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Home  /   Forum   /   Galapagos   /   Morphosys-Galapagos, Therapeutic Antibodies

Aandeel Galapagos AEX:GLPG.NL, BE0003818359

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Morphosys-Galapagos, Therapeutic Antibodies

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451 Posts
Pagina: «« 1 ... 9 10 11 12 13 ... 23 »» | Laatste | Omlaag ↓
  6. Omegaplan 31 januari 2019 19:28
    MorphoSys Announces Settlement in Patent Lawsuit with Janssen and Genmab


    MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) announced today that in its lawsuit against Janssen Biotech and Genmab A/S, the parties have settled the dispute. As a result of this, the parties to the dispute have agreed to drop the mutual claims related to this litigation.

    On April 4, 2016 MorphoSys had filed a lawsuit in the United States (U.S.) District Court of Delaware against Janssen Biotech, and Genmab, A/S for patent infringement of U.S. Patent Number 8,263,746. In 2017, a second and a third patent with US Patent Numbers 9,200,061 and 9,758,590 were added to the lawsuit. MorphoSys had sought redress for alleged infringement by Janssen's and Genmab's daratumumab, a CD38-directed monoclonal antibody for the treatment of multiple myeloma. MorphoSys is dismissing those claims and will not appeal from the previously-announced court order dated January 25, 2019. Janssen and Genmab are dismissing their counterclaims.

  12. flosz 13 maart 2019 23:29
    MorphoSys Presents Results for Fiscal Year 2018 (news with additional features)

    MorphoSys is a well-respected development partner for renowned pharmaceutical and biotechnology companies worldwide. This is not limited to the discovery of compounds, where we have excellent expertise and experience. We are also involved in a variety of partnerships that cover the complete development range – from the identification of target molecules to later stages of development and all the way to market approval. The antibody MOR106 is a good example how to advance the development successfully with partners. We discovered and developed MOR106 together with the Belgian company Galapagos N.V. While Galapagos has identified the target molecule, we have identified the antibody. Preclinical studies have shown that MOR106 plays an important role in certain inflammatory skin diseases. MOR106 is currently in clinical development for the treatment of atopic dermatitis.In July 2018, we, together with Galapagos, signed an exclusive global licensing agreement with the pharmaceutical company Novartis. Should MOR106 be approved for such a broad indication as atopic dermatitis, the partner Novartis will bring in the respec-tive necessary commercial and marketing power. The agreement includes an upfront and potential success-based milestone pay-ments. In addition, Novartis will take over all future cost for re-search and development. In summary, this partnership has created a network resulting in benefits for all stakeholders: First and foremost as we hope for the patients, but also for the companies in terms of joint research and the later commercialization as well as revenue generation.

    www.morphosys.com/sites/default/files...

    In July, we were delighted to announce that, together with our partner Galapagos, we had entered an exclusive global license agreement with Novartis for MOR106. We are developing this antibody as a potential treatment for atopic dermatitis, a debilitating skin disease that affects over 80 million people across the world’s seven largest markets for pharmaceuticals. Bringing medicines to such a large patient population is extremely challenging, which is why it made sense for us to secure the cooperation of a large partner. The deal with Novartis will enable us to advance MOR106 as quickly and broadly as possible while allowing us to allocate more resources elsewhere, in particular, to the development of MOR208

    MOR106 is an investigational fully human IgG1 monoclonal antibody derived from our Ylanthia library and designed to selectively target IL-17C. MOR106 came from the strategic discovery and co-development alliance between Galapagos and MorphoSys, in which both companies contributed their core technologies and expertise. It is the first publicly disclosed monoclonal antibody targeting IL-17C in clinical development worldwide. In preclinical studies, MOR106 has been shown to inhibit the binding of IL-17C to its receptor, thus abolishing its biological activity. Results from rodent inflammatory skin models of atopic dermatitis (AD*) and psoriasis* support clinical development of MOR106 for the treatment of inflammatory diseases. In July 2018, we announced with Galapagos that we had entered into a worldwide exclusive development and commercialization agreement with Novartis Pharma AG (Novartis) for MOR106. AD, the most severe and common type of eczema, is a chronic relapsing inflammatory skin disease that causes severe itch, dry skin and rashes, predominantly on the face, inner side of the elbows and knees, and on hands and feet. Scratching of the affected skin leads to a vicious cycle causing redness, swelling, cracking, scaling of the skin and an increased risk of bacterial infections. Lichenification, thickening of the skin, is characteristic in older children and adults. The National Eczema Association estimates that AD affects over 30  million Americans, and up to 25 % of children and 2-3 % of adults. As many as 50 % of AD patients are diagnosed in the first year of life, and 85 % of patients have a disease onset before age five. Symptoms commonly fade during childhood; however, up to 30 % of the patients will suffer from AD for life. A smaller percentage first develops symptoms as adults.

    WORLDWIDE EXCLUSIVE DEVELOPMENT AND COMMERCIALIZATION AGREEMENT WITH NOVARTIS Our agreement with Novartis was announced in July 2018, and received U.S. anti-trust clearance in September 2018. Under the terms of the agreement, the parties (Galapagos, MorphoSys, Novartis) will cooperate to execute and broaden the existing development plan for MOR106 in AD. Novartis holds exclusive rights for commercialization of any products resulting from the agreement. All current and future research, development, manufacturing and commercialization costs for MOR106 will be covered by Novartis. This includes the ongoing phase  2 IGUANA trial in AD patients, as well as the phase  1 bridging study to evaluate the safety and efficacy of a subcutaneous formulation of MOR106 in healthy volunteers and AD patients. MorphoSys and Galapagos will conduct additional trials to support development of MOR106 in AD. Under the terms of the agreement, Novartis will also explore the potential of MOR106 in indications beyond AD. In addition to the funding of the current and future MOR106 program by Novartis, MorphoSys and Galapagos jointly received an upfront payment of € 95  million. Pending achievement of certain developmental, regulatory, commercial and sales-based milestones, MorphoSys and Galapagos are jointly eligible to receive significant milestone payments, potentially amounting to up to approximately € 850  million, in addition to tiered royalties on net commercial sales in the low-teens to low-twenties percent. Under the terms of their agreement from 2008, Galapagos and MorphoSys share all payments equally (50/50).
  13. flosz 13 maart 2019 23:30
    CLINICAL DATA PRESENTED In February 2018, more detailed clinical results from a phase  1 trial with MOR106 in patients with moderate to severe AD were presented at the American Academy of Dermatology (AAD) conference after initial study data were reported in September 2017. MOR106 showed first signs of activity as well as durable responses and was generally well tolerated in patients with AD. This randomized, double-blind, placebo-controlled phase  1 trial evaluated single ascending doses (SAD) of MOR106 in healthy volunteers and multiple ascending doses (MAD) in patients with moderate-to-severe AD. In the MAD part, 25 patients received four infusions once-weekly of either MOR106 (at the doses of 1, 3 and 10  mg/kg body weight) or placebo in a 3:1 ratio. Patients were followed for 10 weeks after the end of the treatment period. In the MAD part of the study, all adverse drug reactions observed were mild to moderate and transient in nature. No SAEs and no IRRs were recorded. MOR106 exhibited a favorable pharmacokinetic (PK) profile with dose-dependent exposure. At the highest dose level of MOR106 (10  mg/kg body weight), in 83 % of patients (5/6) an improvement of at least 50 % in signs and extent of AD, as measured by the Eczema Area and Severity Index (EASI*)-50, was recorded at week 4. The onset of activity occurred within two to four weeks, depending on the dose administered. Pooled data across all dose cohorts showed that patients treated with MOR106 achieved an EASI improvement compared to baseline of 58 %, 62 %, 72 % and 64 % at week 4, 8, 12 and 14, respectively. For patients receiving placebo, the EASI improvement was 32 %, 40 %, 38 % and 50 %, respectively.

    CLINICAL TRIALS INITIATED IGUANA phase  2 study in AD: In May 2018, we announced with Galapagos that the first patient had been enrolled in IGUANA, a phase  2 study of MOR106 in patients with AD. The placebo-controlled, double-blind study will evaluate the efficacy, safety and PK of MOR106.
    At least 180 patients with moderate-to-severe AD are planned to be treated over a 12-week period with one of three different doses of intravenously (iv) administered MOR106 (1, 3 or 10  mg/ kg) or placebo using two different dosing regimens in multiple centers across Europe. Dosing at two- or four-week intervals will be evaluated over the 12-week treatment period, followed by a 16-week observation period. The primary objective will be assessed by the percentage change from baseline in EASI score at week 12. Phase  1 bridging study. In September 2018, we announced with Galapagos the initiation of a phase  1 bridging study testing a subcutaneous (sc*) formulation of MOR106. This bridging study is a parallel-design phase  1 clinical trial being conducted in two parts. Part 1 is a single center, randomized, open-label study in healthy volunteers who will be treated with different single-dose levels of MOR106 administered subcutaneously or intravenously. Part 2 is a multiple-center, randomized, placebo- controlled, multiple-dose study in patients with moderate to severe AD who will be treated subcutaneously for 12 weeks. Safety and tolerability, PK and occurrence of anti-drug-antibodies after administration of MOR106 will be assessed as endpoints. In addition, the efficacy of MOR106 will be explored in subjects with moderate-to-severe AD.
  14. Omegaplan 19 maart 2019 22:14
    MorphoSys and I-Mab Biopharma Announce Initiation of Pivotal Phase 2 Study of TJ202/MOR202 for Multiple Myeloma


    MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) and I-Mab Biopharma (I-Mab), a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immuno-oncology and autoimmune diseases, announced today that the first patient has been dosed in a phase 2 clinical study in Taiwan to evaluate MorphoSys's investigational human CD38 antibody TJ202/MOR202 in patients with relapsed or refractory multiple myeloma. I-Mab owns the exclusive rights for development and commercialization of TJ202/MOR202 in China, Taiwan, Hong Kong and Macao.

    "Advancing TJ202/MOR202 into a late stage phase 2 trial is a significant achievement," said Dr. Joan Shen, M.D., Head of R&D at I-Mab. "We expect that, if approved, TJ202/MOR202 may provide multiple myeloma patients with an important biologics treatment option that addresses the underlying pathology of the second most common blood cancer worldwide."

    The dosing of the first patient triggers a milestone payment of USD 5 million to MorphoSys.
  17. sanderus_1 24 april 2019 10:51
    Upon the signing of the agreement, all future research, development, manufacturing and commercialization costs for MOR106 will be borne by Novartis. This includes the ongoing Phase 2 IGUANA trial in atopic dermatitis patients as well as a planned Phase 1 study to evaluate the safety and efficacy of a subcutaneous formulation of MOR106 in healthy volunteers and AtD patients. MorphoSys and Galapagos will conduct additional trials to support development of MOR106 in AtD.
  19. Omegaplan 24 april 2019 11:43
    Zekers, gister 6 minuten na dat v Gala,
    Planegg/Munich, Germany, and Mechelen, Belgium, April 23, 2019
    MorphoSys and Galapagos Announce Initiation of GECKO Phase 2 Study with MOR106 in Atopic Dermatitis Patients
    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; NASDAQ: MOR), Galapagos NV (Euronext & NASDAQ: GLPG) and Novartis Pharma AG (SIX: NOVN-CH) announced today the initiation of GECKO, a phase 2 study testing a subcutaneous formulation of MOR106 in combination with topical corticosteroids in patients with moderate to severe atopic dermatitis.
    The GECKO trial aims to randomize 60 patients who receive either a dose of MOR106 or placebo subcutaneously for 8 weeks, together with topical steroids, with a 16 week follow-up period. The primary endpoint of GECKO is the incidence of treatment emergent adverse and serious adverse events through day 169.
  20. flosz 10 mei 2019 21:14
    MOR208 is now tafasitamab!

    Tafasitamab - our proprietary Fc-enhanced antibody targeting CD19 in late stage clinical development for hematological cancers with high unmet medical need.
    www.morphosys.com/pipeline/proprietar...

    MOR106: Proprietary Antibody Against IL-17C
    Ylanthia Antibody Developed in Atopic Dermatitis (AtD)
    MOR & Galapagos worldwide, exclusive partnership with Novartis
    Up-front: EUR 95m
    Milestones: up to approx. EUR 850m
    Royalties: tiered, low teens to low twenties
    Novartis assumes all R&D, manufacturing & commercialization costs
    Update on clinical developments
    Currently ongoing studies with MOR106 in AtD
    Ph2 IGUANA: Patient enrollment to be completed end of 2019
    Ph1 bridging study with subcutaneous formulation: Primary completion of the trial expected end of 2019
    Ph2 GECKO: Expanding clinical development to the U.S. and Canada
    Preparations for a Japanese ethno-bridging study to start in H2 2019
    Under the terms of the agreement, Novartis will explore the
    potential of MOR106 in additional indications other than AtD
    www.morphosys.com/sites/default/files...


    + twitter.com/bertrandbio/status/112610...
    Bijlage:
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