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Update on MOR103 Development Program!

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  1. gogogoo 16 januari 2008 11:36
    Via Flosz

    Voor bij de slides…..VIJF p. MOR103 update:

    MorphoSys AG – Conference Call
    Update on MOR103 Development Program
    January 16, 2008

    The spoken word shall prevail
    Dr. Simon Moroney, CEO, MorphoSys AG
    Good morning and welcome, this is Simon Moroney, CEO of MorphoSys. With me is Dave
    Lemus, our CFO and Marlies Sproll, our CSO.

    Slide 2: Safe Harbor
    First, we would like to welcome you to this conference call and thank you for participating.
    We’ve arranged the call to provide an update on our lead development program MOR103, a
    HuCAL-based fully human therapeutic antibody to treat inflammatory diseases. Before I start, I
    want to remind you that during this conference we will present and discuss certain forwardlooking
    statements concerning the development of MorphoSys’s core technologies, the
    progress of its current research programs and the initiation of additional programs. Should
    actual conditions differ from the Company’s assumptions, actual results and actions may differ
    from those anticipated. You are therefore cautioned not to place undue reliance on such
    forward-looking statements, which speak only as of the date hereof.
    In December of last year, we submitted a clinical trial application (CTA) to initiate a European
    phase I trial of MOR103. The drug candidate is set to become the fifth HuCAL antibody to enter
    the clinic. During today’s call we will describe the target molecule against which MOR103 is
    directed and its biology as well as providing information on the forthcoming phase I study. In
    addition, we will provide an overview of the rheumatoid arthritis market and explain why
    MOR103 provides an extremely lucrative product opportunity for MorphoSys.
    For the participants in the conference call, you can view the accompanying slides on our
    corporate website. After my presentation we will open the call up for your questions.

    Slide 3: The Target
    First of all, some facts regarding the target molecule, which is granulocyte macrophage-colony
    stimulating factor, or GM-CSF for short.
    GM-CSF is a well-studied molecule. It is a cytokine which was originally named for its ability to
    generate granulocyte and macrophage colonies from precursor cells in the bone marrow.
    Indeed the protein GM-CSF is itself a drug - “Leukine” or sargramostim and is used to
    accelerate the recovery of white blood cells following autologous bone marrow transplantation in
    patients with non-Hodgkins lymphoma, Hodgkins disease or acute lymphocytic leukaemia.
    More recently GM-CSF has been shown to control the behavior of various cell types, including
    macrophages and neutrophils, particularly during inflammatory reactions. As shown on slide
    number 3 of the webcast presentation, this is the basis for its relevance as a target for antiinflammatory
    therapy.
    The slide illustrates how blockade of GM-CSF signaling through its receptor can have a positive
    effect on a number of mechanisms that contribute to inflammation and tissue damage. We are
    particularly interested in these mechanisms as they relate to rheumatoid arthritis or RA for short,
    the indication we are initially focusing on. In patients suffering from RA, white blood cells move
    from the bloodstream into the joint. Here, these blood cells play an important role in causing the
    synovium, the thin tissue that lines spaces in joints, to become inflamed, which may ultimately
    result in joint and synovial destruction. As such, RA belongs to the class of auto-immune
    disorders which includes diseases such as multiple sclerosis, Crohn’s disease, systemic lupus
    erythematosus and others.
    Amongst the blood cells recruited to the site of inflammation are neutrophils and macrophages,
    which GM-CSF stimulates in a number of ways. Thus GM-CSF acts as an inflammatory
    mediator, leading to an increased production of pro-inflammatory cytokines such as TNF-alpha
    and IL-6, chemokines such as IL-8 which triggers migration of further cells to the site of
    inflammation and proteases and oxygen species which cause articular destruction. By
    neutralizing GM-CSF, the antibody MOR103 is intended to reduce undesired proliferation and
    activation of inflammatory neutrophils and macrophages and thereby block these damaging
    inflammatory events. As shown on the slide, blocking the effects of GM-CSF may also reduce
    the T- and B-cell response involved in the pathogenic process.
    Several of these mechanisms are clearly implicated in rheumatoid arthritis. Indeed, there is
    specific clinical and pre-clinical evidence that points towards GM-CSF playing a pivotal role in
    RA. First is the observation that administration of therapeutic GM-CSF was found to worsen
    arthritic symptoms in RA patients. Second, RA patients have been found to have elevated levels
    of GM-CSF in their diseased joints. Third, mice that are deficient in GM-CSF are resistant to the
    induction of autoimmune diseases. Additional pre-clinical animal data underpin these findings,
    namely, that anti-GM-CSF antibodies ameliorate disease in mice arthritic models.
    Taken together, these observations strongly support the hypothesis that targeting GM-CSF
    could be an effective means of treating RA. Further data indicate that GM-CSF is also a
    potential target to treat other inflammatory diseases, including multiple sclerosis, asthma and
    chronic obstructive pulmonary disease.

    Slide 4: The Drug
    I’d now like to turn to the drug candidate itself, MOR103.
    MOR103 is an optimized, fully human, HuCAL-derived, IgG1 antibody.
    In a comprehensive program combining internal work with cooperative R&D with contract
    research organizations,we have generated a substantial body of data around MOR103. This is not the time to discuss the data that we have generated, which we will present in full to the
    appropriate audience later this year. In the interests of time, I will briefly summarize those
    results which have convinced us to take this drug candidate into human clinical trials.
    The antibody has an extremely high affinity for its target and is able to block binding of GM-CSF
    to its receptor in vitro. It prevents cytokine release, cell migration, upregulation of adhesion
    molecules as well as numerous other disease-relevant processes. We have studied the efficacy
    of the antibody in two in vivo RA models, namely collagen-induced arthritis in rats and
    streptococcal cell wall induced arthritis in rats. We have also assessed toxicity in rhesus
    monkeys, a species with which MOR103 cross-reacts, with no adverse clinical signs being
    seen.
    Pre-clinical results point to a more fundamental role of GM-CSF than TNF in the pathogenesis
    of rheumatoid arthritis. In the mouse collagen induced arthritis model, only 2 of 15 GM-CSF
    deficient mice developed arthritis, whereas 8 of 26 TNF-deficient mice developed the condition.
    Based on the data that we have generated, and the target biology that I have summarized, we
    believe that MOR103 has the potential to be an effective anti-inflammatory drug.
    I’d like to turn now to intellectual property. We have a strong IP position around this program,
    with interests in patent applications relating to both the target and the drug.
    Regarding the target, MorphoSys has signed an agreement with the University of Melbourne
    providing us with exclusive rights to the use of inhibitors of GM-CSF, under a United States
    patent application and its progeny. MorphoSys believes that the University of Melbourne patent
    applications, once allo
  2. gogogoo 16 januari 2008 11:37
    ....once allowed, will lead to market exclusivity for MOR103 for anti-inflammatory
    indications in the U.S. We see a strong IP position in the US as being of utmost importance for
    the commercial future of this program since the United States today represents 60% of the total
    RA market. Researchers at the University of Melbourne have played a leading role in
    characterizing the role of GM-CSF as a central mediator of inflammatory diseases. Their work is
    fundamental in this area and we are confident that this patent application will be granted and will
    be a valuable asset for our MOR103 program.
    In addition to the license agreement with the University of Melbourne MorphoSys has filed
    additional patent applications on the MOR103 antibody in various countries. We will continue to
    build our worldwide patent position around MOR103 and will update you as progress is made.

    Slide 5: The Market Opportunity in RA
    I want to turn now to the commercial opportunity for our initial focus, namely rheumatoid
    arthritis. As already mentioned, MOR103 has potential as a treatment in several inflammatory
    indications. The question therefore arises as to why we have chosen to focus initially on RA.
    The main reason is that this is the biggest market. Sales of anti-rheumatic drugs reached US$
    10 billion in 2006, exceeding drug sales in any other auto-immune disease. The biggest single
    group of therapies in this market are the biologics, dominated by the anti-TNF drugs Enbrel,
    Remicade and Humira which between them account for 95% of biologics sales.
    The commercial opportunity arises for three reasons – First, fewer than one quarter of patients
    are presently being adequately treated. Second a majority of patients who do respond to
    treatment become non-responders after 1-2 years. And third, the safety profile of the anti-TNF
    therapies remains a concern. This means that the vast majority of the 5-6 million RA patients
    worldwide are in need of better therapeutic alternatives.
    As with any large market in the pharmaceutical industry, RA is an area that is subject to intense
    competition. Indeed, the successes of several biotherapeutics, such as the anti-TNFs just
    mentioned, have transformed the market. Importantly, rheumatologists now accept these
    targeted approaches, but are still looking for alternatives with new mechanisms of action. There
    is therefore a clear and lucrative opportunity for MOR103 if it can be successfully developed.

    Slide 6: Development
    This brings us to the issue of clinical development.On acceptance of our clinical trial
    application, or CTA, MOR103 will become the first fully human antibody against GM-CSF to
    enter clinical trials. The phase I study will be conducted in the Netherlands, and will involve
    approximately 50 healthy volunteers in a randomized, double-blind, placebo-controlled, singleascending
    dose trial. The study will evaluate the safety and tolerability as well as
    pharmacokinetics of escalating doses of MOR103. In this study we have opted to make it
    double-blinded to ensure the highest quality of data in determining the tolerability and safety of the drug.

    Slide 7: Next Steps in MOR103 Development
    We expect the development to proceed according to the following timeline:
    The CTA was filed in late December of last year. We are now awaiting approval from the Dutch
    regulatory authorities which we hope to receive within the first quarter of this year. Immediately
    thereafter we will initiate the trial. We anticipate the phase 1 study will take approximately 1
    year, including final reporting.
    We plan to publish the RA-relevant pre-clinical data that we have generated during the course
    of the year.

    Assuming a successful phase 1 study, we plan to conduct a phase 2a study in rheumatoid
    arthritis patients with the goal of establishing clinical proof of concept. At this stage we do not
    anticipate conducting a phase 3 trial without a partner for the program. To be clear, in light of
    our landmark Novartis deal announced last month, we have complete freedom to partner this
    program when and with whom we choose. By partnering the program after clinical proof of
    concept, we aim to maximize the financial and other commercial terms that we can secure for
    MorphoSys.
    This development is an important step for MorphoSys and underlines the Company’s transition
    from a company purely providing innovative technologies to a developer of innovative antibodybased
    biopharmaceuticals, that we referred to after the announcement of our deal with Novartis.
    That concludes the presentation. In closing, I would like to thank the entire team here at
    MorphoSys who have worked very hard on the development of this exciting product candidate.
    212.14.81.205/uploads/MOR103_CC_ ... _final.pdf
  3. gogogoo 16 januari 2008 11:39
    Nadruk op:

    In the interests of time, I will briefly summarize those
    results which have convinced us to take this drug candidate into human clinical trials.
    The antibody has an extremely high affinity for its target and is able to block binding of GM-CSF
    to its receptor in vitro. It prevents cytokine release, cell migration, upregulation of adhesion
    molecules as well as numerous other disease-relevant processes. We have studied the efficacy
    of the antibody in two in vivo RA models, namely collagen-induced arthritis in rats and
    streptococcal cell wall induced arthritis in rats. We have also assessed toxicity in rhesus
    monkeys, a species with which MOR103 cross-reacts, with no adverse clinical signs being
    seen.
    Pre-clinical results point to a more fundamental role of GM-CSF than TNF in the pathogenesis
    of rheumatoid arthritis. In the mouse collagen induced arthritis model, only 2 of 15 GM-CSF
    deficient mice developed arthritis, whereas 8 of 26 TNF-deficient mice developed the condition.
    Based on the data that we have generated, and the target biology that I have summarized, we
    believe that MOR103 has the potential to be an effective anti-inflammatory drug.
    I’d like to turn now to intellectual property. We have a strong IP position around this program,
    with interests in patent applications relating to both the target and the drug.
  6. forum rang 4 aossa 13 november 2008 14:45
    quote:

    aossa schreef:

    MorphoSys Publishes Preclinical Data from MOR103 Program (PER.C6 inside!)

    11/13/2008 at 07:30 AM
    Antibody Shows Ability to Inhibit Disease in an Established RA Model

    www.investorvillage.com/smbd.asp?mb=2...
    The HAH Conference presentation can be seen on MorphoSys's website from Friday, November 14 by using the following link: www.morphosys.com/en/mor103
  10. forum rang 4 aossa 13 november 2008 16:25
    quote:

    aossa schreef:

    MorphoSys Publishes Preclinical Data from MOR103 Program (PER.C6 inside!)

    11/13/2008 at 07:30 AM
    Antibody Shows Ability to Inhibit Disease in an Established RA Model

    www.investorvillage.com/smbd.asp?mb=2...
    Directe link naar PB van Morphosys (IV lijkt down):
    www.morphosys.com/en/news_investors/p...
  13. flosz 26 november 2008 07:33
    Van IV, by grapes:

    Key US Patent Granted on Antibodies Against GM-CSF to Treat Inflammatory Disorders
    11/25/2008 at 07:30 AM
    IP Position around MorphoSys's MOR103 Program Significantly Strengthened

    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) and the University of Melbourne announced today that the U.S. Patent & Trademark Office (USPTO) has confirmed that it will issue U.S. Patent No. 7,455,836, covering key uses of antibodies against GM-CSF. The patent stems from a provisional patent application filed in the USPTO in 2000 by the University of Melbourne. In 2007, MorphoSys signed an agreement with the University of Melbourne, providing MorphoSys with an exclusive license to this patent family. The claims of the patent are directed to methods of ameliorating the effects of inflammation by administering to a patient an antibody directed against GM-CSF.

    Human cytokine GM-CSF (Granulocyte macrophage-colony stimulating factor) is the target molecule of MorphoSys's proprietary MOR103 antibody program for the treatment of rheumatoid arthritis (RA). MOR103 is the first fully human antibody against GM-CSF in clinical trials. The drug could offer an innovative treatment option for RA based on a mechanism of action distinct from anti-TNF and other competing approaches. In 2004, the market for biopharmaceuticals to treat RA amounted to US$ six billion worldwide and is expected to further increase to US$ 14 billion in 2009.

    "This new patent provides us with broad protection for our proprietary antibody program MOR103 in the United States, which is by far the largest market for RA drugs", commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "Our patent portfolio around this promising antibody-based program now extends beyond the specific MOR103 lead antibody, itself, and we anticipate that MOR103 will find application in other inflammatory disorders as well."

    For further information please contact: Dr. Claudia Gutjahr-Löser, Head of Corporate Communications & Investor Relations, Tel: +49 (0) 89 / 899 27-122, gutjahr-loeser@morphosys.com or Mario Brkulj, Manager Corporate Communications & Investor Relations, Tel: +49 (0) 89 / 899 27-454, brkulj@morphosys.com

    About MOR103 to treat RA:
    Rheumatoid arthritis (RA) is traditionally considered a chronic, inflammatory autoimmune disorder that causes the immune system to attack the joints and affects in particular a membrane, called synovium, which lines each movable joint. It is a disabling and painful inflammatory condition, which can lead to substantial loss of mobility due to pain and joint destruction. As a systemic disease, RA often affects extra-articular tissues throughout the body including the skin, blood vessels, heart, lungs, and muscles. The disease affects approximately 4-6 million people worldwide. In patients suffering from RA, white blood cells move from the bloodstream into the synovium. Here, these blood cells appear to play an important role in causing the synovial membrane to become inflamed. The HuCAL-based antibody MOR103 targets GM-CSF as a means to treat inflammatory diseases such as psoriasis, multiple sclerosis (MS), chronic obstructive pulmonary disease (COPD), asthma, and especially RA. The granulocyte macrophage colony-stimulating factor (GM-CSF) stimulates stem cells to produce granulocytes and macrophages and subsequently activates these differentiated immune cells. GM-CSF is part of the natural immune and inflammatory cascade but has also been identified as an inflammatory mediator in autoimmune disorders like RA leading to an increased production of pro-inflammatory cytokines, chemokines and proteases and thereby ultimately to articular destruction. By neutralizing GM-CSF the HuCAL-based antibody MOR103 reduces undesired proliferation and activation of inflammatory granulocytes and macrophages and intervenes in several pathophysiological pathways. More information and picture material is available at: www.morphosys.com/en/mor103
    www.morphosys.com/en/news_investors/p...
    www.investorvillage.com/smbd.asp?mb=2...
  14. flosz 26 november 2008 07:37
    quote:

    aossa schreef:

    MorphoSys Publishes Preclinical Data from MOR103 Program (PER.C6 inside!)

    11/13/2008 at 07:30 AM
    Antibody Shows Ability to Inhibit Disease in an Established RA Model

    www.investorvillage.com/smbd.asp?mb=2...
    MorphoSys Publishes Preclinical Data from MOR103 Program
    11/13/2008 at 07:30 AM
    Antibody Shows Ability to Inhibit Disease in an Established RA Model

    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today the publication of preclinical data from its most advanced proprietary drug development program MOR103, a fully human HuCAL antibody directed against GM-CSF. The preclinical data, which will be presented today at the Human Antibodies and Hybridomas (HAH) Conference in New York, USA, provides strong supporting evidence for MOR103 as a treatment for rheumatoid arthritis (RA), and forms the basis for the Phase 1 clinical trial currently ongoing.

    "The results published today augment the growing data package we have around our lead proprietary program MOR103 and add further value to the program," commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys. "These findings support our understanding of the target biology of GM-CSF. Specifically we believe that GM-CSF is a key mediator in the inflammatory cascade, leading to increased production of other pro-inflammatory cytokines, chemokines and proteases and thereby ultimately to articular destruction in RA."

    The data released today show that MOR103 inhibits the signs and symptoms of RA in vivo, in a dose-dependent manner. The study used the established streptococcal cell wall-induced arthritis model in rats. The antibody was administered in a range of concentrations, and brought about significant reduction of knee joint swelling and improvement in joint histopathology in a dose-dependent manner. In addition, significantly reduced cytokine levels and white blood cell influx were observed in the synovium surrounding the joints. No relevant toxicity effects were observed in a standard repeat dose rhesus monkey study.

    In vitro, MOR103 showed very strong binding to human GM-CSF, blocking binding to the GM-CSF receptor and effectively inhibiting inflammatory disease-related physiology such as cell proliferation, cell migration and activation. Additionally, the antibody exhibited very high target specificity, with no cross-reactivity to other pro-inflammatory cytokines such as IL-3, IL-4, IL-5 or M-CSF nor any non-specific binding to a panel of human tissues. MOR103 also recognizes rat and rhesus GM-CSF, both helpful criteria with regard to the development process.

    MOR103 is currently being tested in a Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetics of this fully human HuCAL antibody. The Phase 1 trial is a randomized, double-blind, placebo-controlled, single-ascending dose study and is being conducted in seven groups with nine healthy volunteers in each cohort. The dosing of all volunteers has been completed and follow-up analysis is ongoing. Final data are expected in Q2 2009.
  15. flosz 26 november 2008 08:19
    This alliance also complements our development efforts in the field of inflammation and arthritis including our lead program MOR103."
    *********************
    MorphoSys and Galapagos Enter Alliance to Co-develop Novel Therapeutic Antibodies in Bone and Joint Disease
    11/26/2008 at 07:30 AM

    Combination of Proprietary Drug Targets and Unique Technologies to Create Range of New Therapeutic Antibodies

    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) and Galapagos NV (Euronext: GLPG) announced today the launch of a long term co-development alliance aimed at discovering and developing antibody therapies based on novel modes of action in bone and joint disease, including rheumatoid arthritis, osteoporosis and osteoarthritis.

    The alliance spans all activities from target discovery through to completion of proof of concept clinical trials of novel therapeutic antibodies. Both companies will contribute their core technologies and expertise to the alliance. Galapagos will provide antibody targets implicated in bone and joint disease in addition to its adenoviral target discovery platform to discover further targets for antibody development. MorphoSys will contribute its HuCAL antibody technologies to generate fully human antibodies directed against these targets. The initial goal is to further validate the targets through disease-specific in vitro and in vivo testing of the antibodies. After successful validation, the alliance will select antibody programs for pre-clinical and clinical development. Following proof of concept in human clinical trials, programs will be partnered for subsequent development, approval and marketing.

    Under the terms of the agreement, Galapagos and MorphoSys will share the research and development costs, as well as all future revenues equally. Decisions will be made by a Joint Steering Committee comprising members of both companies. An initial set of three targets implicated in bone and joint disease has been selected for the collaboration, and Galapagos is already commencing with production of these proteins for the alliance. Generation of antibodies directed against these targets will start in 2009. More targets will be selected using Galapagos' target discovery platform to fuel the alliance in the coming years. If successful, the first antibody programs based on these novel targets could enter the clinic within four to five years.

    "With this alliance, we are adding a biologics strategy to our small molecule drug discovery. Galapagos is the world leader in discovery of novel targets, and this alliance with MorphoSys enables us to explore the potential of proprietary antibody targets. Antibody approaches have proven to be successful in developing new therapies for major diseases, including rheumatoid arthritis. Having both approaches, small molecules and antibodies, to fill our product pipeline in bone and joint disease will further establish Galapagos as the leader in this field," said Onno van de Stolpe, Chief Executive Officer of Galapagos. "With our cash position and revenue streams from both BioFocus DPI and our pharma alliances, we are in a good financial position to enter into this alliance to create value for our shareholders."

    "This alliance represents a major step in our efforts to gain access to novel antibody targets for proprietary drug development in disease areas with a high unmet medical need. The partnership with Galapagos combines both the scientific and financial strength of two leading companies in their space," said Dr. Simon Moroney, Chief Executive Officer of MorphoSys. "We are excited to combine our broad antibody expertise with Galapagos' target discovery capabilities and disease know-how to form a successful partnership. The access to novel disease-related target molecules from a renowned partner accelerates the expansion of our proprietary antibody pipeline. This alliance also complements our development efforts in the field of inflammation and arthritis including our lead program MOR103."

    With this strategic alliance, MorphoSys gains access to a proven target discovery engine as well as to Galapagos' expertise in bone and joint disease, to support its therapeutic antibody pipeline expansion. The three main indications of bone and joint disease - rheumatoid arthritis, osteoporosis and osteoarthritis - all represent very significant market opportunities with several million people affected worldwide and combined sales of drug treatments of more than US$ 15 billion in 2006.

    Through the alliance with MorphoSys, Galapagos enters the rapidly growing market for therapeutic antibodies. In 2007, total sales for the 20 antibody drugs on the market amounted to more than US$ 25 billion and antibody sales are forecast to increase to approximately US$ 50 billion in 2013. Fully human antibodies are recognized as the next generation and the majority of therapeutic antibodies currently in development are humanized or fully human. The average industry timescale from discovery to pre-clinical development of antibody therapies is only two to three years, considerably shorter than the average six years for small molecules. Antibodies also incur lower attrition rates than small molecules.

    Galapagos and MorphoSys will conduct a conference call and live audio webcast today at 02:00 p.m. CET (8:00 a.m EST) to provide detailed information on the alliance.

    Dial-in number for the Conference Call (listen-only):
    Germany & U.K. residents: +32 2 401 53 06
    For U.S. residents: +1 866 931 1567

    Please dial in 10 minutes before the beginning of the conference.

    Approximately two hours after the press conference, the archived webcast will be available for replay of the conference on www.morphosys.com and www.glpg.com.

    For further information please contact: Dr. Claudia Gutjahr-Löser, Head of Corporate Communications & Investor Relations, Tel: +49 (0) 89 / 899 27-122, gutjahr-loeser@morphosys.com or Mario Brkulj, Manager Corporate Communications & Investor Relations, Tel: +49 (0) 89 / 899 27-454, brkulj@morphosys.com

    www.morphosys.com/en/news_investors/p...
  16. flosz 26 november 2008 08:27
    Galapagos en MorphoSys gaan gezamenlijk antilichaam-medicijnen ontwikkelen voor bot- en gewrichtsziekten
    Combinatie van nieuwe medicijn targets en unieke technologieën om pijplijn van nieuwe antilichaam-medicijnen te creëren
    Klik hier om toegang te krijgen tot de audio-webcast presentatie om 14:00 uur, inbelnummer +32.2.401.53.06
    Mechelen, België en München, Duitsland; 26 november 2008 – Galapagos NV (Euronext: GLPG) en MorphoSys AG (FSE: MOR) kondigen vandaag een langdurige alliantie aan om gezamenlijk medicijnen te ontwikkelen gebaseerd op antilichamen met een nieuw werkingsmechanisme tegen bot- en gewrichtsziekten, met name reuma, botontkalking en artrose.
    De alliantie omvat het hele traject vanaf target discovery tot aan klinisch proof of concept voor de nieuwe therapeutische antilichamen. De twee bedrijven brengen beide hun kerntechnologie en expertise in bij de alliantie. Galapagos levert targets voor antilichamen bij bot- en gewrichtsziekten, plus haar target discovery platform om additionele targets voor antilichamen te identificeren. MorphoSys gebruikt haar HuCAL technologie om volledig humane antilichamen tegen de targets van Galapagos te ontwikkelen. In de alliantie zullen de targets worden gevalideerd, zowel door in vitro als in vivo testen met de antilichamen; vervolgens zullen deze antilichamen in preklinisch en klinisch onderzoek verder worden ontwikkeld. Bij het bereiken van klinisch proof of concept in patiënten, zullen er voor de programma’s partners gezocht worden die de verdere ontwikkeling, registratie en marktintroductie zullen verzorgen.
    Op basis van de overeenkomst zullen Galapagos en MorphoSys zowel de R&D kosten als de toekomstige inkomsten gelijk delen. Een Joint Steering Committee met leden uit beide bedrijven zal de alliantie leiden. De bedrijven hebben een eerste set van drie targets in bot- en gewrichtsziekten geselecteerd voor de samenwerking en Galapagos is al gestart met de productie van deze target eiwitten Het ontwikkelen van antilichamen tegen deze targets zal starten in 2009. Met de technologie van Galapagos zullen in de komende jaren nog meer targets voor de alliantie geselecteerd worden. Als de alliantie succesvol verloopt, kunnen de eerste antilichamen op basis van deze nieuwe targets binnen vier à vijf jaar in de kliniek getest worden.
    “Met deze alliantie voegen we een antilichaam-strategie toe aan onze ontwikkeling van geneesmiddelen op basis van chemische moleculen. Galapagos is wereldleider op gebied van het ontdekken van nieuwe targets en door deze samenwerking met MorphoSys kunnen we deze nu ook voor de ontwikkeling van antilichamen inzetten. Antilichamen hebben hun sporen al verdiend bij de ontwikkeling van nieuwe medicijnen tegen ernstige ziekten waaronder ook reuma. Door beide benaderingen te gebruiken - zowel antilichamen als chemische moleculen - breiden we onze product pijplijn in bot- en gewrichtsziekten verder uit en versterken daarmee onze leidende positie op dit gebied,” aldus Onno van de Stolpe, Chief Executive Officer van Galapagos. “Door onze kaspositie en inkomstenstroom uit zowel BioFocus DPI als onze farma allianties, verkeren we in een goede positie om deze alliantie aan te gaan en waarde voor onze aandeelhouders te creëren.”
    “Deze alliantie is voor ons een grote stap met de toegang tot nieuwe targets voor geneesmiddelontwikkeling in ziektes waarvoor nog weinig medicijnen beschikbaar zijn. De samenwerking met Galapagos brengt twee zowel wetenschappelijk als financieel sterke partijen samen,” zet Simon Moroney, Chief Executive Officer van MorphoSys. “We zijn blij dat we onze brede ervaring op gebied van antilichamen in deze alliantie kunnen combineren met de target discovery en kennis van botziekten van Galapagos. De toegang tot nieuwe ziekte-gerelateerde targets van een dergelijk gerenommeerde partner accelereert de uitbreiding van onze eigen pijplijn van antilichamen. Deze alliantie sluit mooi aan bij onze onderzoek op gebied van ontstekingen en reuma, inclusief ons belangrijkste programma MOR103.”
    Met deze strategische alliantie krijgt MorphoSys toegang tot zowel een bewezen target discovery technologie, als tot de ervaring van Galapagos op het gebied van bot- en gewrichtsziekten en draagt het bij aan de uitbreiding van de pijplijn van eigen therapeutische antilichamen. De drie belangrijkste bot- en gewrichtsziekten – reuma, botontkalking en artrose – vertegenwoordigen elk een significante markt met enkele miljoenen patiënten wereldwijd. Het totale verkoopcijfer voor behandelingen van deze ziekten bedroeg in 2006 meer dan $15 miljard.
    Door de alliantie met MorphoSys begeeft Galapagos zich op de snel groeiende markt voor medicijnen op basis van antilichamen. In 2007 bedroeg het totale verkoopcijfer voor de 20 therapeutische antilichamen die op de markt zijn meer dan $25 miljard; dit zal naar verwachting oplopen tot ongeveer $50 miljard in 2013. Volledig humane antilichamen worden beschouwd als de volgende generatie; de meeste antilichamen die op dit moment worden ontwikkeld zijn van humane oorsprong. De gemiddelde tijd die nodig is vanaf ontdekking tot preklinische ontwikkeling voor een antilichaam is slechts twee tot drie jaar, aanmerkelijk korter dan de gemiddelde zes jaar voor kandidaat medicijnen uit chemische moleculen. Antilichamen hebben ook een grotere kans op succes in het ontwikkelingstraject naar geneesmiddel.
    Teleconferentie en webcast presentatie
    Galapagos zal vandaag om 14.00 uur een voor ieder toegankelijke teleconferentie houden. Deze teleconferentie wordt ook via webcast uitgezonden. Voor deelname aan de teleconferentie kunt u +32.2.401.53.06 bellen, minimaal tien minuten voor aanvang. Na de presentatie van de resultaten zal er een vraag- en antwoordsessie volgen. Klik hier pulse.companywebcast.nl/playerv1_0/de... om toegang te krijgen tot de audio-webcast presentatie. De presentatie zal onmiddellijk na de uitzending beschikbaar zijn om nogmaals te beluisteren.

    Over antilichamen
    Antilichamen zijn eiwitten in ons lichaam die vreemde stoffen zoals bacteriën en virussen herkennen en er zich aan binden waarna onze afweercellen deze kunnen vernietigen. Elk mens heeft ongeveer één à twee miljard verschillende antilichamen die voortdurend in de bloedstroom actief zijn om infecties en ziektes aan te pakken. Het idee om specifieke antilichamen als medicijn tegen bepaalde ziektes te gebruiken ontstond al meer dan 25 jaar geleden. Het onderzoek bij het ontwikkelen van antilichaam-medicijnen richt zich op antilichamen die specifieke targets kunnen blokkeren of juist activeren.
    www.glpg.com/press/2008/35%27.htm
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