BioPharma Terug naar discussie overzicht

Genmab, de Deense parel

1. sheriff Grover 30 augustus 2012 11:14

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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
   
   
2. [verwijderd] 30 augustus 2012 15:33

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   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.
3. sheriff Grover 13 december 2012 19:01

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   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
4. sheriff Grover 17 december 2012 10:00

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   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.
   
   
5. sheriff Grover 15 februari 2013 17:30

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   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
   
   
6. sheriff Grover 28 februari 2013 20:48

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   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
   
7. [verwijderd] 1 maart 2013 16:15

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   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 ?
8. sheriff Grover 13 maart 2013 14:39

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   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
   
   
   
   
9. poolbeer 19 maart 2013 21:16

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   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.
10. sheriff Grover 20 maart 2013 14:00

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    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
    
11. sheriff Grover 20 maart 2013 14:05

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    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
12. poolbeer 20 maart 2013 20:54

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    quote:

    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.
13. poolbeer 20 maart 2013 22:05

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    quote:

    poolbeer schreef op 20 maart 2013 20:54:

    [...]
    
    Bedankt. Lees in pb hierboven dat all options are open.
    

    pardon moet zijn: discussing “all options”
14. sheriff Grover 25 maart 2013 09:10

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    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.
    
    
15. sheriff Grover 27 maart 2013 09:57

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    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.
    
16. sheriff Grover 2 april 2013 16:44

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    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
    
17. sheriff Grover 9 april 2013 09:43

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    Nordea verhoogt koersdoel van DKR 146 naar DKR 191
    
    Sheriff Grover
18. poolbeer 9 april 2013 10:25

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    quote:

    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.
19. sheriff Grover 16 april 2013 20:33

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    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
    
20. sheriff Grover 1 mei 2013 17:47

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    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.