XOMA - 500 Beiträge pro Seite

[BigLinus]

XOMA develops and manufactures innovative biopharmaceuticals at its research, pre-clinical, clinical development and production facilities in Berkeley, California.

Medical Targets: cancer, immunological and inflammatory disorders, and infectious diseases.

Core Technologies: developing and manufacturing recombinant antibodies and proteins using genetic engineering and cell expression systems.

Business Strategy: XOMA develops products from research through manufacturing scale-up and clinical trials, and partners products for clinical trials, commercialization and marketing.

Strategic Alliances:





Antibody and Protein Products

Raptiva™
Genentech and XOMA are developing Raptiva (efalizumab), a humanized anti-CD11a monoclonal antibody, to treat moderate-to-severe psoriasis, rheumatoid arthritis and other immunological indications.

In September, Genentech and XOMA announced that a third, double-blinded Phase III trial conducted with Genentech material achieved its primary efficacy endpoint and was consistent with data obtained with two previous Phase III Raptiva studies that used both Genentech and XOMA material.

Raptiva investigators also presented encouraging new interim data from an open-label extended treatment study at the American Academy of Dermatology meeting in August 2002. The study demonstrated that 79.1 percent of the cohort of patients completing one year of Raptiva therapy maintained 50 percent or greater improvement in Psoriasis Area and Severity Index (PASI) scores (PASI 50). Sixty-one percent of this cohort had 75 percent or greater PASI improvement (PASI 75) after one year of therapy. Genentech continues to enroll psoriasis patients in a number of ongoing studies that are producing additional safety data and will provide data useful for practicing dermatologists and patients.

Three Critical Steps in Psoriasis Pathogenesis Targeted by Raptiva™


Subject to additional input from the FDA, Genentech and XOMA plan to submit a BLA (Biologics Licensing Application) by the end of 2002.

In August 2002, it was announced that Serono will be the marketing partner for Raptiva in Europe and the Americas outside the United States. Serono has announced its intention to file for marketing approval in Europe in the first quarter of 2003.

XOMA and Genentech have a cost and profit sharing agreement for Raptiva in the United States, and XOMA will receive a royalty on sales outside the United States.

Subject to additional input from the FDA, Genentech and XOMA plan to submit a BLA (Biologics Licensing Application) by the end of 2002.

Raptiva and Rheumatoid Arthritis
In addition to the ongoing psoriasis program, XOMA and Genentech are currently conducting a Phase II efficacy study of Raptiva in moderate-to-severe rheumatoid arthritis patients. Enrollment is targeted to complete at the end of 2002, and patients will be followed for an additional six months.

Millennium Collaboration: CAB2 and MLN01
Millennium and XOMA are developing two biotherapeutic agents, CAB2 and MLN01, for certain vascular inflammation indications. CAB2 is a recombinant fusion protein that inhibits complement activation. MLN01 is a humanized monoclonal antibody that inhibits inflammatory responses by blocking the attachment of Beta 2 integrins to their adhesion molecules. Process development work and preclinical testing is currently ongoing, leading to clinical studies in 2003.

Onyx Collaboration: ONYX-015
In January 2001, Onyx Pharmaceuticals, Inc. and XOMA entered into a strategic process development and manufacturing relationship. XOMA is responsible for the scale-up production and manufacturing of ONYX-15, a genetically engineered and modified human adenovirus that targets abnormal cells within the p53 function, for the treatment of various cancer types.

Onyx is currently conducting Phase III trials in head and neck cancer patients. Phase I/II clinical trials evaluating ONYX-015 in patients with liver metastases of colorectal cancer and pancreatic cancer have also been conducted in addition to a Phase I clinical trial evaluating ONYX-015 in patients who have advanced cancers with lung tumors.

ING-1 Internal Development Program
ING-1 is a broad-spectrum anti-cancer antibody. XOMA is conducting a series of Phase I studies in patients with a variety of refractory adenocarcinomas to evaluate the safety, immunogenicity, pharmacodynamics and pharmacokinetics of ING-1 in patients, and to document any observed anti-tumor activity. ING-1 uses XOMA’s patented Human Engineering™ (HE) technology to reduce potential immunogenicity. HE is available for licensing. Encouraging first clinical data on ING-1 and HE were presented at the American Society of Clinical Oncology (ASCO) in May 2002.


ING-1 Mechanism of Action



BPI-Derived Products
BPI (bactericidal/permeability-increasing protein) is a human host-defense protein. It kills bacteria, neutralizes endotoxins, enhances antibiotic activity (including against resistant strains), and inhibits angiogenesis.

NEUPREX® is an injectable formulation of rBPI 21 for systemic administration. In January 2000, Baxter became XOMA’s NEUPREX® development and marketing partner. In July 2001, Baxter initiated a Phase II study testing NEUPREX® in patients with Crohn’s disease, a systemic inflammatory condition primarily affecting the gastrointestinal tract that may be associated with endotoxemia.

XOMA is also testing BPI-derived anti-angiogenic compounds with potential for treating retinal disorders, such as diabetic retinopathy, the leading cause of adult blindness. Results of in vitro and in vivo studies conducted by Harvard’s Joslin Diabetes Center showed that these compounds inhibit abnormal growth of blood vessels in the retina without adversely affecting retinal pigment epithelial cells (RPEs) or retinal pericytes, which are essential for healthy functioning of the retina. Joslin is conducting further research in collaboration with XOMA.

Cell Expression Technology
XOMA has been a leader in the field of recombinant protein and antibody development and manufacturing since the early 1980s. XOMA’s antibody expression technology and its expertise in genetic engineering and cell expression systems is supported by a broad patent portfolio and various licensing agreements with more than 25 biotechnology and pharmaceutical companies worldwide.

Thus far, XOMA has entered into two cross-licensing agreements for antibody-related technologies in 2002; one in February with Morphosys AG and one in September with Biosite, Incorporated. Under the respective agreements, MorphoSys and Biosite receive licenses to use the XOMA antibody expression technology for antibody phage display research and for the development and production of antibodies and antibody products. From MorphoSys, XOMA will receive the MorphoSys HuCAL GOLD antibody library for use in XOMA’s target discovery and research programs. From Biosite, XOMA will have the right to present an agreed number of targets to Biosite and receive Biosite Omniclonal expression libraries, including screened high-affinity antibodies for each target presented. Additional license rights were granted and received under these cross-license agreements.

Diagnostics

Diagnostic Products Corporation
(DPC) is developing diagnostic tests for the detection of systemic infections from XOMA’s LBP (lipopolysaccharide binding protein) assay and marketing them in Europe.

XOMA Product Development Pipeline


Ciao BigLinus

[BigLinus]

[BigLinus]

XOMA and Dyax Cross-License Antibody Technologies
Dyax Becomes Third Licensee of XOMA Technology Among Antibody Library Companies
Wednesday October 16, 8:31 am ET


BERKELEY, Calif. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 16, 2002--XOMA Ltd. (Nasdaq: XOMA - News) and Dyax Corp. (Nasdaq: DYAX - News) announced today they have entered into a cross-licensing agreement for antibody-related technologies. Under the agreement, Dyax receives a license to use XOMA`s antibody expression technology for developing antibody products for itself and for Dyax collaborators. Dyax also receives a license for the production of antibodies under the XOMA patents. XOMA will receive license and royalty payments from Dyax in addition to a Dyax antibody library and a license to Dyax`s phage display patents known as the Ladner patents.

The agreement also provides for a release of Dyax and its collaborators from claims under the XOMA patents arising from any past activities using Dyax technology to the extent they also used XOMA`s antibody expression technology and allows Dyax to use the XOMA technology in combination with its own technology in any future collaborations.

"We are very pleased to enter into this antibody related licensing arrangement with Dyax, a company with excellent capabilities in the important field of antibody discovery and selection," said Jack Castello, Chairman, President and Chief Executive Officer, XOMA Ltd. "Our license to Dyax, being the third such license this year with a significant antibody library company, further validates the fundamental position our antibody expression technology holds in the phage display arena. We are also pleased to expand our target discovery and therapeutic antibody development capabilities with the Dyax antibody library and a license to the Ladner patents, which are fundamental to the practice of antibody phage display."

"Through this agreement, Dyax is pleased to add XOMA`s bacterial antibody expression technology to the package of technology and services we are able to provide to our current and future antibody technology customers," said Henry E. Blair, Chairman and CEO of Dyax Corp. "We are especially pleased to gain access to this key technology for Dyax`s internal therapeutic product development and manufacturing programs."

About XOMA and its Antibody Expression Technology

Bacterial antibody expression is an enabling technology used to discover and screen, as well as develop and manufacture, recombinant antibodies for commercial purposes. Expression of antibodies by phage display technology depends upon the expression and secretion of antibody domains from bacteria as properly folded, functional proteins. XOMA scientists were the first to demonstrate the secretion of antibody domains directly from bacterial cells as fully functional, properly folded molecules. XOMA has received six U.S. patents to date that broadly cover the secretion of functional immunoglobulins from bacteria, including antibody fragments such as Fab and single-chain antibodies. Corresponding foreign patents have also been granted. Access to XOMA`s patent estate is necessary for the practice of antibody phage display and other antibody screening applications.

XOMA develops and manufactures innovative biopharmaceuticals for disease targets that include cancer, immunological and inflammatory disorders, and infectious diseases. XOMA`s programs include collaborations with: Genentech, Inc. on the Raptiva(TM) antibody for psoriasis (Phase III), rheumatoid arthritis (Phase II) and other indications; Onyx Pharmaceuticals, Inc. to develop and manufacture its ONYX-015 product for various cancers (Phase II and III); Baxter Healthcare Corporation to develop NEUPREX® (rBPI-21) for Crohn`s disease (Phase II) and other indications; and Millennium Pharmaceuticals, Inc. on two biotherapeutic agents for certain vascular inflammation indications (preclinical). Earlier-stage development programs include compounds to treat cancer, retinopathies, autoimmune diseases and infections. For more information about XOMA`s pipeline and activities, please visit XOMA`s web site at www.xoma.com.

About Dyax and its Phage Display Technology

Dyax`s Ladner patents have the earliest priority date for phage display patents in the United States and are the core patents in phage display technology. With 4 granted patents in the United States, Dyax has over 60 licensees to the Ladner patents, making this patent licensing program one of the most successful in the biotechnology industry. Access to the Ladner patents is necessary to the practice of any display technology, including the display of antibodies, peptides, and proteins on any cell, spore, or virus, including bacteriophage.

Dyax Corp. is a biopharmaceutical company focused on the discovery, development and commercialization of therapeutic products. The Company uses its patented phage display technology to rapidly identify a broad range of protein, peptide, and antibody compounds that bind with high affinity and high specificity to targets of interest, with the objective of selecting those compounds with the greatest potential for advancement into clinical development. Dyax currently has two recombinant proteins in phase I and II clinical trials. DX-88 is being studied in two indications (hereditary angioedema and cardiopulmonary bypass), while DX-890 is being studied for cystic fibrosis. Dyax leverages its technology broadly through licenses and collaborations in therapeutics and in non-core areas of affinity separations, diagnostics and imaging, and research reagents. Through its subsidiary, Biotage, Inc., Dyax develops, manufactures and sells chromatography separations systems and products worldwide for drug discovery and purification.

Ciao BigLinus

[BigLinus]

BPI Peptide Program: Mycoprex(tm),
and Other BPI-derived Peptides

Introduction
XOMA Corporation has a pipeline of therapeutic products based on bactericidal/permeability-increasing protein (BPI), a human host-defense protein with multiple anti-infective properties. Scientists at XOMA have identified a number of peptides and peptidomimetics, small molecular derivatives of BPI, that have shown potent activity in five therapeutic areas. XOMA is developing a number of these BPI-derived peptide compounds for pharmaceutical use. XOMA`s current peptide program is focused primarily on developing a BPI-derived antifungal peptide product, and on antiangiogenesis peptides.

What is BPI?
BPI was discovered by XOMA`s collaborators at New York University Medical School and is found in certain white blood cells (neutrophils). As part of the natural host-defense system against bacterial infection, BPI kills and neutralizes gram-negative bacteria, and inhibits angiogenesis (growth of blood vessels).

XOMA scientists found that derivatives of BPI showed all these activities and also enhanced the activity of antibiotics. An injectable formulation of one of these derivatives, NEUPREX®, a systemic formulation of rBPI-21, is now in clinical trials.

BPI-derived Peptides
XOMA scientists discovered three active areas (functional domains) within the N-terminal fragment of BPI (the amino-terminal 199 amino acid fragment). XOMA researchers have identified and characterized a number of peptides (small chains of amino acids) derived from these domains that show potential as new pharmaceuticals. XOMA scientists have derived distinct groups of potent peptides from BPI with five types of bioactivity:

- antifungal (kills or inhibits fungi)
- antibacterial (kills or inhibits bacteria)
- endotoxin-neutralizing (inhibits toxic bacterial molecule)
- heparin-neutralizing (inhibits anticoagulant activity of heparin)
- anti-angiogenic (inhibits growth of new blood vessels)

XOMA has undertaken a screening program for BPI-derived peptides. A number of peptide compounds have undergone testing in vitro and in vivo for safety and efficacy. A number of these experiments have been presented at ICAAC from 1994 through 1997 (XOMA presentations: ICAAC `96, ICAAC `97, ICAAC `98, ICAAC `99).

Patent Position
XOMA is building a broad patent position related to its work with BPI, including BPI-derived peptides, and now controls more than 50 issued patents in the U.S. and Europe, plus notices of allowance, and applications for more than 20 additional patents.

Near-Term Therapeutic Targets
XOMA is developing active peptide compounds from the BPI platform for the five different pharmaceutical applications. At present, development priority is focused on one group of these peptides that showed potent fungicidal activity against multiple strains of common pathogenic fungi.

A safer and more effective fungicidal than those currently available could be used to treat systemic fungal infections, a growing problem in AIDS patients and others with compromised immune systems. Several antifungal peptide compounds are now in toxicology studies and XOMA is seeking a development partner to collaborate on bringing one of them (to be called Mycoprex(tm)) into the clinic.

Longer-Term Targets
Antiangiogenesis: the company is also developing anti-angiogenic compounds that may be useful in treating ophthalmic conditions, chronic inflammatory conditions or treat tumors by preventing blood vessel growth (angiogenesis).

The antibacterial properties of BPI-derived peptides suggest additional applications. Given the increasing concern over bacterial resistance to antibiotics, antibacterials with a different mode of action could be combined with available antibiotics to overcome antibiotic resistance. XOMA scientists have produced BPI-derived peptides that kill certain gram-positive bacteria and mycoplasma, as well as gram-negative bacteria. A peptide product with a broad spectrum of antimicrobial activity could expand XOMA`s pipeline of infectious disease therapies.

Ciao BigLinus

[VASCO@DAGAMA]

>


...Mein Gott BigLinus



du musst es ja nötig haben!

Mit wieviel Aktien bist du eingestiegen?

>

[BigLinus]

@Vasco
Ich bin selbst bei einem Totalverlust bei XOMA im Plus! Hoffentlich klappt es mit meinem Lieblingsinvest nochmals so gut.
Ciao BigLinus

[eck64]

Hallo Big Linus:
Mit Xoma kennst du dich ja aus.
Schreib mal was aus deiner Sicht über den Deal mit Morphosys. Lizenzaustausch und zusätzlich Aktien. Muss/wird Xoma die verkaufen? Was ist die Xoma-Lizenz sonst so wert?
Usw. Was dir so einfällt.

Danke vorab.

[eck64]

Hi BigLinus,
schönes Wochenende gehabt? Schreibst du mal was? Oder gib eine gute Quelle an, bezüglich des Lizenzwertes....

[VASCO@DAGAMA]

>
Möchte ja nicht unhöflich sein!

Aber eine Frage eck64 warum kennt sich BigLinus
mit Xoma aus?


Ich meine irgendwelche Texte und Bildchen in English
aus dem Internet herunterladen und bei W. O. reinstellen das kann doch jeder!



Bedeutet das etwa man ist dann Xoma Fachmann?



Gruß

Vasco

[VASCO@DAGAMA]

>

Hallo Biglinus

Würde mit Xoma vorsichtig sein!


:O>Wenn die wieder eine Pleite mit ihrer Forschung erleben dann gibts kein halten mehr!

Dümpelt mir schon zu lange auf der Stelle.
Mit Tendenz in Richtung Süden!



VaSCO
>

[eck64]

Wie gut er sich wirklich auskennt weiß ich natürlich nicht. Aber immerhin hat er sich mit XOMA beschäftigt und hier einiges an Infos reingestellt, damit alleine kennt er sich schon besser aus als ich z.B.

@Vasco:
Wenn du dich nicht nur zum mosern berufen fühlst, sondern auch mit Infos dienen kannst, dann tue dir keinen Zwang an. Kriegen andere die Lizenz umsonst und nur Mor ist so blöd mit eigener Lizenz und zusätzlich einem stattlichen Paket und späteren Tantiemen zu bezahlen? Darfst mir gerne auf die Sprünge helfen.

[VASCO@DAGAMA]

>
Eine Frage der Zeit wann Morphosys pleite ist.
<

[VASCO@DAGAMA]

>
Muß schon sagen, dass BigLinos sich einige Arbeit gemacht hat!

...Tat ich es wurden nur beleidigende Kommentare abgegeben!

Wer das Risiko eingehen will Xoma über Nacht im Depot zu lassen, muß damit schlafen gehen.

Da in Frankfurt so gut wie kein Handel stattfindet,
könnte man Schwierigkeiten bekommen den Wert zu einem angemessenen Preis zu verkaufen.
...Es sei denn man kann an der Nasdaq handeln, damit dezimiert sich das Risiko beträchtlich!
>

[eck64]

#12
Sehr fundiert, Vasco.
Klar geht Mor pleite, wenn sich kein weiterer Finazier findet. Ist doch ein alter Hut.

Bloss warum schenkt XOMA eine Lizenz an einen Pleitekandidaten gegen Aktien her? Irgendwie scheinen deine geistreichen postings darauf hinzudeuten, dass du auch keine Ahnung hast. Habe abe nichts dagegen, wenn du mich vom Gegenteil überzeugst....

[VASCO@DAGAMA]

Human Genome Sciences:



Kursverluste nach Zahlen.


:ONettoverlust auf 75,1 Mio. Dollar verdreifacht,

:OUmsatz bei 1,6 Mio. Dollar

Tiefrote Zahlen hat das Biotech-Unternehmen
für das abgelaufene Quartal ausgewiesen.

Daran wird sich auf Sicht mehrerer Jahr nichts ändern.

Der Kurs der Aktie von Human Genome Sciences (HGSI) hat auf die Zahlen für das abgelaufene Quartal Nachbörslich mit einem Abschlag von 7,9 Prozent reagiert.


Die Gesellschaft hat eine Nettoverlust

:Ovon 75,1 Mio. Dollar bzw. 58 Cent je Aktie ausgewiesen.

Das ist nicht nur mehr als das Dreifache

vom vergleichbaren Vorjahresquartal, sondern auch ein riesiger Verlust gegenüber den geradezu

kümmerlichen 1,6 Mio. Dollar Umsatz.




>Nun kann sich jedermann ausrechnen
was passieren wird.

>

[VASCO@DAGAMA]

@
ALSO DOCH!



:O>Kräftiger Ausschlag in den R O T E N Bereich!!




Xoma hat am 15.11.2002

über das abgelaufene dritte Quartal berichtet.

Im dritten Quartal ist der Verlust gegenüber dem Vorjahr
von -6,8 auf -12,3 Mio. Dollar gestiegen.

Verlusterhöhung fast 100 %.


Das entspricht -17 Cent je Aktie.

Der Umsatz ist im gleichen Zeitraum

von 3,3 auf 4,2 Mio. Dollar gestiegen.

Die Kosten für Forschung und Entwicklung haben sich

von 8,2 auf 9,7 Mio. Dollar erhöht.




>Medikament und Hoffnungsträger auf der WARTELISTE:

Wäre alles nach Plan verlaufen, dann hätte Raptiva bereits früher den Markteintritt geschafft.

Die US-Behörden haben für den Kandidaten jedoch einen Strich durch die rechnung gemacht.

Von dieser Verzögerung ist Xoma deutlich stärker betroffen als Genentech:

Das Unternehmen schreibt tiefrote Zahlen und erst sprudelnde Erträge aus Tantiemen im Zusammenhang mit Raptiva könnten daran etwas ändern. Das Problem ist, dass

Xoma nur noch

:O>über 36,2 Mio. Dollar Cash verfügt,

was für US-Verhältnisse ein sehr schmales Finanz-Polster ist.

Die Cash-Reserven reichen nach Angaben des Unternehmens, um die geplanten Projekte bis Mitte 2004 zu finanzieren.

Eine Zulassung von Raptiva würde es der Gesellschaft zweifelsfrei erleichtern, die finanzielle Lage durch weitere Mittel zu verbessern.

Bislang gehen Analysten davon aus, dass im kommenden Jahr die Gesellschaft weiter Verluste auf dem Niveau schreibt, wie 2002.


@

[VASCO@DAGAMA]

:
...Und Zeichen stehen weiterhin

:O>auf R O T

:

[fromToronto]

...........................................................

:O>Wie man sehen kann stehen die Zeichen

immer noch auf ROT!


...........................................................

[fromToronto]

...........................................................

>Wie man sehen kann stehen die Zeichen

:O>immer noch auf ROT!


...........................................................