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Morphosys-Galapagos, Therapeutic Antibodies

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  1. forum rang 4 harvester 24 november 2017 18:01

    • harvester

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    November 23, 2017 - MorphoSys Announces That Its Licensee Janssen Has Received Approval for Tremfya® (Guselkumab) in Europe for the Treatment of Moderate-to-Severe Plaque Psoriasis

    MorphoSys entitled to royalties on net sales of Janssen’s Tremfya®
    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced today that its licensee Janssen-Cilag International NV (Janssen), has reported that the European Commission has granted approval of Tremfya® (guselkumab) in the European Union for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. In July 2017, the drug received U.S. FDA approval for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
    Tremfya® (guselkumab) is a fully human anti-IL-23 monoclonal antibody developed by Janssen and was generated utilizing MorphoSys’s proprietary HuCAL antibody library technology. MorphoSys is eligible to receive royalties on net sales of Tremfya®.
    Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG, said: “We are very pleased that Janssen has now received market authorization for Tremfya® in Europe after U.S. approval was granted in July of this year. We expect this drug will provide an important treatment option for patients living with moderate-to-severe plaque psoriasis.”
    “Guselkumab is the first antibody that has received approval in Europe based on MorphoSys’s technologies. With more than 100 MorphoSys compounds currently in development, we look forward to advancing novel antibodies in a wide variety of serious diseases where we see a strong need for alternative treatment options“, added Dr. Markus Enzelberger, Chief Scientific Officer of MorphoSys.
    Beyond plaque psoriasis, Janssen is studying Tremfya® (guselkumab) in a Phase 3 psoriatic arthritis development program.
    Further information can be found in the press release issued by Janssen on November 23, 2017.
  2. forum rang 4 harvester 30 november 2017 19:27

    • harvester

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    30 Nov. - MorphoSys Signs Regional License Agreement for Antibody MOR202 with I-Mab

    November 30, 2017 / 11:07 am, CET

    Planegg/Munich, Germany, November 30, 2017

    MorphoSys Signs Regional License Agreement for Antibody MOR202 with I-Mab



    - MorphoSys to receive a USD 20 million upfront payment and entitled to tiered, double digit royalties on net sales of MOR202 plus milestone payments of up to USD 100 million from I-Mab

    - I-Mab receives exclusive development and commercialization rights to MOR202 in China, Taiwan, Hong Kong and Macao

    - I-Mab Biopharma (a fully owned affiliate of I-Mab) management has extensive experience that is particularly well-suited to developing MOR202 for the Greater Chinese market

    - MorphoSys increases its financial guidance for 2017: revenues of EUR 63 to 66 million and EBIT of EUR -66 to -71 million expected

    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) and I-Mab announced today that they have entered into an exclusive regional licensing agreement to develop and commercialize MOR202 in China, Taiwan, Hong Kong and Macao. MOR202 is MorphoSys's proprietary investigational antibody against CD38, for which recruitment of a European Phase 1/2a clinical study in relapsed/refractory multiple myeloma has been concluded.

    Under the terms of the agreement, I-Mab Biopharma will assume exclusive responsibility for all subsequent development and commercialization of MOR202 in the agreed territory. MorphoSys receives an immediate upfront payment of USD 20 million. MorphoSys will be entitled to receive additional success-based clinical and commercial milestone payments from I-Mab of up to approximately USD 100 million, as well as tiered double-digit royalties on net sales of MOR202 in the territory.

    In connection with the license agreement with I-Mab, MorphoSys has increased its financial guidance. For the year 2017, MorphoSys now expects revenues in the range from EUR 63 to 66 million (up from previously EUR 46 to 51 million) and earnings before interest and taxes (EBIT) of EUR -66 to -71 million (up from previously EUR -75 to -85 million). Guidance for revenues and EBIT includes royalty income on Tremfya(R) sales in Q3 2017, but does not include any royalty income on Tremfya(R) sales in Q4 2017. Following the partnering of MOR202, proprietary R&D expenses will be in the range from EUR 96 to 100 million (previously EUR 85 to 95 million).

    I-Mab Biopharma intends to start clinical development of MOR202 to treat patients with multiple myeloma in China next year.

    "Our deal with I-Mab is the first step in our plan to secure the development and commercialization of MOR202. In I-Mab, we have found an ideal partner with a highly dedicated and experienced team who are committed to developing MOR202 as fast as possible for the Chinese market", commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG.

    "We are very excited to partner with MorphoSys to develop this highly differentiated investigational oncology medicine for unmet needs in China. This partnership marks a latest addition to our China portfolio of clinical stage assets, which parallels with our global immuno-oncology portfolio of innovative biologics", said Jingwu Zang, founder and CEO of I-Mab Biopharma.

    About MOR202 and the ongoing phase 1/2a study in multiple myeloma
    The investigational drug MOR202 is a human HuCAL antibody directed against CD38, a highly expressed and validated target in multiple myeloma. Preclinical findings also support an anti-CD38 approach in other therapeutic fields beyond multiple myeloma including solid tumors and autoimmune diseases. MOR202 is currently in a phase 1/2a, open-label, multi-center, dose-escalation clinical study conducted in several sites in Germany and Austria. The study is evaluating the safety and preliminary efficacy of MOR202 with low dose dexamethasone and in combination with the immunomodulatory drugs (IMiDs) pomalidomide (POM) and lenalidomide (LEN) plus DEX in patients with relapsed/refractory multiple myeloma. The primary endpoints of the trial are the safety, tolerability and recommended dose of MOR202 with DEX and in combination with the IMiDs. Secondary outcome measures are pharmacokinetics and preliminary efficacy based on overall response rate, duration of response, time-to-progression, and progression-free survival.
  3. forum rang 4 harvester 9 december 2017 15:48

    • harvester

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    Wellicht binnenkort weer een update over de patent infringement zaak van Morphosys tegen Genmab en JNJ die Darzalex verkopen als product tegen kanker. Het is iets tegen CD38 cellen. Dat is ook het target van MOR 202 waar Morphosys Op 30 november een licentie voor de Chinese markt heeft verstrekt aan I-mab.
  6. HansGarrincha 6 november 2018 15:25

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    Opmerkelijke terugval van Morphosys in korte tijd van top boven de E120 naar bodem onder E78 en nu weer dik boven de E100. Prachtig voor korte ritten in retrospect.
  8. flosz 28 november 2018 23:38

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    MOR106 Ph.2 study status update (nov.19) Recruiting, Recruiting, Recruiting...
    A Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics (PK)/Pharmacodynamics (PD) of MOR106 in Subjects With Moderate to Severe Atopic Dermatitis clinicaltrials.gov/ct2/history/NCT035...
    Bijlage:
  10. [verwijderd] 7 december 2018 14:37

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    Germany has long been seen as one of the flourishing life sciences hubs in Europe. With its numerous hotspots – Berlin, Heidelberg, Munich, Mannheim just to name a few – it presents the perfect breeding ground for every young biotech company.

    labiotech.eu/sponsored/guide-biotech-...
  17. nelis h 17 januari 2019 22:14

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    Morphosys/Janssen ook met UC onderzoek

    ===

    Planegg/Munich, Germany, January 17, 2019

    MorphoSys Announces that its Licensee Janssen has Expanded Clinical Development of Guselkumab (Tremfya(R)) into Ulcerative Colitis

    MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) announced today that its licensee Janssen Research & Development, LLC (Janssen), has further expanded the clinical development of guselkumab (Tremfya(R)) into ulcerative colitis (UC).
    Janssen has initiated a proof-of-concept phase 2a clinical trial in patients with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease. This randomized, double-blind study will evaluate the efficacy and safety of guselkumab in combination with golimumab compared to guselkumab or golimumab monotherapy in approximately 210 patients with moderately to severely active UC.
  18. flosz 26 januari 2019 13:33

    • flosz

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    $MOR Announces That Its Patents Were Ruled Invalid in Patent Lawsuit Against Janssen and Genmab

    MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) announces that it was informed today that in its lawsuit against Janssen Biotech and Genmab A/S, the United States (U.S.) District Court of Delaware, based on a hearing held November 27, 2018, has ruled in a Court Order on January 25, 2019, that the asserted claims of three MorphoSys patents with U.S. Patent Numbers 8,263,746, 9,200,061 and 9,758,590 are invalid. The Court thus granted a motion for Summary Judgement of invalidity filed by Janssen Biotech and Genmab, A/S against the three patents held by MorphoSys. As a result of this decision, the jury trial scheduled for February 2019 to consider defendants' alleged infringement and the validity of the MorphoSys patents will now not take place.
    MorphoSys's management is disappointed with the decision and is considering all of its options. The company has the right to appeal this judgement to the Federal Circuit.
    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 sought redress for infringement by Janssen's and Genmab's daratumumab, a CD38-directed monoclonal antibody for the treatment of multiple myeloma.
    This court decision has no bearing upon the composition of matter patent protection for MorphoSys's own CD38 antibody MOR202 and thus MorphoSys's ability to develop MOR202 in various indications.

    www.morphosys.com/media-investors/med...
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  20. flosz 26 januari 2019 14:48

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    Idd. En hoe gaat het verder mbt patenten in China( I-MAB vs JNJ Darzalex, misschien gaan JNJ en Genmab daar ook achteraan), we gaan het zien.
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