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Morphosys-Galapagos, Therapeutic Antibodies

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MorphoSys Initiates Phase 2 Study of Anti-CD19 Antibody MOR208 in B-cell Acute Lymphoblastic Leukemia
April 26, 2013 / 7:30 am, CET

MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX) announced today that it has dosed the first patient in a Phase 2 clinical trial of MOR208 in B-cell acute lymphoblastic leukemia (B-ALL). MOR208 is a potent monoclonal Fc optimized anti-CD19 antibody to which MorphoSys gained worldwide access via an exclusive license and collaboration agreement with Xencor in 2010.

The US-based study is an open-label, multicenter, single-arm clinical trial designed to assess the efficacy of MOR208 in patients suffering from relapsed or refractory B-ALL. Secondary outcome measures include response duration, safety and pharmacokinetics of MOR208. In total, 30 patients are planned to be enrolled. More information on the trial can be found by searching for MOR208 at www.clinicaltrials.gov.

"Due to its high expression levels on non-Hodgkin's lymphomas and B-cell leukemias CD19 represents a particularly attractive immunotherapy target for hematological cancers," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "What is unique about MOR208 is that the antibody comprises only a very minor change to the Fc part of the molecule leading to significantly increased potency."

MOR208 has shown in a Phase 1/2a trial encouraging signs of preliminary anti-tumor activity and an acceptable safety and tolerability profile in patients with high-risk, heavily pretreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In addition to the Phase 2 trial in B-ALL MorphoSys is about to start a second Phase 2 trial in Non-Hodgkin's Lymphoma (NHL).

B-cell malignancies, such as B-ALL, NHL and CLL affect more than one hundred and fifty thousand patients in the seven major markets each year. The target molecule CD19 is expressed more broadly and earlier in B-cell development than CD20, the target of the marketed cancer drug Rituxan®. Therefore targeting CD19 could potentially allow for an even broader therapeutic use of MOR208 than marketed anti-CD20 antibodies.

About MorphoSys:
MorphoSys developed HuCAL, the most successful antibody library technology in the pharmaceutical industry. By successfully applying this and other patented technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human healthcare.
Together with its pharmaceutical partners, MorphoSys has built a therapeutic pipeline of more than 70 human antibody drug candidates for the treatment of cancer, rheumatoid arthritis, and Alzheimer's disease, to name just a few. With its ongoing commitment to new antibody technology and drug development, MorphoSys is focused on making the healthcare products of tomorrow. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about MorphoSys, visit www.morphosys.com.

HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla®, Ylanthia® and 100 billion high potentials® are registered trademarks of MorphoSys AG.

Slonomics® is a registered trademark of Sloning BioTechnology GmbH, a subsidiary of MorphoSys AG.

This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve risks and uncertainties. Should actual conditions differ from the Company's assumptions, actual results and actions may differ from those anticipated. MorphoSys does not intend to update any of these forward-looking statements as far as the wording of the relevant press release is concerned.

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morphosys KOERSDETAILS in 1 jaar van Eur 16 naar ruim EUR 34
Vertraagd 30-apr-13 11:31
Koers 34,476
Verschil +0,05 (+0,14%)
Hoog 34,713
Laag 34,330
Volume 2.008
Volume gemiddeld 1.232
Volume gisteren 2.613
Vertraagd 30-apr-13 11:31
Bied 34,110 (700)
Laat 34,200 (700)
Open 34,330
Close 34,427
52 weeks hoog 35,194
52 weeks laag 16,039
Gala-diner
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quote:

grapesharvester schreef op 30 april 2013 12:01:

morphosys KOERSDETAILS in 1 jaar van Eur 16 naar ruim EUR 34
Vertraagd 30-apr-13 11:31
Koers 34,476
Verschil +0,05 (+0,14%)
Hoog 34,713
Laag 34,330
Volume 2.008
Volume gemiddeld 1.232
Volume gisteren 2.613
Vertraagd 30-apr-13 11:31
Bied 34,110 (700)
Laat 34,200 (700)
Open 34,330
Close 34,427
52 weeks hoog 35,194
52 weeks laag 16,039
Galapagos binnen een jaar naar de 45 euro?
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Binnen 2 jaar 45 euro is ook goed .

Wordt weer eens tijd voor een flinke hap omhoog .
Gala-diner
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quote:

bioscience schreef op 30 april 2013 13:36:

Binnen 2 jaar 45 euro is ook goed .

Wordt weer eens tijd voor een flinke hap omhoog .

Ik verwacht toch dat het wel eens snel kon gaan, verwacht nog diversen mooie ontwikkelingen dit jaar.
Ondertussen zal de service-divisie blijven groeien en daardoor de waarde daarvan mee groeien.
Ik schat dat een liefhebber er nu al ruim 300 miljoen voor over zou hebben, die waarde wordt uiteraard niet alleen door de omzet en winst bepaald, de unieke technologie die ze in huis hebben heeft ook een behoorlijke waarde voor bepaalde partijen.
Blijf erbij dat de koers nog steeds niet hoog is, bar weinig 'fantasie' in verwerkt.
Komt tijd, komt Galapagos!
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MorphoSys AG Reports Results for the First Quarter of 2013
May 03, 2013 / 7:00 am, CET

First Quarter Positively Impacted by Sale of AbD Serotec

Conference call and webcast (in English) today at 2:00pm CET (1:00pm GMT/8:00am EST)

MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX) today announced its financial results for the three months ending 31 March 2013. Group revenues from continuing operations increased by 44 % to EUR 16.9 million compared to the same period of the previous year. The reason for the increase was a fully paid-up license payment from Bio-Rad for a non-exclusive license for HuCAL in research and diagnostic applications in connection with the sale of the Company's AbD Serotec segment to Bio-Rad. Earnings before interest and taxes (EBIT) from continued operations amounted to EUR 2.5 million (Q1 2012: EUR -0.7 million). On 31 March 2013, MorphoSys's cash, securities and interest-bearing assignable loans amounted to EUR 177.4 million (31 December 2012: EUR 135.7 million).
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Highlights of the First Quarter

MorphoSys completes sale of AbD Serotec to Bio-Rad. With the divestment of AbD Serotec completed, MorphoSys can devote 100% of its attention to building value in its core therapeutics business.
MorphoSys and Heptares sign alliance to develop antibody therapeutics targeting G protein-coupled receptors (GPCRs). The collaboration opens up new target space for therapeutic antibodies from the MorphoSys Ylanthia platform.
MorphoSys receives first patent on novel antibody platform Ylanthia in the US.
MorphoSys achieves first clinical milestone in a partnered program in 2013 as Novartis completes clinical trial application for a phase 1 study using a HuCAL antibody in ophthalmology.
At the end of the first quarter of 2013, the MorphoSys partnered and proprietary pipeline comprises 21 clinical programs.
Shortly after the end of the first quarter, MorphoSys initiates a share buy-back program, and plans to acquire up to 85,000 shares. The Company intends to use the shares primarily for its long-term incentive programs for its management.
"We expect 2013 to be a very exciting year for MorphoSys with our pipeline being once again the main newsflow and value driver," stated Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "With the sale of AbD Serotec successfully completed, we can now focus on advancing our proprietary and partnered development pipeline."

"The Q1 2013 results again highlight the attractive terms we were able to secure in the AbD Serotec divestment. With the sale of AbD Serotec we strengthened our financial resources, allowing us to increase our investments in proprietary research and development," commented Jens Holstein, Chief Financial Officer of MorphoSys AG.
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In EUR million* Q1 2013 Q1 2012
Continuing Operations:
Group Revenues 16.9 11.7
Total Operating Expenses 14.6 12.5
Other Income/Expenses 0.2 0.1
Earnings Before Interest and Taxes (EBIT) 2.5 (0.7)
Profit/Loss from Continuing Operations 1.9 (0.3)
Profit/Loss from Discontinued Operations 6.0 (0.2)
Consolidated Net Profit 7.9 (0.5)
Total EPS (diluted) in EURO 0.33 (0.02)
* Differences due to rounding
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MorphoSys AG (MOR)koers vandaag omhoog +2.59% € 35.22
gisteren het volgende bericht:

Antibody MOR208 in Non-Hodgkin's Lymphoma
May 13, 2013 / 7:30 am, CET

MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX) announced today that it has dosed the first patient in a Phase 2 clinical trial of MOR208 in Non-Hodgkin's Lymphoma (NHL). MOR208 is a potent Fc-optimized anti-CD19 antibody to which MorphoSys gained worldwide rights via an exclusive license and collaboration agreement with Xencor in 2010.

The open-label, multicenter, single-arm clinical trial is designed to assess the efficacy of MOR208 in patients with relapsed or refractory Non-Hodgkin's Lymphoma. Secondary outcome measures include response duration, safety and pharmacokinetics of MOR208. A total of up to 120 patients are planned to be enrolled in four separate sub-indications (FL, MCL, DLBCL and other forms of indolent NHL). More information on the trial can be found by searching for MOR208 at www.clinicaltrials.gov. The trial is to be conducted at sites across both Europe and the US.

"In MOR208 we have a very exciting cancer program with a huge potential. Evaluating MOR208 in NHL and B-ALL - building on the data we already have for CLL - should enable us to assess the therapeutic benefit and broader commercial potential of the molecule in hematological malignancies," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "Broadening the drug's development program into additional indications is intended to maximize the value of this compound."

MOR208 showed encouraging signs of preliminary anti-tumor activity and an acceptable safety and tolerability profile in a Phase 1/2a trial in patients with high-risk, heavily pretreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In addition to the phase 2 trial in NHL, MorphoSys is currently evaluating the compound in a phase 2 trial in B-cell Acute Lymphoblastic Leukemia (B-ALL).

B-cell malignancies, such as B-ALL, NHL and CLL affect more than one hundred and fifty thousand patients in the seven major markets each year. The target molecule CD19 is expressed more broadly and earlier in B-cell development than CD20, the target of the marketed cancer drug Rituxan®. Therefore targeting CD19 could potentially allow for an even broader therapeutic use of MOR208 than marketed anti-CD20 antibodies.
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Op 26 june 2013 door Aston martin in de koersdraad van Gala geplaatst: Morphosys:Development of novel therapeutic antibody approach being evaluated in clinical trials for patients with multiple myeloma

MorphoSys will hold a conference call on Thursday, June 27, at 4:00pm CEST (3:00pm GMT/10:00am EDT)
Celgene secures worldwide rights to MOR202, whereby the companies will jointly develop MOR202 globally and co-promote the product in Europe
MorphoSys retains a 50/50 profit sharing in its co-promotion territory and is eligible to receive tiered double-digit royalties outside of the co-promotion territory

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) and Celgene Corporation (CELG) today announced an agreement to jointly develop MOR202 globally and to co-promote MOR202 in Europe. MOR202 is a fully human monoclonal antibody targeting CD38 to treat patients with multiple myeloma (MM) and certain leukemias. MOR202 is currently being evaluated in a phase 1/2a trial in patients with relapsed/refractory myeloma. MorphoSys and Celgene will collaborate on the development of MOR202 in multiple myeloma and other indications and share costs on a 1/3:2/3 basis.
Under the terms of the agreement, MorphoSys will receive an upfront license fee of EUR 70.8 million (US $92 million) and Celgene will invest EUR 46.2 million (US $60 million) to subscribe for new shares of MorphoSys AG. The new shares will be issued at a price to be determined upon the transaction becoming effective following clearance by the US antitrust authorities under the Hart-Scott-Rodino Act. The share price will include at least a premium of 15% of the closing price of the MorphoSys share prior to the signature of the agreement. MorphoSys may be entitled to receive additional development, regulatory and sales milestones, in addition to tiered double digit royalties on net sales outside the co-promotion territory. MorphoSys retains a 50/50 profit sharing in its co-promotion territory. The total potential value of this transaction, assuming all development, regulatory and sales milestones are reached, may be up to EUR 628 million (US $818 million).
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Naar aanleiding van het bericht van 26 juni, vraag ik mij af wat dit voor gevolgen heeft voor de gezamenlijke ontwikkeling met Gala op het gebied van botten waar dit draadje mee startte.

Duidelijk beschikt Morphosys nu over meer cash dan ooit.
De koers is overigens inmiddels gestegen van EUR 38 tot EUR 48. Niet verkeerd voor 10 dagen.
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Ik heb begrepen dat Morpho en Gala medio 2013 gezamenlijk een presentatie geven over de voortgang. Als de presentatie vooraf wordt gegaan door een indrukwekkend PB ben ik tevreden.
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stappa schreef op 6 juli 2013 11:05:

Ik heb begrepen dat Morpho en Gala medio 2013 gezamenlijk een presentatie geven over de voortgang. Als de presentatie vooraf wordt gegaan door een indrukwekkend PB ben ik tevreden.
Op zich is het niet raar dat er een update komt (positief of negatief) omdat er inmiddels vijf jaar zijn verstreken en in het eerste bericht het doel was gesteld om na vijf jaar de fase te bereiken die zij in de samenwerking voor ogen hadden.
Kun je aangeven waar je de info vandan hebt dat er inderdaad medio 2013 een update komt? Ik kan het zelf nergens vinden.

Midden 2013 zou volgende week al kunnen zijn.

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@grapesharverster

Bij de presentatie van de jaarcijfers 2012 van Morphosys (05 maart 2013) heeft Thomas Schiessle van EQUI.TS GmbH tijdens de Q&A de volgende vraag gesteld:

And the second question is specific on collaboration with Galapagos. Will there be any inflection point in the current year to be reached?

Met het volgende antwoord van Simon Moroney van Morphosys.

Regarding Galapagos, I hope that we'll be able to give an update with our friends at Galapagos on progress this year. We continue to work together with them, and we're looking forward to be able to give you an interim update perhaps later in the year, together with Galapagos.

Voor de PDF:
www.morphosys.com/sites/default/files...

blz 17 voor de passage
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grapesharvester schreef op 6 juli 2013 10:52:

Naar aanleiding van het bericht van 26 juni, vraag ik mij af wat dit voor gevolgen heeft voor de gezamenlijke ontwikkeling met Gala op het gebied van botten waar dit draadje mee startte.

Duidelijk beschikt Morphosys nu over meer cash dan ooit.
De koers is overigens inmiddels gestegen van EUR 38 tot EUR 48. Niet verkeerd voor 10 dagen.
Inmiddels is de koers van Morphosys verder opgelopen naar EUR 51.57.
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31 July Morphosys - Outlook for 2013

MorphoSys re-confirmed its guidance for 2013, which was updated on 3 June 2013 to reflect the impact of the license agreement with GSK for the future development of MOR103. The licensing agreement with Celgene for MOR202 is subject to clearance by the US antitrust authorities under the Hart-Scott-Rodino Act, and will become effective as soon as this condition has been met. Therefore, potential financial implications are not yet reflected in the current guidance.

The Company's management expects revenues of approximately EUR 68 million to EUR 72 million and an EBIT of EUR -2 million to EUR +2 million.

Verdere details van persbericht zie website Morphosys.
Nog geen tijd gehad de conference call te beluisteren.

Opmerkelijk voorts dat Morgan Stanley inmiddels meer dan 5% heeft opgebouwd in Morphosys. Als toesteming voor Celgene deal binnen is volgt weer een update en upgrade van de guidance.
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de webcast van Morphosys is op hun website beschikbaar.

Daar spreekt veel vertrouwen uit voor de toekomst.
Het voorbehoud voor de toestemming van de deal met Celgene lijkt slechts een formaliteit.

Morphosys wil met het verkregen en te verkrijgen geld bestaande produkt ontwikkelingen gaan versnellen en ook zaken gaan kopen voor meer spreiding in de pipeline.
Verder meldt Morphosys voortgang in de ontwikkelingen met partners, waarbij in meerdere programma's het moment dichterbij komt dat daar door de partners iets over naar buiten gebracht gaat worden (zelf mogen zij dat niet doen).
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Koers nu boven de EUR 59
Is hard gegaan met een koersstijging van EUR 18 naar EUR 59 binnen 12 maanden. Ik ben benieuwd wie hier aan het verzamelen is. Dat kan Celgene zelf zijn of JP Morgan of Morgan Stanley (beiden al of niet in opdracht van Celgene), maar ook een andere partner zoals Takeda.

quote:

grapesharvester schreef op 3 augustus 2013 23:48:

de webcast van Morphosys is op hun website beschikbaar.

Daar spreekt veel vertrouwen uit voor de toekomst.
Het voorbehoud voor de toestemming van de deal met Celgene lijkt slechts een formaliteit.

Morphosys wil met het verkregen en te verkrijgen geld bestaande produkt ontwikkelingen gaan versnellen en ook zaken gaan kopen voor meer spreiding in de pipeline.
Verder meldt Morphosys voortgang in de ontwikkelingen met partners, waarbij in meerdere programma's het moment dichterbij komt dat daar door de partners iets over naar buiten gebracht gaat worden (zelf mogen zij dat niet doen).
harrysnel
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Novartis receives FDA breakthrough therapy designation for BYM338 (bimagrumab) for sporadic inclusion body myositis (sIBM)

"..BYM338 was developed by the Novartis Institutes for Biomedical Research (NIBR), in collaboration with Morphosys, whose HuCAL library was used to identify the antibody..."

www.novartis.com/newsroom/media-relea...
Gala-diner
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quote:

harrysnel schreef op 20 augustus 2013 12:17:

Novartis receives FDA breakthrough therapy designation for BYM338 (bimagrumab) for sporadic inclusion body myositis (sIBM)

"..BYM338 was developed by the Novartis Institutes for Biomedical Research (NIBR), in collaboration with Morphosys, whose HuCAL library was used to identify the antibody..."

www.novartis.com/newsroom/media-relea...
Blijkbaar een beloftevolle partner voor Galapagos!
Bedankt voor de post, Harry.
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Vertraagd 19 apr 2024 17:35
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