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Market Monitor

Crucell « Terug naar discussie overzicht

MOR103 (PerC6 inside) PHASE I

181 Posts, Pagina: « 1 2 3 4 5 6 7 8 9 10 » | Laatste

Omlaag ↓

gogogoo 28 april 2008 10:59

Voor degenen die het niet weten. MOR103 Program = PER.C6 inside.

[verwijderd] 28 april 2008 11:17

Zag net dat Flosz het al eerder gepost had :

Goede morgen.....

MorphoSys Announces Completion of First Dosing in Phase 1 Trial for MOR103 Program
Per.c6 inside!
04/28/2008 at 07:30 AM
viewtopic.php?f=8&t=107&p=7319#p7319
flosz
Moderator

Berichten: 2081
Geregistreerd op: do maart 01, 2007 22:42

SJC 28 april 2008 11:42

Het staat op zich ook wel redelijk aardig duidelijk zichtbaar in de titel.

gogogoo 28 april 2008 11:51

quote:
SJC schreef:
Het staat op zich ook wel redelijk aardig duidelijk zichtbaar in de titel.

En toch schijnt het belang niet door te dringen van de posting van gocrucellgo. Voortgang in de pipeline van de licentienemers. Als de eerste producten op basis van per.c6 op de markt gaan komen dan wordt het echt leuk.

gogogoo 29 april 2008 09:25

door flosz op di apr 29, 2008 6:48

MorphoSys AG Reports First Quarter 2008 Results
04/29/2008 at 07:30 AM
Revenues up 16 %, Operating Profit Tripled

MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX) today announced its financial results according to International Financial Reporting Standards (IFRS) for the first quarter ending March 31, 2008. Group revenues increased by 16 % to EUR 16.3 million (Q1 2007: EUR 14.1 million) and operating profit tripled to EUR 4.1 million (Q1 2007: EUR 1.3 million). Net profit amounted to EUR 3.3 million (Q1 2007: EUR 0.6 million). At the end of the first quarter of 2008 MorphoSys's cash position amounted to EUR 111.8 million (December 31, 2007: EUR 106.9 million).

Highlights of the First Quarter of 2008:
• MorphoSys received approval from regulatory authorities in the Netherlands to initiate a phase 1 clinical study for its proprietary therapeutic program MOR103. 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. The phase 1 trial started as planned and the first dosing regimen in healthy volunteers was already completed.
• MorphoSys signed a PER.C6® license agreement with Dutch biotechnology company Crucell N.V. 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.
• The therapeutic partnerships with Astellas as well as with Daiichi Sankyo were extended to run their full course.
• Partnered pipeline grew to 54 active therapeutic antibody projects (up from 50 at the end of 2007); number of pre-clinical candidates remained constant at 23.
• MorphoSys signed a collaboration agreement with Sigma-Aldrich to design, produce and distribute unique recombinant research antibodies using MorphoSys's proprietary HuCAL GOLD technology.
• MorphoSys's business unit AbD Serotec has received a multiple research antibody order from Proteomika SL, a Spanish biotechnology company specializing in biomarker discovery. The order ranks Proteomika among the largest customers for custom monoclonals services provided by AbD Serotec.
• MorphoSys's collaboration with Novartis has been recognized as the "European Pharma Deal of the Year" in Sachs Associates' Life Science Innovation Awards.

"The first quarter aptly demonstrates continued growth and increasing profitability for both lines of our business." commented Dave Lemus, Chief Financial Officer of MorphoSys AG. "As targeted, the AbD segment has begun its swing into financial profitability for the year, and we expect increased milestone payments on the therapeutic side of our business in coming quarters to help support higher levels of revenues, profits and proprietary product investment."

www.morphosys.com/en/news_invest ... e-604.html
**********************************
Progress Proprietary Pipeline
MOR103
In January 2008, MorphoSys announced an agreement with the University of Melbourne providing
MorphoSys with exclusive access to rights covering the use of inhibitors of GM-CSF under a U.S.
patent application and its progeny. MorphoSys believes that the University of Melbourne’s patent
applications, once allowed, will lead to market exclusivity for therapeutic antibodies targeting GMCSF
for anti-inflammatory indications in the U.S., which represents the lion's share of the total
rheumatoid arthritis (RA) market. In 2004, the market for biopharmaceuticals to treat RA
amounted to US$ 6 billion worldwide and is expected to further increase to US$ 14 billion in 2009.
The University of Melbourne receives an upfront payment, milestone payments associated with
clinical development and royalty payments based on net sales of products in the U.S. In addition
to the intellectual property rights secured under the agreement with the University of Melbourne,
MorphoSys has filed additional patent applications on the antibodies it has generated in its
MOR103 program.
In February 2008, MorphoSys announced that the regulatory authorities in the Netherlands have
approved the clinical trial application (CTA) to initiate a phase 1 study of the HuCAL-derived antibody
MOR103. MorphoSys had submitted the clinical trial application in December 2007. In parallel,
MorphoSys has received a manufacturing license from the Bavarian government, allowing
MorphoSys to release clinical trial material for MOR103 clinical studies as a sponsor.

In our Therapeutic Antibodies segment, significant progress was made both on the partnered and
proprietary side of the business. With regard to our proprietary pipeline, we advanced our lead
program MOR103 according to plan. Following the CTA filing in December 2007, we received
approval from Dutch authorities within six weeks. In the interim, a phase 1 trial has been initiated;
the first dosing regimen is completed. Thereby the drug candidate has become the fifth HuCAL
antibody in the clinic. Early in 2008, we announced that the underlying target molecule is granulocyte
macrophage-colony stimulating factor, also known as GM-CSF. At the same time, we disclosed
an exclusive in-licensing agreement on a fundamental U.S. patent application involving
GM-CSF as a means of treating inflammatory diseases. We expect this license to allow Morpho-
Sys an exclusive position on marketing rights for therapeutic antibodies targeting GM-CSF in the
U.S., the largest market for arthritis treatment.
On the partnered side of our therapeutic business, we saw the extension of two alliances with
leading pharmaceutical companies in Japan, more specifically, Astellas and Daiichi Sankyo. Both
companies decided to continue our partnerships thereby securing access to our technology using
pre-existing options to extend the contract till 2012 and 2011, respectively.

Research and Development Expenses
Expenses for research and development increased by € 0.4 million to € 5.3 million (Q1 2007:
€ 4.9 million) mainly due to higher personnel costs (Q1 2008: € 2.4 million; Q1 2007: € 1.9 million)
and increased costs for intangibles (Q1 2008: € 1.4 million; Q1 2007: € 1.0 million) which were
partly offset by a decrease in costs for external services (Q1 2008: € 0.3 million; Q1 2007:
€ 0.8 million). The two proprietary products currently being internally developed by MorphoSys are
MOR103 and MOR202.
In the first three months of 2008, the Company incurred costs for proprietary product development
and technology development in the amount of € 0.8 million and € 0.3 million, respectively (Q1
2007: € 1.0 million and € 0.2 million, respectively).
212.14.81.205/uploads/MOR_Q1-2008_e.pdf

MorphoSys First-Quarter Net Rises Fivefold on Novartis Payment
MorphoSys AG, the German biotechnology company working with Novartis AG, said first- quarter profit rose more than fivefold on payments from its drug development partners.
www.bloomberg.com/apps/news?pid= ... er=germany

04/29/2008 - Three Months 2008 Results
MorphoSys will publish its first three months’ 2008 results on April 29, 2008 at 7:30 a.m. CEST.
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 Compan

[verwijderd] 8 mei 2008 08:41

Event: Deutsche Bank 33rd Annual Health Care Conference

View the Webcast

www.morphosys.com/en

flosz 8 mei 2008 09:11

quote:
gocrucellgo schreef:
Event: Deutsche Bank 33rd Annual Health Care Conference

View the Webcast

www.morphosys.com/en

MPSYY.PK - Morphosys AG

EVENT TITLE
Morphosys AG at Deutsche Bank Securities Inc. Health Care Conference

DATE / TIME
Tuesday, May 6, 2008 2:50 PM ET

Zie vooral slide 13 t/m. 16
10:21

webcastingplayer.corporate-ir.net/pla...

[verwijderd] 8 mei 2008 10:29

preclinical data presentatie dus gepland midden dit jaar.

flosz 19 mei 2008 08:22

Schering-Plough Extends Antibody Alliance with MorphoSys
05/19/2008 at 07:30 AM
Third Extension with Major Pharmaceutical Company after Landmark Deal with Novartis

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that Schering-Plough Corporation has decided to extend the current collaboration between the two companies for one year. The collaboration, announced in May 2006, has a maximum term of 5 years until 2011 and may be extended by Schering-Plough after each single year. Under the agreement, Schering-Plough will continue to have access to MorphoSys's proprietary antibody library HuCAL GOLD at its research site in Palo Alto, California, the location of Schering-Plough Biopharma, an affiliate of Schering-Plough Research Institute. Furthermore, the contract provides Schering-Plough with the option to develop and commercialize HuCAL-derived therapeutic antibodies, in which case MorphoSys would receive exclusive license fees, milestone payments, as well as royalties. Under the extended agreement MorphoSys continues to receive annual user fees for access to its HuCAL platform. Further financial details were not disclosed.

"Today's news is yet another clear signal that our HuCAL technology will continue to form the basis of antibody-based drug development programs at a number of leading pharmaceutical companies," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys. "We are very pleased with Schering-Plough's decision to continue using our HuCAL GOLD technology for their antibody development programs."

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...

flosz 19 mei 2008 12:46

A well diversified Biotech
Morphosys develops therapeutic and research antibodies for
commercialisation and for its own account. Through a close
collaboration with Novartis, Morphosys is well financed to buildup
an internal drug development pipeline while remaining
profitable. We believe the company to be significantly
undervalued and see Morphosys’ fair value at EUR 80.
Partnered antibodies programs: 54 partnered programs (4 in clinical,
23 in preclinical and 27 in discovery development). If everything goes
well Morphosys is to receive up to EUR 12m in milestone payments and
c. 5% royalties on product sales for an average program.
Novartis deal: Committed payments of USD 600m over 10 years. One
half of this amount will be devoted to Morphosys’ research funding,
while the other half are technology license fees. Success-based
milestones on products development could bring additional USD 400m
in milestones. Moreover, MOR is entitled to royalty payments in the midsingle
digits.
Proprietary antibodies programs: MOR103 (Phase I) and MOR202
(Preclinical) primarily targeting rheumatoid arthritis and Multiple
Myeloma are well on track towards the next development stages.
Strong Q1 2008 results: Sales increased by 16% to EUR 16.3m.
Driven by higher levels of funded research and licensing fees from
Novartis. A 5% decrease in operating expenses allowed group EBIT to
surge by 215% to EUR 4.1m. EPS rose from EUR 0.09 to EUR 0.44
Triggers: 1) Clinical proof of concept data of a MOR Alzheimer
antibody developed by Roche in H2 2008e. 2) MOR might receive a
payment of c. EUR 30m - that is not included in our forecasts - for the
internalization of MOR Hucal technology at Novartis in ‘08e or ‘09e.
Valuation: Primarily based on a SOTP approach we see Morphosys’
fair value at EUR 80 per share. Please note that the current market cap
equals more or less Morphosys’ net cash position and committed cash
flows over the next nine years from Novartis. Hence, the Hucal
technology and the antibody pipeline are more or less for free.

Martin Possienke, CEFA
Equinet
+49 69 58997 412
martin.possienke@equinet-ag.de
Edouard Aubery
Equinet
+49 69 58997-439
edouard.aubery@equinet-ag.de

[verwijderd] 16 juni 2008 09:21

OncoMed Pharmaceuticals Extends License Agreement for Use of MorphoSys's Core Technology

06/16/2008 at 07:30 AM

Parties Initiate First Fully Human Antibody Programs Targeting Cancer Stem Cells

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that U.S. based biopharmaceutical company OncoMed Pharmaceuticals, Inc. has triggered its pre-existing option to extend the current license agreement between the two companies and has initiated two therapeutic antibody development programs targeting cancer stem cells. Under the extended agreement, which now runs until June 2010, MorphoSys continues to grant OncoMed access to its proprietary antibody library HuCAL GOLD for the use in the research and development of human therapeutic antibodies for the treatment of various cancers by targeting cancer stem cells. The extended agreement includes annual user fees to MorphoSys for OncoMed's access to the HuCAL platform. The two-year extension includes an option for OncoMed to develop and commercialize up to 3 additional HuCAL-derived therapeutic antibodies. In all cases MorphoSys stands to receive exclusive license fees, milestone payments, as well as royalties on end products. Further financial details were not disclosed.

Founded in August 2004, OncoMed Pharmaceuticals is discovering and developing monoclonal antibodies and proteins capable of eliminating "cancer stem cells", which are believed to play a key role in the establishment, metastasis and recurrence of cancer. OncoMed is at the forefront of applying research from the University of Michigan to isolate, purify, and analyze cancer stem cells. The company has established a large library of antibodies as well as proteins capable of binding to the cell surface proteins expressed on cancer stem cells and inhibiting cancer stem cell growth. Recently OncoMed has established a strategic alliance to discover, develop and market novel cancer stem cell antibody therapeutics with GlaxoSmithKline.

"We have been very successful in developing antibodies that show great promise in treating cancer," stated Paul Hastings, Chief Executive Officer of OncoMed. "The HuCAL technology has proven to be an effective tool for generating these antibodies and we are pleased to be able to continue our productive relationship with MorphoSys."
"Our core HuCAL technology continues to deliver new therapeutic antibody candidates," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys. "We are excited about these programs with OncoMed, which have the potential to revolutionize cancer therapy. Today's news continues a series of extensions with existing partners who have the ability to terminate or extend collaborations through pre-existing options. This clearly demonstrates the ongoing commitment by all of our partners to bring innovative HuCAL-based antibody drugs to patients."
www.morphosys.com/en/news_investors/p...

flosz 20 juni 2008 07:53

Ik plak 'm hier even bij...er was ooit een Sigma-draad, waar ?, geen flauw idee.

Sigma-Aldrich

Under Five Year Agreement, Academic Steering Committee will Identify Antibody Targets in the Areas of Cancer, Stem Cell and Autoimmune Research to be Produced by Sigma-Aldrich
ST. LOUIS, June 19 /PRNewswire-FirstCall/ -- Sigma-Aldrich (Nasdaq: SIAL) today announced it has entered into a five-year collaboration to develop optimal cell lines for the production of monoclonal antibodies. Scientists at the University of California, San Francisco will lead the research into antibodies for a variety of cancer targets, autoimmune diseases, stem cell characteristics and commonly neglected disease targets.
Under the terms of the agreement, research targets will be determined by a steering committee composed of leading scientists at UCSF, including Lewis Lanier, Ph.D. Professor and Vice Chair, Department of Microbiology & Immunology; Jeffrey Bluestone, Ph.D. Director, UCSF Diabetes Center; and Susan Fisher, Ph.D. Professor, Department of Cell & Tissue Biology. The committee will direct research into antibodies for cancer targets, stem cell surface markers and autoimmune disease targets. The University will have free access to the antibodies resulting from the partnership for its ongoing immunology and disease research.
"Sigma-Aldrich is committed to developing the most comprehensive and highly validated collection of monoclonal antibodies available for the cell biology research community," said Dr. David Smoller, President of Sigma-Aldrich's Research Biotech Business Unit. "By partnering with the highly regarded UCSF research team, Sigma-Aldrich is helping to further promote the study of a number of important cancer targets, regenerative medicine applications and neglected diseases."
Sigma-Aldrich is expanding its antibody content offering as part of its plan to become a leading developer and manufacturer of the next generation of monoclonal antibody products for life science researchers. Earlier this year, the company announced a partnership to distribute the highly-validated Prestige antibodies powered by Atlas Antibodies, the commercial arm of the Human Proteome Resource. Sigma-Aldrich is also collaborating with AbD Serotec, a Division of MorphoSys, to design, produce and distribute unique recombinant research antibodies using MorphoSys's proprietary HuCAL GOLD technology.
www.corporate-ir.net/ireye/ir_site.zh...
***************************

Sigma developed a medium optimized for the growth of Per.C6®
cells and designed to meet the regulatory needs of manufacturers
for the production of biotherapeutic agents.
www.sigmaaldrich.com/sigma/general%20...

Alliances with manufacturing contractors :Sigma-Aldrich Corp. Dec. 2003 PER.C6® Medium development

MorphoSys signed a collaboration agreement with Sigma-Aldrich to design, produce and distribute unique recombinant research antibodies using MorphoSys's proprietary HuCAL GOLD technology.
www.morphosys.com/en/news_investors/p...

flosz 9 juli 2008 08:43

Boehringer Ingelheim Gains Access to Additional MorphoSys Technology
07/09/2008 at 07:30 AM
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that Boehringer Ingelheim has exercised a pre-existing option to use MorphoSys's proprietary RapMAT technology for faster antibody optimization as part of the existing technology transfer agreement between the two companies. As a result, Boehringer Ingelheim will have access to MorphoSys's RapMAT technology module alongside the existing installation of the Company's proprietary antibody library HuCAL GOLD at Boehringer Ingelheim's research site in Vienna, Austria. Under the extended agreement, MorphoSys will receive annual user fees for the RapMAT technology and for access to its HuCAL platform. Financial details were not disclosed.

RapMAT, which stands for "rapid maturation", improves the options for identifying antibodies from the HuCAL libraries and reduces the time for generation of promising therapeutic lead molecules. The RapMAT technology is completely compatible with the HuCAL GOLD antibody library. MorphoSys believes that the use of RapMAT can greatly speed up antibody drug discovery, while widening the pool of drug candidates from which to choose.

Under the framework of the present five-year agreement, Boehringer Ingelheim has the option to receive multiple exclusive licenses on new therapeutic antibody programs. Today, the collaboration encompasses four active therapeutic antibody programs in various indications. Two new programs have been started recently and HuCAL-derived antibodies are currently being optimized at MorphoSys on behalf of Boehringer Ingelheim.

"As part of our internal antibody generation process at MorphoSys, RapMAT has already led to earlier achievement of milestones in partnered programs. We thus welcome Boehringer Ingelheim's decision to broaden its technological portfolio and use our RapMAT technology module to speed up their internal drug development process as well," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys. "Boehringer Ingelheim is an important partner; the collaboration has resulted to date in promising drug candidates for various therapeutic areas."
www.morphosys.com/en/news_investors/p...

flosz 16 juli 2008 09:19

MorphoSys and Integrated BioTherapeutics Provide Update Regarding USAMRIID Biodefense Project

Jul 15, 2008
AbD Serotec, a division of MorphoSys AG, announced today that its customer, US-based Integrated BioTherapeutics Inc. (IBT), has received a five-year, NIH research grant to develop human antibody therapeutics against staphylococcal enterotoxin B, a bacterial-derived toxin from Staphylococcus aureus. The project is a continuation of a biodefense-related project initiated by USAMRIID, an organization of the U.S. Army Medical Research and Materiel Command, in September 2006 using AbD Serotec’s custom monoclonal antibody services. Under the terms of the agreement, IBT will use a selection of HuCAL-based antibodies originally generated by AbD Serotec against staphylococcal enterotoxin B in in vitro and in vivo experiments to identify lead neutralizing candidates and is expected to order additional antibody material as well as other services offered by AbD Serotec. Financial details of the agreement were not disclosed.
Staphylococcal enterotoxins are involved in a variety of human pathologies ranging from hospital and community-acquired infections, sepsis, toxic shock syndrome, to atopic dermatitis. Staphylococcal enterotoxin B is also considered as a potential agent of bioterrorism. Currently no vaccines or immunotherapeutics are available against staphylococcal toxins or S. aureus infections. The research collaboration between IBT and AbD Serotec follows a novel paradigm in the fight against these pathogens by targeting toxins released by bacteria which can distract the immune system and cause massive and even fatal damage.
”This grant allows us to continue a very promising project initiated by USAMRIID and AbD Serotec,” said Dr. M. Javad Aman, President and CSO of IBT, “IBT is extremely pleased to have access to AbD’s unique technology for developing antibodies with therapeutic potential in this important medical area.”
“Today’s news marks yet another promising development of a pre-existing customer relationship of AbD Serotec,” comments Dr. Achim Knappik, Head of R&D at AbD Serotec. “We look forward to work with Integrated BioTherapeutics on this promising project in the field of infectious diseases which is an interesting research market for AbD Serotec.”
www.morphosys.com/en/news_investors/c...

[verwijderd] 17 juli 2008 09:04

First AbD Serotec generated HuCAL Antibodies Distributed as Part of Clinical Diagnostic Kits for Autoimmune Diseases by Phadia

07/17/2008 at 07:30 AM

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that Phadia AB, a world leader in autoimmunity and allergy testing, has implemented a series of HuCAL-based recombinant antibodies in its marketed autoimmune tests Varelisa(TM) and EliA(TM). Thereby Phadia becomes the first diagnostic company to introduce recombinant antibodies in an autoimmune screening platform. AbD Serotec, MorphoSys's division for research and diagnostic antibodies, receives license fees and will continuously supply Phadia with recombinant antibody material. Further financial details were not disclosed.

Phadia and AbD Serotec began collaborating in September 2005, bringing together Phadia's expertise in the development, manufacturing and marketing of complete blood test systems and AbD Serotec's leading recombinant antibody technology HuCAL. AbD Serotec has generated a series of recombinant antibodies in the IgA, IgM and IgG1 format, which Phadia will implement in its marketed autoimmune tests Varelisa(TM), a classical ELISA microtiter platform, and the fully automated system for the measurement of autoantibodies EliA(TM). The set of recombinant HuCAL antibodies provided by AbD Serotec act as recombinant control antibodies and replace human serum to standardize autoimmune assays.

Autoimmune diseases include juvenile diabetes, various forms of rheumatism, hepatitis, thyroiditis and a variety of skin diseases. An early diagnosis can improve the treatment options and increase the quality of life for patients significantly. However, since the early symptoms, especially of systemic autoimmune diseases like rheumatoid disorders, can be very diffuse, several years can pass from the onset of the disease until a correct diagnosis is made. New easy-to-use and cost-effective diagnostic methods could shorten the time-to-diagnosis and subsequent treatment.

"Phadia has a long track record in using advanced techniques such as recombinant gene technology to produce a wide range of precise and reliable diagnostic tests for autoimmune diseases," commented Stefan Eschbach, Vice President of Phadia. "The use of recombinant control antibodies was shown to increase the accuracy and reproducibility of diagnostic tests. AbD Serotec's ability to generate these highly-specific recombinant antibodies in various formats using the HuCAL technology has been extremely helpful in this regard."

"Today's news marks the first market entry of a clinical diagnostic kit comprising a HuCAL antibody," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys. "This development is a significant step forwards for recombinant antibody technology in the diagnostics field, and a major operational milestone for our AbD unit."
www.morphosys.com/en/news_investors/p...

[verwijderd] 23 juli 2008 09:43

MorphoSys Licenses RapMAT Technology to Astellas

07/23/2008 at 07:30 AM

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that Astellas Pharma Inc. has exercised a pre-existing option to use MorphoSys's proprietary RapMAT technology for faster antibody optimization as part of the existing technology transfer agreements between the two companies. As a result, Astellas will have access to MorphoSys's RapMAT technology module alongside the existing installation of the Company's proprietary antibody library HuCAL GOLD at Astellas' research site in Tsukuba, Japan. Under the extended agreement MorphoSys will receive annual user fees for the RapMAT technology and continues to receive annual user fees for access to its HuCAL platform. Further financial details were not disclosed.

RapMAT, which stands for "rapid maturation", improves the options for identifying antibodies from the HuCAL libraries and reduces the time for generating promising therapeutic lead molecules. The RapMAT technology is completely compatible with the HuCAL GOLD antibody library. MorphoSys believes that the use of RapMAT can greatly speed up antibody drug discovery, while widening the pool of drug candidates from which to choose.

"Today's news marks our second RapMAT-based technology deal with an existing partner. We welcome Astellas's decision to broaden its technological portfolio and use our RapMAT technology module to speed up their internal drug development process," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys. "Developments such as RapMAT are a result of our strategy to maintain our technological leadership in the field of human therapeutic antibodies, and thereby further strengthen our position in the market for this important class of drugs."
www.morphosys.com/en/news_investors/p...

[verwijderd] 29 juli 2008 08:31

MorphoSys AG Reports Six Months 2008 Results

07/29/2008 at 07:30 AM

Highlights of the Second Quarter of 2008:

The phase 1 trial for MOR103 continues according to plan and is on track for completion and final reporting in Q1 2009.

Partnered pipeline comprises 54 active therapeutic antibody projects (up from 50 at the end of 2007); number of pre-clinical candidates increased to 27.

Extension of therapeutic partnerships with Schering-Plough and OncoMed.

Boehringer Ingelheim exercised a pre-existing option to use MorphoSys's proprietary RapMAT technology for faster antibody optimization.

Expansion of target sourcing network through research collaboration with the Berlin-based Leibniz-Institut für Molekulare Pharmakologie (FMP).

www.morphosys.com/en/news_investors/p...

[verwijderd] 30 juli 2008 10:00

Research & Development / Alliance Management
Progress Proprietary Pipeline
MOR103
In April 2008, MorphoSys 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.
Strategy: Expansion of Proprietary Product Pipeline
As announced earlier this year, MorphoSys remains committed to adding new programs to the
existing proprietary projects MOR103 and MOR202. In that vein, during the first six months of the
year, analysis and decisions have been made regarding the same. Emerging from this process, it
was decided that the future growth of the Company’s proprietary pipeline will stem from three
sources: de novo program starts based on our HuCAL technology, co-development projects and
in-licensing activities relating to new programs.

Progress Partnered Pipeline
During the second quarter of 2008, no new programs were started. The two exclusive licenses
acquired by OncoMed are not yet part of this calculation. MorphoSys’s existing partnered therapeutic
antibody pipeline currently comprises 54 programs in total (up from 50 at the beginning of
the year), of which currently 4 are in phase 1 clinical development, 27 in pre-clinical development,
and 23 in research.

212.14.81.205/uploads/MOR_Q2-2008_e_f...

flosz 2 september 2008 08:45

MorphoSys Announces Publication of First MOR103 Data
09/02/2008 at 07:30 AM
MOR103 anti-GM-CSF Antibody Shows Subpicomolar Affinity for its Target Molecule

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today 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 GM-CSF 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, which are present only at low concentrations in patients such as GM-CSF, 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 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.

"We are very pleased with the results we have seen so far with MOR103 and the generation process stands out as a showcase for MorphoSys's antibody generation capabilities using our HuCAL technology," commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys. "While the antibody's affinity is merely one feature which influences its capability as a drug we believe based on the overall data we have generated so far that MOR103 represents a very promising therapeutic candidate in our pipeline."

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

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

www.morphosys.com/en/news_investors/p...

flosz 3 september 2008 08:35

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...

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