Crucell Terug naar discussie overzicht

MOR103 (PerC6 inside) PHASE I

1. flosz 4 september 2008 10:21

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   MPSYY.PK - Morphosys AG
   
   EVENT TITLE
   Morphosys AG at NewsMakers in the Biotech Industry
   
   DATE / TIME
   Thursday, September 4, 2008 9:30 AM ET
   www.corporate-ir.net/ireye/conflobby....
   
2. aossa 4 september 2008 15:34

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   Iemand de webcast aan het volgen (15:30h onze tijd) ?
3. flosz 4 september 2008 17:13

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   Ja, 25 minuutjes.
   
   RA(MOR103):
   Q4 2008: Publish pre-clinical data
   Q1 2009: Report Phase I results
   
   Presentatie & slides gelijk aan:
   
   Sal. Oppenheim–European Healthcare Investors Conference 2008
   September 3, 2008
   
   MOR103
   Proprietary Inflammation Programme
   
   Drug
   MOR103, a fully human IgG1 HuCAL antibody that binds GM-CSF with very high affinity
   
   Primary indication
   Rheumatoid arthritis, potential in asthma, COPD…
   
   Clinical Development
   Phase I study ongoing in Holland
   Approx. 50 healthy volunteers in a randomized, double-blind, placebo-controlled, single-ascending dose trial
   Safety, tolerability & pharmacokinetics
   Q4 2008: Publish pre-clinical data
   Q1 2009: Report Phase I results
   
   Strong IP Position
   Exclusive license to US patent application covering treatment of inflammation with inhibitors of GM-CSF
   Patent applications on the MOR103 antibody family
   
   MOR202: Proprietary Cancer Programme
   
   Drug
   MOR202, a fully human IgG1 HuCAL antibody that binds CD38, a marker on multiple myelomaand some leukemia cell-lines
   
   Primary indication
   Multiple myeloma
   
   Function
   Induces cell-killing by ADCC, CDC & apoptosis
   
   Development Timeline
   Q1 2008: Development candidate selected
   Q1 2008: Process development commenced
   Q1 -Q4 2009: Toxicology & safety
   Q1 2010: submit CTA
   Q2 2010: Commence Phase I
   
   www.morphosys.com/uploads/080903_Morp...
   ********************************
   Nu nog even de webcast van CEGE.
4. flosz 16 september 2008 16:43

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   Dr. Laurence Barker Announced as the New Head of Business Development
   
   Syntaxin are delighted to announce the appointment of Dr. Laurence Barker to the newly created role of Head of Business Development.
   Dr. Barker joins Syntaxin from MorphoSys AG where he held the position of Associate Director, Business Development.
   
   During this time, he led the negotiations and completed several complex licensing deals and strategic collaborations with US, European and Japanese organisations, including those with the large Japanese pharma companies Daiichi-Sankyo, Astellas and Shionogi. He was also a key member of the MorphoSys team that negotiated and signed the transformational strategic partnership with Novartis in 2007. Prior to MorphoSys, Dr. Barker was Project Manager at Sympore GmbH, a private drug discovery company, where he led a multidisciplinary project team within research and early development.
   www.syntaxin.com/biopharma-news-artic...
   ********************************
   
   Interview Moroney(mrt.)
   www.executiveinterviews.com/2642-morp...
   
   *****************************
   Wpw, geef jij voor mij CEGE even een schop onder de kont....
   
5. [verwijderd] 16 september 2008 18:09

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   Hoy flosz.
   Ben je er niet op tijd uit? Het kwam ook zo plotseling. Ik gelukkig wel en denk er nu aan om weer in te stappen, Medx 010 en Gvax werken weldegelijk, Zwaar overdreven deze reactie. Maar ja!!
   Een tip om je verlies goed te maken kan zijn: Ryland Oil Corporation. DYODD
   Verwacht over een paar weken flinke olie en gas vondst aankondigingen.
   www.investorvillage.com/smbd.asp?mb=1...
   
6. flosz 19 september 2008 13:10

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   Hoi W.
   Dank je wel, vanmiddag weer zo’n 33% schop s'il vous plait! Even voor de klap eruit (stom toeval, intuïtief, veel geluk?)…maar beetje ongeduldig op 0,97 (gewoon stom).
   Gr.
   ******************************
   Success, Better Technology Drive Pharma's Antibody Lust
   
   By Jennifer Boggs
   Assistant Managing Editor
   ATLANTA - There's no question that "antibodies have come a long way in the last 20 to 25 years," said Fritz Rudert, general manager of German consulting firm FHR Consult and moderator of a panel on antibodies at the first annual BioPharm America conference.
   Most of the success has followed the 1998 approval of Genentech Inc.'s Herceptin (trastuzumab), the first commercially successful antibody. Now, antibodies have become the go-to drugs for big pharma looking to fill emptying pipelines and aiming for a competitive position in the biologics market.
   Over the past several years, antibody drugs and antibody technologies have been at the center pharma's craze for biologics. On the acquisition front, deals have included London-based AstraZeneca plc's 2006 purchase of Cambridge Antibody Technology, which it later merged with more recent acquisition MedImmune Inc., and London-based GlaxoSmithKline plc's buyout of privately held Domantis Ltd., of Cambridge, UK, in early 2007.
   Meanwhile, other antibody firms have formed lucrative partnerships, such as Tarrytown, N.Y.-based Regeneron Inc., which signed a potential $1 billion discovery and development deal with Sanofi-Aventis Group, of Paris, and Rockville, Md.-based MacroGenics Inc., which secured a deal, also potentially worth $1 billion, with Indianapolis-based Eli Lilly & Co. to develop anti-CD3 antibody teplizumab in Type I diabetes.
   Deal-making in the antibody field "has really taken off in the last few years," Rudert said, adding that both mean up-front payments and overall deal volumes are on the rise for antibodies and varying antibody technologies. M&A also is up, "sort of culminating" with Roche Holdings AG's $44 billion offer for Genentech Inc., which has two of the biggest antibody products on the market, Herceptin and blockbuster Avastin (bevacizumab).
   Genentech has rejected Roche's offer, though the general consensus is that the deal ultimately will go through, but at a higher price.
   And panelists said the hunger for antibodies is not likely to abate any time soon, especially as antibody development and manufacturing capabilities continue to improve.
   "It's such a good class of drugs," said Simon Moroney, CEO of MorphoSys AG. "It took so long to iron out all the bugs, but [antibodies] will probably stay popular for at least two to three more decades."
   An Inauspicious Beginning
   While Herceptin is credited with kicking off the antibody space's success story, it was not the first antibody to gain FDA approval. That distinction goes to Johnson & Johnson's Orthoclone (muromonab), an anti-CD3 antibody developed using a murine antibody technology, which was approved in 1986 for treating organ rejection but failed to make a big splash in the market due in part to its association with serious side effects such as anaphylactic shock, cardiovascular problems and life-threatening episodes of cytokine release syndrome.
   The problem, it turned out, was that murine antibody technology had only limited success because there's just too much dissimilarity between mouse and human antibodies, Rudert said.
   Chimeric antibody technologies (a combination of mouse and human antibodies) were better, but it wasn't until the development of human antibody technologies that the space began to heat up. And coming down pipelines now are drugs created using antibody-drug conjugate (ADC) technologies, which might prove even more effective.
   Beyond that, there are the antibody-drug conjugate technologies - the attachment of a drug to an antibody - which might prove even more effective. Among the most advanced ADC drugs in development is Branford, Conn.-based CuraGen Corp., which last week completed enrollment in a Phase II study of CR011-vcMMAE, a product that comprises a fully human monoclonal antibody against GPNMB that is linked to monomethyl auristatin, a tubulin destabilizing agent, in patients with advanced melanoma.
   But, even with the advancements, antibodies still carry a certain amount of development risk.
   "A lot of people think antibodies are a slam dunk," said panelist Margaret Karow, executive director of research at Thousand Oaks, Calif.-based Amgen Inc., which markets Vectibix (panitumumab), an anti-EGFR antibody approved in colorectal cancer. "But they are proteins," meaning they come with the same challenges as other protein drugs in development.
   They've had their share of safety issues, for one. Cambridge, Mass.-based Biogen Idec Inc.'s multiple sclerosis drug Tysabri (natalizumab, partnered with Dublin, Ireland-based Elan Corp. plc) has been linked to potentially fatal brain disease progressive multifocal leukoencephalopathy, and the FDA recently issued an alert on the increase in serious fungal infections associated with anti-tumor necrosis factor-alpha inhibitor antibodies such as Centocor's Remicade (infliximab). Even worse was the shocking Phase I trial of now-defunct Tegenero AG's TGN1412 antibody that sent six healthy volunteers to intensive care.
   Despite those bumps, antibodies have become the fastest-growing drug class, with nearly 1,000 compounds in research and development, many of those in partnership with big pharma.
   Pharma "Scrambling" for Antibodies
   In one of the largest antibody partnerships to date, German biotech MorphoSys AG signed a massive 10-year discovery and development alliance with Novartis AG that could be worth more than $1 billion, including $600 million that Novartis has committed to pay over the course of the agreement.
   
7. flosz 19 september 2008 13:13

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   Munich, Germany-based MorphoSys picked Novartis after offering the deal, auction-style, to 10 or so top industry players, which just goes to show how far antibody firms have come.
   "We started doing business in the mid-1990s when there were no takers," MorphoSys' Moroney told BioWorld Financial Watch. But thanks to the high-profile antibody approvals from Genentech, Centocor and Biogen, antibody products started pulling in significant revenues, and "that's when pharma woke up," he added. Now, he said, marketed antibody drug sales total about $20 billion per year.
   MorphoSys's HuCal (Human Combinatorial Antibody Library) technology is a phage display library designed to build up an antibody in a modular fashion. It has been the center of the company's numerous partnerships as well as its own internal pipeline. Alone and with partners, the company has a total of 56 compounds in various stages of development, Moroney said, adding that "our goal is to become an antibody powerhouse."
   With the Novartis deal, expected to be the last such collaboration entered by MorphoSys, the firm is assured of a large number of new programs, Moroney said, and the German biotech can "count on about $30 million in free cash flow from the deal over the next 10 years."
   That, plus the $200 million currently on its balance sheet, puts the firm "in a happy position to invest in our own pipeline," he said.
   MorphoSys' lead drug, MOR103, a fully human HuCAL antibody directed against granulocyte macrophage-colony stimulating factor for treating rheumatoid arthritis, started a Phase I trial in April.
   The company, which is staffed by 300 employees and has a market cap of about $500 million, has no interest in becoming one of the antibody firms bought out by big pharma, but that's not to say that pharma won't come knocking.
   "We've seen a flurry of acquisitions," Moroney said during the panel discussion. "As the pool of available companies gets smaller, that [interest] will move beyond into the antibody scaffold companies" like Domantis.
   "Pharma scrambled to get their hands on those [antibody firms] and now they'll scramble to get their hands on the next-generation [firms]," he added, though he questioned whether M&A is the best solution for the continued development of antibody technology.
   "Historically, technology hasn't flourished when absorbed by a pharma firm," he said.
   Amgen's Karow agreed, but said pharma firms seem to be learning that "integration sucks the life out of" technology firms and are allowing their acquired companies to operate as separate entities.
   AstraZeneca opted to let Gaithersburg, Md.-based MedImmune (plus CAT) continue operating on its own, and the firm serves as the biologics division of AstraZeneca. And Basel, Switzerland-based Roche has promised to let Genentech continue as a separate unit at its South San Francisco-based headquarters if an acquisition gains shareholder approval.
   Beverley Carr, director of drug discovery transactions at GSK, said there's an increasing trend for big pharma to buy firms and to keep them intact.
   "That's something I can see continuing to happen," she said. "It's what we've done with Domantis and it's worked very well in the short term."
   Published September 15, 2008
   www.bioworld.com/servlet/com.accumedi...
   
8. [verwijderd] 24 september 2008 10:52

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   MorphoSys Nominates First Pre-Development Program in Antibody Collaboration
   
   09/24/2008 at 07:30 AM
   
   MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that it has exercised its first option to participate in the development of a therapeutic antibody program within its collaboration with Novartis. In a first, pre-development step, Novartis will fund the companies' joint efforts until the program reaches formal pre-clinical development. MorphoSys will recognize its share of the funding as additional revenues.
   
   In December 2007, 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 over the 10-year lifetime of the agreement. Under the co-development options, MorphoSys may elect to participate in a selection of projects through cost and profit sharing with financial participation reflecting its level of investment in the respective programs. The pre-development agreement provides MorphoSys with the option to enter a formal co-development for the respective program with Novartis. Certain early stage costs in these programs are being funded by Novartis.
   
   "Today's news marks another significant step in our plans to expand our proprietary drug development activities. This is a great opportunity for MorphoSys to become involved in developing an antibody against a very promising target together with Novartis," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys. "We see these pre-development options as an extremely valuable component of our deal with Novartis as they give us the opportunity to build our drug development capability in conjunction with one of the strongest and most experienced companies in the pharmaceutical industry."
   www.morphosys.com/en/news_investors/p...
9. flosz 29 september 2008 12:39

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   Shionogi Extends Research Partnership with MorphoSys
   09/29/2008 at 07:30 AM
   MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that Shionogi & Co., Ltd., Osaka, Japan, has elected to extend its current license agreement covering the use of MorphoSys's HuCAL technology in drug discovery, for three additional years. Under the terms of the agreement, Shionogi will continue to have the right to use MorphoSys's proprietary antibody library HuCAL GOLD for research purposes at one of its research sites. MorphoSys will receive annual user fees from Shionogi for access to the HuCAL technology. Further financial details were not disclosed.
   
   "We are very pleased with Shionogi's decision to continue using our HuCAL GOLD technology as a research tool. Today's news underscores our ongoing ability to pursue a broad range of R&D-based alliances with leading pharmaceutical companies worldwide," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys.
   
   MorphoSys and Shionogi signed a three-year license agreement on the use of MorphoSys's HuCAL technology in September 2005. Under the terms of the agreement, MorphoSys granted Shionogi access to its HuCAL GOLD antibody library for research applications in Shionogi's drug discovery programs.
   www.morphosys.com/en/news_investors/p...
   
10. flosz 26 oktober 2008 21:27

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    10/30/2008 - Nine Months 2008 Results
    MorphoSys will publish its first nine months’ 2008 results on October 30, 2008 at 7:30 a.m. CET.
    At 2:00 p.m. CET (1:00 p.m. GMT, 9:00 a.m. EDT), the Management Board of MorphoSys AG will host a public conference call to present MorphoSys’s financial results for the first nine months of 2008 and provide further details on the Company’s latest developments.
    
    Dial-in numbers (listen only):
    Germany: +49 (0) 69 71049 1462
    United Kingdom: +44 (0) 1212 604860
    USA: +1 (1) 866 347 1957
    
    An audio replay and manuscripts of the conference will be available on www.morphosys.com/conferencecalls in the afternoon of the same day.
    
11. flosz 30 oktober 2008 07:52

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    <<< MOR103 is currently being tested in a phase 1 clinical trial to assess safety, tolerability and the
    pharmacokinetics of this fully human high-affinity anti-GM-CSF HuCAL antibody. MorphoSys intends
    to present pre-clinical data for MOR103 at the HAH - Human Antibodies and Hybridomas
    Conference on November 12, 2008 in New York, USA, as well as at the IBC's 19th Annual International
    Antibody Engineering Conference on December 9, 2008, in San Diego, USA. >>>
    
    3rd INTERIM REPORT JANUARY – SEPTEMBER 2008
    
    For the nine months ended September 30, 2008, Group revenues were broadly in line with Company
    expectations at € 53.3 million, a 21% increase compared to the same period in the prior year.
    Operating profits came in at € 15.1 million, more than doubling the previous year’s profit of € 6.9
    million, which was ahead of original Company projections, arising from (i) certain external costs
    being held below original expectations, and (ii) through the addition of two cohorts to the MOR103
    Phase 1 trial pushing additional development costs into next year.
    In our Therapeutic Antibodies segment, MorphoSys presented compelling data on its lead proprietary
    asset, MOR103, an antibody against the target GM-CSF. The phase 1 trial in Holland continues
    according to plan, and the program continues to be on track for the regulatory filing for a phase
    1b/2a clinical trial in the first half of 2009. Additionally, the Company also unveiled plans during the
    quarter to co-develop an antibody with Novartis in a cost and profit sharing arrangement. Such codevelopment
    deals are seen as significantly value-adding, in that MorphoSys benefits from the
    development experience of its partners, with the added benefit that the upside of these deal structures
    exceeds that from our traditional partnered business.
    Expenses for research and development increased by € 2.6 million to € 18.3 million (first nine
    months 2007: € 15.7 million). This was mainly due to higher personnel costs in the Therapeutic
    Antibodies segment mainly associated with increases in proprietary drug development and partnered
    activities (first nine months 2008: € 7.7 million; first nine months 2007: € 6.2 million) as well
    as increased costs for intangibles in connection with the patent portfolio in-licensed from Dyax in 2007 (first nine months 2008: € 4.2 million; first nine months 2007: € 3.1 million). This increase was
    partly offset by lower costs for external services (first nine months 2008: € 2.4 million; first nine
    months 2007: € 2.7 million), namely external lab funding. The two proprietary products currently
    being developed by MorphoSys are MOR103 and MOR202.
    
    Research & Development / Alliance Management
    Progress Proprietary Pipeline
    
    MOR103
    In September 2008, MorphoSys announced the publication of a first data package for its most
    advanced proprietary drug development program MOR103, a fully human HuCAL antibody directed
    against GM-CSF, in the journal "Molecular Immunology".
    The data presented show that MOR103 is able to block disease-relevant processes such as GMCSF-
    dependent proliferation and signal transduction in vitro. Additionally, the publication describes
    that MorphoSys was able to achieve a 5,000-fold increase in affinity and a 2,000-fold increase in
    potency compared to the parental antibody using its established optimization technology. With a
    resulting affinity - or binding strength - of 400 femtomolar, MOR103 represents the first known anti-
    GM-CSF agent with a subpicomolar affinity for its target. Targeting of antigens such as GM-CSF,
    which are present only at low concentrations in patients, will require antibodies with low picomolar
    to subpicomolar affinities in order to reach efficacy in vivo at low dose levels. The high affinity is
    also expected to lead to a beneficial dosing regimen and cost of goods advantage.
    MOR103 is currently being tested in a phase 1 clinical trial to assess safety, tolerability and the
    pharmacokinetics of this fully human high-affinity anti-GM-CSF HuCAL antibody. MorphoSys intends
    to present pre-clinical data for MOR103 at the HAH - Human Antibodies and Hybridomas
    Conference on November 12, 2008 in New York, USA, as well as at the IBC's 19th Annual International
    Antibody Engineering Conference on December 9, 2008, in San Diego, USA.
    
    212.14.81.205/uploads/MOR_Q3-2008_e.pdf
    
    *The MOR103 Phase 1 trial continues according to plan and dosing
    of all volunteers has been completed. This includes two
    additional, higher dosage groups which were incorporated based on
    favourable safety and tolerability observed in the lower-dosed
    cohorts.
    
    *Publication in Molecular Immunology of compelling data on lead proprietary development program MOR103, an antibody against GM-CSF to treat rheumatoid arthritis.
    
    www.morphosys.com/en/news_investors/p...
    
    
12. flosz 31 oktober 2008 08:45

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    INTERVIEW: MorphoSys sieht durch Finanzkrise Chance für Zukäufe
    30.10.2008 - 10:44
    DÜSSELDORF (Dow Jones)--Die Turbulenzen an den Finanzmärkten könnten für die MorphoSys AG nach Einschätzung des Managements auch Chancen bieten. "Möglicherweise erhöhen sie die Möglichkeiten für gezielte Zukäufe", sagte der Vorstandsvorsitzende des Martinsrieder Biotechnologie-Unternehmens, Simon Moroney, am Donnerstag im Gespräch mit Dow Jones Newswires
    
    Für die Branche insgesamt sei die Situation schwierig, und zwar für private wie für börsennotierte Unternehmen gleichermaßen. Er könne sich nicht vorstellen, dass die Lage in den kommenden Monaten besser werde. "Akquisitionen und Fusionen könnten in der Branche zunehmen," erwartet Moroney.
    
    Sein eigenes Unternehmen sei dabei wegen der guten Kapitalausstattung und der Mittelzuflüsse aus Partnerschaften in einer sehr guten Position. So hatte MorphoSys am 30. September einen Bestand an liquiden Mitteln und veräußerbaren Wertpapieren von rund 127 Mio EUR; zum Jahresende 2007 waren es nur 107 Mio EUR gewesen.
    
    Zudem war der Zufluss an Meilensteinzahlungen im dritten Quartal mit 4,6 Mio EUR so hoch ausgefallen wie nie zuvor in der Unternehmensgeschichte. Da aber in diesem Zeitraum kein Meilenstein für Fortschritte bei klinischen Entwicklungen angefallen waren, also andere Erfolgszahlungen für den Anstieg verantwortlich sein müssen, spreche das Ergebnis für eine sehr gute Leistung des Geschäftes mit frühen Projekten, sagte Moroney.
    
    Die globale Finanzkrise habe die Geldanlage des Unternehmens in einem Geldmarktfonds, in dem derzeit rund 84 Mio EUR geparkt sind, auch in den vergangenen Wochen nicht beeinträchtigt, versicherte Moroney. Das sei zuletzt in den vergangenen Tagen erneut überprüft worden: "Die Investition ist sehr, sehr sicher."
    
    Positiv äußerte sich Moroney auch zu den Fortschritten bei dem wichtigsten Medikamentenprojekt, das das Unternehmen in eigener Regie entwickelt - den Antikörper MOR103 gegen entzündliche Erkrankungen wie Rheumatoide Arthritis.
    
    Aufgrund des guten Sicherheits- und Verträglichkeitsprofils bei fünf Patientengruppen in der ersten klinischen Phase wurden zwei Gruppen mit höheren Dosierungen zusätzlich in die Studie mit MOR103 aufgenommen. "Das gibt uns deutlich mehr Flexibilität für die zweite klinische Phase", sagte Moroney.
    nachrichten.finanztreff.de/news_news,awert,ticker,bwert,,id,28062278,sektion,uebersicht.html
    
13. [verwijderd] 19 januari 2009 10:37

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    MorphoSys Provides Update on Pipeline Activities in 2009
    
    01/19/2009 at 07:30 AM
    
    MorphoSys to Accelerate the Expansion and Advancement of its Proprietary Pipeline
    
    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) today outlined its planned proprietary developments for 2009 and provided an update on its partnered antibody pipeline. The Company intends to advance and broaden its proprietary therapeutic antibody pipeline with its most advanced compound MOR103 expected to enter a phase 2 clinical trial in the second half of 2009. MorphoSys is in a robust position to increase its investment in proprietary drug development, with strong and increasing revenues from its partnered discovery business, a cash balance in excess of EUR 130 million at December 31, 2008 and no material bank debt. The Company plans to more than double its investment in proprietary R&D in 2009, and expects to record a healthy profit as in previous years.
    
    "MorphoSys is ideally positioned to advance its pipeline in 2009", commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "We have a solid financial foundation, plus a proven technology and promising targets, which together give us the means of building a very strong proprietary drug pipeline. Even in this challenging economic climate, MorphoSys is ideally positioned to build value by advancing its pipeline, while maintaining profitability."
    
    The Company's proprietary pipeline activities in 2009 are projected to comprise:
    i) The start of a phase 1b/2a clinical trial in rheumatoid arthritis for lead compound MOR103;
    ii) Finalizing the evaluation of MOR103 in a second indication and preparation for an additional phase 2 clinical trial;
    iii) Formal pre-clinical development and manufacturing of clinical grade material for MOR202;
    iv) The addition of up to 5 proprietary de novo programs to its pipeline, one of which was already started recently;
    v) One pre-development program with Novartis - the pre-development agreement provides MorphoSys with the option to enter a formal co-development for the respective program;
    vi) Validation of three targets together with Galapagos which are intended to become the subject of therapeutic antibody programs in the future.
    
    As a result of the planned activities MorphoSys's proprietary pipeline at year-end could consist of up to 8 programs in total, including one co-development program with Novartis - up from two fully-owned and one pre-development program in 2008.
    
    "The expansion of our proprietary pipeline is a key value driver for MorphoSys and we expect to achieve significant progress during 2009 in this regard", commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "By the end of 2009, we plan to have a rich proprietary pipeline based on the well-established and widely-proven HuCAL technology while enjoying the tailwind from our partner pipeline programs further advancing into clinical trials."
    
    The phase 1 clinical trial for MOR103 in healthy volunteers has been completed and is currently in the analysis stage. The final data will be reported in Q2 2009. Additional pre-clinical investigations of MOR103 in animal models for other inflammatory diseases are currently being conducted. MorphoSys intends to out-license MOR103 for the treatment of rheumatoid arthritis after establishing clinical proof-of-concept. With regard to the cancer program MOR202, formal pre-clinical development is ongoing. In 2009, toxicology studies will be conducted to support regulatory filing for a phase 1 clinical trial. Production of clinical material for MOR202 and MOR103 for the phase 1 and 2 trials, respectively, will continue during the course of 2009. Recently, MorphoSys added one de novo HuCAL antibody program to its portfolio against an undisclosed oncology target. In 2009, MorphoSys anticipates antibody generation and in depth in vitro profiling of target-specific antibody candidates. One additional oncology target has already been selected and the respective antibody program will be started in the course of 2009. Further targets in inflammatory and oncology indications will be evaluated in 2009, which may be the basis for further proprietary HuCAL programs.
    
    Complementing its portfolio of fully owned programs, MorphoSys has secured several co-development options in its partnerships with Novartis and Galapagos and will continue to evaluate additional opportunities. Within these programs, development costs are shared equally or, in the case of MorphoSys's partnership with Novartis, early-stage costs are fully covered by the partner. In 2008, MorphoSys exercised its first option to participate in the development of a therapeutic antibody program within its collaboration with Novartis. The agreement provides MorphoSys with the option to enter formal co-development of the program, sharing costs and profits up to 50%. As a result of the alliance signed with Galapagos in November 2008, an initial set of three targets has been selected for validation through disease-specific in vitro and in vivo testing with antibodies provided by MorphoSys. If these studies are successful, the alliance will select antibody programs for pre-clinical and clinical development. Under the terms of the agreement, Galapagos and MorphoSys will share the research and development costs, as well as all future revenues, equally. In 2009, Galapagos will conduct the production of these three proteins for the alliance and MorphoSys will generate antibodies directed against the targets. Additionally, Galapagos will apply its target discovery platform during 2009 and the parties may select additional targets for subsequent joint target validation studies.
    
    Summarizing all planned activities, MorphoSys today provided a snapshot of the status of its proprietary pipeline envisioned for the end of 2009: The Company anticipates having three targets in validation studies jointly with Galapagos, up to six proprietary compounds in the discovery stage including one co-development program with Novartis, one program in formal pre-clinical development, and one antibody in a phase 2 study. Of the total 2009 R&D budget, approximately half, or EUR 18 million - EUR 20 million, will be invested in proprietary drug and technology development. The majority of this investment is earmarked for the further development of MOR103 and MOR202.
    
    Additionally, the Company will continue to evaluate opportunities to acquire or in-license drug candidates from third parties, potentially exploiting its strong balance sheet to secure attractive opportunities. These activities could significantly increase the value of MorphoSys beyond the plans outlined today.
    
    "We expect our revenues to continue to grow, enabling us to channel significant funds into our proprietary R&D", commented Dave Lemus, Chief Financial Officer of MorphoSys AG. "We are in a sound financial position to create new value for our shareholders by investing in selected pipeline programs. We anticipate making investments in 2009 of approximately EUR 18 million to EUR 20 million in proprietary R&D. Even with this substantial increase in R&D investment, we expect to maintain a healthy level of profit."
    
    Meanwhile, the Company's partnered pipeline continues to progress. The partnered pipeline is distinguished from proprietary activities by the fact that the former is fully funded by the Company's par
14. flosz 19 januari 2009 10:38

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    Dat is timing! lol
    
    Meanwhile, the Company's partnered pipeline continues to progress. The partnered pipeline is distinguished from proprietary activities by the fact that the former is fully funded by the Company's partners. As of the beginning of 2009, MorphoSys's partnered pipeline consists of 55 partnered programs, including one program in phase 2 clinical trials. The partnered pipeline is the source of ongoing milestone payments and will provide lucrative royalty streams in the years to come.
    
    As part of the expansion of its proprietary and partnered development efforts, MorphoSys intends to further build its R&D team. As a result, the Company is expecting to hire more than 40 new employees in R&D in 2009, mainly at the Group's headquarters in Munich, Germany.
    
    MorphoSys will provide further details around its pipeline activities and give financial guidance for the full year at its year-end 2008 Results Press Conference and Analyst Meeting in Frankfurt, Germany on February 26, 2009
    www.morphosys.com/en/news_investors/p...
    
    (Niets vandaag bij IQ, ARK en Transgene....)
    
15. flosz 1 februari 2009 14:25

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    MorphoSys Appoints New Head of Research Antibody Business
    01/29/2009 at 07:30 AM
    Dieter Feger joins MorphoSys from Leading Diagnostic Supplier Abbott Diagnostics
    
    MorphoSys AG (FSE: MOR; Prime Standard Segment) announced today the appointment of a new Head of its AbD Serotec business for research and diagnostic antibodies. Dieter Feger joins MorphoSys from Abbott Diagnostics, Illinois, a global leader in in vitro diagnostics. For the last four years, he held the position of Marketing Director - Global Marketing, most recently with responsibility for Infectious Diseases, Abbott Diagnostics' biggest reagent franchise. Prior to that, he spent 18 years with Abbott in Europe, in a variety of roles including sales, product management, operational management and marketing before moving to the US. He replaces Dieter Lingelbach who has left MorphoSys to pursue new opportunities.
    
    "I am delighted to welcome Dieter Feger to the management team of MorphoSys. He brings deep experience from his work at Abbott Diagnostics, one of the industry's leading companies, that will assist AbD Serotec to seek new growth opportunities and to expand its footprint in the diagnostics industry," commented Dr Simon Moroney, Chief Executive Officer of MorphoSys AG. "I would like to thank Dieter Lingelbach for his invaluable contribution to establishing AbD Serotec as a leading supplier of research antibodies and wish him well in the future."
    
    MorphoSys began offering custom antibody services to the research and diagnostic markets in 2003. Two successful acquisitions of US and UK-based antibody suppliers with strong catalog and industrial antibody production businesses have significantly strengthened and broadened MorphoSys's position in the research antibody market. Today, MorphoSys's AbD Serotec unit is among the top 20 antibody suppliers worldwide.
    
    "I'm looking forward to working with the team of AbD Serotec in Germany, the UK and the US to increase the unit's market share in the research antibody markets and to seek new opportunities in the diagnostics industry," commented Dieter Feger, Head of AbD Serotec and Senior Vice President. "MorphoSys's HuCAL technology is a unique tool to generate novel research reagents and diagnostics which has already led to a number of first-of-a-kind products."
    
    MorphoSys will publish its full year 2008 results and financial guidance for 2009 at its year-end 2008 Results Press Conference and Analyst Meeting in Frankfurt, Germany on February 26, 2009. Invitations for the conference in Frankfurt and the webcast will be sent out in due course.
    www.morphosys.com/en/news_investors/p...
    
16. flosz 24 februari 2009 12:32

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    Upcoming Conference Call
    
    02/26/2009 - Year End 2008 and Q4 Results
    
    MorphoSys will publish its Annual Financial Results 2008 on February 26, 2009 at 7:30 a.m. CET.
    MorphoSys will hold its Analyst and Press Conference in Frankfurt, Germany. Additionally, the Management Team of MorphoSys AG will host a conference call and audio webcast to present MorphoSys’s Annual Financial Results 2008 and provide an outlook for 2009.
    DATE: Thursday, 26th February 2009
    TIME: 14:00 p.m. CET
    DIAL IN No: +49 (0) 69 710491462 (listen-only)
    UK RESIDENTS: +44 (0) 1212 604860
    US RESIDENTS: +1 (1) 866 347 1957
    We request that you call the number above up to 10 minutes early to ensure a prompt start and a secure line.
    MorphoSys AG offers participants the opportunity to follow the presentation through a simultaneous slide presentation online.
    Slide presentation with sound: www.thomson-webcast.net/de/dispatchin...
    Slide presentation without sound for participants of the conference call
    A slide-synchronized audio replay of the conference will be available following the live event on www.morphosys.com
    
17. harvester 25 februari 2009 23:16

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    Morphosys conf call 7.30 wordt morgen interessant.
    
    Lijkt mij net als Crucell ondergewaardeerd, is winstgevend, heeft 22.5 miljoen aandelen uitstaan met ongeveer dezelfde koers als Crucell.
    
    Verwachten voor 2009 10 a 20% groei.
    
    Hebben net een paar goede mensen aangenomen.
    
    1) Dr. Ulrich Moebius joins MorphoSys from Medigene AG, a TecDAX listed German biopharmaceutical company. For the last nine years, he held the position of Head of Pre-clinical Development.
    2) New Head of its AbD Serotec business for research and diagnostic antibodies. Dieter Feger joins MorphoSys from Abbott Diagnostics, Illinois, a global leader in in vitro diagnostics.
    
    Heb zelf inmiddels wat aandelen gekocht.
    Er is wel veel minder handel in dan bij Crucell.
    
    Wel een aantal grote partijen als Novartis met meer dan 5% en vele contracten met verschillende partijen + licenties van Crucell (voor de eigen programma's)
    Hebben ook een behoorlijke pot geld.
    
    Ben benieuwd met welke projecten de genoemde 2 personen zich gaan bezig houden.
    het onderzoeksbudget wordt in ieder geval verdubbeld gesteund door de hogere omzetten voor werk voor de big pharma's.
18. [verwijderd] 26 februari 2009 00:04

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    Ben met je eens .... is ook een van die pareltjes die binnen de biotech die zeker de moeite van het volgen en ook het investeren waard zijn.
    Crucell ligt er imho wel veel beter voor gezien de fundamentals en de pipeline en als ik daarvan uitga vindt ik de koers wat aan de hoge kant.
    Biotech gaat booming worden en de enige juiste vraag is wanneer en niet of het zo is.
    Dat zal verschillen per bedrijf .
    De oude Pharma is op sterven na dood en is ook niet zo gek want het is nog steeds geen maatwerk en dat is wel wat biotech gaat neerzetten.
    Maar hebben vanuit het verleden wel heel veel geld ter beschikking.
    
    Steeds meer betere tuning en steeds betere adaptie aan wisselende problematiek.
    Dat is biotech...... in zeer korte tijd straks een vaccin kunnen maken dat specifiek of heel breed bescherming kan bieden tegen HxNy...... or whatever en dat in grote hoeveelheden beschikbaar kunnen maken.
    Ook de "nice markten "kunnen voorzien worden van goede producten......... het zal je kind of partner maar zijn ....die in die catagorie valt.
    Vanuit de historie van Crucell is ook veel onderzoek gedaan op oncologisch gebied en gaan we op termijn nog het nodige van horen.
    
    Ben met jou heel benieuwd wat het allemaal brengen gaat
    
    ian
    
    
19. flosz 26 februari 2009 09:22

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    The proprietary pipeline advanced as planned. MOR103 entered
    phase 1 of clinical development in April 2008. The
    phase 1 clinical trial for MOR103 in healthy volunteers has
    been completed and is currently in the analysis stage. The
    fi nal data will be reported in Q2 2009.
    MorphoSys AG Reports Strong Financial Results for Fiscal Year 2008
    02/26/2009 at 07:30 AM
    Sound Financial Foundation to Support Increased R&D Investment
    
    Press conference call (in German) today at 09:30 am CET
    Conference call and webcast of the analyst meeting and press conference today at 02:00 pm CET (01:00 pm GMT; 08:00 am EST)
    
    
    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 financial year ending December 31, 2008. The Company achieved Group revenues of EUR 71.6 million (2007: EUR 62.0 million) and more than doubled its operating profit to EUR 16.4 million (2007: EUR 7.0 million). The Research Antibodies segment AbD made the all-important transition to profitability in 2008. Group net profit after taxes increased to EUR 13.2 million (2007: EUR 11.5 million). At the end of the year 2008 MorphoSys's cash position amounted to EUR 137.9 million (2007: EUR 106.9 million).
    
    Highlights of the Year 2008:
    • First Proprietary Program Enters Clinical Trials: Lead program MOR103 successfully completed a phase 1 trial in healthy volunteers.
    • Strengthening of Proprietary Pipeline: Co-development agreement with Galapagos to develop therapeutic antibodies against novel disease targets. Start of a first pre-development program within the Novartis Alliance.
    • Strong Growth of Partnered Drug Pipeline: First partnered compound enters phase 2 clinical trials during the year. Substantial growth of partnered pipeline to 55 active therapeutic antibody projects (up from 50 at the end of 2007); number of preclinical candidates increased to 29 (up from 23 at the end of 2007). Overall pipeline progress resulted in milestone payments of EUR 9.9 million (2007: EUR 12.1 million).
    • Strong Base of Partnerships: Renewal and extension of four therapeutic partnerships, namely Astellas Pharma, Daiichi Sankyo, OncoMed Pharmaceuticals and Schering-Plough as well as a research collaboration with Shionogi.
    • AbD Segment: Operating profitability achieved; appointment of Dieter Feger as new head of the unit.
    • Management: Dr. Arndt Schottelius appointed as Chief Development Officer, to lead the Company's expanding therapeutic development activities.
    • Increased R&D activities: Increased investment in proprietary drug and technology development; up by 26 % year-on-year to EUR 7.7 million.
    • Technology: New antibody library HuCAL PLATINUM unveiled
    
    "The year 2008 has been a tremendous success for MorphoSys", stated Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "Our pipeline of HuCAL-derived drugs is advancing well, and our financial strength is enabling us to channel more investment into our very promising proprietary programs. I'm delighted that we have been able to strengthen the Company's management during the year, and am convinced that we are well-positioned to perform well on both sides of the business in 2009."
    
    "Our solid financial position and operational profitability uniquely position us in today's difficult capital market environment," commented Dave Lemus, Chief Financial Officer of MorphoSys AG. "Moreover, based on committed revenue streams from our broad portfolio of long-term partnerships allied with our strong balance sheet, the company is ideally positioned to increase its proprietary R&D activities, and to build long-term shareholder value."
    www.morphosys.com/en/news_investors/p...
    
    INFLAMMATORY DISEASES
    MorphoSys’s current lead compound MOR103 has potential as
    a treatment in several infl ammatory indications, with rheumatoid
    arthritis representing the biggest single market. Sales
    of anti-rheumatic drugs exceeded US $ 10 billion in 2007,
    exceeding drug sales in any other autoimmune diseases. As
    with any large market in the pharmaceutical industry, rheumatoid
    arthritis (RA) is an area that is subject to intense competition.
    Biologics, dominated by the anti-TNF drugs Enbrel®,
    Remicade® and Humira®, which together generate roughly
    95 % of biologics sales, comprise the biggest single group of
    existing therapies in this market.
    The commercial opportunity arises for three reasons. First,
    less than one-quarter of patients are presently being adequately
    treated. Second, a majority of patients who do respond
    to treatment become non-responders after one to two years.
    And third, the safety profi le of the anti-TNF therapies remains
    a concern. This means that the vast majority of the fi ve to six
    million RA patients worldwide are in need of better therapeutic
    alternatives.
    MOR103 is a fully human HuCAL-derived antibody directed
    against GM-CSF, a therapeutic target for the treatment of
    various infl ammatory disorders. In 2008, MorphoSys initiated
    a phase 1 clinical trial using MOR103 for the treatment of
    rheumatoid arthritis. The phase 1 trial in healthy volunteers
    has been completed and is currently in the analysis stage.
    MOR202 is a fully human HuCAL antibody directed against
    CD38, a therapeutic target for the treatment of multiple
    myeloma and certain leukemias. During 2008, the Company
    advanced this program into formal preclinical development.
    As a result of the alliance signed with Galapagos in November
    2008, an initial set of three targets has been selected for
    validation through disease-specifi c in vitro and in vivo testing
    with antibodies provided by MorphoSys. If these studies
    are successful, the alliance will select antibody programs
    for preclinical and clinical development. Under the terms of
    the agreement, Galapagos and MorphoSys will share the research
    and development costs, as well as all future revenues,
    equally.
    For its proprietary development programs, MorphoSys
    achieved its goal of advancing its lead program MOR103
    through a phase 1 clinical trial. The second program
    MOR202 progressed as planned into formal preclinical
    development. Two additional cancer targets were selected
    in 2008.
    With regard to its proprietary drug development plans, the
    development process of the MOR103 and MOR202 programs
    remained on track. In March 2008, MorphoSys announced
    the signing of a PER.C6® license agreement with Dutch biotechnology
    company Crucell NV 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. In 2008, DSM started to
    produce clinical-grade MOR202 material. For MOR103, the
    phase 1 study in healthy volunteers was started in April 2008
    and is currently in the analysis stage.
    Additionally, the Company has worked out a budget and plan
    to advance the pipeline expansion in 2009.
    
    In 2008, the Company signifi cantly strengthened the patent
    position for its lead development program MOR103 and added
    additional layers of protection for its expanding technology
    portfolio, making many new patent fi lings covering its proprietary
    programs and innovative technology.
    
    
20. flosz 26 februari 2009 09:23

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    FIRST DATA ON MOR103
    During the course of 2008, MorphoSys published initial biophysical
    and preclinical data for its most advanced proprietary
    drug development program MOR103, a fully human
    HuCAL antibody directed against GM-CSF for the treatment
    of infl ammatory disorders. MOR103 is currently being tested
    in a phase 1 clinical trial to assess safety, tolerability and the
    pharmacokinetics of this antibody.
    Preclinical data published in September 2008 in the journal
    “Molecular Immunology” show that MOR103 is able to block
    disease-relevant processes such as GM-CSF-dependent cell
    proliferation as well as signal transduction in vitro. Additionally,
    the publication describes that MorphoSys was able to
    achieve a 5,000-fold increase in affi nity and a 2,000-fold increase
    in potency compared to the parental antibody using its established optimization technology. With a resulting affi
    nity – or binding strength – of 400 femtomolar, MOR103
    represents the fi rst known anti-GM-CSF agent with a subpicomolar
    affi nity for its target. Targeting antigens such as GMCSF,
    which are present only at low concentrations in patients,
    will require antibodies with low picomolar to subpicomolar
    affi nities in order to reach effi cacy in vivo at low dose levels.
    The high affi nity is also expected to lead to a benefi cial
    dosing regimen and cost of goods advantage.
    Additionally, the antibody exhibited very high target specifi
    city, with no undesired cross-reactivity to other pro-infl ammatory
    cytokines such as IL-3, IL-4, IL-5 or M-CSF nor any
    non-specifi c binding to a panel of human tissues. MOR103
    also recognizes rat and rhesus GM-CSF, both helpful criteria
    with regard to the development process.
    Complementing the data package, MorphoSys released preclinical
    data in November 2008 showing that MOR103 also
    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 signifi cant reduction of knee joint swelling and improvement
    in joint histopathology in a dose-dependent manner.
    In addition, signifi cantly reduced cytokine levels and
    white blood cell infl ux were observed in the synovium surrounding
    the joints. No relevant toxicity eff ects were observed
    in a standard repeat-dose rhesus monkey study.
    The preclinical and biophysical data provide strong supporting
    evidence for MOR103 as a treatment for rheumatoid
    arthritis (RA), and formed the basis for the phase 1 clinical
    trial.
    EXPECTED COMMERCIAL DEVELOPMENT
    With the Novartis deal ensuring a steady stream of cash
    fl ows over the coming years, MorphoSys will concentrate on
    strengthening its proprietary pipeline. The Company will
    now focus more on in-licensing activities for interesting targets
    or innovative development programs, as well as codevelopment
    opportunities. In most cases, after clinical proof
    of concept, the development candidates will be out-licensed
    to partners. For MOR103, the most advanced development program
    in MorphoSys’s pipeline, out-licensing is envisioned for
    2011/2012, although unexpected development events could
    change this timeline.
    
    EXPECTED RESEARCH AND DEVELOPMENT
    The Company’s R&D budget for proprietary drug and technology
    development will more than double to between € 18 million
    and € 20 million in 2009. The majority of this investment
    will be channeled into clinical and preclinical development
    activities for MOR103 and MOR202. The trend of increasing
    investments will continue in 2010 and the years thereafter,
    although the size of such increases will depend on the status
    of the Company’s drug pipeline as well as revenue development.
    Notwithstanding this, the Company is committed to remaining
    profi table.
    The Company’s proprietary pipeline activities in 2009 are
    projected to comprise:
    • The start of a phase 1b/2a clinical trial in rheumatoid arthritis
    for its lead compound MOR103;
    • Finalizing the evaluation of MOR103 in a second indication
    and preparation for an additional phase 2 clinical trial;
    • Formal preclinical development and manufacturing of clinical-
    grade material for MOR202;
    • The addition of up to fi ve proprietary de novo programs to
    its pipeline, one of which has already been started recently;
    • One predevelopment program with Novartis; the predevelopment
    agreement provides MorphoSys with the option to
    enter a formal co-development for the respective program;
    • Validation of three targets together with Galapagos which
    might be the subject of therapeutic antibody programs in
    the future.
    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. PER.C6,
    a human-derived production cell line, combines the advantages of high
    productivity with – in contrast to other, animal-derived production cell
    lines – a human glycosylation pattern of the resulting antibody product
    and thus was considered to be very well suited for the production of
    HuCAL-derived human antibodies in high yields.
    As of December 31, 2008, the license had a remaining amortization
    period of eight years.
    In March 2008, MorphoSys signed an additional PER.C6® license and
    manufacturing agreement with Crucell and DSM Biologics expanding
    the rights to use the PER.C6® cell line in the production of clinical grade
    material for the development of the Company’s proprietary therapeutic
    cancer antibody program MOR202.
    As of December 31, 2008, the license had a remaining amortization
    period of nine years.
    212.14.81.205/uploads/MOR-YE2008_IFRS...