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Genmab, de Deense parel
GENMAB AMENDS OFATUMUMAB PIVOTAL STUDY IN NHL TO SINGLE ARM STUDY
Copenhagen, Denmark; September 27, 2007 – Genmab A/S (OMX: GEN) announced today it has amended the design of an ongoing pivotal study of ofatumumab (HuMax-CD20®) in rituximab refractory follicular non-Hodgkin’s lymphoma (NHL) to a single arm trial that will now include approximately 81 patients. All patients will receive one infusion of 300 mg of ofatumumab followed by 7 weekly infusions of 1000 mg of ofatumumab. The original study design included 162 patients, who would have received one infusion of 300 mg of ofatumumab followed by 7 weekly infusions of either 500 or 1000 mg of ofatumumab. This is the first study of ofatumumab dedicated to patients with rituximab-refractory follicular lymphoma. In order to establish that ofatumumab is efficacious in this refractory setting, reducing the number of patients in the trial will help to expedite a result. The lower dose (500 mg) was dropped to reduce the total number of patients to be accrued and ensure that these very sick patients receive the maximum dose. Data from patients who were already treated in the 500 mg dose group will be analyzed for safety and included in the secondary efficacy analysis, but will not be included in the primary efficacy analysis. “This change to the pivotal study design will allow us to treat all the refractory patients with a higher dose level of ofatumumab, allowing the maximum opportunity for response and longer lasting effects in this patient population,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. Ofatumumab is an investigational drug being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any market. www.genmab.com/PressCentre/RecentNews...
GENMAB TO ATTEND TWO OCTOBER INVESTOR CONFERENCES
Copenhagen, Denmark; October 1, 2007 - Genmab A/S (OMX: GEN) announced today its management will attend at two investor conferences in October 2007. Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab will present at the Natexis Bleichroeder Hidden Gems Conference in New York City at 1:15PM local time on October 8. Dr. Drakeman's presentation will be available via live and archived webcast at www.genmab.com. Chief Operating Officer Claus Møller, M.D., Ph.D. will participate in the Lehman Brothers Healthcare Investor Conference in London on October 22. www.genmab.com/PressCentre/RecentNews...
ROCHE FILES CTA FOR THIRD GENMAB ANTIBODY
Copenhagen, Denmark; October 2, 2007 - Genmab A/S (OMX: GEN) announced today that its partner Roche has filed a Clinical Trial Application (CTA) with the British Medicines and Healthcare products Regulatory Agency (MHRA) for a Genmab antibody developed under the companies' collaboration. Genmab will receive a milestone payment from Roche which does not influence Genmab's financial guidance for 2007. Under the agreement with Roche, Genmab utilizes its broad antibody expertise and development capabilities to create human antibodies to a broad range of disease targets identified by Roche. Genmab receives milestone and royalty payments based on successful products. In certain circumstances, Genmab may obtain rights to develop products based on disease targets identified by Roche. If all goals are reached, the value of the collaboration to Genmab could be USD 100 million, plus royalties. "We are pleased that the third antibody created by Genmab under our partnership with Roche is entering the clinic and to now have eight products in clinical development," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "Genmab has now achieved the eleventh milestone under the collaboration." Latest Trade Info Traded Last +/- % Shares traded Bid Ask High Low Market Cap. 02-10-2007 17:57 328 0.00 218,266 328 329 334 328 14,598 M DKK / 2,774 M USD 1,958 M EUR
Reden voor de daling van 4% behoudens sentiment??
GENMAB WINS SCRIP’S BIOTECH COMPANY OF THE YEAR AWARD
Copenhagen, Denmark; December 5, 2007 - Genmab A/S (OMX: GEN) announced today it has won the 2007 Scrip Biotech Company of the Year award. The award was presented December 4, 2007 at an awards ceremony and gala dinner at the London Hilton on Park Lane hotel. The award recognizes Genmab's accomplishments during 2006 and 2007 including our work to bring new products closer to their first markets, raise capital, enter significant licensing agreements, maintain strong management, address unmet medical needs through development of our new technology UniBody® and to transform Genmab from an early stage to a more mature world leading biotechnology company. "Receiving the Scrip Award is a testament to the skill and efficiency of all Genmab employees who have worked hard to make our business grow. We are delighted to have won and are honored to receive this year's Scrip Award for Biotech Company of the Year," said Lisa N. Drakeman, Ph.D., Chief Executive Officer at Genmab. www.genmab.com/PressCentre/RecentNews...
Rumours in the market that Novo will bid for Genmab. Industry experts say a buy-out will only work at DK 1000-1200. messages.finance.yahoo.com/Stocks_%28...
Dank voor posten.
Misschien dat de reden voor koersstijging is, dat is de deal van het Zwitserse Novartis en Morphosys.
Morphosys doet zelfde type R&D als Genmab. ____________________________________________________ Forbes: Novartis Builds Its Antibodies Vidya Ram, 12.03.07, 1:00 PM ET LONDON - Biotechnology companies usually have to renew contracts every two to three years. Therefore it's not surprising that shares in German antibody research company MorphoSys shot up after Swiss drug maker Novartis announced a 10-year contract with the company worth over $1 billion. Shares in MorphoSys soared by 10.41 euros ($15.26), or 25.3%, to 51.60 euros ($75.63) in midday trading in Frankfurt on Monday, reacting to Novartis' announcement over the weekend. Novartis shares traded down 0.8%, at 63.85 Swiss francs ($56.57) in Zurich. "This is a transforming deal for MorphoSys," said MorphoSys Chief Executive Simon Moroney. "This alliance heralds a new chapter in our corporate development as it offers us the perfect construct to increase significantly the value of our proprietary drug development pipeline while simultaneously maximizing our financial interest in partnered programs." The deal will make MorphoSys into Novartis' main collaborator for the discovery and development of therapeutic antibodies for a wide range of diseases, giving Novartis almost exclusive access to its technology, including to its library of more than 10 billion human antibodies. Novartis retains an option to prolong the contract for an additional two years. etc....
En andere reden voor koersstijging van Genmab is, dat de FDA geen toestemming geeft voor gebruik van Avastin (Genentech) igv borstkanker. Bijgevolg Genentec (DNA) koers: - 9.1 %
Dwz meer interesse in human anti-bodies van Genmab...zou je zeggen...
Market Report: Glaxo targets Danish group to save its bacon
By Nick Clark Published: 06 December 2007 The pharma giant GlaxoSmithKline could be back on the acquisition trail as talk circulated that it was preparing a bid for a Danish biotechnology group. This came on a day that the market soared more than 2 per cent, as investors bet on the Bank of England cutting interest rates today. Rumours did the rounds in the afternoon that Glaxo was set to target Denmark's Genmab, which has a market capitalisation of ¿2.1bn. The companies have previously had licensing and development deals together, but talk yesterday was of a full takeover. Glaxo closed up 16p at 1,304p. Glaxo has had tough times recently, with sales hit by the scare over the diabetes drug Avandia. news.independent.co.uk/business/analy...
GENMAB’S HUMAX-CD38 ENTERS PHASE I/II CLINICAL TRIAL FOR MULTIPLE MYELOMA
Copenhagen, Denmark; December 7, 2007 - Genmab A/S (OMX: GEN) announced today it has initiated a Phase I/II safety and dose finding study of HuMax-CD38™ for the treatment of multiple myeloma (MM). The study will include a maximum of 122 patients with MM who are relapsed or refractory to at least two different prior treatments and are without further established treatment options. "HuMax-CD38 is the ninth Genmab antibody to enter clinical development," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We are looking forward to the results of this safety study and hope that HuMax-CD38 may one day offer a new potential treatment for multiple myeloma patients who have run out of treatment options." About the trial This open label dose escalation safety study will consist of two parts. In Part 1, 26 to 62 patients will be enrolled depending on the number of dose levels reached during escalation. Patients in Part 1 will be divided into cohorts at various doses of HuMax-CD38, with each patient receiving 7 infusions. The first infusion will be followed by a 3 week period of safety monitoring with the following 6 doses to be given at weekly intervals. In Part 2, 60 patients will be enrolled with 20 patients in each of three dose levels. The highest dose in Part 2 will be the highest safe dose in Part 1 and two dose levels below. Patients in Part 2 will receive 6 infusions of HuMax-CD38 at weekly intervals. In each part of the study, patients will attend 12 follow up visits at 2 to 4 week intervals to assess safety and efficacy and will be followed every 12 weeks thereafter until disease progression, initiation of alternative treatment for MM or death for a maximum total of 2 years from study start. About HuMax-CD38 HuMax-CD38 is a fully human antibody that targets the CD38 molecule which is highly expressed on the surface of multiple myeloma tumor cells. In preclinical studies, HuMax-CD38 was more effective in triggering the immune system killing mechanisms Antibody-Dependent Cellular Cytotoxicity (ADCC) and Complement Dependent Cytotoxicity (CDC), than other human CD38 antibodies when tested on multiple myeloma tumors. HuMax-CD38 also potently killed tumor cells from a patient with a CD38/138 positive plasma cell leukemia which was refractory to chemotherapy at the time of analysis. Furthermore, treatment with HuMax-CD38 slowed tumor growth in both preventive and therapeutic settings in SCID mice in animal models. HuMax-CD38 is the first antibody known to block the ecto-enzymatic activity of CD38. About Multiple Myeloma Multiple Myeloma is a plasma cell disorder, characterized by uncontrolled and progressive proliferation of a plasma cell clone. The proliferation of myeloma cells causes displacement of the normal bone marrow. MM accounts for approximately 1% of all malignancies and 10% of all hematologic malignancies with a higher frequency in African Americans where MM accounts for 20% of all hematologic malignancies. In the US, approximately 11,000 deaths each year are related to MM and the estimated number of new cases is rising. At present, no cure is available, and the mean survival is approximately 3-5 years. www.genmab.com/PressCentre/RecentNews...
Danish shares higher midmorning, led up by Novozymes; Genmab lower
Genmab AS fell 9.50 dkr to 339.00, following a sharp upturn earlier in the week on unconfirmed takeover rumours. According to RB Boersen, ING cut its rating for the pharmaceutical company to 'sell' from 'hold', saying a takeover would be unlikely. www.hemscott.com/news/latest-news/ite...
FOURTH GENMAB ANTIBODY DEVELOPED UNDER ROCHE COLLABORATION TO ENTER CLINIC
Copenhagen, Denmark; December 11, 2007 – Genmab A/S (OMX: GEN) announced today that an Investigational New Drug application (IND) for a Genmab antibody developed under the company’s collaboration with Roche has been filed with the FDA by Roche. Genentech and Roche are collaborating on development of the antibody which selectively blocks the interaction of the OX40 ligand and its receptor. The companies are evaluating the antibody for the treatment of asthma. Genmab will receive a milestone payment from Roche which does not influence Genmab's financial guidance for 2007. In pre-clinical data published in a recent article and commentary in The Journal of Clinical Investigation, treatment with the human OX40L blocking antibody led to significant therapeutic effects in a nonhuman primate model of allergic inflammation. The mechanisms of action of the human antibody include effective blockade of OX40L binding to its receptor, and depletion of cells expressing OX40L. Depletion of OX40L-expressing cells was shown to depend on interaction of immune effector cells with the therapeutic antibody. The observed in vivo efficacy of the OX40L-specific antibody may also involve restoration of peripheral tolerance mechanisms. Breaking of tolerance promotes development of autoimmune and allergic diseases. Under the agreement with Roche, Genmab utilizes its broad antibody expertise and development capabilities to create human antibodies to a broad range of disease targets identified by Roche. Genmab receives milestone and royalty payments based on successful products. In certain circumstances, Genmab may obtain rights to develop products based on disease targets identified by Roche. “Four of the antibodies developed by Genmab under our collaboration with Roche have now entered the clinic. We believe this achievement is a testament to the skill of Genmab’s pre-clinical development team who work carefully to select the best product candidates and Roche’s dedicated focus on progressing them to market,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. www.genmab.com/PressCentre/RecentNews...
GENMAB ANNOUNCES DETAILS OF PLANNED OFATUMUMAB PHASE II STUDY IN MULTIPLE SCLEROSIS
Copenhagen, Denmark; December 13, 2007 – Genmab A/S (OMX: GEN) announced today details of a planned Phase II study of ofatumumab (HuMax-CD20®) for the treatment of relapsing remitting multiple sclerosis (RRMS). Approximately 324 patients will be enrolled in the study which will be conducted under Genmab’s collaboration with GlaxoSmithKline (GSK). The study is expected to begin in the first quarter of 2008. Ofatumumab is an investigational, fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 receptor on the surface of B-cells. Other anti-CD20 antibodies currently available or in development bind to a different epitope on the CD20 receptor. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. “Multiple sclerosis is a debilitating disease for which there are currently few treatments,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “We hope our fully human antibody, ofatumumab, may offer another potential treatment option for patients suffering from this incapacitating disease.” About the trial The double blind randomized trial will consist of two parts. Part A will include approximately 36 patients in one of three increasing dose cohorts (100 mg, 300 mg or 700 mg of ofatumumab) randomized to receive ofatumumab or placebo. An independent data monitoring committee (IDMC) will evaluate the safety of each sequential cohort prior to progression to the next cohort. When all patients in Part A have had their week 4 MRI scan, the IDMC will evaluate the data before Part B of the study begins. Part B will consist of a 48 week treatment period of approximately 288 patients. Patients will be randomized to treatment with 100 mg, 300 mg, or 700 mg of ofatumumab or placebo. After week 24, patients on an active dose will receive re-treatment with the same dose of ofatumumab or placebo. Patients on placebo will receive ofatumumab at the highest tolerated dose from Part A. The objective of the study is to determine the safety and tolerability of three doses of ofatumumab and the dose response of ofatumumab on disease activity on MRI in patients with RRMS. The primary endpoints are safety and cumulative number of new Gd-enhanced lesions from week 8 to week 24. About Relapsing Remitting Multiple Sclerosis Multiple Sclerosis (MS) is an inflammatory disease of the central nervous system. MS is twice as common in females as in males, occurs with a peak incidence at the age of 35 years and incidence varies widely in different populations and ethnic groups. The etiology of MS remains unknown, but the geographic variation points towards possible environmental and genetic factors. The most common form of MS is relapsing remitting MS characterized by unpredictable recurrent attacks where the symptoms usually evolve over days and are followed by either complete, partial or no neurological recovery. No progression of neurological impairment is experienced between attacks. www.genmab.com/PressCentre/RecentNews...
GENMAB INITIATES OFATUMUMAB PHASE II STUDY IN DIFFUSE LARGE B-CELL LYMPHOMA
Copenhagen, Denmark; December 13, 2007 – Genmab A/S (OMX:GEN) announced today that study centers have been initiated and are ready to enroll patients in a Phase II study of ofatumumab (HuMax-CD20®) to evaluate treatment of relapsed Diffuse Large B-Cell Lymphoma (DLBCL) in patients ineligible for or relapsed following a stem cell transplant. Approximately 75 patients will be enrolled in the study which is being conducted under Genmab’s collaboration with GlaxoSmithKline (GSK). Genmab will receive a milestone payment of approximately DKK 87.2 million from GSK upon treatment of the first patient in the study, expected in the near future. Ofatumumab is an investigational, fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 receptor on the surface of B-cells. Other anti-CD20 antibodies currently available or in development bind to a different epitope on the CD20 receptor. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. “We have now expanded the ofatumumab clinical development program into a fourth disease area,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “We hope ofatumumab will offer a new and effective treatment option for patients suffering from DLBCL.” About the trial In this open label trial, each patient will receive 8 weekly infusions of ofatumumab. The first infusion will be 300 mg and the 7 subsequent infusions will be 1000 mg of ofatumumab. Disease status will be assessed 4 weeks after the last infusion and then every 3 months for a total of 24 months after treatment start according to the “Revised response criteria for malignant lymphoma.” After 24 months, patients will be followed until initiation of alternative DLBCL treatment or month 60. The objective of the study is to determine the efficacy of ofatumumab in patients with relapsed DLBCL ineligible for transplant or relapsed after transplant. The primary endpoint of the study is objective response over a 6 month period from start of treatment. About Diffuse Large B-Cell Lymphoma Diffuse Large B-Cell Lymphoma is a cancer of the B-lymphocytes and represents 30% of non-Hodgkin’s lymphomas in adults and is the most common lymphoid malignancy in the western world. There are an estimated 63,000 new cases of DLBCL diagnosed in the per year. The median age at diagnosis is about 65 years. www.genmab.com/PressCentre/RecentNews...
GENMAB ANNOUNCES UPDATE ON OFATUMUMAB PROGRAM
Conference Call to be Held December 19 Copenhagen, Denmark; December 14, 2007 – Genmab A/S (OMX: GEN) announced today it will give an update on the ofatumumab (HuMax-CD20®) development program during a conference call on December 19, 2007 at 2:00PM GMT/3:00PM CET/9:00AM EST. Genmab’s CEO Lisa N. Drakeman, Ph.D., will be joined on the call by Dr. Moncef Slaoui, Chairman, Research & Development at GlaxoSmithKline (GSK). Ofatumumab is an investigational drug being developed to treat chronic lymphocytic leukemia, follicular non-Hodgkin’s lymphoma, rheumatoid arthritis and diffuse large B-cell lymphoma under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. It is not yet approved in any market. Conference Call The conference call will be held on Wednesday, December 19, 2007 at: 3:00PM CET 2:00PM GMT 9:00AM EST The dial in numbers are as follows: +1 800 334 0872 (in the US) +1 913 312 1277 (outside the US) The conference call will be held in English. A live webcast of the call will be available at www.genmab.com. The webcast will also be archived on Genmab’s website. www.genmab.com/PressCentre/RecentNews...
R1507 ANTIBODY TO ENTER PHASE II STUDY TO TREAT SARCOMA
Copenhagen, Denmark; December 20, 2007 – Genmab A/S (OMX: GEN) announced today that its partner, Roche has initiated a Phase II clinical study of R1507 for the treatment of recurrent or refractory sarcoma The R1507 antibody was created by Genmab under the company’s agreement with Roche and initiation of the trial will trigger a milestone payment to Genmab of USD 500,000. “R1507 will be the first antibody created by Genmab under our agreement with Roche to enter Phase II development,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “We believe that R1507 may offer an additional treatment option to sarcoma patients.” About Sarcoma Sarcoma is a cancer of the connective tissue including muscle, bone, fat, nerve, cartilage, blood vessel and deep skin tissue. Due to the wide variety of types of sarcoma, the disease is often difficult to detect, is often misdiagnosed and is complex to treat. Sarcoma is a rare type of cancer with US incidence of approximately 9,000 to 11,000 new cases per year. Of these approximately 8,000 are cases of soft tissue sarcoma and 2,000 are sarcoma of the bone. www.genmab.com/PressCentre/RecentNews...
GENMAB TO PRESENT AT THE 26TH ANNUAL JPMORGAN HEALTHCARE CONFERENCE
Copenhagen, Denmark; January 3, 2008 - Genmab A/S (OMX: GEN) announced today Chief Executive Officer Lisa N. Drakeman, Ph.D. will present at the 26th Annual JPMorgan Healthcare Conference in San Francisco, California. Dr. Drakeman is scheduled to present at 11:00AM local time on January 8, 2008. A live and archived webcast of the presentation will be available at www.genmab.com. www.genmab.com/PressCentre/RecentNews...
GENMAB ANNOUNCES HUMAX-CD32B PRE-CLINICAL PROGRAM
Copenhagen, Denmark; January 4, 2008 – Genmab A/S (OMX: GEN) announced today a new pre-clinical antibody program called HuMax-CD32b™. This fully human IgG1,k antibody targets the CD32b receptor found on immune cells and hematological tumors. HuMax-CD32b may have therapeutic potential in the treatment of B-cell chronic lymphocytic leukemia, small lymphocytic lymphoma, Burkitt’s lymphoma, follicular lymphoma and diffuse large B-cell lymphoma. The lead candidate for HuMax-CD32b was selected from a panel of over 60 antibodies based on its excellent selectivity and binding ability for the CD32b target and potent triggering of the immune system killing mechanism antibody-dependent cellular cytotoxicity (ADCC). The antibody was highly effective in suppressing tumor growth in in vivo mouse tumor models in which tumor growth was monitored by highly sensitive bioluminescence imaging. In animal models, HuMax-CD32b has been shown to induce impressive anti-tumor responses. The CD32b receptor has an inhibitory role on immune cells and blockade of CD32b has been documented to strongly potentiate the therapeutic effects of other anti-tumor antibodies. An antibody targeting CD32b may thus be attractive for combination therapy with other antibodies. “We believe HuMax-CD32b has great potential as a cancer therapeutic, both because of its impressive anti-tumor activity, and the potential for combination with other therapeutic antibodies, such as antibodies directed to CD20 or CD38.” said Prof. Jan G. J. van de Winkel, Ph.D., Chief Scientific Officer at Genmab A/S. www.genmab.com/PressCentre/RecentNews...
De geruchten blijven!!.....
Various sources confirm an imminent bid on the table for genmab at between 600-700 danish krona. Glaxo have been confirmed as potential suitors and maybe in final stages, in confirming a formal bid. messages.finance.yahoo.com/Stocks_%28... messages.finance.yahoo.com/mb/GNMSF.PK
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