    "Claus was one of Genmab's founders ten years ago and has been an essential part of building Genmab into a world leading biotechnology company. He has made significant contributions across a range of activities including the development of ofatumumab. We wish to offer our sincere thanks to Claus for his many years of service with the company and wish him the best in his future endeavors," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
    
20. flosz 8 oktober 2008 13:32

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    OFATUMUMAB INDUCES LONG LASTING CLINICAL RESPONSES IN PHASE II RA STUDY
    Data to be presented at ACR meeting
    
    Copenhagen, Denmark; October 8, 2008 – Genmab A/S (OMX: GEN) announced today that data showing that rheumatoid arthritis patients who participated in the ofatumumab (HuMax-CD20®) Phase II study achieved long lasting results at the 48 week follow up period. The data will be presented in a poster session at the ACR/ARHP 2008 Annual Scientific Meeting in San Francisco, California on October 26, 2008. The full abstract can be found at www.abstractsonline.com/plan/ViewAbst...
    
    Ofatumumab is an investigational, new generation, human monoclonal antibody that targets a distinct membrane proximal, small loop epitope (specific binding site) of the CD20 molecule on the surface of B-cells. Ofatumumab is being developed to treat chronic lymphocytic leukemia, follicular non-Hodgkin's lymphoma, diffuse large B-cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved for sale in any country.