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Genmab A/S: Additional details concerning issue of shares to Johnson & Johnson Development Corporation as part of the daratumumab agreement Company Announcement - Johnson & Johnson Development Corporation to subscribe to 5.4 million shares of nominally DKK 1 at a price of DKK 88 per share - Total investment of DKK 475 million (approx. $80 million) in Genmab shares - Issue of shares is dependent on closing of the daratumumab license agreement between Genmab and Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson Copenhagen, Denmark; August 30, 2012 - Genmab A/S (OMX: GEN) announced today additional details concerning the subscription of shares by Johnson & Johnson Development Corporation (JJDC) as part of the global license and development agreement for daratumumab (HuMax®-CD38) between Genmab (see Genmab's Company Announcement 20) and Janssen Biotech, Inc., one of the Janssen Pharmaceutical companies of Johnson & Johnson. The issue of new shares to Johnson & Johnson consists of a private placement of 5.4 million shares of nominally DKK 1 by Genmab to JJDC registered in New Jersey. The new shares will be issued by Genmab under the authorization to the board of directors from Genmab's shareholders granted at the annual general meeting on April 6, 2011. The new shares will be issued for cash without pre-emptive rights for Genmab's existing shareholders, and no person or entity other than JJDC will participate in the private placement. Each share has a subscription price of DKK 88 per share of a nominal value of DKK 1 (one). Genmab's closing share price on August 29, 2012 was DKK 67.85. The new shares have the same rights and privileges as all other shares issued by Genmab. The new shares are freely transferable negotiable instruments and will carry full rights to dividends as of the date of issue. Under the terms of the share subscription agreement, JJDC has agreed to certain customary restrictions on trading Genmab shares. Genmab currently has 44,907,142 shares outstanding and after completion of the private placement the number of shares will be 50,307,142. After the issue of the new shares, JJDC will own 10.73% of Genmab's share capital. A private placement prospectus containing more details of the placement is being prepared and will be published in accordance with applicable rules and regulations. The prospectus will be published as soon as possible after the signing of the share subscription agreement. The share subscription agreement is subject to customary closing conditions, including antitrust clearance of the daratumumab license agreement between Genmab and Janssen from the Federal Trade Commission and the Antitrust Division of the Department of Justice under the Hart-Scott-Rodino Act and approval of the prospectus by the Danish Financial Supervisory Authority. An application will be made for the admittance and listing of the new shares for trading on the NASDAQ OMX Copenhagen A/S. About daratumumab Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma (MM). Daratumumab targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells. Daratumumab could also have potential in other tumors on which CD38 is expressed. About Genmab A/S Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company's first marketed antibody, ofatumumab (Arzerra®), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab's validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab's strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com. Contact: Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com
Genmab is en blijft een groeibriljantje. Goed dat ik vorig jaar heb bijgetankt. Ik hou ze voorlopig vast. De koers kan nu snel verder herstellen en de komende jaren zien er zeer interessant uit.
Genmab A/S: Genmab Reduces Fair Value of Minnesota Manufacturing Facility to Zero, Moves Sale into 2013 and Updates 2012 Guidance Company Announcement -- Fair value of the manufacturing facility reduced to zero -- Non-cash impairment charge of DKK 331 million (USD 58 million) -- Sale now projected in Q1 2013, aggressive sales process proceeding -- No impact to guidance from continuing operations Copenhagen, Denmark; December 13, 2012 - Genmab A/S (OMX: GEN) announces a change to the previous guidance from November 7, 2012 to reflect the reduction in value of the Minnesota manufacturing facility and a move of the sale into 2013. "There was a lot of activity and interest in the facility over recent months, but no firm offer has been received. Due to the continued uncertainty, we have taken the step to write down the facility to zero and will now enter into an aggressive sales process with the aim of closing a transaction within the next few months," said Jan van de Winkel, Ph.D. Chief Executive Officer of Genmab. The fair value of the facility less costs to sell has been reduced from USD 58 million to zero, this results in the recognition of a non-cash impairment charge of approximately DKK 331 million at a USD/DKK exchange rate of 5.7054. Genmab is now proceeding with an aggressive sales process aided by its agent PharmaBioSource. Additional information on the opportunity to acquire this facility can be found on the dedicated website genmab-facility.com. Following the reduction in the fair value of the Minnesota facility and the transfer of a projected sale to the first quarter of 2013, Genmab is changing the 2012 financial guidance as previously announced on November 7, 2012. There are no changes to the results from continuing operations or to the year end cash balance excluding the sale of the facility. Zo dat is dan $ 300 miljoen door het putje , HULDE !! sheriff grover
Genmab A/S: Genmab Unveils A New Antibody Technology Platform: HexaBody Company Announcement -- HexaBody platform is a novel technology platform to potently enhance antibody therapeutics -- Multiple new business opportunities created -- Additional details on technology platform to be provided today at Genmab's Post-ASH Seminar Copenhagen, Denmark; December 17, 2012 - Genmab A/S (OMX: GEN) announced today the addition of a new proprietary technology, the HexaBody' platform, to its suite of next generation antibody technologies. The HexaBody platform is a novel technology that allows the creation of differentiated antibody therapeutics by enhancing the natural target killing abilities of antibodies in a fundamentally new way. The HexaBody platform will be used to create novel differentiated antibody therapeutics, to improve the efficacy of existing antibody products, and to potentially repurpose drug candidates that were unsuccessful in previous clinical trials due to lack of potency. "We are very excited about the multiple new business opportunities the HexaBody platform may create. This innovative technology will provide Genmab and our potential partners with the possibility to improve upon existing products and thereby extend their life cycles. We believe the HexaBody platform provides cutting edge technology and the opportunity to create fundamentally new products, robustly enhance existing products, and to repurpose discontinued products," said Jan van de Winkel, Ph.D., Chief Executive Officer at Genmab. The HexaBody platform will be further described today at Genmab's Post-ASH Seminar which can be viewed via webcast on our website www.genmab.com at 2:00PM GMT / 3:00PM CET / 9:00AM EST. Webcast viewers may submit questions during the Q&A portion of the live webcast via the webcast player or by dialing +44 20 3140 0722 (international participants) or +1 718 705 7514 (US participants) and asking for the Genmab call. About the HexaBody platform The HexaBody platform is Genmab's novel proprietary technology designed to increase the potency of antibodies. Antibodies have a natural ability to eliminate pathogens and tumor cells by various cytotoxic mechanisms. The HexaBody platform strengthens the killing ability of antibodies while retaining regular structure and specificity. The technology has the potential to enhance antibody therapeutics for a broad range of applications in cancer and infectious diseases. About Genmab A/S Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company's first marketed antibody, ofatumumab (Arzerra®), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab's validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab's strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.
Genmab Rises as Danske Sees FDA Breakthrough: Copenhagen Mover By Peter Levring - Feb 15, 2013 2:44 PM GMT+0100. Genmab A/S advanced to a three-day high in Copenhagen trading as Danske Bank A/S said the company may get a “breakthrough” designation by the U.S. Food and Drug Administration for an experimental cancer drug. Genmab rose as much as 2.4 percent, the most since Feb. 12. The stock advanced 2 percent to 99.45 kroner at 2:16 p.m. in the Danish capital, with trading volume at 53 percent of the three- month daily average. Shares in the Copenhagen-based drug developer rose more than any of the 20 companies in the OMX Copenhagen 20 benchmark index, which slid 0.1 percent. Genmab’s daratumumab, a drug partnered with Johnson & Johnson for multiple myeloma, a type of cancer that starts in the plasma cells in bone marrow, is an “obvious candidate” to receive a breakthrough therapy designation by the FDA, Danske analyst Thomas Bowers said. “We have been positively surprised by the efficacy that this antibody has demonstrated in myeloma,” Bowers said in a telephone interview. “Perhaps it can get on the market as a single agent. I think it ticks all the boxes to get the breakthrough designation from the FDA.” Genmab spokeswoman Rachel Gravesen declined to say whether the company has applied for breakthrough status, when contacted by phone today. Ibrutinib, an experimental therapy for blood cancers being developed by Pharmacyclics Inc., received the breakthrough status from the FDA two days ago, giving it a head-start on the road to approval. Bowers said he’s keeping a buy recommendation on the Genmab shares and raised the 12-month price target by 20 kroner to 135 kroner per share. Five analysts recommend buying shares in Genmab, one is neutral and two recommend reducing stock holdings in the company. To contact the reporter on this story: Peter Levring in Copenhagen at plevring1@bloomberg.net To contact the editor responsible for this story: Tasneem Brogger at tbrogger@bloomberg.net Het lijkt er zowaar wat zonniger uit te gaan zien ! Sheriff Grover
Fabriek verkocht voor $ 10 miljoen ......... dat heeft dus echt 300 miljoen gekost duur foutje ... Genmab A/S: Genmab Announces Sale of Manufacturing Facility to Baxter Company Announcement - Genmab sells manufacturing facility to Baxter Healthcare Corporation - Genmab receives USD 10 million Copenhagen, Denmark; February 28, 2013 - Genmab A/S (OMX: GEN) announced today the signing and closing of an agreement with Baxter Healthcare Corporation for the sale of Genmab's non-plasma-derived antibody manufacturing facility, located in Brooklyn Park, Minnesota, USA, for USD 10 million.Under the terms of the agreement Genmab receives the USD 10 million (approximately DKK 57 million) in cash and Baxter acquires the facility, land, and equipment at the Brooklyn Park site. Baxter will offer employment to the 23 employees currently supporting the facility. "We have delivered on our commitment to execute the sale of the antibody manufacturing facility in the first quarter of this year and are very pleased that Baxter acquired the facility, including the 23 employees who have maintained the facility to such a high standard," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. About Genmab A/S Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company's first marketed antibody, ofatumumab (Arzerra®), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab's validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab's strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com. Contact: Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communication T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com
Hoop ooit nog eens vernemen waarom mevrouw Lisa, onder wiens verantwoording dit Amerikaanse avontuur aangegaan is, destijds zonder opgaaf van redenen, zo plotseling vertrokken is. Of heb ik iets gemist ?
Stap voor stap gaat het er beter uitzien .... Nordea heel positief rapport uitgebracht met een koersdoel van DKR 148 , conclusie Nordea: At our target price of DKK 146 per share, Genmab moves up to around Immunogen's level in tech value, but is still 25% below Algeta and Isis and 40% below Thrombogenics and Swedish Orphan Biovitrum. www.algeta.com/ www.thrombogenics.com/ www.isip.com/Pipeline/Therapeutic-Are... www.sobi.com/ We have chosen quite a broad biopharma and biotech peer group that illustrates the major value gap between Genmab and some of highest valued peers, such as Pharmacyclics, Onyx, Medivation and Algeta. The tech value gap between Genmab and some of these loss-making biopharma peers is five to tenfold, which is food for thought. To look specifically at one company, Pharmacyclics in the US has a tech value of around USD 6bn, ie ten times that of Genmab. Pharmacyclics has one project in phase III, two in phase II and one in phase I and partnerships with Janssen and Servier. We acknowledge that Pharmacyclics' lead programme, Ibrutinib, has been characterised as a breakthrough compound by the FDA and it could very well be the "next big thing" within lymphomas, but this is still a very large value gap to Genmab. Furthermore, Genmab's Daratumumab could very well be the "next big thing" in multiple myeloma and it cannot be ruled out that it could be selected as breakthrough therapy too. En hier een stuk over Genmab duobody in een toonaangevend amerikaans tijdschrift pnas : www.pnas.org/content/early/2013/03/08... Sheriff Grover
Genmab’s daratumumab, a drug partnered with Johnson & Johnson for multiple myeloma, a type of cancer that starts in the plasma cells in bone marrow, is an “obvious candidate” to receive a breakthrough therapy designation by the FDA, Danske analyst Thomas Bowers said. Sheriff Grover je bent aardig ingevoerd in Genmab materie. Heb een vraag over de breakthrough therapy designation by the FDA. Denk je dat Genmab deze aanvraag heeft gedaan? Waarom ontkennen ze dat? Doen ze dit om de concurrentie niet wijzer te maken. De danske analyst lijkt me wel iemand die er kijk op heeft.
www.bloomberg.com/news//2013-03-20/ge... Genmab Rises as Nordea Says Bet on Cancer Drug: Copenhagen Mover By Christian Wienberg - Mar 20, 2013 12:49 PM GMT+0100. Genmab A/S (GEN) rose the most in a week in Copenhagen trading after Nordea Bank AB said an experimental cancer treatment that the Danish company is developing with Johnson & Johnson (JNJ) will boost the share price. Genmab rose 4.2 percent, the most since March 13, to 125.40 kroner at 12:40 p.m. in the Danish capital, with trading volume at 143 percent of the three-month daily average. Findings presented at a scientific session that Nordea hosted confirm Genmab’s daratumumab is “a clearly unique asset” in the growing market for treating multiple myeloma, the bank said. Nordea repeated a strong buy recommendation on the shares of the Copenhagen-based drugmaker. “We believe that daratumumab could be the next big thing in multiple myeloma,” Michael Novod, an analyst with Nordea in Copenhagen, said in the note. The market for multiple myeloma is “set to grow rapidly,” approaching $9 billion in 2020 amid better diagnosis and treatment of the disease, Novod said. The cancer starts in the plasma cells in bone marrow. Genmab and partner J&J, which is based in New Brunswick, New Jersey, are discussing “all options” for speeding up regulatory approval of daratumumab, Chief Executive officer Jan Van de Winkel said in a March 7 phone interview. To contact the reporter on this story: Christian Wienberg in Copenhagen at cwienberg@bloomberg.net
Hallo poolbeer , nou dat valt reuze mee hoor dat ingevoerde .. ik heb geen idee of en zo ja waarom .. weet alleen idd dat de vraag door van de Winkel werd beantwoord met dat J&J over die aanvraag ging en dat hij niet wist of het al gebeurd was of nog zou gaan gebeuren .. mvrgr Sheriff Grover
sheriff Grover schreef op 20 maart 2013 14:05 :
Hallo poolbeer , nou dat valt reuze mee hoor dat ingevoerde ..
ik heb geen idee of en zo ja waarom .. weet alleen idd dat de vraag door van de Winkel werd beantwoord met dat J&J over die aanvraag ging en dat hij niet wist of het al gebeurd was of nog zou gaan gebeuren ..
mvrgr Sheriff Grover
Bedankt. Lees in pb hierboven dat all options are open.
poolbeer schreef op 20 maart 2013 20:54 :
[...]
Bedankt. Lees in pb hierboven dat all options are open.
pardon moet zijn: discussing “all options”
Genmab A/S: Arzerra Receives Approval in Japan Company Announcement -- Arzerra® approved in Japan for relapsed / refractory CLL -- Genmab to receive DKK 20 million milestone payment from GSK Copenhagen, Denmark; March 25, 2013 - Genmab A/S (OMX: GEN) and GlaxoSmithKline (GSK) announced today the approval of Arzerra (ofatumumab) by the Japanese Ministry of Health, Labor and Welfare (MHLW) for use in patients with relapsed / refractory CD20-positive chronic lymphocytic leukemia (CLL). The approval triggers a milestone payment of DKK 20 million from GSK to Genmab. "We are pleased that patients in Japan will now have access to Arzerra. Japan is another important market for Arzerra and commercialization continues on track," said Jan van de Winkel, Ph.D. Chief Executive Officer of Genmab. This milestone payment is included in Genmab's 2013 financial guidance. About ofatumumab Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops (Teeling et al 2006). Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.
Telegraaf 27-03 Biotech in ASML-jasje door SONNY DUIJN AMSTERDAM – Chipmachinemaker ASML wordt alom geroemd voor zijn investeringsprogramma waarbinnen chipproducenten als Intel en Samsung meebetalen aan ontwikkeling van nieuwe technologie. Veel minder bekend is de variant van het Deense biotechbedrijf Genmab, dat dankzij zijn R&D-vestiging in Utrecht een vergelijkbaar programma voert: het investeert in nieuwe, betere technologie, terwijl farmaciereuzen eraan meebetalen en de technologie gebruiken. „Vorig jaar hebben we deals gesloten rond onze DuoBodytechnologie, met een potentiele dealwaarde van meer dan $1,9 miljard”, zegt topman Jan van de Winkel, die zwaar inzet op de licensering van de nieuwe technologie en dus meer van het traditionele biotechmodel afstapt. Een doorsnee biotechbedrijf doet er vaak zo’n 15 jaar over om een medicijn te ontwikkelen, en wordt flink op de huid gezeten door toezichthouders. Het idee is vaak om commerciële rechten van een medicijn te verkopen aan farmaciereuzen om later mijlpaalbetalingen te ontvangen. Het Deense beursgenoteerde Genmab, dat zwaar inzet op deals met farmaciebedrijven, maakt voor ontwikkeling van geneesmiddelen tegen kanker therapeutische, menselijke antilichamen. De markt voor therapeutische antilichamen is volgens van de Winkel in 2016 al zo’n $60 miljard groot ($44 miljard in 2011). Het eerste medicijn dat Genmab op de markt heeft gebracht, Arzerra, is in acht jaar ontwikkeld. Twee andere medicijnen worden in klinische trials getest. Arzerra richt zich onder meer op een bepaald type bloedkanker, chronische lymphatische leukemie, en is vermarkt door GSK. Maar de innovatie ging Genmab niet snel genoeg. Daarom besloot het een nieuwe, eigen technologie (waarmee een speciaal type – bispecifiek – antilichaam wordt gemaakt) te commercialiseren. ’DuoBody’ is door de verkoop van licenties beschikbaar voor farmaceuten, en Van de Winkel is laaiend enthousiast: „Afgelopen jaar hebben we drie deals op dit gebied gesloten, met Janssen, Novartis en de Aziatische partij Kyowa Hakko Kirin.” Met de DuoBody-technologie worden antilichamen geproduceerd die twee verschillende ziektegerelateerde ’targets’ tegelijk kunnen aanpakken. „De techniek is uitermate geschikt voor efficiënte productie op zeer grote schaal”, legt de topman uit. Genmab maakte omgerekend zo’n €65 miljoen omzet in 2011, en verwacht binnen „enige jaren” winstgevend te worden. Zijn nieuwe doelstellingen, voor 2013, heeft Van de Winkel voor een groot gedeelte opgehangen aan de verwachte successen van de nieuwe technologieën. Genmab heeft nog een nieuwe technologie in de maak, genaamd HexaBody.
Genmab A/S: Daratumumab Granted Fast Track Designation from US Food and Drug Administration Company Announcement -- Daratumumab receives Fast Track designation in double refractory multiple myeloma -- Potential for expedited development Copenhagen, Denmark; April 2, 2013 - Genmab A/S (OMX: GEN) announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation for daratumumab. This designation covers patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or are double refractory to a PI and an IMiD. "Fast Track designation for daratumumab means that the FDA recognizes the potential of daratumumab to fill an unmet medical need in multiple myeloma, and that we may be able to reduce the development time and expedite review of the product," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop and commercialize daratumumab. About Fast Track designation Fast Track designation is intended to facilitate the development and expedite the review of drugs intended for the treatment of serious conditions and fill an unmet medical need. This designation will enable more frequent interactions with the FDA during drug development. In addition, portions of marketing applications for drugs with Fast Track designation can be submitted before a complete application is submitted, known as rolling review. About daratumumab Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in Phase I/II clinical development for multiple myeloma (MM). Daratumumab targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells. Daratumumab could also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma. About Multiple Myeloma Multiple myeloma is a cancer of plasma cells and accounts for approximately 1% of all cancers and is the most prevalent blood cancer in the US and second in Europe. According to American Society of Cancer estimates, approximately 21,700 new cases of multiple myeloma will be diagnosed and approximately 10,710 deaths will occur in the US in 2012. At present, no cure is available. The 5-year relative survival rate for multiple myeloma is around 40%. New treatment modalities might improve the survival. About Genmab A/S Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company's first marketed antibody, ofatumumab (Arzerra®), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab's validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab's strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com. Contact: Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com
Nordea verhoogt koersdoel van DKR 146 naar DKR 191 Sheriff Grover
sheriff Grover schreef op 9 april 2013 09:43 :
Nordea verhoogt koersdoel van DKR 146 naar DKR 191
Sheriff Grover
Behoorlijke koersdoel verhoging. Hebben er vertrouwen in.
Genmab A/S: Genmab Announces Final US Court Judgment in Favor of Arzerra in Patent Infringement Lawsuit Company Announcement -- Final ruling of U.S. Court of Appeals in favor of GSK in Arzerra patent infringement case Copenhagen, Denmark; April 16, 2013 - Genmab A/S (OMX: GEN) announced today that the U.S. Court of Appeals for the Federal Circuit has upheld the U.S. District Court's judgment in favor of GlaxoSmithKline (GSK) in a patent infringement case involving Arzerra brought against GSK by Genentech and Biogen Idec. The two companies appealed the court order on the patent claim construction which led to the judgment in favor of GSK in December 2011. The U.S. Court of Appeals for the Federal Circuit has upheld the District Court's original decision and the lawsuit is now over unless Genentech and Biogen Idec are granted further review by the Federal Circuit or the Supreme Court. Genentech and Biogen Idec originally filed the lawsuit in 2010 with the U.S. District Court for the Southern District of California claiming Arzerra infringed U.S. Patent No. 7,682,612 covering methods of treating Chronic Lymphocytic Leukemia (CLL) with CD20 antibodies. GSK denied infringement and claimed the patent was invalid and unenforceable. Arzerra, Genmab's CD20 antibody, is partnered with GSK and is marketed in the US and Europe as well as other territories. About Genmab A/S Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company's first marketed antibody, ofatumumab (Arzerra®), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab's validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab's strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com. Contact: Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com
Genmab A/S: Daratumumab Receives Breakthrough Therapy Designation from US Food and Drug Administration Company Announcement -- Daratumumab receives Breakthrough Therapy Designation in double refractory multiple myeloma -- Potential for expedited development Copenhagen, Denmark; May 1, 2013 - Genmab A/S (OMX: GEN) announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and IMiD. Breakthrough Therapy Designation is a program intended to expedite the development and review of drugs to treat serious or life-threatening diseases in cases where preliminary clinical evidence shows that the drug may provide substantial improvements over available therapy. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop and commercialize daratumumab. "Breakthrough designation allows us to work together with our strategic partner Janssen and the FDA to expedite the development of daratumumab in multiple myeloma, so patients suffering from this devastating type of blood cancer could potentially receive access to this medicine much sooner," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. About Breakthrough Therapy Designation The Breakthrough therapy Designation was enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA) and is intended to expedite development of drugs to treat serious and life-threatening medical conditions when preliminary clinical evidence demonstrates that the drug may have substantial improvement on at least one clinically significant endpoint over available therapies. Breakthrough Therapy Designation includes all the features of the Fast Track Designation, as well as more intensive guidance from the FDA on a drug's clinical development program. About daratumumab Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in Phase I/II clinical development for multiple myeloma (MM). Daratumumab targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells. Daratumumab could also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma. About Multiple Myeloma Multiple myeloma is a cancer of plasma cells and accounts for approximately 1% of all cancers and is the most prevalent blood cancer in the US and second in Europe. According to American Society of Cancer estimates, approximately 21,700 new cases of multiple myeloma will be diagnosed and approximately 10,710 deaths will occur in the US in 2012. At present, no cure is available. The 5-year relative survival rate for multiple myeloma is around 40%. New treatment modalities might improve the survival.
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BNP Paribas S.A.
Boeing Company
Bols (Lucas Bols N.V.)
Bone Therapeutics
Borr Drilling
Boskalis
BP PLC
bpost
Brand Funding
Brederode
Brill
Bristol-Myers Squibb
Brunel
C/Tac
Campine
Canadese aandelen
Care Property Invest
Carmila
Carrefour
Cate, ten
CECONOMY
Celyad
CFD's
CFE
CGG
Chinese aandelen
Cibox Interactive
Citygroup
Claranova
CM.com
Co.Br.Ha.
Coca-Cola European Partners
Cofinimmo
Cognosec
Colruyt
Commerzbank
Compagnie des Alpes
Compagnie du Bois Sauvage
Connect Group
Continental AG
Corbion
Core Labs
Corporate Express
Corus
Crescent (voorheen Option)
Crown van Gelder
Crucell
CTP
Curetis
CV-meter
CVC Capital Partners
Cyber Security 1 AB
Cybergun
D'Ieteren
D.E Master Blenders 1753
Deceuninck
Delta Lloyd
DEME
Deutsche Cannabis
DEUTSCHE POST AG
Dexia
DGB Group
DIA
Diegem Kennedy
Distri-Land Certificate
DNC
Dockwise
DPA Flex Group
Draka Holding
DSC2
DSM
Duitse aandelen
Dutch Star Companies ONE
Duurzaam Beleggen
DVRG
Ease2pay
Ebusco
Eckert-Ziegler
Econocom Group
Econosto
Edelmetalen
Ekopak
Elastic N.V.
Elia
Endemol
Energie
Energiekontor
Engie
Envipco
Erasmus Beursspel
Eriks
Esperite (voorheen Cryo Save)
EUR/USD
Eurobio
Eurocastle
Eurocommercial Properties
Euronav
Euronext
Euronext
Euronext.liffe Optiecompetitie
Europcar Mobility Group
Europlasma
EVC
EVS Broadcast Equipment
Exact
Exmar
Exor
Facebook
Fagron
Fastned
Fingerprint Cards AB
First Solar Inc
FlatexDeGiro
Floridienne
Flow Traders
Fluxys Belgium D
FNG (voorheen DICO International)
Fondsmanager Gezocht
ForFarmers
Fountain
Frans Maas
Franse aandelen
FuelCell Energy
Fugro
Futures
FX, Forex, foreign exchange market, valutamarkt
Galapagos
Gamma
Gaussin
GBL
Gemalto
General Electric
Genfit
Genmab
GeoJunxion
Getronics
Gilead Sciences
Gimv
Global Graphics
Goud
GrandVision
Great Panther Mining
Greenyard
Grolsch
Grondstoffen
Grontmij
Guru
Hagemeyer
HAL
Hamon Groep
Hedge funds: Haaien of helden?
Heijmans
Heineken
Hello Fresh
HES Beheer
Hitt
Holland Colours
Homburg Invest
Home Invest Belgium
Hoop Effektenbank, v.d.
Hunter Douglas
Hydratec Industries (v/h Nyloplast)
HyGear (NPEX effectenbeurs)
HYLORIS
Hypotheken
IBA
ICT Automatisering
Iep Invest (voorheen Punch International)
Ierse aandelen
IEX Group
IEX.nl Sparen
IMCD
Immo Moury
Immobel
Imtech
ING Groep
Innoconcepts
InPost
Insmed Incorporated (INSM)
IntegraGen
Intel
Intertrust
Intervest Offices & Warehouses
Intrasense
InVivo Therapeutics Holdings Corp (NVIV)
Isotis
JDE PEET'S
Jensen-Group
Jetix Europe
Johnson & Johnson
Just Eat Takeaway
Kardan
Kas Bank
KBC Ancora
KBC Groep
Kendrion
Keyware Technologies
Kiadis Pharma
Kinepolis Group
KKO International
Klépierre
KPN
KPNQwest
KUKA AG
La Jolla Pharmaceutical
Lavide Holding (voorheen Qurius)
LBC
LBI International
Leasinvest
Logica
Lotus Bakeries
Macintosh Retail Group
Majorel
Marel
Mastrad
Materialise NV
McGregor
MDxHealth
Mediq
Melexis
Merus Labs International
Merus NV
Microsoft
Miko
Mithra Pharmaceuticals
Montea
Moolen, van der
Mopoli
Morefield Group
Mota-Engil Africa
MotorK
Moury Construct
MTY Holdings (voorheen Alanheri)
Nationale Bank van België
Nationale Nederlanden
NBZ
Nedap
Nedfield
Nedschroef
Nedsense Enterpr
Nel ASA
Neoen SA
Neopost
Neovacs
NEPI Rockcastle
Netflix
New Sources Energy
Neways Electronics
NewTree
NexTech AR Solutions
NIBC
Nieuwe Steen Investments
Nintendo
Nokia
Nokia Oyj
Nokia OYJ
Novacyt
NOVO-NORDISK AS
NPEX
NR21
Numico
Nutreco
Nvidia
NWE Nederlandse AM Hypotheek Bank
NX Filtration
NXP Semiconductors NV
Nyrstar
Nyxoah
Océ
OCI
Octoplus
Oil States International
Onconova Therapeutics
Ontex
Onward Medical
Onxeo SA
OpenTV
OpGen
Opinies - Tilburg Trading Club
Opportunty Investment Management
Orange Belgium
Oranjewoud
Ordina Beheer
Oud ForFarmers
Oxurion (vh ThromboGenics)
P&O Nedlloyd
PAVmed
Payton Planar Magnetics
Perpetuals, Steepeners
Pershing Square Holdings Ltd
Personalized Nursing Services
Pfizer
Pharco
Pharming
Pharnext
Philips
Picanol
Pieris Pharmaceuticals
Plug Power
Politiek
Porceleyne Fles
Portugese aandelen
PostNL
Priority Telecom
Prologis Euro Prop
ProQR Therapeutics
PROSIEBENSAT.1 MEDIA SE
Prosus
Proximus
Qrf
Qualcomm
Quest For Growth
Rabobank Certificaat
Randstad
Range Beleggen
Recticel
Reed Elsevier
Reesink
Refresco Gerber
Reibel
Relief therapeutics
Renewi
Rente en valuta
Resilux
Retail Estates
RoodMicrotec
Roularta Media
Royal Bank Of Scotland
Royal Dutch Shell
RTL Group
RTL Group
S&P 500
Samas Groep
Sapec
SBM Offshore
Scandinavische (Noorse, Zweedse, Deense, Finse) aandelen
Schuitema
Seagull
Sequana Medical
Shurgard
Siemens Gamesa
Sif Holding
Signify
Simac
Sioen Industries
Sipef
Sligro Food Group
SMA Solar technology
Smartphoto Group
Smit Internationale
Snowworld
SNS Fundcoach Beleggingsfondsen Competitie
SNS Reaal
SNS Small & Midcap Competitie
Sofina
Softimat
Solocal Group
Solvac
Solvay
Sopheon
Spadel
Sparen voor later
Spectra7 Microsystems
Spotify
Spyker N.V.
Stellantis
Stellantis
Stern
Stork
Sucraf A en B
Sunrun
Super de Boer
SVK (Scheerders van Kerchove)
Syensqo
Systeem Trading
Taiwan Semiconductor Manufacturing Company (TSMC)
Technicolor
Tele Atlas
Telegraaf Media
Telenet Groep Holding
Tencent Holdings Ltd
Tesla Motors Inc.
Tessenderlo Group
Tetragon Financial Group
Teva Pharmaceutical Industries
Texaf
Theon International
TherapeuticsMD
Thunderbird Resorts
TIE
Tigenix
Tikkurila
TINC
TITAN CEMENT INTERNATIONAL
TKH Group
TMC
TNT Express
TomTom
Transocean
Trigano
Tubize
Turbo's
Twilio
UCB
Umicore
Unibail-Rodamco
Unifiedpost
Unilever
Unilever
uniQure
Unit 4 Agresso
Univar
Universal Music Group
USG People
Vallourec
Value8
Value8 Cum Pref
Van de Velde
Van Lanschot
Vastned
Vastned Retail Belgium
Vedior
VendexKBB
VEON
Vermogensbeheer
Versatel
VESTAS WIND SYSTEMS
VGP
Via Net.Works
Viohalco
Vivendi
Vivoryon Therapeutics
VNU
VolkerWessels
Volkswagen
Volta Finance
Vonovia
Vopak
Warehouses
Wave Life Sciences Ltd
Wavin
WDP
Wegener
Weibo Corp
Wereldhave
Wereldhave Belgium
Wessanen
What's Cooking
Wolters Kluwer
X-FAB
Xebec
Xeikon
Xior
Yatra Capital Limited
Zalando
Zenitel
Zénobe Gramme
Ziggo
Zilver - Silver World Spot (USD)
Indices
AEX
910,04
-0,54%
EUR/USD
1,0871
+0,12%
FTSE 100
8.391,50
-0,39%
Germany40^
18.661,20
-0,57%
Gold spot
2.414,35
-0,49%
NY-Nasdaq Composite
16.794,87
+0,65%
Stijgers
Dalers