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MOR103 (PerC6 inside) PHASE I

1. [verwijderd] 20 februari 2008 20:38

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   quote:

   flosz schreef:

   [quote=WarrumBuffet]
   flosz& &???
   [/quote]
   & soes, charlie, flo of Jazz Jones....afhankelijk van welke kat er op de muis zit.
   Alias was weg, vandaar. Inmiddels weer gewoon flosz. Opzegging alias flosz& is de deur uit.
   gr.
   

   Okee!
   
   Goed je hier weer terug te zien, flosz!
   
   WB
2. [verwijderd] 21 februari 2008 10:48

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   MorphoSys und Astellas verlängern Allianz zur Entwicklung neuer Antikörpermedikamente
   
   Die MorphoSys AG (Frankfurt: MOR; Prime Standard Segment, TecDAX) gab heute bekannt, dass Astellas Pharma Inc., Japans zweitgrößter Pharmakonzern, die bestehende Kooperation verlängert hat. Die ursprünglich im März 2007 unterzeichnete Zusammenarbeit erstreckt sich nun über die gesamte Laufzeit von fünf Jahren bis März 2012. Im Rahmen der Vereinbarung gewährt MorphoSys Astellas weiterhin Zugang zur seiner HuCAL GOLD-Antikörperbibliothek an seinem Forschungsstandort in Tsukuba, Japan, für den Einsatz in Astellas' pharmazeutischer Wirkstoffforschung. Astellas verfügt unverändert über Optionen, mehrere HuCAL-basierte Antikörperprogramme zu entwickeln und zu kommerzialisieren, wofür MorphoSys Lizenz- und Meilensteinzahlungen sowie umsatzabhängige Tantiemen auf alle resultierenden Produkte erhält. Im Rahmen der Verlängerung sichert sich MorphoSys jährliche Lizenzzahlungen über die Restlaufzeit des Vertrags für den Zugang zur HuCAL-Plattform. Weitere finanzielle Einzelheiten wurden nicht bekannt gegeben.
   
   'Wir sind sehr erfreut über den erfolgreichen Verlauf unserer Kooperation mit Astellas und ihre Entscheidung, weiterhin unsere Antikörperbibliothek HuCAL GOLD für therapeutische Antikörperentwicklung zu nutzen', erklärte Dr. Simon Moroney, Vorstandsvorsitzender von MorphoSys. 'Die heutige Nachricht verdeutlicht anschaulich, dass unsere Kerntechnologie HuCAL unverändert die Basis der Medikamentenentwicklung bei einer Vielzahl der Pharmakonzerne weltweit bleiben wird.'
   
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3. [verwijderd] 27 februari 2008 12:11

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   MorphoSys und Sigma-Aldrich unterzeichnen Lizenzvereinbarung für rekombinante Forschungsantikörper
   
   Die MorphoSys AG (Frankfurt: MOR; Prime Standard Segment, TecDAX) und Sigma-Aldrich (Nasdaq: SIAL) gaben heute den Beginn einer Zusammenarbeit zur Entwicklung, Produktion und Vermarktung neuer rekombinanter Forschungsantikörper auf Basis der HuCAL GOLD-Technologie von MorphoSys bekannt. MorphoSys' Geschäftssegment AbD Serotec wird, basierend auf der firmeneigenen HuCAL GOLD-Antikörperbibliothek, neuartige Antikörper gegen eine vertraglich zugesicherte Anzahl an Zielmolekülen von Sigma-Aldrich entwickeln und charakterisieren. Bei HuCAL GOLD handelt es sich um die jüngste und leistungsfähigste Version von MorphoSys' Antikörperbibliotheken für die In-vitro-Herstellung hochspezifischer und vollständig menschlicher Antikörper. Die hohe Vielfalt an Antikörpern in der Sammlung ermöglicht die schnelle und erfolgreiche Entwicklung von Antikörpern gegen Zielmoleküle, die bisher durch Standardverfahren zur Antikörperentwicklung nur schwierig zu erreichen war. Sigma-Aldrich wird diese HuCAL-Antikörper für den Einsatz in Forschungsanwendungen durch seine etablierten Online-Vertriebsplattformen 'Antibody Explorer(TM)' und 'Your Favorite Gene Search(TM)' vermarkten.
   
   'Wir sind begeistert von dem Potenzial dieser Partnerschaft', kommentiert Dr. David Smoller, Präsident der Geschäftseinheit für biotechnologische Forschungserzeugnisse von Sigma-Aldrich. 'Die rekombinante Antikörpertechnologie HuCAL wird Forschern den Zugang zu Antikörpern ermöglichen, die durch Standardverfahren zur Antikörperentwicklung nicht zugänglich sind. In Verbindung mit dem Standard-Angebot und Entwicklungsverfahren von Sigma-Aldrich wird diese leistungsstarke Technologie die Forschung ihrem Fernziel näher bringen, einen Antikörper für jedes Gen und eines Tages auch für jedes Protein des menschlichen Körpers zur Verfügung zu haben.'
   
   'Mit Sigma-Aldrich und AbD Serotec bündeln zwei führende Anbieter von Forschungsantikörpern ihre Kräfte, um Forschern durch Sigma-Aldrichs weltweites Vertriebsnetzwerk und Marktpräsenz einen direkten Zugang zu HuCAL-basierten Forschungsantikörpern zu bieten', erklärt Dr. Simon Moroney, Vorstandsvorsitzender der MorphoSys AG. 'Der Vertrag unterstützt unser Ziel, eine steigende Anzahl HuCAL-basierter Forschungsantikörper einzuführen, und wird AbD Serotecs Präsenz und die Akzeptanz rekombinanter Forschungsantiköper in der Forschungsgemeinschaft weiter erhöhen.'
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4. flosz 28 februari 2008 08:40

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   MorphoSys AG Reports Financial Results for Fiscal Year 2007 - Significant Increase of Revenues, Operating Profit and Net Income
   02/28/2008 at 07:30 AM
   MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX) today announced its financial results according to International Financial Reporting Standards (IFRS) for the three-months' period and fiscal year ending December 31, 2007. The Company achieved Group revenues of EUR 62.0 million (2006: EUR 53.0 million) and an operating profit of EUR 7.0 million (2006: EUR 6.2 million), which included advisory fees relating to the Novartis deal of approx. EUR 4.5 million. Net profit nearly doubled to EUR 11.5 million (2006: EUR 6.0 million), including a tax benefit of EUR 2.3 million. At the end of the year 2007 MorphoSys's cash position amounted to EUR 106.9 million (2006: EUR 66 million).
   
   Highlights of the Year 2007:
   
   • US $ 600 Million Landmark Deal with Novartis: MorphoSys and Novartis forged one of the most comprehensive strategic alliances in the discovery and development of biopharmaceuticals. Financial terms include committed payments in excess of US $ 600 million during the expected 10-year lifetime of the agreement. Additionally, the expanded alliance includes rights to co-develop and co-detail products in specific territories through creation of MorphoSys's own sales force.
   • Strong Therapeutic Partnered Pipeline Growth: Substantial growth of partnered pipeline to 50 active therapeutic antibody projects (up from 43 at the beginning of 2007); two new antibodies with partners entered clinical trials during the year; number of pre-clinical candidates increased to 23 (up from 14 at the beginning of 2007). Overall pipeline progress resulted in increased milestone payments of EUR 12.1 million (2006: EUR 7.5 million).
   • First Proprietary Program Enters the Clinic: Development of lead compound MOR103 MOR202remained on track. MorphoSys has filed a clinical trial application (CTA) for MOR103 for rheumatoid arthritis in 2007 and expects to start clinical trials in Q1 2008; MorphoSys disclosed GM-CSF as underlying target molecule of MOR103 program and secured strong intellectual property position around target and molecule.
   
   Financial Outlook for 2008:
   For 2008, MorphoSys anticipates total revenues of EUR 73 million to EUR 77 million. Additionally, MorphoSys expects to increase its operating profit to EUR 9 million to EUR 11 million, including investments in technology and product development in the amount of EUR 13 million. The Company will provide detailed guidance in today's press conference and conference call.
   
   MorphoSys will hold a public conference call today at 10:30 a.m. CET to present the Annual Financial Results 2007 and report on current developments.
   Dial-in number for the Conference Call (listen-only):
   Germany: +49 (0)69 5007 1312
   For U.K. residents: +44 (0)20 7806 1962
   Confirmation Code: 1442837
   
   Please dial in 10 minutes before the beginning of the conference.
   In addition, MorphoSys offers participants the opportunity to follow the presentation through a simultaneous slide presentation online at www.morphosys.com.
   
   Approximately two hours after the press conference, a slide-synchronized audio replay of the conference will be available on www.morphosys.com.
   www.morphosys.com/en/news_investors/p...
   
5. flosz 28 februari 2008 08:42

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   For MOR103, MorphoSys filed a CTA (clinical trial application) in December 2007. In addition, MorphoSys secured a strong IP position around the underlying target molecule for MOR103.
   Additionally, MorphoSys continued to develop proprietary therapeutic antibody candidates in
   the area of infl ammation and oncology. The Company’s proprietary antibody pipeline currently
   consists of two programs, namely MOR103 and MOR202. In December 2007, MorphoSys submitted
   a clinical trial application (CTA) in the Netherlands to initiate a phase 1 clinical trial
   using the HuCAL-derived antibody MOR103 for the treatment of rheumatoid arthritis. The
   phase 1 trial is a randomized, double-blind, placebo-controlled, single-ascending dose trial and will be conducted in healthy volunteers. The study will evaluate MOR103’s safety and tolerability
   as well as the pharmacokinetics of escalating doses. MOR202 is a fully human HuCAL antibody
   directed against CD38, a therapeutic target for the treatment of multiple myeloma and
   certain leukemias. During 2007, the Company conducted further pre-clinical studies, which
   produced promising results in animal tumor models.
   
   In recent years, MorphoSys has in-licensed and co-developed various innovative expression
   systems and has developed effi cient production processes customized for the requirements
   described above. For the expression of antibody fragments, MorphoSys uses mainly bacterial
   expression systems. Production platforms have been generated e.g. based on Wacker’s innovative
   E. coli secretion system and effi cient E. coli production processes have been co-developed
   with Lonza. For the production of full IgGs, MorphoSys predominantly used the HKB11 cell
   line in-licensed from Bayer and the PER.C6® cell line from Crucell as the basis for the design of
   in-house platforms. Both cell lines are of human origin and allow the production of human
   antibodies in human cell lines. This concept has been followed for the fi rst time in the MOR103
   program, using human cell lines from the bench through clinical trials.
   
   Besides selection of an appropriate expression system, the design of the overall manufacturing
   strategy is crucial as well. Effi cient process development in production and testing activities
   (offi cially summarized as CMC – Chemistry, Manufacturing & Control) takes into consideration
   the key criteria in this fi eld, which are speed, cost and quality. CMC determines the economy
   and quality of manufacturing, which is one of the most comprehensive steps in the entire development
   strategy. The major challenge here is to design a robust process reliably providing a safe
   pharmaceutical ingredient at acceptable costs. The ability to assure, over time, reproducible
   physical and chemical properties of an active pharmaceutical ingredient is critical for regulatory
   approval and therapeutic success.
   For the production of clinical-grade material of MOR103, MorphoSys has signed a license agreement
   with the Dutch biotechnology company Crucell N.V. and a biopharmaceutical manufacturing
   agreement with Crucell’s partner DSM Biologics.
   
   As MorphoSys is increasing its proprietary therapeutic activities, a quality assurance system
   was implemented during 2007. Additionally, the Company applied for a manufacturing license,
   allowing MorphoSys to release clinical trial material for MOR103 clinical studies as a sponsor.
   The manufacturing license was issued by the Bavarian government in January 2008.
   
   PATENTS AND LICENSES
   In 2007, as the Company’s patent portfolio continued to mature, the Company began pursuing
   national phase patent protection in numerous countries for its MOR103 and MOR202 programs,
   and fi led numerous patent applications for new proprietary platform technologies. Currently, the
   Company is prosecuting about 20 different proprietary patent families worldwide, which is in
   addition to the numerous collaboration-based antibody patent families the Company is pursuing
   in cooperation with its partners.
   
   With MOR103, the fi rst proprietary antibody program is ready to start clinical development.
   This is the area in which the management sees the opportunity for future value generation.
   With the proprietary HuCAL technology, MorphoSys can offer improved treatment options and
   take advantage of new growth opportunities.
   
   MorphoSys achieved its goals of 50 partnered therapeutic antibody programs as well as the CTA
   fi ling for its proprietary compound MOR103. The anticipated new marketing alliance in the
   AbD segment wasn’t concluded by year-end, partially as a result of the MorphoSys Management
   Board focusing on concluding the strategic collaboration with Novartis.
   
   EXCLUSIVE LICENSE TO KEY PATENT FOR MOR103 FROM THE UNIVERSITY OF MELBOURNE
   During 2007, MorphoSys signed an agreement with the University of Melbourne providing
   MorphoSys with exclusive access to all rights under a US patent application and its progeny
   covering certain uses of inhibitors of the human cytokine GM-CSF (granulocyte-macrophage
   colony-stimulating factor). GM-CSF is the target molecule for MorphoSys’s proprietary MOR103
   antibody program for the treatment of rheumatoid arthritis (RA) and other infl ammatory diseases.
   MorphoSys expects that the license obtained from the University of Melbourne will lead
   to market exclusivity for therapeutic antibodies targeting GM-CSF in the US for infl ammatory
   disorders, once a favorable US patent is granted.
   
   RESEARCH AND DEVELOPMENT EXPENSES
   Costs for research and development increased by w 4.7 million to w 22.2 million (2006:
   w 17.5 million) mainly due to higher personnel costs (2007: w 8.5 million; 2006: w 7.2 million).
   The two proprietary products currently being internally developed by MorphoSys are MOR103
   and MOR202. In 2007, the Company incurred costs for proprietary product development and
   technology development in the amount of w 4.9 million and w 1.2 million respectively (2006:
   w 2.1 million and w 0.9 million).
   
   Through in-licensing new target molecules, the Company seeks to expand and enhance its
   proprietary pipeline. After clinical proof of concept corresponding to a phase 2/2a study,
   MorphoSys strives to collaborate with companies with comprehensive expertise in late-stage
   clinical development and commercialization. By taking its two internal antibody programs
   MOR103 and MOR202 forward without a partner, the Company stands to benefi t from more
   lucrative fi nancial terms at such time when an alliance for further development is signed.
   
   SUBSEQUENT EVENTS
   On January 16, 2008, MorphoSys disclosed that human cytokine GM-CSF (granulocytemacrophage
   colony-stimulating factor) is the target molecule for the Company’s proprietary
   MOR103 antibody program for the treatment of rheumatoid arthritis (RA). With MOR103,
   MorphoSys is developing the fi rst fully human therapeutic antibody against that target in clinical
   trials, which is an innovative non-TNF treatment option for patients suffering from RA.
   No other signifi cant events of which the Company is aware took place between the closing date
   of December 31, 2007, and the Management Report fi nalization date of February 11, 2008.
   
   
6. flosz 28 februari 2008 08:44

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   Vervolg.
   
   During the 2008 fi scal year, MorphoSys will seek to fi nalize the phase 1 trial for its proprietary
   compound MOR103, which will be the basis for phase 2 studies in patients, to prove clinical
   effi cacy in humans. For MOR202, formal pre-clinical development is intended to be started in
   2008, with the aim to start clinical development in 2009.
   
   EXPECTED EARNINGS SITUATION
   MorphoSys’s management anticipates total revenues growth of at least 15 % in the current fi scal
   year in comparison to 2007. The revenue breakdown between the two segments is anticipated
   to remain relatively constant in 2008 compared to the prior year.
   On the basis of the Management Board’s current planning, expenses are expected to increase
   in 2008 and 2009. COGS is anticipated to increase corresponding to sales of the AbD segment.
   In upcoming years, MorphoSys will increase its investment in proprietary drug development in
   order to further develop its proprietary antibody pipeline, including MOR103 and MOR202.
   S, G&A expenses are expected to increase slightly. On the basis of current planning, MorphoSys
   will strive to remain profi table on an operating level in 2008 and 2009. For 2008, an overall
   operating profi t exceeding that of 2007 is anticipated.
   
   CRUCELL N.V., THE NETHERLANDS
   In August 2006, MorphoSys AG signed a second PER.C6® license
   agreement with Dutch biotechnology company Crucell N.V.
   and a biopharmaceutical manufacturing agreement with its
   technology partner DSM Biologics. The license agreements
   allow MorphoSys to use the PER.C6® cell line in the production
   of clinical-grade material for the development of its proprietary
   therapeutic antibody program MOR103. Production of clinicalgrade
   material is a relevant step to keep to the timeline for this
   project.
   ***As of December 31, 2007, the license had a remaining amortization
   period of nine years.***
   
   UNIVERSITY OF MELBOURNE, AUSTRALIA
   During 2007, MorphoSys signed an agreement with the University
   of Melbourne providing MorphoSys with exclusive
   access to all rights under a US patent application and its progeny
   covering certain uses of inhibitors of the human cytokine
   GM-CSF (Granulocyte-macrophage colony-stimulating factor).
   GM-CSF is the target molecule for MorphoSys’s proprietary
   MOR103 antibody program for the treatment of rheumatoid
   arthritis (RA) and other infl ammatory diseases. MorphoSys
   expects that the license obtained from the University of Melbourne
   will lead to market exclusivity for therapeutic antibodies
   targeting GM-CSF in the US for infl ammatory disorders,
   once a favorable US patent is granted.
   212.14.81.205/uploads/MOR_Consolidate...
   
7. [verwijderd] 1 maart 2008 08:48

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   Sehr herzlich willkommen.. zuruck Flosz!
8. [verwijderd] 5 maart 2008 10:08

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   AbD Serotec erhält Großauftrag für Forschungsantikörper von Proteomik-Spezialist Proteomika
   (pressebox) Martinsried, 05.03.2008 - Die MorphoSys AG (Frankfurt: MOR; Prime Standard Segment, TecDAX) gab heute bekannt, dass ihr Geschäftssegment AbD Serotec einen umfangreichen Auftrag für Forschungsantikörper vom spanischen Biotechnologie-Unternehmen Proteomika S.L., Derio/Spanien, erhalten hat. Proteomika, ein Spezialist im Bereich der Entdeckung neuer Biomarker, hat neuartige HuCAL-basierte Forschungsantikörper von AbD Serotec gegen ein breites Spektrum an Zielmolekülen geordert. Zusätzlich umfasst die Vereinbarung die Produktion von Antigen-Material. AbD Serotec wird dabei die von MorphoSys entwickelte HuCAL-GOLD-Antikörper-Technologie und AgX(TM), das firmeneigene bakterielle Expressionssystem für Antigene, einsetzen. Mit diesem Auftrag gehört Proteomika zu den Großkunden von AbD Serotec im Bereich kundenspezifischer monoklonaler Antikörper und Dienstleistungen. Finanzielle Einzelheiten wurden nicht bekannt gegeben.
   
   Proteomika wurde 2002 als Tochtergesellschaft der Progenika Biopharma S.A. gegründet. Ziel von Proteomika ist es, die Suche nach neuen Biomarkern für die Entwicklung innovativer diagnostischer Verfahren und Methoden zur Krankheitsvorsorge voranzutreiben. Durch Forschungskooperationen mit zahlreichen Pharma- und Biotechnologie-Unternehmen will Proteomika nicht-invasive diagnostische und pharmakoproteomische Marker sowie neue therapeutische Zielmoleküle identifizieren und validieren. Zusätzlich ist Proteomika stark in interne Entwicklungsprojekte eingebunden, die in Zusammenarbeit mit dem bioGUNE Research Institute, Derio/Spanien, durchgeführt werden und Krebserkrankungen sowie weitere Krankheitsbereiche abdecken.
   
   Dr. Laureano Simon, Vorstandsvorsitzender von Proteomika, kommentiert die Vertragsunterzeichnung wie folgt: "Proteomika ist sehr erfreut über die Zusammenarbeit mit AbD Serotec, dem Branchenführer bei maßgeschneiderten Antikörpern für Forschungsanwendungen. Die kurzen Produktionszeiten, die AbD Serotec erreicht, und die hohe Qualität der resultierenden Forschungsantikörper werden die Suche nach Biomarkern und deren Validierung deutlich beschleunigen und es damit Proteomika ermöglichen, neue diagnostische Verfahren und Methoden zur Krankheitsvorsorge schneller auf den Markt zu bringen."
   
   "Wir freuen uns, dass Proteomika unsere HuCAL-GOLD-Forschungsantikörper in seinen Proteomik-Programmen einsetzen wird", kommentierte Dr. Simon Moroney, CEO der MorphoSys AG. "Dieser Auftrag ist einer der größten von AbD Serotec und unterstreicht eindrucksvoll die Vorteile unserer HuCAL-Technologie für maßgeschneiderte Forschungsanwendungen in der Proteomik."
   
   www.pressebox.de/pressemeldungen/morp...
9. flosz 17 maart 2008 08:13

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   Leiden, The Netherlands, 17 March 2008 - Dutch biotechnology company Crucell N.V. and DSM Biologics, a business unit of DSM Pharmaceutical Products, today announced that German-based MorphoSys AG has decided to extend the PER.C6® technology licensing agreement entered in September 2004, exercising an option for clinical and commercial production of antibodies. The extended license agreement allows MorphoSys to use the PER.C6® production platform for its proprietary therapeutic cancer antibody program MOR202, as well as for clinical and commercial production of MOR202. Financial details of the agreement were not disclosed.
   **********************************************
   
   HuCAL® and HuCAL GOLD® are registered trademarks of MorphoSys AG
   MOR202 is a fully human HuCAL antibody
   directed against CD38, a therapeutic target for the treatment of multiple myeloma and
   certain leukemias. During 2007, the Company conducted further pre-clinical studies, which
   produced promising results in animal tumor models.
   
   For MOR202, formal pre-clinical development is intended to be started in
   2008, with the aim to start clinical development in 2009.
   
   For its proprietary development programs, MorphoSys achieved its goal and fi led the necessary
   application to start clinical development of its lead program MOR103. The second program MOR202 progressed as planned.
   
   RESEARCH AND DEVELOPMENT EXPENSES
   Costs for research and development increased by w 4.7 million to w 22.2 million (2006:
   w 17.5 million) mainly due to higher personnel costs (2007: w 8.5 million; 2006: w 7.2 million).
   The two proprietary products currently being internally developed by MorphoSys are MOR103
   and MOR202. In 2007, the Company incurred costs for proprietary product development and
   technology development in the amount of w 4.9 million and w 1.2 million respectively (2006:
   w 2.1 million and w 0.9 million).
   Through in-licensing new target molecules, the Company seeks to expand and enhance its
   proprietary pipeline. After clinical proof of concept corresponding to a phase 2/2a study,
   MorphoSys strives to collaborate with companies with comprehensive expertise in late-stage
   clinical development and commercialization. By taking its two internal antibody programs
   MOR103 and MOR202 forward without a partner, the Company stands to benefi t from more
   lucrative fi nancial terms at such time when an alliance for further development is signed.
   212.14.81.205/uploads/MOR_Consolidate...
   
   MOR202
   MOR202 is a fully human HuCAL antibody directed against CD38, a therapeutic target for the treatment of multiple myeloma and certain leukemias. CD38 is a membrane-bound glycoprotein which is highly expressed on multiple myeloma tumor cells and certain leukemias. In pre-clinical studies, MOR202 effectively killed cancer cells from primary patient tumor material and specific hematologic cancer cell lines. Furthermore, preclinical efficacy was shown by demonstrating strong inhibition of tumor growth in a SCID-mouse xenograft tumor model.
   Additionally, MorphoSys showed that in an in vivo animal model, MOR202 demonstrated superior efficacy in comparison to Velcade, one of the better therapeutic options for Multiple Myeloma patients currently on the market. This data was presented during the ASCO (American Society of Oncology) meeting in Chicago in June 2007.
   
   Swoboda, Bodo Brocks, Andreas Popp, Olaf Broders, Daniela Della Ducata, Margit Urban, Robert Friesen
   MOR202 is one of MorphoSys’ internal development programs targeting the cell surface antigen CD38 that is found to be expressed on various cell lines derived from B cell, T cell, and myeloid/monocytic
   tumors. Especially in the indication of multiple myeloma (MM), which remains an incurable malignancy with a median survival of 3-4 years, a strong expression has been reported in the majority of patients’
   tumor samples. CD38-specific human antibodies were selected from MorphoSys' proprietary HuCAL GOLD® phage display library by cell panning strategies. A lead candidate (MOR202) was selected from
   several antibodies recognizing different epitopes on CD38 and subjected to further in vitro and in vivo characterization as follows: MOR202 exhibits an affinity in the low nanomolar range, recognizes CD38 on
   many cell lines of different cancer origin and most importantly on all primary MM-patient samples in FACS and IHC. The fully human IgG1 MOR202 is able to kill CD38-expressing cell lines and primary MM
   cells from patients efficiently by ADCC in a concentration-dependent manner, whereas early progenitor cells are not affected as demonstrated by a clonogenic assay. Finally, excellent efficacy could be shown
   in a SCID-mouse xenograft model, resulting in significantly reduced tumour growth (RPMI8226) and overall survival, which was even superior to Velcade tested in the same model.
   212.14.81.205/uploads/MOR202_CD38_ASC...
   
10. bilbo3 17 maart 2008 11:06

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    Als je de licentie met Morphosys uitbreidt van Mor103 met Mor202, dan heb je te maken met een tevreden klant/licentienemer. Bestaande klanten kunnen het weten en bepalen uiteindelijk het succes van je onderneming.
    Een mooi bericht en dat mag ook wel eens gezegd worden.
    
11. aossa 17 maart 2008 11:25

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    En er is meer ...
    Morphosys heeft de intensie om in verder gevorderde fasen een grote farma partner aan te trekken.
    
    Die gaat ook PER.C6 leren kennen.
    
    Crucell is imo te vergelijken met een junior-goudmijntje <lol>.
    Een cursusje juniors (cadeautje van roos) ...
    www.iex.nl/forum/topic.asp?forum=23&t...
    
    Ga mee met de trend en beleg in goud: 'biotech-goud' !
    (Just an humble opinion)
    
12. josti5 17 maart 2008 11:35

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    'Ga mee met de trend en beleg in goud: 'biotech-goud'!'
    
    Goud zal Per.C6 zeker blijken te zijn: iemand de ABP-man in Buitenhof nog gehoord, inzake de ABP-blik op bedrijven, waar de royalties binnen afzienbare tijd gaan binnenstromen?
    
    Laat Crucell er daar 1 van zijn, en niet zo'n kleintje ook...
    
13. flosz 17 maart 2008 12:00

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    MOR-PB
    
    MorphoSys Obtains Agreement For Production Of Antibody Material In Mor202 Program With Crucell And DSM
    
    Martinsried / München, Germany, Mar 17, 2008 - (ABN Newswire) - MorphoSys AG (Frankfurt Stock Exchange: MOR; Prime Standard Segment, TecDAX) today announced the signing of a PER.C6® license agreement with Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL) and technology partner DSM Biologics. This license agreement allows MorphoSys to use the PER.C6® cell line in the production of clinical grade material for the development of its proprietary therapeutic cancer antibody program MOR202. MOR202 is a fully human HuCAL antibody directed against CD38, a therapeutic target for the treatment of multiple myeloma and certain leukemias. Financial details on these agreements were not disclosed.
    
    This set-up brings together a fully human antibody to treat blood-borne cancers with production capabilities in the same fully-human environment. Manufacturing human antibodies in such a manner offers several potential advantages over alternative production methods.
    
    "Today's news shows that MorphoSys's MOR202 program is on track towards the next development stages - formal pre-clinical development in 2008 and 2009 and the filing of an application for clinical trials early 2010," commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys. "Based on the positive experiences we have gained with Crucell's cell line and DSM's manufacturing capabilities within our lead program MOR103 we have chosen to continue to use this set-up for MOR202."
    *****************************
    Uit dec. 2007:
    MorphoSys and Novartis Forge New Strategic Alliance to Establish Innovative Therapeutic Antibody Pipeline - One of the Industry's Largest Pharma-Biotech R&D Collaborations
    
    12/02/2007 at 20:01 PM
    • MorphoSys and Novartis enter into a comprehensive long term alliance to accelerate discovery of therapeutic antibodies for use against a wide range of diseases
    • MorphoSys to become Novartis's main technology collaborator in the area of antibody discovery and development
    • Financial terms include committed payments in excess of US$600 million over the lifetime of the agreement, with further potential for significant additional milestones, profit sharing and/or royalty payments based on products emerging from the collaboration
    • MorphoSys obtains certain co-development rights for selected programs as well as rights to co-detail the resulting products in specific territories through creation of its own sales force
    • Financial strength provided by the agreement to enable MorphoSys to increase the breadth and speed of its proprietary drug development activities
    
    I want to emphasize that although we are making a
    large commitment to this one partner, we retain our ability to build MorphoSys outside of the
    deal. For example, we remain committed to pushing forward our two in-house programs
    MOR103 and MOR202. While we certainly intend to keep Novartis informed about the progress
    of these programs, we are under no obligation that they be our partner for their further
    development or commercialization.
    
    What will we do with the strategic flexibility we have won? We are committed to further growth.
    In addition to MOR103 and MOR202, we are now evaluating a number of other attractive
    opportunities. These include re-acquiring or co-developing ongoing HuCAL programs with
    existing or new partners, or de novo programs. To emphasize what I said before, future pipeline
    building will not comprise new fee-for-service discovery deals.
    212.14.81.205/uploads/071203_MOR-NOV_...
    
14. [verwijderd] 27 maart 2008 14:59

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    Weer een mooi bericht Morphosys-Daiichi Sankyo
    
    Daiichi Sankyo Ltd. Nov. 2007 PER.C6® Portfolio antibodies
    
    
    Daiichi Sankyo verlängert Allianz mit MorphoSys für die Verwendung von HuCAL GOLD zur Entwicklung neuer Antikörpermedikamente
    
    Die MorphoSys AG (Frankfurt: MOR; Prime Standard Segment, TecDAX) gab heute bekannt, dass Daiichi Sankyo Company, Ltd. seine bestehende Option ausgeübt hat, die Kooperation zwischen den beiden Unternehmen zu verlängern. Die ursprünglich im März 2006 unterzeichnete Zusammenarbeit hatte eine Laufzeit von zwei Jahren mit der Option zur Verlängerung für weitere drei Jahre bis März 2011. Im Rahmen der Vereinbarung gewährt MorphoSys Daiichi Sankyo weiterhin Zugang zur firmeneigenen HuCAL GOLD-Antikörperbibliothek an seinem Forschungsstandort in Tokio. Unverändert beinhaltet der Vertrag die Option für Daiichi Sankyo, bis zu sechs HuCAL-basierte Antikörperprogramme zu entwickeln und zu kommerzialisieren, wofür MorphoSys exklusive Lizenz- und Meilensteinzahlungen sowie Tantiemen erhält. Derzeit umfasst die Zusammenarbeit ein aktives therapeutisches Antikörperprogramm. Die Verlängerung löst eine zusätzliche Zahlung von Daiichi Sankyo an MorphoSys aus und hat eine Erhöhung der Forschungsfinanzierung zur Folge. Außerdem sichert sich MorphoSys im Rahmen der Verlängerung jährliche Lizenzzahlungen für den Zugang zur HuCAL-Plattform. Weitere finanzielle Einzelheiten wurden nicht bekannt gegeben.
    
    'Wir sind sehr erfreut über den erfolgreichen Verlauf unserer Kooperation mit Daiichi Sankyo und der Entscheidung, weiterhin auf unsere Antikörperbibliothek HuCAL GOLD für die unternehmensinterne Forschung zu vertrauen', erklärte Dr. Simon Moroney, Vorstandsvorsitzender von MorphoSys. 'Wir erwarten, dass diese Allianz unsere wachsende Pipeline von HuCAL-basierten therapeutischen Wirkstoffen verstärken wird.'
    
    www.f-tor.de/board/archive/index.php/...
    
    
15. flosz 4 april 2008 07:35

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    MorphoSys’s most advanced internal development program is MOR 103 – a therapeutic HuCAL antibody for
    the treatment of rheumatoid arthritis. Approximately four to six million people worldwide suffer from this
    disease. The MorphoSys antibody MOR 103 attacks a central node in the network of disease-mediating factors
    and could potentially inhibit and/or limit the destruction of joints triggered by the disease, including
    hand, knee, shoulder, foot, and hip joints. In 2008, MorphoSys will begin clinical development of this antibody
    with tests in healthy volunteers.
    
    Rheumatoid arthritis (RA) is a chronic inflammatory
    autoimmune disease, thought to be caused by a disorder
    of the immune system. The immune system is usually
    able to distinguish between the body’s own tissues and
    foreign bodies such as viruses or bacteria, but occasionally
    it mistakenly recognizes the body’s own healthy cells as
    foreign. In RA, this process mainly occurs in a membrane
    called the synovial membrane, which surrounds every
    mobile joint in the human body and creates a protective,
    fluid-filled sac around the joint.
    In the diseased joint, disruption of the normal inflammation
    process results in a significant chronic swelling and ultimately
    leads to destruction of the cartilage and bone tissue
    as well as progressive deformation of the joint. Damage can
    also occur throughout the whole body, including the skin,
    blood vessels, heart, lungs, and muscles. A wide range of
    immune cells builds up in the joint, which causes further
    progression of the disease by stimulating the production of
    various signalling molecules. MorphoSys’s drug candidate
    aims to disrupt this chain of events.
    The target molecule GM -CSF, a growth factor for white
    blood cells that is bound by MOR103, plays a key role in the
    disease process that destroys joints. GM -CSF is part of the
    natural immune and inflammatory cascade, but is also an
    inflammatory mediator in autoimmune processes such as
    RA. In inflamed joints where GM -CSF is found in high levels,
    it also contributes strongly to the release of other signalling
    molecules. GM -CSF binds to its complementary receptor
    on the surface of specific immune cells in the joint, stimulating
    their activation and proliferation. Two categories of
    white blood cells that are activated in this process, the neutrophils
    and the macrophages, act directly to increase the
    production of a complex network of pro-inflammatory and
    pathogenic molecules in surrounding tissues, as well as further increasing the immune reaction by activating B and
    T cells. These processes create an increasing vicious circle
    that ultimately leads to increased destruction of the joint.
    
    The HuCAL-derived antibody MOR103 acts to neutralize
    GM -CSF, which should reduce the unwanted dispersal and
    activation of the inflammatory immune cells in the diseased
    joint and in this way attempts to disrupt the inflammatory
    cycle.
    There is specific scientific evidence that points towards
    GM -CSF playing a pivotal role in RA. Injection of GM -CSF
    was found to worsen arthritic symptoms in RA patients.
    On the other hand, mice unable to produce the protein
    GM -CSF are resistant to the induction of autoimmune
    diseases. Additionally, the number of macrophages in an
    inflamed joint is directly correlated with the extent of the
    joint damage in human RA patients, which further validates
    this target molecule. Finally, MorphoSys’s antibody
    MOR103 itself has already shown various promising results
    in two animal models of RA.
    
    C o n v i n c i n g s c i e n t i f i c r e s u lt s i n a s t r o n g
    m a r k e t p o s i t i o n
    
    The market for drugs for the treatment of rheumatoid
    arthritis shows very strong growth. In 2004, worldwide
    sales figures for modern biopharmaceutical drugs to
    treat RA were in the region of US $ 6 billion. The market is
    expected to increase further to US $ 14 billion in 2009,
    and is a highly competitive sector in the pharmaceutical
    industry.
    There is currently no cure for RA. In recent years, drugs
    developed through biotechnology – among them other
    therapeutic antibodies – have greatly improved the treatment
    options. Despite this recent progress, the demand
    for additional improved treatment methods remains huge.
    The MOR103 approach mirrors that of the most successful
    class of anti-inflammatory agents known to date, namely
    the group of substances that neutralize the soluble cytokine
    TNF (tumor necrosis factor-alpha). In this regard, MOR103 is expected to belong to the class of immunosuppressive
    agents, albeit exhibiting a distinct mechanism
    of action compared to the anti-TNFs. Therapeutics with
    new mechanisms of action are high on the wish list of most
    practicing rheumatologists.
    To further improve the competitive position of MOR103,
    MorphoSys has built up a strong position in intellectual
    property for its program. MorphoSys announced an agreement
    with the University of Melbourne in 2007, providing
    the Company with exclusive access to rights covering the
    use of inhibitors of GM-CSF, under a US patent application
    and its progeny. Scientists Professor John Hamilton
    and Professor Gary Anderson, whose discoveries are
    covered in the patent application, have been leaders for
    many years in the field of basic GM-CSF biology and
    understanding the role of this target molecule in the progression
    of RA. Their fundamental work in this area is increasingly acknowledged as the basis for targeted anti-
    GM-CSF therapy.
    As per evaluation by MorphoSys AG, the license acquired
    by MorphoSys can lead to exclusive marketing rights
    for therapeutic antibodies targeting GM -CSF in the USA.
    The USA represents the lion’s share of the market for drugs
    to treat RA. In addition to the licensing of this patent,
    MorphoSys has filed additional patent applications for the
    HuCAL-derived antibody MOR103.
    The important scientific basis, the new mode of action,
    and the previously available data on the target molecule
    GM -CSF combine to increase MorphoSys’s confidence
    in MOR103 as an attractive candidate in its portfolio for
    the treatment of RA. Above all, the strong patent position
    and the low level of direct competition suggest that the
    approach has significant economic potential.
    ********************
    
    Interview with Prof. Dr. Burkhardt.
    
    Prof. Dr. Burkhardt serves as Professor of Rheumatology
    and Head of the Division of Rheumatology at the University
    of Frankfurt. During his career he participated in a variety
    of late-stage clinical studies of biologicals such as TNF -
    blocking agents, IL-1 receptor antagonists and the therapeutic
    antibody Rituximab® for the treatment of RA , and
    other inflammatory indications.
    
    There are drugs already on the market for the treatment
    of RA . Do you really think that more are needed?
    *Prof. Dr. Burkhardt | In my opinion there is still a substantial
    unmet medical need, because fewer than 25 % of
    patients achieve a sustained remission, which is the best
    achievable state of an RA-patient under presently available
    treatment options. A large group of patients do not benefit
    at all from current treatments and there are safety concerns
    associated with long-term use of existing anti-TNF therapies.
    These considerations are strong incentives that drive the
    search for new treatment options, particularly for drugs with
    innovative modes of action such as MOR103.
    
    
16. flosz 4 april 2008 07:36

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    Why is the target molecule GM -CSF a promising starting
    point for treatment of RA ?
    *Prof. Dr. Burkhardt | Antibodies that neutralize GM-CSF
    could constitute a new generation of medicines that reduce
    inflammation with greater beneficial effects. Scientific
    results point to a fundamental role of GM-CSF in critical
    pathogenic pathways of rheumatoid arthritis that are currently
    not adequately addressed by the available drugs.
    Above all, the effect of GM-CSF is rather restricted to particular
    locations, such as the inflamed joints, whereas usually it
    plays only a minor role in the rest of the body. This could reduce
    the likelihood of unwanted side effects from treatment.
    
    What potential do you see for the treatment of other
    inflammatory conditions?
    *Prof. Dr. Burkhardt | The target molecule GM-CSF plays
    distinct roles in the immune system and consequently could
    be a target for a wide range of anti-inflammatory therapies.
    The antibody MOR103 could also have potential for the
    treatment of other diseases such as psoriasis, multiple sclerosis,
    chronic bronchitis, or asthma, but new research
    has to be performed to establish its therapeutic use in each
    disease entity.
    *********************
    In August 2006, MorphoSys AG signed a second PER.C6® license
    agreement with Dutch biotechnology company Crucell N.V.
    and a biopharmaceutical manufacturing agreement with its
    technology partner DSM Biologics. The license agreements
    allow MorphoSys to use the PER.C6® cell line in the production
    of clinical-grade material for the development of its proprietary
    therapeutic antibody program MOR103. Production of clinicalgrade
    material is a relevant step to keep to the timeline for this
    project.
    As of December 31, 2007, the license had a remaining amortization
    period of nine years.
    ***************************
    “For the MOR202 project MorphoSys employees have
    invested blood, sweat and tears – literally !”
    
    In 2008, MorphoSys will begin formal preclinical testing for MOR202, and upon completion, the antibody
    should be ready to start clinical studies in 2010. The antibody is designed to treat several types of blood
    cancer, in particular multiple myeloma. The first lab tests for MOR202 were in fact conducted using blood
    samples from healthy volunteer MorphoSys employees.
    For MOR202, formal pre-clinical development is intended to be started in
    2008, with the aim to start clinical development in 2009.
    
    www.morphosys.com/uploads/MOR_GB2007_...
    
17. [verwijderd] 24 april 2008 11:30

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    Flosz:
    
    MorphoSys and the Leibniz-Institut für Molekulare Pharmakologie Sign Broad Research Partnership
    
    04/24/2008 at 07:30 AM
    
    MorphoSys Further Broadens Therapeutic Target Sourcing Network
    
    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) today announced a broad alliance with the Leibniz-Institut für Molekulare Pharmakologie (FMP), Berlin, covering the use of fully human recombinant research antibodies and commercialization of resulting products. Under the terms of the agreement, the FMP will receive access to novel HuCAL GOLD-based research antibodies from MorphoSys's AbD Serotec unit to identify and validate target molecules with potential medical applications. MorphoSys retains commercialization rights for all antibodies emerging from the collaboration both as research antibody tools distributed via the AbD Serotec sales catalogue as well as in therapeutic or diagnostic applications. Financial details of the agreement were not disclosed.
    
    Research at Leibniz-Institut für Molekulare Pharmakologie (FMP) focuses on the structures, functions and interactions of proteins and on the development of new concepts for interfering pharmacologically with their functions. This places the research activity of the institute at the forefront of drug development. An interdisciplinary approach is crucial to this type of work, and a particular strength of the FMP is the close interaction in the fields of chemistry and biology. The research activities of the FMP are clustered into the three sections "Structural Biology", "Signal Transduction/Molecular Genetics", and "Chemical Biology". Through the alliance with MorphoSys researchers across all three sections of the FMP get access to HuCAL-based fully human antibodies against novel target molecules.
    
    "We are looking forward very much to cooperating with MorphoSys. This kind of public-private partnership provides us with the perfect tools to study the proteins we are working on - in order to elucidate their function and to evaluate their potential as drug targets," says Walter Rosenthal, director of the Leibniz-Institut für Molekulare Pharmakologie. "We are proud to be the first German scientific institution that holds such a cooperation with MorphoSys - strong support for our efforts to open new ways to transfer scientific results into therapy."
    
    "This agreement builds on relationships we have in place with leading, medically-focused research institutes in Japan and the U.S., including the Burnham Research Institute. This expanding network represents a promising way for MorphoSys and AbD Serotec to access the therapeutic targets and research products of tomorrow," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "With its high quality of interdisciplinary research and its clear focus on translational medicine the FMP is a perfect addition to this network which will ultimately strengthen MorphoSys's proprietary drug development capabilities."
    
    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...
18. [verwijderd] 24 april 2008 14:21

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    Invitation to Q1 2008 Conference Call of MorphoSys AG On April 29, 2008
    
    At 10:00 a.m. CEST, the Management Board of MorphoSys AG will host a public conference call to present MorphoSys's financial results for the first three months of 2008 and provide further details on the Company's latest developments.
    
    www.primenewswire.com/newsroom/news.h...
19. [verwijderd] 28 april 2008 10:08

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    MorphoSys Announces Completion of First Dosing in Phase 1 Trial for MOR103 Program
    
    04/28/2008 at 07:30 AM
    
    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) today announced the completion of a first dosing regimen in a phase 1 clinical study on healthy volunteers of the HuCAL-derived antibody MOR103 with no adverse events reported. Six healthy volunteers in the first dosing group have been enrolled and received MOR103 injections, while three volunteers received placebo. The safety review of the medical data from the lowest dosing group yielded a determination that it was safe to proceed with the second dosing group. The randomized, double-blind, placebo-controlled, single-ascending dose trial will be conducted in approx. 50 healthy volunteers and is being conducted in a Clinical Pharmacology Unit (CPU) in Utrecht, the Netherlands. The trial is scheduled to be finalized in 2008 and final reporting is expected in Q1 2009.
    
    The Company's lead development program, MOR103, is a fully human HuCAL antibody directed against GM-CSF (granulocyte macrophage-colony stimulating factor), being developed in the area of inflammatory diseases, such as rheumatoid arthritis, where current treatment options are inadequate. Due to its diverse functions in the immune system, GM-CSF can be considered a target for a broad spectrum of anti-inflammatory therapies. MorphoSys had submitted the clinical trial application in December 2007 and received the approval by the Dutch authorities six weeks later. The study will evaluate the safety and tolerability as well as pharmacokinetics of escalating doses of MOR103.
    
    "We are very pleased to see our first proprietary drug candidate progress according to plan," commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG. "Antibodies that neutralize GM-CSF could represent a new generation of medicines that reduce inflammation with greater beneficial effects."
    
    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.iex.nl/forum/post.asp?forum=228&t...
20. gogogoo 28 april 2008 10:20

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    Mooi bericht. AB.