Gliatech-tun around bald in Sicht - 500 Beiträge pro Seite
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Ich bin nach wie vor davon überzeugt, dass Gliatech bald einen Turn around
par exellence hinlegen wird, da die Verkäufe, welche zum fatalen
Kurssturz geführt haben, eine reine Ueberreaktion des naiven Börsenpublikums
gewesen sind.Psychologie ist alles, auf gute wie auf schlechte Nachrichten
Reagiert das Volk immer übertrieben.
Also Gliatechinaer nicht aufgeben und durchhalten, wir werden belohnt werden.
SECOP
par exellence hinlegen wird, da die Verkäufe, welche zum fatalen
Kurssturz geführt haben, eine reine Ueberreaktion des naiven Börsenpublikums
gewesen sind.Psychologie ist alles, auf gute wie auf schlechte Nachrichten
Reagiert das Volk immer übertrieben.
Also Gliatechinaer nicht aufgeben und durchhalten, wir werden belohnt werden.
SECOP
Gliatech hat keine Probleme mit Verkäufen. GLIA hat Probleme mit der FDA:
Hier ist z.Z. die Frage , hat GLIA die FDA mit getürkten Unterlagen bei der Zulassung beschissen oder war es nur ein leichtfertiger Umgang mit Daten gewesen. Im ersten Fall wird die Zulassung zurückgezogen...
Es ist nicht das erste Mal, daß die Jungs Probleme mit der FDA hatten.
Top oder Flopp ? Beides ist möglich.
Hier ist z.Z. die Frage , hat GLIA die FDA mit getürkten Unterlagen bei der Zulassung beschissen oder war es nur ein leichtfertiger Umgang mit Daten gewesen. Im ersten Fall wird die Zulassung zurückgezogen...
Es ist nicht das erste Mal, daß die Jungs Probleme mit der FDA hatten.
Top oder Flopp ? Beides ist möglich.
Yep, ich kann JSK nur zustimmen..
GLIA hat am Freitag gegen den Trend , wenn auch geringfügig , zugelegt. Meinen Zukauf habe ich leider zu eng limitiert, werde am Montag etwas "großzügiger" sein müssen.
Hi Leute,
die Ergebnisse waren vielleicht ein erster Lichtblick. Mal sehen wie es bei den
Analysten ankommt.
Nachzulesen unter:
http://news.stockmaster.com/display_news.asp?mode=news&doc_i…
Um 10:58 in NY 7$ (+14,29%)
CU
Pillehuhn
die Ergebnisse waren vielleicht ein erster Lichtblick. Mal sehen wie es bei den
Analysten ankommt.
Nachzulesen unter:
http://news.stockmaster.com/display_news.asp?mode=news&doc_i…
Um 10:58 in NY 7$ (+14,29%)
CU
Pillehuhn
Trading Spotlight
Hallo an alle,
wie schon im Guilford thread geposted, sehe ich die Situation grundsätzlich wie JSK.
Wenn ich mich für eine Seite entscheiden muß tendiere ich zu der Meinung, daß alles eine Formsache ist. Zwar ärgerlich für Investoren, aber das Produkt muß in Ordnung sein wenn man sich die Akzeptanz in den Klinken anschaut!
Hoffen wir, daß GLIA wieder auf die Beine kommt, Vertrauen aufbaut und nicht wieder enttäuscht.
Aber das Verhalten von Guilford gibt mir immer noch Rätsel auf.
Ich habe GLIA ebenfalls nochmals nachgekauft, denn die ADCON-Produkte haben mein volles Vertrauen!
winetrader
wie schon im Guilford thread geposted, sehe ich die Situation grundsätzlich wie JSK.
Wenn ich mich für eine Seite entscheiden muß tendiere ich zu der Meinung, daß alles eine Formsache ist. Zwar ärgerlich für Investoren, aber das Produkt muß in Ordnung sein wenn man sich die Akzeptanz in den Klinken anschaut!
Hoffen wir, daß GLIA wieder auf die Beine kommt, Vertrauen aufbaut und nicht wieder enttäuscht.
Aber das Verhalten von Guilford gibt mir immer noch Rätsel auf.
Ich habe GLIA ebenfalls nochmals nachgekauft, denn die ADCON-Produkte haben mein volles Vertrauen!
winetrader
Hallo,
zwar ist die Börse momentan sehr stark an earnings und profit interessiert, aber die letzte Veröffentlichung von GLIA MUSS einige Leute davon überzeugt haben, daß ADCON in Ordnung ist. Weiterhin die strategische Ausrichtung und die konsequente weitere Vorgehensweise gibt dem Wert wohl wieder Perspektive.
Erstaunlich ist das gehandelte Volumen vom gestrigen Tag. Scheinbar kommen auch wieder die großen Investoren zurück.
Wir dürfen gespannt sein wie nachhaltig dieser "Schub" ist.
@JSK:
Bin wohl doch richtig rein.
War mehr Musik als bei PC.
winetrader
zwar ist die Börse momentan sehr stark an earnings und profit interessiert, aber die letzte Veröffentlichung von GLIA MUSS einige Leute davon überzeugt haben, daß ADCON in Ordnung ist. Weiterhin die strategische Ausrichtung und die konsequente weitere Vorgehensweise gibt dem Wert wohl wieder Perspektive.
Erstaunlich ist das gehandelte Volumen vom gestrigen Tag. Scheinbar kommen auch wieder die großen Investoren zurück.
Wir dürfen gespannt sein wie nachhaltig dieser "Schub" ist.
@JSK:
Bin wohl doch richtig rein.
War mehr Musik als bei PC.
winetrader
@winetrader
Wie siehst du die Lage von Gliatech sind ja unter die Marke von 5 Dollar gefallen. Lohnt sich ein Einstieg nun oder gibt es schlechte Nachrichten von Gliatech die diese Kurse rechtfertigen. Bin nämlich am überlegen ob ich in GLIA mir eine kleine Position aufbaue. Das gleiche gilt für Lifecell
unter 2 Dollar was ist da los?
Gruß Predo
Wie siehst du die Lage von Gliatech sind ja unter die Marke von 5 Dollar gefallen. Lohnt sich ein Einstieg nun oder gibt es schlechte Nachrichten von Gliatech die diese Kurse rechtfertigen. Bin nämlich am überlegen ob ich in GLIA mir eine kleine Position aufbaue. Das gleiche gilt für Lifecell
unter 2 Dollar was ist da los?
Gruß Predo
Ja, diesen Wert gibt es noch!
In letzter Zeit hat sich GLIA von seinen Tiefsständen gelöst. Frischer Wind, Zuversicht und "neue Besen" scheinen ihre Wirkung zu haben. Scheinbar glauben auch die ersten Investoren wieder an den erfolgreichen Ausgang des FDA-Problems.
winetrader
In letzter Zeit hat sich GLIA von seinen Tiefsständen gelöst. Frischer Wind, Zuversicht und "neue Besen" scheinen ihre Wirkung zu haben. Scheinbar glauben auch die ersten Investoren wieder an den erfolgreichen Ausgang des FDA-Problems.
winetrader
Gliatech Gab Anwendung Vollständigkeit PolitikZeichen Heraus
Fotorezeptor Newswire
Samstag Dezember 23 5:45pm
Cleveland, Dez. 23 / PRNewswire / -- Gliatech Inc. (Nasdaq: GLIA ) verkündete heute den Empfang eines Zeichens von der Nahrung und Drogeleitung (" FDA ") das angab, daß die Bestimmungen der Anwendung Vollständigkeit Politik (" AIP ") sollte an Gliatech angewendet werden, das auf der herausgegebenen Formular-cFda 483 August 23, 2000 hinsichtlich des Pfostenzustimmung US-KLINISCHEN Versuches von ADCON(R)(R)-L basiert. Die vorher verkündete Formular-cFda 483 kennzeichnete bestimmte Einzelteile, die die Aufnahme der Daten und des ProzeßGliatech verwendet wurden in der Aufnahme betreffen und diese Daten der FDA in Bezug auf den US-KLINISCHEN Versuch von ADCON(R)(R)-L darstellen.
In Übereinstimmung mit FDA-Politik setzt die FDA die Gültigkeit der Daten und der Informationen in den Anwendungen Gliatech fest. Die Gültigkeit Einschätzung nimmt Priorität über substantivischer wissenschaftlicher Datenzusammenfassung, bis die Fragen betreffend sind Datenvollständigkeit behoben sind. Infolgedessen verschieben die FDA seine substantivische Zusammenfassung aller Anwendungen der Vormarketing-Zustimmung (" PMA ") oder DIE PMA-Ergänzungen, die von Gliatech eingelegt worden sind. Drei aktuelle Anwendungen die schwebende Zustimmung durch die Mitte für Einheiten und radiologische Gesundheit (CDRH) werden durch diese Politik beeinflußt.
" die schwebenden Anwendungen, die beeinflußt werden, umfassen zwei zusätzliche Anwendungen ADCON(R)(R)-L betreffend sind Aktualisierungsvorgänge, um Einsätze und Produktfreigabespezifikationen zu verpacken. Zusätzlich wird die modulare PMA-Unterordnung für ADCON(R)(R)-P zitiert. Diese modulare Unterordnung wird nicht erwartet, bis funktionierenden Hauptoffizier der Jahresmitte 2001, " sagte Rodney E. Dausch, von Gliatech durchgeführt zu werden. " der Empfang des AIP-Zeichens beeinflußt die aktuelle Verwendbarkeit von ADCON(R)(R)-L nicht zu den Patienten. ",
" Gliatech hat die fortwährenden Diskussionen betreffend sind die Formular-cFda 483 mit der FDA gehabt und wird an einer vollen Zerlegung der Formular-cFda 483 festgelegt. Wir haben bereits eine Anzahl von internen Qualitätsprozeduren eingeführt, um diese Punkte anzusprechen und externe Revisionen, um die Gültigkeit und die Genauigkeit der Daten sicherzustellen, " angegebener Steven L. Basta, Präsident von Gliatech beauftragen.
Gliatech hat auch Berater beibehalten, um eine komplette Auswertung seines Prozesses für klinisches Studien Management und Training durchzuführen. Zusätzlich hat Gliatech Manager und Personalbauteile seinen klinischen Forschung und Qualitätssicherung Abteilungen hinzugefügt.
" wir bleiben überzeugter, daß ADCON(R)(R)-L sicher und wirkungsvoll ist und bedeutenden medizinischen Nutzen zu den Chirurgen und zu den Patienten zur Verfügung stellt, " angegebener Clark E. Tedford, Ph.D., Executivvizepräsident, Forschung und Entwicklung. " die Firma hat für Erwägung durch die FDA die Daten der Kerspintomographie (MRI) unter kontrollierten Bedingungen durch einen unabhängigen, ausgebildeten und blind gemachten Experten neu bewertend vorgeschlagen. Diese Aufwertung findet gegründet auf einer Zusammenfassung und einem Zusammentreffen mit der Agentur statt. Im September schlug die Firma die Zurücknahme der PMA-Ergänzung in der Frage vor und entnahm die Ergänzung mit Zusammentreffen von der Agentur. Die anwesende Tätigkeit durch die Agentur liefert eine formale Einheit, in der wir Zerlegung der Formular-cFda 483 und der dazugehörige AIP behandeln können. Die Firma bereitet eine Antwort zum FDA`s-cAip-Zeichen vor und wird einlegen dieses bei der FDA auf eine fristgerechte Art und Weise. ",
Gliatech nimmt an der Entdeckung und der Entwicklung von biosurgery und von therapeutischen Produkten, um chirurgische Resultate zu verbessern teil und neurologische Störungen zu behandeln. Die biosurgeryprodukte schließen die ADCON(R)(R)-Familie der Produkte, die entworfen werden, um das postoperative Schrammen und die Adhäsionen zu hemmen, und des eigenen monoclonal Antikörpers mit ein, um anti-inflammatory Störungen zu behandeln. Werden neurologische Störungprogramme Gliatech auf Entwicklung der kleinen Moleküldrogeanwärter, um den kognitiven Zustand des nervösen Systems zu modulieren gerichtet und die Symptome von Schizophrenie zu behandeln.
Bestimmte Anweisungen in diesem Pressekommuniqué setzen " Vorwärts-forward-looking Anweisungen " fest, daß abhängig von Gefahren und Ungewißheiten seien Sie, die die tatsächlichen Resultate Gliatech veranlassen können, zu den Erwartungen unterschiedlich zu sein, die ausdrücklich oder durch solche Vorwärts-forward-looking Anweisungen angedeutet sind. **time-out** solch Faktor mit.einschließen, aber sein nicht begrenzt zu, Ungewißheit von Markt Abnahme von Gliatech Produkt, d Ungewißheit von Unkosten dazugehörig mit klinisch Versuch und Forschung Bemühung welch können beeinflussen d fortsetzen Rentabilität von Gliatech, d Fähigkeit von Gliatech zu erreichen ein ausreichend angeben von d Material used in d herstellen von sein ADCON(R)(R) Produkt, Ungewißheit von regulatory Genehmigung durch die zuständige Aufsichtsbehörde, d timing und Inhalt von Entscheidung einschließlich Zusammenfassung von Daten durch d FDA, einschließlich d Entscheidung in Bezug auf fortsetzen Verkauf von ADCON(R)(R)-L, Produkt wieder.aufrufen und d Untersuchungs- Beobachtung durch d FDA, d Ungewißheit von Markt Zustand und ander Gefahr Faktor ausführlich in Gliatech sek Archivierung.
Quelle: Gliatech Inc..
Kontakt: Steven L. Basta, Präsident, 216-831-3200 oder Adam D. Gridley, Beziehung zwischen den Investorenmanager, 216-831-3200, Äußeres 3019, beide von Gliatech
Quelle: Fotorezeptor Newswire
Fotorezeptor Newswire
Samstag Dezember 23 5:45pm
Cleveland, Dez. 23 / PRNewswire / -- Gliatech Inc. (Nasdaq: GLIA ) verkündete heute den Empfang eines Zeichens von der Nahrung und Drogeleitung (" FDA ") das angab, daß die Bestimmungen der Anwendung Vollständigkeit Politik (" AIP ") sollte an Gliatech angewendet werden, das auf der herausgegebenen Formular-cFda 483 August 23, 2000 hinsichtlich des Pfostenzustimmung US-KLINISCHEN Versuches von ADCON(R)(R)-L basiert. Die vorher verkündete Formular-cFda 483 kennzeichnete bestimmte Einzelteile, die die Aufnahme der Daten und des ProzeßGliatech verwendet wurden in der Aufnahme betreffen und diese Daten der FDA in Bezug auf den US-KLINISCHEN Versuch von ADCON(R)(R)-L darstellen.
In Übereinstimmung mit FDA-Politik setzt die FDA die Gültigkeit der Daten und der Informationen in den Anwendungen Gliatech fest. Die Gültigkeit Einschätzung nimmt Priorität über substantivischer wissenschaftlicher Datenzusammenfassung, bis die Fragen betreffend sind Datenvollständigkeit behoben sind. Infolgedessen verschieben die FDA seine substantivische Zusammenfassung aller Anwendungen der Vormarketing-Zustimmung (" PMA ") oder DIE PMA-Ergänzungen, die von Gliatech eingelegt worden sind. Drei aktuelle Anwendungen die schwebende Zustimmung durch die Mitte für Einheiten und radiologische Gesundheit (CDRH) werden durch diese Politik beeinflußt.
" die schwebenden Anwendungen, die beeinflußt werden, umfassen zwei zusätzliche Anwendungen ADCON(R)(R)-L betreffend sind Aktualisierungsvorgänge, um Einsätze und Produktfreigabespezifikationen zu verpacken. Zusätzlich wird die modulare PMA-Unterordnung für ADCON(R)(R)-P zitiert. Diese modulare Unterordnung wird nicht erwartet, bis funktionierenden Hauptoffizier der Jahresmitte 2001, " sagte Rodney E. Dausch, von Gliatech durchgeführt zu werden. " der Empfang des AIP-Zeichens beeinflußt die aktuelle Verwendbarkeit von ADCON(R)(R)-L nicht zu den Patienten. ",
" Gliatech hat die fortwährenden Diskussionen betreffend sind die Formular-cFda 483 mit der FDA gehabt und wird an einer vollen Zerlegung der Formular-cFda 483 festgelegt. Wir haben bereits eine Anzahl von internen Qualitätsprozeduren eingeführt, um diese Punkte anzusprechen und externe Revisionen, um die Gültigkeit und die Genauigkeit der Daten sicherzustellen, " angegebener Steven L. Basta, Präsident von Gliatech beauftragen.
Gliatech hat auch Berater beibehalten, um eine komplette Auswertung seines Prozesses für klinisches Studien Management und Training durchzuführen. Zusätzlich hat Gliatech Manager und Personalbauteile seinen klinischen Forschung und Qualitätssicherung Abteilungen hinzugefügt.
" wir bleiben überzeugter, daß ADCON(R)(R)-L sicher und wirkungsvoll ist und bedeutenden medizinischen Nutzen zu den Chirurgen und zu den Patienten zur Verfügung stellt, " angegebener Clark E. Tedford, Ph.D., Executivvizepräsident, Forschung und Entwicklung. " die Firma hat für Erwägung durch die FDA die Daten der Kerspintomographie (MRI) unter kontrollierten Bedingungen durch einen unabhängigen, ausgebildeten und blind gemachten Experten neu bewertend vorgeschlagen. Diese Aufwertung findet gegründet auf einer Zusammenfassung und einem Zusammentreffen mit der Agentur statt. Im September schlug die Firma die Zurücknahme der PMA-Ergänzung in der Frage vor und entnahm die Ergänzung mit Zusammentreffen von der Agentur. Die anwesende Tätigkeit durch die Agentur liefert eine formale Einheit, in der wir Zerlegung der Formular-cFda 483 und der dazugehörige AIP behandeln können. Die Firma bereitet eine Antwort zum FDA`s-cAip-Zeichen vor und wird einlegen dieses bei der FDA auf eine fristgerechte Art und Weise. ",
Gliatech nimmt an der Entdeckung und der Entwicklung von biosurgery und von therapeutischen Produkten, um chirurgische Resultate zu verbessern teil und neurologische Störungen zu behandeln. Die biosurgeryprodukte schließen die ADCON(R)(R)-Familie der Produkte, die entworfen werden, um das postoperative Schrammen und die Adhäsionen zu hemmen, und des eigenen monoclonal Antikörpers mit ein, um anti-inflammatory Störungen zu behandeln. Werden neurologische Störungprogramme Gliatech auf Entwicklung der kleinen Moleküldrogeanwärter, um den kognitiven Zustand des nervösen Systems zu modulieren gerichtet und die Symptome von Schizophrenie zu behandeln.
Bestimmte Anweisungen in diesem Pressekommuniqué setzen " Vorwärts-forward-looking Anweisungen " fest, daß abhängig von Gefahren und Ungewißheiten seien Sie, die die tatsächlichen Resultate Gliatech veranlassen können, zu den Erwartungen unterschiedlich zu sein, die ausdrücklich oder durch solche Vorwärts-forward-looking Anweisungen angedeutet sind. **time-out** solch Faktor mit.einschließen, aber sein nicht begrenzt zu, Ungewißheit von Markt Abnahme von Gliatech Produkt, d Ungewißheit von Unkosten dazugehörig mit klinisch Versuch und Forschung Bemühung welch können beeinflussen d fortsetzen Rentabilität von Gliatech, d Fähigkeit von Gliatech zu erreichen ein ausreichend angeben von d Material used in d herstellen von sein ADCON(R)(R) Produkt, Ungewißheit von regulatory Genehmigung durch die zuständige Aufsichtsbehörde, d timing und Inhalt von Entscheidung einschließlich Zusammenfassung von Daten durch d FDA, einschließlich d Entscheidung in Bezug auf fortsetzen Verkauf von ADCON(R)(R)-L, Produkt wieder.aufrufen und d Untersuchungs- Beobachtung durch d FDA, d Ungewißheit von Markt Zustand und ander Gefahr Faktor ausführlich in Gliatech sek Archivierung.
Quelle: Gliatech Inc..
Kontakt: Steven L. Basta, Präsident, 216-831-3200 oder Adam D. Gridley, Beziehung zwischen den Investorenmanager, 216-831-3200, Äußeres 3019, beide von Gliatech
Quelle: Fotorezeptor Newswire
NASDAQ minus 7% GLIA plus 35% !!
Die Biotech-Szene erweist sich selbst im Falle von Wackelkandidaten wie Gliatech als sicherer Hafen für Investoren. Hoffentlich hält dies an !?!!
Die Biotech-Szene erweist sich selbst im Falle von Wackelkandidaten wie Gliatech als sicherer Hafen für Investoren. Hoffentlich hält dies an !?!!
Jetzt sind da die echten Hartgesottenen nach Kostolanys Denkweise drin. Was soll die nach den vergangenen Meldungen das schrecken, dass Cisco wohl doch nicht os viel verdienen, wird sich der Großteil der Anleger.
Gestern war der Tag der small caps
Gestern war der Tag der small caps
Mein Text ist ja absolut unleserlich 
(schäm).
Als Interpretationshilfe: Das meinte der "Künstler" in Wirklichkeit.
-------
Jetzt sind da die echten Hartgesottenen in diesem Wert, die Kostolany in seinen Büchern so bezeichnete.
Solche Anleger schrecken aktuelle Cisco-Downgrades von Investmenthäusern oder Gewinnwarnungen von Internetfirmen nicht mehr. Verglichen mit der Reihe von furchtbaren Nachrichten, die GLIA so die letzten Monate produziert hat, haben die bereits den schlimmsten Fall, die Pleite, als Möglichkeit einkalkuliert.
Gestern war der Tag der small caps, viele waren im Plus!
Der Puhvogel, der sich vielleicht mal als Dichter der modernen Literatur versuchen sollte.
(schäm).Als Interpretationshilfe: Das meinte der "Künstler" in Wirklichkeit.
-------
Jetzt sind da die echten Hartgesottenen in diesem Wert, die Kostolany in seinen Büchern so bezeichnete.
Solche Anleger schrecken aktuelle Cisco-Downgrades von Investmenthäusern oder Gewinnwarnungen von Internetfirmen nicht mehr. Verglichen mit der Reihe von furchtbaren Nachrichten, die GLIA so die letzten Monate produziert hat, haben die bereits den schlimmsten Fall, die Pleite, als Möglichkeit einkalkuliert.
Gestern war der Tag der small caps, viele waren im Plus!
Der Puhvogel, der sich vielleicht mal als Dichter der modernen Literatur versuchen sollte.
GLIA heute wieder einmal abgestürzt wegen Problem bei Lieferanten.
Von Sturz kann aus dieser Höhe allerdings kaum noch die Rede sein...
Bißchen viel Pech in letzter Zeit, wenn es denn nur Pech war..
:O
Von Sturz kann aus dieser Höhe allerdings kaum noch die Rede sein...
Bißchen viel Pech in letzter Zeit, wenn es denn nur Pech war..
:O
Nach ausführlichem Studium aller Yahoo-Beiträge etc. zu GLIA gehe ich davon aus, dass die Unterlagen zur Zulassung von Adcon-L gezielt und stümperhaft gefälscht wurden...
So etwas soll vorkommen...
So etwas soll vorkommen...
aus Reuters gestern:
``It`s a whole new can of worms for Gliatech,`` SG Cowen analyst Eric Schmidt said, referring to the company`s suspension of shipments. ``And with this new issue, investor confidence in the company is likely to further erode.``
Das wars dann wohl. Irgendwann geht den Jungs auch noch das Geld aus, einzige Hoffnung : ein neuer Käufer...
``It`s a whole new can of worms for Gliatech,`` SG Cowen analyst Eric Schmidt said, referring to the company`s suspension of shipments. ``And with this new issue, investor confidence in the company is likely to further erode.``
Das wars dann wohl. Irgendwann geht den Jungs auch noch das Geld aus, einzige Hoffnung : ein neuer Käufer...
Gliatech hires auditor to help resolve FDA issues
CLEVELAND, Feb 16 (Reuters) - Surgical products maker Gliatech Inc. <GLIA.O> on Friday said it had hired an auditor, Health Policy Associates, to help it resolve issues raised by federal regulators concerning the company`s methods of recording data from product trials.
In December, Gliatech said it had received a letter from the Food and Drug Administration questioning its methods of recording clinical trial data for its gel for preventing post-surgical scarring. The FDA issued an Application Integrity Policy (AIP) letter, meaning that it was looking into the validity of the Gliatech data and information.
Gliatech said Health Policy Associates has extensive experience working with companies that have experienced FDA regulatory difficulty. It said the auditor had been successful in working with such companies to improve internal systems and resolve regulatory concerns.
In accordance with FDA policy, Gliatech said it would work with the auditor to assess the validity of data and information in Gliatech`s future submissions prior to FDA review. It said the auditor would assist it in developing improved systems and procedures.
Gliatech shares were hit hard by the FDA concerns. The shares closed at $3-11/16 on the Nasdaq on Thursday.
((--New York Equities Desk, 212 859 1700))
REUTERS
Rtr 08:22 02-16-01
CLEVELAND, Feb 16 (Reuters) - Surgical products maker Gliatech Inc. <GLIA.O> on Friday said it had hired an auditor, Health Policy Associates, to help it resolve issues raised by federal regulators concerning the company`s methods of recording data from product trials.
In December, Gliatech said it had received a letter from the Food and Drug Administration questioning its methods of recording clinical trial data for its gel for preventing post-surgical scarring. The FDA issued an Application Integrity Policy (AIP) letter, meaning that it was looking into the validity of the Gliatech data and information.
Gliatech said Health Policy Associates has extensive experience working with companies that have experienced FDA regulatory difficulty. It said the auditor had been successful in working with such companies to improve internal systems and resolve regulatory concerns.
In accordance with FDA policy, Gliatech said it would work with the auditor to assess the validity of data and information in Gliatech`s future submissions prior to FDA review. It said the auditor would assist it in developing improved systems and procedures.
Gliatech shares were hit hard by the FDA concerns. The shares closed at $3-11/16 on the Nasdaq on Thursday.
((--New York Equities Desk, 212 859 1700))
REUTERS
Rtr 08:22 02-16-01
@ all
So nun muß ich einfach mal meine Meinung zu Gliatech posten. Mit dieser Aktie werdet Ihr nie ordenliche Gewinne erzielen. Diese Unternehmen ist einfach nur lächerlich, ich verstehen nicht wieso ich auf so einen Tip hören konnte! Die Firma ist massiv unterbewertet das ich nicht lache! Mag sein das das Produkt gut ist aber das die einfach nicht schaffen das Zeug an den Mann zu bringen ist stümperhaft! Probleme mit der FDA, Probleme mit dem Zulieferer -->das Produkt wurde vom Markt genommen. Da kann die Aktie auch nicht steigen ist doch ganz einfach. Ich rate auch verkauft den Mist und schaut Euch mal paar interessante Konservative Werte wie Unisys an! Ich für meinen Teil hab genug!
Predo
So nun muß ich einfach mal meine Meinung zu Gliatech posten. Mit dieser Aktie werdet Ihr nie ordenliche Gewinne erzielen. Diese Unternehmen ist einfach nur lächerlich, ich verstehen nicht wieso ich auf so einen Tip hören konnte! Die Firma ist massiv unterbewertet das ich nicht lache! Mag sein das das Produkt gut ist aber das die einfach nicht schaffen das Zeug an den Mann zu bringen ist stümperhaft! Probleme mit der FDA, Probleme mit dem Zulieferer -->das Produkt wurde vom Markt genommen. Da kann die Aktie auch nicht steigen ist doch ganz einfach. Ich rate auch verkauft den Mist und schaut Euch mal paar interessante Konservative Werte wie Unisys an! Ich für meinen Teil hab genug!
Predo
Gliatech Inc. Invites You to Join its Fourth Quarter and Year End 2000 Conference Call on the Web
CLEVELAND, Feb. 26 /PRNewswire/ -- In conjunction with Gliatech`s Fourth Quarter earnings release, you are invited to listen to its conference call that will be broadcast live over the Internet on Wednesday, February 28th, 2001 at 10 A.M. EST with Robert P. Pinkas, Chairman and Acting CEO, Steven L. Basta, President, Rodney E. Dausch, Vice President and COO, Clark E. Tedford, Executive Vice President, Research & Development and Thomas F. Barnish, Vice President and CFO of Gliatech Inc. (Nasdaq: GLIA)
What: Gliatech Inc. Fourth Quarter and Year End 2000 Earnings Release
When: February 28, 2001 @ 10:00 AM EST
Where: http://www.videonewswire.com/GLIATECH/022801/
How: Live over the Internet -- Simply log on to the web at the
address above
Contact: Adam D. Gridley
Investor Relations Manager
216.831.3200
gridleya@gliatech.com
Gliatech is engaged in the discovery and development of biosurgery and therapeutic products to improve surgical outcomes and to treat neurological disorders. The biosurgery products include the ADCON(R) family of products, which are designed to inhibit postsurgical scarring and adhesions, and a proprietary monoclonal antibody to treat anti-inflammatory disorders. Gliatech`s neurological disorders programs are focused on developing small molecule drug candidates to modulate the cognitive state of the nervous system and to treat the symptoms of schizophrenia.
If you are unable to participate during the live webcast, the call will be archived on the Web site www.gliatech.com .
(Minimum Requirements to listen to broadcast: The RealPlayer software, downloadable free from www.real.com/products/player/index.html , and at least a 14.4Kbps connection to the Internet. If you experience problems listening to the broadcast, send an email to webmaster@vdat.com .)
CLEVELAND, Feb. 26 /PRNewswire/ -- In conjunction with Gliatech`s Fourth Quarter earnings release, you are invited to listen to its conference call that will be broadcast live over the Internet on Wednesday, February 28th, 2001 at 10 A.M. EST with Robert P. Pinkas, Chairman and Acting CEO, Steven L. Basta, President, Rodney E. Dausch, Vice President and COO, Clark E. Tedford, Executive Vice President, Research & Development and Thomas F. Barnish, Vice President and CFO of Gliatech Inc. (Nasdaq: GLIA)
What: Gliatech Inc. Fourth Quarter and Year End 2000 Earnings Release
When: February 28, 2001 @ 10:00 AM EST
Where: http://www.videonewswire.com/GLIATECH/022801/
How: Live over the Internet -- Simply log on to the web at the
address above
Contact: Adam D. Gridley
Investor Relations Manager
216.831.3200
gridleya@gliatech.com
Gliatech is engaged in the discovery and development of biosurgery and therapeutic products to improve surgical outcomes and to treat neurological disorders. The biosurgery products include the ADCON(R) family of products, which are designed to inhibit postsurgical scarring and adhesions, and a proprietary monoclonal antibody to treat anti-inflammatory disorders. Gliatech`s neurological disorders programs are focused on developing small molecule drug candidates to modulate the cognitive state of the nervous system and to treat the symptoms of schizophrenia.
If you are unable to participate during the live webcast, the call will be archived on the Web site www.gliatech.com .
(Minimum Requirements to listen to broadcast: The RealPlayer software, downloadable free from www.real.com/products/player/index.html , and at least a 14.4Kbps connection to the Internet. If you experience problems listening to the broadcast, send an email to webmaster@vdat.com .)
Gliatech Announces 2000 Year End and Fourth Quarter Results
CLEVELAND, Feb. 28 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA) today announced financial results and earnings for the fourth quarter and fiscal year ended December 31, 2000. Product sales increased to $5.6 million for the fourth quarter of 2000 compared to $2.8 million in the fourth quarter of 1999. Product sales in the fourth quarter of 1999 were limited due to the temporary unavailability of ADCON-L for sale in the United States resulting from the import alert issued in October 1999. Fourth quarter product sales decreased 8.7% compared to third quarter 2000 product sales of $6.1 million due to the market impact of (i) the issuance of the FDA Form 483 to the Company in August of 2000 and (ii) the termination of the contemplated merger with Guilford Pharmaceuticals, Inc. ("Guilford") in August 2000. Product sales for fiscal 2000 decreased 3.7% to $25.5 million compared to $26.5 million in fiscal 1999.
On January 22, 2001, Gliatech announced that it implemented a voluntary recall of ADCON(R)-L worldwide and ADCON(R)-T/N outside of the U.S. as a result of a recall by the supplier of a raw material used in the manufacture of these products.
The Company recorded a net loss in the fourth quarter of 2000 of $6.1 million, or $(0.63) per share, compared to a net loss of $2.9 million, or $(0.31) per share in the fourth quarter of 1999. The Company incurred $4.1 million in non-recurring charges in the fourth quarter of 2000 relating to the product recall of ADCON-L and ADCON T/N, which included a $2.4 million provision for product sales returns and a $1.7 million provision for obsolete inventory included in cost of products sold. Net loss for fiscal 2000 was $12.9 million, or $(1.35) per share, compared to a net loss in fiscal 1999 of $0.4 million, or $(0.04) per share. The net loss in fiscal 2000 included non- recurring charges of $7.5 million, which consisted of $4.5 million related to the lease settlement, $1.2 million related to severance of former employees and $1.8 million related to professional services associated with the merger, in addition to the $4.1 million of fourth quarter charges related to the product recall. Excluding non-recurring items, net loss would have been $2.1 million, or $(0.22) per share for the fourth quarter of 2000 and $1.3 million, or $(0.14) per share for fiscal 2000. Business Outlook
As a result of the recall, the Company will recognize a provision for sales returns in the first quarter of 2001 for all product sales made prior to the implementation of the recall. The Company anticipates reintroduction of these products outside the U.S. will occur in the second quarter of 2001. In addition, the Company is working with the FDA on appropriate U.S. regulatory review of the issues related to the product recall under the AIP guidelines. The Company expects to incur substantial losses until the re-launch of ADCON(R)-L in the U.S. The Company is exploring certain strategic alternatives which include, without limitation, potential funding sources such as equity and debt financing and seeking strategic partners. There can be no assurance that the Company will be able to consummate any such strategic alternatives on terms satisfactory to the Company, or at all. Board of Directors
Gliatech has made changes to its Board of Directors. Irving S. Shapiro and John L. Ufheil, both of whom have served as directors since 1993, have resigned, and Steven L. Basta, President of Gliatech, has been appointed to the Board of Directors. "We thank Irving and Jack for their long history of service to the Company. Their hard work and leadership will be missed and we wish them well in future endeavors," stated Robert P. Pinkas, Chairman and Acting Chief Executive Officer of Gliatech. "Steve`s appointment to the Board of Directors brings both a high level of enthusiasm and leadership to the composition of the Board of Directors, and I believe we are well positioned to guide the Company forward in the anti-adhesion industry." Fourth Quarter Developments
Gliatech announced results from its pilot clinical study for ADCON(R)-A Adhesion Control in a Barrier Solution (ADCON(R) solution), which is designed to inhibit scarring and adhesions following abdominal and colorectal surgeries. The results indicated a 41% to 59% decrease in the mean length, number and severity of adhesions. The results from the study also indicated that the safety profile for ADCON(R) solution was comparable to the safety profile for the control patients. Submission of these results is subject to AIP guidelines.
Gliatech scientists presented three papers at the 30th Annual Society of Neuroscience meeting in New Orleans in November relating to preclinical programs. The first paper describes the utility of distinct histamine H3 receptor antagonists in the regulation of appetite and weight gain in preclinical models, which demonstrated that once-a-day oral administration of the novel H3 agent for two weeks reduced both food intake and weight gain. The second paper describes the development of histamine H3 agonists for potential therapeutic use during myocardial ischemia, which is a condition associated with heart disease. The third paper discloses the cloning of multiple forms of the glycine transporter in the human brain. Blocking the glycine transport system may have therapeutic potential in the treatment of various brain disorders including schizophrenia. NASD Review
The National Association of Securities Dealers ("NASD") has instituted a review regarding certain trading activity in Company stock prior to the August 2000 announcement of the termination of the proposed merger with Guilford. The Company is cooperating with the NASD in this review. About Gliatech Inc.
Gliatech is engaged in the discovery and development of biosurgery and therapeutic products to improve surgical outcomes and to treat neurological disorders. The biosurgery products include the ADCON(R) family of products, which are designed to inhibit postsurgical scarring and adhesions, and a proprietary monoclonal antibody to treat anti-inflammatory disorders. Gliatech`s neurological disorders programs are focused on development of small molecule drug candidates to modulate the cognitive state of the nervous system and to treat the symptoms of schizophrenia.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, uncertainty of market acceptance of Gliatech`s products, the uncertainty of expenses associated with clinical trials and research efforts which may affect the profitability of Gliatech, the ability of Gliatech to obtain an adequate supply of the materials used in the manufacture of its ADCON(R) products, uncertainty of regulatory approvals, the status of the Company with respect to AIP, the timing and content of decisions including review of data by the FDA, including the decisions with respect to sale of ADCON(R)-L, product recalls and the inspectional observations by the FDA, the uncertainty of market conditions and other risk factors detailed in Gliatech`s SEC filings.
There will be a conference call at 10:00 a.m. EDT today to discuss Gliatech`s fourth quarter financial results. This call will be broadcast live over the Internet at http://www.videonewswire.com/GLIATECH/022801/ and will be archived at Gliatech`s website located at http://www.gliatech.com. A replay of the call will be available until March 4, 2001. The replay telephone number is 1-888-568-0349.
Consolidated Statements of Operations
(In thousands, except
share and per share Three Months Ended Twelve Months Ended
data) December 31, December 31,
2000 1999 2000 1999
Revenues (Unaudited) (Unaudited)
Product sales $5,558 $2,756 $25,513 $26,495
Provision for returns
related to recall (2,400) - (2,400) -
Total 3,158 2,756 23,113 26,495
Government grants and
research contracts - 268 542 1,458
Total revenues 3,158 3,024 23,655 27,953
Operating costs and expenses
Cost of products sold 2,099 1,334 6,853 4,973
Provision for obsolete
inventory related
to recall 1,650 - 1,650 -
Total 3,749 1,334 8,503 4,973
Research and development 2,167 2,448 9,364 12,754
Selling, general and
administrative 3,588 1,902 12,192 11,300
Merger related and
severance costs - 780 7,541 780
Total operating costs
and expenses 9,504 6,464 37,600 29,807
Loss from operations (6,346) (3,440) (13,945) (1,854)
Interest income 218 514 1,026 1,459
Net loss $(6,128) $(2,926) $(12,919) $(395)
Diluted net loss
per share $(0.63) $(0.31) $(1.35) $(0.04)
Average diluted shares
outstanding 9,652,637 9,478,437 9,564,315 9,472,532
Balance Sheet Data: December 31,
2000 1999
(In thousands) (Unaudited)
Cash and cash equivalents and $8,464 $19,101
short-term investments
Other current assets 4,830 7,492
Total current assets 13,294 26,593
Long term investments 3,642 1,713
Property and equipment, net 3,197 3,233
Other assets, net 1,043 845
Total assets $21,176 $32,384
Accounts payable and other $4,675 $3,214
accrued expenses
Other current liabilities 998 2,778
Total current liabilities 5,673 5,992
Stockholders` equity: 15,503 26,392
Total Liabilities and Stockholders` Equity $21,176 $32,384
/CONTACT: Adam D. Gridley, Investor Relations Manager of Gliatech Inc., 216-831-3200, x3019/
CLEVELAND, Feb. 28 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA) today announced financial results and earnings for the fourth quarter and fiscal year ended December 31, 2000. Product sales increased to $5.6 million for the fourth quarter of 2000 compared to $2.8 million in the fourth quarter of 1999. Product sales in the fourth quarter of 1999 were limited due to the temporary unavailability of ADCON-L for sale in the United States resulting from the import alert issued in October 1999. Fourth quarter product sales decreased 8.7% compared to third quarter 2000 product sales of $6.1 million due to the market impact of (i) the issuance of the FDA Form 483 to the Company in August of 2000 and (ii) the termination of the contemplated merger with Guilford Pharmaceuticals, Inc. ("Guilford") in August 2000. Product sales for fiscal 2000 decreased 3.7% to $25.5 million compared to $26.5 million in fiscal 1999.
On January 22, 2001, Gliatech announced that it implemented a voluntary recall of ADCON(R)-L worldwide and ADCON(R)-T/N outside of the U.S. as a result of a recall by the supplier of a raw material used in the manufacture of these products.
The Company recorded a net loss in the fourth quarter of 2000 of $6.1 million, or $(0.63) per share, compared to a net loss of $2.9 million, or $(0.31) per share in the fourth quarter of 1999. The Company incurred $4.1 million in non-recurring charges in the fourth quarter of 2000 relating to the product recall of ADCON-L and ADCON T/N, which included a $2.4 million provision for product sales returns and a $1.7 million provision for obsolete inventory included in cost of products sold. Net loss for fiscal 2000 was $12.9 million, or $(1.35) per share, compared to a net loss in fiscal 1999 of $0.4 million, or $(0.04) per share. The net loss in fiscal 2000 included non- recurring charges of $7.5 million, which consisted of $4.5 million related to the lease settlement, $1.2 million related to severance of former employees and $1.8 million related to professional services associated with the merger, in addition to the $4.1 million of fourth quarter charges related to the product recall. Excluding non-recurring items, net loss would have been $2.1 million, or $(0.22) per share for the fourth quarter of 2000 and $1.3 million, or $(0.14) per share for fiscal 2000. Business Outlook
As a result of the recall, the Company will recognize a provision for sales returns in the first quarter of 2001 for all product sales made prior to the implementation of the recall. The Company anticipates reintroduction of these products outside the U.S. will occur in the second quarter of 2001. In addition, the Company is working with the FDA on appropriate U.S. regulatory review of the issues related to the product recall under the AIP guidelines. The Company expects to incur substantial losses until the re-launch of ADCON(R)-L in the U.S. The Company is exploring certain strategic alternatives which include, without limitation, potential funding sources such as equity and debt financing and seeking strategic partners. There can be no assurance that the Company will be able to consummate any such strategic alternatives on terms satisfactory to the Company, or at all. Board of Directors
Gliatech has made changes to its Board of Directors. Irving S. Shapiro and John L. Ufheil, both of whom have served as directors since 1993, have resigned, and Steven L. Basta, President of Gliatech, has been appointed to the Board of Directors. "We thank Irving and Jack for their long history of service to the Company. Their hard work and leadership will be missed and we wish them well in future endeavors," stated Robert P. Pinkas, Chairman and Acting Chief Executive Officer of Gliatech. "Steve`s appointment to the Board of Directors brings both a high level of enthusiasm and leadership to the composition of the Board of Directors, and I believe we are well positioned to guide the Company forward in the anti-adhesion industry." Fourth Quarter Developments
Gliatech announced results from its pilot clinical study for ADCON(R)-A Adhesion Control in a Barrier Solution (ADCON(R) solution), which is designed to inhibit scarring and adhesions following abdominal and colorectal surgeries. The results indicated a 41% to 59% decrease in the mean length, number and severity of adhesions. The results from the study also indicated that the safety profile for ADCON(R) solution was comparable to the safety profile for the control patients. Submission of these results is subject to AIP guidelines.
Gliatech scientists presented three papers at the 30th Annual Society of Neuroscience meeting in New Orleans in November relating to preclinical programs. The first paper describes the utility of distinct histamine H3 receptor antagonists in the regulation of appetite and weight gain in preclinical models, which demonstrated that once-a-day oral administration of the novel H3 agent for two weeks reduced both food intake and weight gain. The second paper describes the development of histamine H3 agonists for potential therapeutic use during myocardial ischemia, which is a condition associated with heart disease. The third paper discloses the cloning of multiple forms of the glycine transporter in the human brain. Blocking the glycine transport system may have therapeutic potential in the treatment of various brain disorders including schizophrenia. NASD Review
The National Association of Securities Dealers ("NASD") has instituted a review regarding certain trading activity in Company stock prior to the August 2000 announcement of the termination of the proposed merger with Guilford. The Company is cooperating with the NASD in this review. About Gliatech Inc.
Gliatech is engaged in the discovery and development of biosurgery and therapeutic products to improve surgical outcomes and to treat neurological disorders. The biosurgery products include the ADCON(R) family of products, which are designed to inhibit postsurgical scarring and adhesions, and a proprietary monoclonal antibody to treat anti-inflammatory disorders. Gliatech`s neurological disorders programs are focused on development of small molecule drug candidates to modulate the cognitive state of the nervous system and to treat the symptoms of schizophrenia.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, uncertainty of market acceptance of Gliatech`s products, the uncertainty of expenses associated with clinical trials and research efforts which may affect the profitability of Gliatech, the ability of Gliatech to obtain an adequate supply of the materials used in the manufacture of its ADCON(R) products, uncertainty of regulatory approvals, the status of the Company with respect to AIP, the timing and content of decisions including review of data by the FDA, including the decisions with respect to sale of ADCON(R)-L, product recalls and the inspectional observations by the FDA, the uncertainty of market conditions and other risk factors detailed in Gliatech`s SEC filings.
There will be a conference call at 10:00 a.m. EDT today to discuss Gliatech`s fourth quarter financial results. This call will be broadcast live over the Internet at http://www.videonewswire.com/GLIATECH/022801/ and will be archived at Gliatech`s website located at http://www.gliatech.com. A replay of the call will be available until March 4, 2001. The replay telephone number is 1-888-568-0349.
Consolidated Statements of Operations
(In thousands, except
share and per share Three Months Ended Twelve Months Ended
data) December 31, December 31,
2000 1999 2000 1999
Revenues (Unaudited) (Unaudited)
Product sales $5,558 $2,756 $25,513 $26,495
Provision for returns
related to recall (2,400) - (2,400) -
Total 3,158 2,756 23,113 26,495
Government grants and
research contracts - 268 542 1,458
Total revenues 3,158 3,024 23,655 27,953
Operating costs and expenses
Cost of products sold 2,099 1,334 6,853 4,973
Provision for obsolete
inventory related
to recall 1,650 - 1,650 -
Total 3,749 1,334 8,503 4,973
Research and development 2,167 2,448 9,364 12,754
Selling, general and
administrative 3,588 1,902 12,192 11,300
Merger related and
severance costs - 780 7,541 780
Total operating costs
and expenses 9,504 6,464 37,600 29,807
Loss from operations (6,346) (3,440) (13,945) (1,854)
Interest income 218 514 1,026 1,459
Net loss $(6,128) $(2,926) $(12,919) $(395)
Diluted net loss
per share $(0.63) $(0.31) $(1.35) $(0.04)
Average diluted shares
outstanding 9,652,637 9,478,437 9,564,315 9,472,532
Balance Sheet Data: December 31,
2000 1999
(In thousands) (Unaudited)
Cash and cash equivalents and $8,464 $19,101
short-term investments
Other current assets 4,830 7,492
Total current assets 13,294 26,593
Long term investments 3,642 1,713
Property and equipment, net 3,197 3,233
Other assets, net 1,043 845
Total assets $21,176 $32,384
Accounts payable and other $4,675 $3,214
accrued expenses
Other current liabilities 998 2,778
Total current liabilities 5,673 5,992
Stockholders` equity: 15,503 26,392
Total Liabilities and Stockholders` Equity $21,176 $32,384
/CONTACT: Adam D. Gridley, Investor Relations Manager of Gliatech Inc., 216-831-3200, x3019/
Gliatech Provides Update on FDA Regulatory Matters
CLEVELAND, Feb. 28 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA) announced today that the Company has initiated work with its recently appointed independent auditor, Health Policy Associates (HPA) to identify and resolve matters of interest to the U.S. Food and Drug Administration (FDA) related to the Company`s application integrity policy (AIP) status. The FDA has communicated to HPA three initial areas of focus. The first area is the efficacy of ADCON(R)-L, which will be assessed in the re-read of the U.S. study magnetic resonance images (MRI). The second area is the safety of ADCON(R)-L, which will be evaluated by HPA based on a review of preclinical safety studies, adverse events in the U.S. clinical study and medical complaints reported to the Company from surgeons using ADCON(R)-L since its introduction. The purpose of the safety audit is to review adverse events and the relationship, if any, to ADCON(R)-L. The third area is manufacturing procedures and test results, including the modified container packaging changes related to the Company`s recent voluntary recall of ADCON(R)-L and ADCON(R)-T/N worldwide. Gliatech`s voluntary recall was related to a recall by the supplier of a raw material component of these products. In addition, as part of the AIP process, Gliatech will review and enhance its internal policies and procedures, which will be subject to audit by HPA.
"Successful relaunch of ADCON(R)-L in the U.S. will be subject to the findings of the independent auditor, the outcome of the U.S. study MRI re-read, the results of our change in manufacturing process, and any additional requests of the FDA. We are working concurrently on each of these items and believe that work on each of the three key areas of interest can be ready for submission to the FDA within the next several months," stated Steven Basta, President of Gliatech.
Gliatech has engaged an independent clinical research organization (CRO) to conduct the independent MRI re-read from the U.S. clinical study of ADCON(R)-L. The Company has submitted the proposed re-read protocol to the FDA and has received FDA comments on this protocol. The independent CRO is making the recommended changes to the protocol, which will be resubmitted to the FDA shortly. Upon concurrence from the FDA on the revised protocol, the independent CRO will initiate the re-read. The MRI re-read will be conducted in response to the Form FDA 483 received by the Company on August 23, 2000 concerning the post approval U.S. clinical trial of ADCON(R)-L. The conduct of this MRI re-read study will be audited by HPA.
The Company has also been advised by the FDA of an ongoing governmental investigation related to past integrity issues and areas of FDA concern. Although the scope and specific topics of this investigation are not known at this time, this investigation could result in potential civil or criminal penalties filed against the Company or its employees. The Company intends to cooperate with this investigation to resolve these questions as quickly as possible.
Gliatech is engaged in the discovery and development of biosurgery and therapeutic products to improve surgical outcomes and to treat neurological disorders. The biosurgery products include the ADCON(R) family of products, which are designed to inhibit postsurgical scarring and adhesions, and a proprietary monoclonal antibody to treat anti-inflammatory disorders. Gliatech`s neurological disorders programs are focused on development of small molecule drug candidates to modulate the cognitive state of the nervous system and to treat the symptoms of schizophrenia.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, uncertainty of market acceptance of Gliatech`s products, the uncertainty of expenses associated with clinical trials and research efforts which may affect the profitability of Gliatech, the ability of Gliatech to obtain an adequate supply of the materials used in the manufacture of its ADCON(R) products, uncertainty of regulatory approvals, the status of the Company with respect to AIP, the timing and content of decisions including review of data by the FDA, including the decisions with respect to sale of ADCON(R)-L, product recalls and the inspectional observations by the FDA, the uncertainty of market conditions and other risk factors detailed in Gliatech`s SEC filings.
There will be a conference call at 10:00 a.m. EDT today to discuss Gliatech`s fourth quarter financial results and an update on FDA regulatory matters. This call will be broadcast live over the Internet at http://www.videonewswire.com/GLIATECH/022801/ and will be archived at Gliatech`s website located at http://www.gliatech.com . A replay of the call will be available until March 4, 2001. The replay telephone number is 1-888- 568-0349.
/CONTACT: Adam D. Gridley, Investor Relations Manager of Gliatech Inc., 216-831-3200, x3019/
CLEVELAND, Feb. 28 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA) announced today that the Company has initiated work with its recently appointed independent auditor, Health Policy Associates (HPA) to identify and resolve matters of interest to the U.S. Food and Drug Administration (FDA) related to the Company`s application integrity policy (AIP) status. The FDA has communicated to HPA three initial areas of focus. The first area is the efficacy of ADCON(R)-L, which will be assessed in the re-read of the U.S. study magnetic resonance images (MRI). The second area is the safety of ADCON(R)-L, which will be evaluated by HPA based on a review of preclinical safety studies, adverse events in the U.S. clinical study and medical complaints reported to the Company from surgeons using ADCON(R)-L since its introduction. The purpose of the safety audit is to review adverse events and the relationship, if any, to ADCON(R)-L. The third area is manufacturing procedures and test results, including the modified container packaging changes related to the Company`s recent voluntary recall of ADCON(R)-L and ADCON(R)-T/N worldwide. Gliatech`s voluntary recall was related to a recall by the supplier of a raw material component of these products. In addition, as part of the AIP process, Gliatech will review and enhance its internal policies and procedures, which will be subject to audit by HPA.
"Successful relaunch of ADCON(R)-L in the U.S. will be subject to the findings of the independent auditor, the outcome of the U.S. study MRI re-read, the results of our change in manufacturing process, and any additional requests of the FDA. We are working concurrently on each of these items and believe that work on each of the three key areas of interest can be ready for submission to the FDA within the next several months," stated Steven Basta, President of Gliatech.
Gliatech has engaged an independent clinical research organization (CRO) to conduct the independent MRI re-read from the U.S. clinical study of ADCON(R)-L. The Company has submitted the proposed re-read protocol to the FDA and has received FDA comments on this protocol. The independent CRO is making the recommended changes to the protocol, which will be resubmitted to the FDA shortly. Upon concurrence from the FDA on the revised protocol, the independent CRO will initiate the re-read. The MRI re-read will be conducted in response to the Form FDA 483 received by the Company on August 23, 2000 concerning the post approval U.S. clinical trial of ADCON(R)-L. The conduct of this MRI re-read study will be audited by HPA.
The Company has also been advised by the FDA of an ongoing governmental investigation related to past integrity issues and areas of FDA concern. Although the scope and specific topics of this investigation are not known at this time, this investigation could result in potential civil or criminal penalties filed against the Company or its employees. The Company intends to cooperate with this investigation to resolve these questions as quickly as possible.
Gliatech is engaged in the discovery and development of biosurgery and therapeutic products to improve surgical outcomes and to treat neurological disorders. The biosurgery products include the ADCON(R) family of products, which are designed to inhibit postsurgical scarring and adhesions, and a proprietary monoclonal antibody to treat anti-inflammatory disorders. Gliatech`s neurological disorders programs are focused on development of small molecule drug candidates to modulate the cognitive state of the nervous system and to treat the symptoms of schizophrenia.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, uncertainty of market acceptance of Gliatech`s products, the uncertainty of expenses associated with clinical trials and research efforts which may affect the profitability of Gliatech, the ability of Gliatech to obtain an adequate supply of the materials used in the manufacture of its ADCON(R) products, uncertainty of regulatory approvals, the status of the Company with respect to AIP, the timing and content of decisions including review of data by the FDA, including the decisions with respect to sale of ADCON(R)-L, product recalls and the inspectional observations by the FDA, the uncertainty of market conditions and other risk factors detailed in Gliatech`s SEC filings.
There will be a conference call at 10:00 a.m. EDT today to discuss Gliatech`s fourth quarter financial results and an update on FDA regulatory matters. This call will be broadcast live over the Internet at http://www.videonewswire.com/GLIATECH/022801/ and will be archived at Gliatech`s website located at http://www.gliatech.com . A replay of the call will be available until March 4, 2001. The replay telephone number is 1-888- 568-0349.
/CONTACT: Adam D. Gridley, Investor Relations Manager of Gliatech Inc., 216-831-3200, x3019/
Bei gliatech.com gibt´s ne neue Meldung, und die liest sich ziemlich verheerend.
Macht euch euer eigenes Bild!
Macht euch euer eigenes Bild!
Welche Meldung?
Einfach anklicken:www.gliatech.com -investor relations-press relations.
In Kürze: Umsatz gewachsen, Verluste gewachsen, anscheinend geringe Chancen auf Zulassung von Adcon in Amerika, Untersuchung wegen Insiderhandels am Hals, und ein paar unverbindliche Sprüche, dass man noch einiges in der Pipeline hat. (Wenn ich alles richtig verstanden habe.)
In Kürze: Umsatz gewachsen, Verluste gewachsen, anscheinend geringe Chancen auf Zulassung von Adcon in Amerika, Untersuchung wegen Insiderhandels am Hals, und ein paar unverbindliche Sprüche, dass man noch einiges in der Pipeline hat. (Wenn ich alles richtig verstanden habe.)
Gliatech Receives Recommendation for ISO 9001 Recertification and Initiates Manufacturing Validation for Relaunch of ADCON(R)-L Outside of the U.S. in June 2001
CLEVELAND, April 18 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA) announced today that it has successfully completed an International Standards Organization (ISO) 9001 audit that was conducted by KEMA Registered Quality B.V. (KEMA), a European Notified Body. In addition, the Company has completed process development work relating to a raw material used in the manufacture of ADCON(R)-L and initiated manufacturing validation runs. The Company anticipates relaunch of ADCON(R)-L outside the U.S. in June 2001.
Based on the results of the ISO audit, Gliatech has received a recommendation for recertification by KEMA for the development, manufacture and distribution of ADCON(R)-L and ADCON(R)-T/N (collectively ADCON(R) gel) outside the U.S. in accordance with ISO 9001. KEMA, a 74 year-old testing and certification company, headquartered in the Netherlands, is a registered Notified Body of the European Economic Area and, in this capacity, is responsible for approving and assessing compliance with the European Union Medical Devices Directive.
As previously announced in January 2001, Gliatech implemented a voluntary recall of ADCON(R) gel as a result of a voluntary recall by the supplier of a raw material component of the ADCON(R) gel. The Company has completed process development work and the related testing associated with the change in packaging of the raw material used in ADCON(R) gel production outside of the U.S. As a result of the completion of the process development work, the Company has now initiated manufacturing validation runs of ADCON(R) gel production. Gliatech anticipates that these validation runs will be completed on schedule for the relaunch of ADCON(R)-L outside of the U.S. in June 2001. Relaunch of ADCON(R)-L in the U.S. is subject to the submission and approval of the additional data identified previously as part of the Food and Drug Administration`s Application Integrity Policy status.
Gliatech has also recently expanded its distribution network in Eastern Europe by entering into distribution agreements in Hungary and Poland. Upon relaunch, ADCON(R)-L will be sold in 35 countries outside of the U.S.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R) gel and ADCON(R) solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to treat inflammatory disorders.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, uncertainty of market acceptance of Gliatech`s products, the uncertainty of expenses associated with clinical trials and research efforts which may affect the profitability of Gliatech, the ability of Gliatech to obtain an adequate supply of the materials used in the manufacture of its ADCON(R) products, uncertainty of the success of the relaunch of ADCON(R)-L outside the U.S., uncertainty of regulatory approvals, the status of the Company with respect to AIP, the timing and content of decisions including review of data by the FDA, including the decisions with respect to sale of ADCON(R)-L, product recalls and the inspectional observations by the FDA, the uncertainty of market conditions and other risk factors detailed in Gliatech`s SEC filings.
/CONTACT: Adam D. Gridley, Investor Relations Manager of Gliatech Inc., 216-831-3200, x3019/
CLEVELAND, April 18 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA) announced today that it has successfully completed an International Standards Organization (ISO) 9001 audit that was conducted by KEMA Registered Quality B.V. (KEMA), a European Notified Body. In addition, the Company has completed process development work relating to a raw material used in the manufacture of ADCON(R)-L and initiated manufacturing validation runs. The Company anticipates relaunch of ADCON(R)-L outside the U.S. in June 2001.
Based on the results of the ISO audit, Gliatech has received a recommendation for recertification by KEMA for the development, manufacture and distribution of ADCON(R)-L and ADCON(R)-T/N (collectively ADCON(R) gel) outside the U.S. in accordance with ISO 9001. KEMA, a 74 year-old testing and certification company, headquartered in the Netherlands, is a registered Notified Body of the European Economic Area and, in this capacity, is responsible for approving and assessing compliance with the European Union Medical Devices Directive.
As previously announced in January 2001, Gliatech implemented a voluntary recall of ADCON(R) gel as a result of a voluntary recall by the supplier of a raw material component of the ADCON(R) gel. The Company has completed process development work and the related testing associated with the change in packaging of the raw material used in ADCON(R) gel production outside of the U.S. As a result of the completion of the process development work, the Company has now initiated manufacturing validation runs of ADCON(R) gel production. Gliatech anticipates that these validation runs will be completed on schedule for the relaunch of ADCON(R)-L outside of the U.S. in June 2001. Relaunch of ADCON(R)-L in the U.S. is subject to the submission and approval of the additional data identified previously as part of the Food and Drug Administration`s Application Integrity Policy status.
Gliatech has also recently expanded its distribution network in Eastern Europe by entering into distribution agreements in Hungary and Poland. Upon relaunch, ADCON(R)-L will be sold in 35 countries outside of the U.S.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R) gel and ADCON(R) solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to treat inflammatory disorders.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, uncertainty of market acceptance of Gliatech`s products, the uncertainty of expenses associated with clinical trials and research efforts which may affect the profitability of Gliatech, the ability of Gliatech to obtain an adequate supply of the materials used in the manufacture of its ADCON(R) products, uncertainty of the success of the relaunch of ADCON(R)-L outside the U.S., uncertainty of regulatory approvals, the status of the Company with respect to AIP, the timing and content of decisions including review of data by the FDA, including the decisions with respect to sale of ADCON(R)-L, product recalls and the inspectional observations by the FDA, the uncertainty of market conditions and other risk factors detailed in Gliatech`s SEC filings.
/CONTACT: Adam D. Gridley, Investor Relations Manager of Gliatech Inc., 216-831-3200, x3019/
wow
wieder +++ an der nasdaq
Gliatech Inc. GLIA
Apr. 20, 2001 10:22 ET Market Open
Last Sale: $ 3.73
Net Change: 0.67 21.9%
Today`s High: $ 3.8
Today`s Low: $ 3.19
Best Bid: $ 3.61
Best Ask: $ 3.73
Volume: 32,500
Previous Close: $ 3.06
wieder +++ an der nasdaq
Gliatech Inc. GLIA
Apr. 20, 2001 10:22 ET Market Open
Last Sale: $ 3.73
Net Change: 0.67 21.9%
Today`s High: $ 3.8
Today`s Low: $ 3.19
Best Bid: $ 3.61
Best Ask: $ 3.73
Volume: 32,500
Previous Close: $ 3.06
wauu was denn jetzt los????????
hab gar nicht´s mitbekommen.
hab gar nicht´s mitbekommen.
@mvlengen
vielleicht kriegen sie ihr ADCON(R)-L problem (fda, zulieferer, etc) ja wieder in den griff. im rahmen der rezertifizierung nach ISO 9001 ist offensichtlich hier ein grosses augenmerk drauf gelegt worden. s. nachricht vom 18. april.
gruss wunram
vielleicht kriegen sie ihr ADCON(R)-L problem (fda, zulieferer, etc) ja wieder in den griff. im rahmen der rezertifizierung nach ISO 9001 ist offensichtlich hier ein grosses augenmerk drauf gelegt worden. s. nachricht vom 18. april.
gruss wunram
hmmm sieht gut aus bin mal auf heute abend gespannt
und weiter gehts, trotz schwächelnder nasdaq
Gliatech Inc. GLIA
Apr. 23, 2001 10:37 ET Market Open
Last Sale: $ 4.25
Net Change: 0.45 11.84%
Today`s High: $ 4.4
Today`s Low: $ 3.7
Best Bid: $ 4.1
Best Ask: $ 4.25
Volume: 49,100
Previous Close: $ 3.8
Gliatech Inc. GLIA
Apr. 23, 2001 10:37 ET Market Open
Last Sale: $ 4.25
Net Change: 0.45 11.84%
Today`s High: $ 4.4
Today`s Low: $ 3.7
Best Bid: $ 4.1
Best Ask: $ 4.25
Volume: 49,100
Previous Close: $ 3.8
Gliatech Inc. Invites You to Join Its First Quarter Conference Call on the Web
FROM PR NEWSWIRE CLEVELAND 216-566-7777 GLIA
Gliatech Inc. Invites You to Join Its First Quarter Conference Call on the Web
CLEVELAND, April 23 /PRNewswire Interactive News Release/ -- In conjunction with Gliatech`s (Nasdaq: GLIA) First Quarter earnings release, you are invited to listen to its conference call that will be broadcast live over the Internet on Wednesday, April 25th, 2001 at 10 A.M. EST with Robert P. Pinkas, Chairman and Acting CEO, Steven L. Basta, President, Rodney E. Dausch, COO, Clark E. Tedford, Executive Vice President, Research & Development and Thomas F. Barnish, Vice President and CFO of Gliatech Inc.
What: Gliatech Inc. First Quarter Earnings Release
When: April 25th, 2001 10 AM EST
Where: http://www.videonewswire.com/GLIATECH/042501/
How: Live over the Internet -- Simply log on to the web at the
address above
Contact: Adam D. Gridley
Investor Relations Manager
216.831.3200
gridleya@gliatech.com
FROM PR NEWSWIRE CLEVELAND 216-566-7777 GLIA
Gliatech Inc. Invites You to Join Its First Quarter Conference Call on the Web
CLEVELAND, April 23 /PRNewswire Interactive News Release/ -- In conjunction with Gliatech`s (Nasdaq: GLIA) First Quarter earnings release, you are invited to listen to its conference call that will be broadcast live over the Internet on Wednesday, April 25th, 2001 at 10 A.M. EST with Robert P. Pinkas, Chairman and Acting CEO, Steven L. Basta, President, Rodney E. Dausch, COO, Clark E. Tedford, Executive Vice President, Research & Development and Thomas F. Barnish, Vice President and CFO of Gliatech Inc.
What: Gliatech Inc. First Quarter Earnings Release
When: April 25th, 2001 10 AM EST
Where: http://www.videonewswire.com/GLIATECH/042501/
How: Live over the Internet -- Simply log on to the web at the
address above
Contact: Adam D. Gridley
Investor Relations Manager
216.831.3200
gridleya@gliatech.com
Gliatech Announces First Quarter 2001 Results
CLEVELAND, April 25 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA) today announced financial results for the first quarter ended March 31, 2001. Due to the Company`s voluntary recall of ADCON(R)-L and ADCON(R)-T/N in January 2001, there were no net product sales in the first quarter of 2001 compared to $6.8 million in the first quarter of 2000. Cost of products sold increased to $1.4 million in the first quarter of 2001 compared to $1.2 million in the first quarter of 2000. Cost of products sold in 2001 includes $1.1 million of operating and revalidation costs incurred at the Company`s manufacturing facility in Solon, Ohio and its third party contract manufacturer, European Medical Contract Manufacturing, as well as $0.3 million of product recall costs. Selling, general and administrative expenses decreased to $2.3 million in the first quarter of 2001 compared to $3.5 million in the first quarter of 2000 primarily due to reduced commission expense. The Company recorded a net loss in the first quarter of 2001 of $5.9 million, or $(0.61) per share, compared to net income of $0.1 million, or $0.01 per share in the first quarter of 2000.
As of March 31, 2001, Gliatech had approximately $9.2 million of cash, cash equivalents and short-term investments. The Company is currently in active discussions regarding potential funding sources such as equity and debt financing and is engaged in discussions with strategic partners for its pharmaceutical programs. While the Company anticipates that it will secure additional financing, there can be no assurance that the Company will be able to secure such funding or consummate any strategic alternatives on terms satisfactory to the Company, or at all.
Q2 International Relaunch
Gliatech announced on April 18, 2001 that it has successfully completed an International Standards Organization (ISO) 9001 audit that was conducted by KEMA Registered Quality B.V. (KEMA), a European Notified Body. In addition, the Company has completed process development work relating to a raw material used in the manufacture of ADCON(R)-L and initiated manufacturing validation runs. The Company anticipates relaunch of ADCON(R)-L outside the U.S. in June 2001.
About Gliatech Inc.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R) gel and ADCON(R) solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to treat inflammatory disorders.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of the Company to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, uncertainty of market acceptance of the Company`s products, the uncertainty of expenses associated with clinical trials and research efforts which may affect the profitability of the Company, the ability of the Company to consummate any strategic alternatives on satisfactory terms, or at all, the ability of the Company to obtain an adequate supply of the materials used in the manufacture of its ADCON(R) products, uncertainty of regulatory approvals, the status of the Company with respect to AIP, the timing and content of decisions including review of data by the FDA, including the decisions with respect to sale of ADCON(R)-L, product recalls and the inspectional observations by the FDA, the uncertainty of market conditions and other risk factors detailed in Gliatech`s SEC filings.
There will be a conference call at 10:00 a.m. EDT today to discuss Gliatech`s first quarter financial results. This call will be broadcast live over the Internet at http://www.videonewswire.com/GLIATECH/042501/ and will be archived at Gliatech`s website located at http://www.gliatech.com . A replay of the call will be available until April 29, 2001. The replay telephone number is 1-800-876-8729.
GLIATECH INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
Three Months Ended
(In thousands, except share and per share data) March 31,
2001 2000
Revenues
Net product sales $- $$6,831
Government grants - 243
Total revenues - 7,074
Operating costs and expenses
Cost of products sold (a) 1,365 1,202
Research and development 2,362 2,573
Selling, general and administrative 2,336 3,452
Total operating costs and expenses 6,063 7,227
Loss from operations (6,063) (153)
Interest income, net 199 270
Net (loss) income $(5,864) $117
(Loss) earnings per share
Basic $ (0.61) $0.01
Diluted $ (0.61) $0.01
Average shares outstanding
Basic 9,682,637 9,489,341
Diluted 9,682,637 9,698,465
(a) Cost of products sold in 2001 includes $1.1 million of operating and
revalidation costs incurred at the Company`s manufacturing facility
in Solon, Ohio, and its third party contract manufacturer, European
Medical Contract Manufacturing, as well as $0.3 million of product
recall costs. Cost of products sold in 2000 includes $0.4 million of
operating costs incurred at the Company`s Solon, Ohio manufacturing
facility.
CONSOLIDATED BALANCE SHEET
(unaudited)
(In thousands) March 31, December 31,
2001 2000
Balance Sheet Data:
Cash, cash equivalents and short-term investments $9,176 $8,464
Other current assets 3,183 4,830
Total current assets 12,359 13,294
Long term investments 3,642
Property and equipment, net 3,046 3,197
Other assets, net 1,064 1,043
Total assets $16,469 $21,176
A/P and other accrued expenses $6,112 $3,840
Other current liabilities 692 1,833
Total current liabilities 6,804 5,673
Stockholders` equity 9,665 15,503
Total liabilities & stockholders` equity $16,469 $21,176
MAKE YOUR OPINION COUNT - Click Here
http://tbutton.prnewswire.com/prn/11690X17286277
/CONTACT: Adam D. Gridley, Investor Relations Manager of Gliatech Inc., 216-831-3200, x3019/
CLEVELAND, April 25 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA) today announced financial results for the first quarter ended March 31, 2001. Due to the Company`s voluntary recall of ADCON(R)-L and ADCON(R)-T/N in January 2001, there were no net product sales in the first quarter of 2001 compared to $6.8 million in the first quarter of 2000. Cost of products sold increased to $1.4 million in the first quarter of 2001 compared to $1.2 million in the first quarter of 2000. Cost of products sold in 2001 includes $1.1 million of operating and revalidation costs incurred at the Company`s manufacturing facility in Solon, Ohio and its third party contract manufacturer, European Medical Contract Manufacturing, as well as $0.3 million of product recall costs. Selling, general and administrative expenses decreased to $2.3 million in the first quarter of 2001 compared to $3.5 million in the first quarter of 2000 primarily due to reduced commission expense. The Company recorded a net loss in the first quarter of 2001 of $5.9 million, or $(0.61) per share, compared to net income of $0.1 million, or $0.01 per share in the first quarter of 2000.
As of March 31, 2001, Gliatech had approximately $9.2 million of cash, cash equivalents and short-term investments. The Company is currently in active discussions regarding potential funding sources such as equity and debt financing and is engaged in discussions with strategic partners for its pharmaceutical programs. While the Company anticipates that it will secure additional financing, there can be no assurance that the Company will be able to secure such funding or consummate any strategic alternatives on terms satisfactory to the Company, or at all.
Q2 International Relaunch
Gliatech announced on April 18, 2001 that it has successfully completed an International Standards Organization (ISO) 9001 audit that was conducted by KEMA Registered Quality B.V. (KEMA), a European Notified Body. In addition, the Company has completed process development work relating to a raw material used in the manufacture of ADCON(R)-L and initiated manufacturing validation runs. The Company anticipates relaunch of ADCON(R)-L outside the U.S. in June 2001.
About Gliatech Inc.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R) gel and ADCON(R) solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to treat inflammatory disorders.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of the Company to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, uncertainty of market acceptance of the Company`s products, the uncertainty of expenses associated with clinical trials and research efforts which may affect the profitability of the Company, the ability of the Company to consummate any strategic alternatives on satisfactory terms, or at all, the ability of the Company to obtain an adequate supply of the materials used in the manufacture of its ADCON(R) products, uncertainty of regulatory approvals, the status of the Company with respect to AIP, the timing and content of decisions including review of data by the FDA, including the decisions with respect to sale of ADCON(R)-L, product recalls and the inspectional observations by the FDA, the uncertainty of market conditions and other risk factors detailed in Gliatech`s SEC filings.
There will be a conference call at 10:00 a.m. EDT today to discuss Gliatech`s first quarter financial results. This call will be broadcast live over the Internet at http://www.videonewswire.com/GLIATECH/042501/ and will be archived at Gliatech`s website located at http://www.gliatech.com . A replay of the call will be available until April 29, 2001. The replay telephone number is 1-800-876-8729.
GLIATECH INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
Three Months Ended
(In thousands, except share and per share data) March 31,
2001 2000
Revenues
Net product sales $- $$6,831
Government grants - 243
Total revenues - 7,074
Operating costs and expenses
Cost of products sold (a) 1,365 1,202
Research and development 2,362 2,573
Selling, general and administrative 2,336 3,452
Total operating costs and expenses 6,063 7,227
Loss from operations (6,063) (153)
Interest income, net 199 270
Net (loss) income $(5,864) $117
(Loss) earnings per share
Basic $ (0.61) $0.01
Diluted $ (0.61) $0.01
Average shares outstanding
Basic 9,682,637 9,489,341
Diluted 9,682,637 9,698,465
(a) Cost of products sold in 2001 includes $1.1 million of operating and
revalidation costs incurred at the Company`s manufacturing facility
in Solon, Ohio, and its third party contract manufacturer, European
Medical Contract Manufacturing, as well as $0.3 million of product
recall costs. Cost of products sold in 2000 includes $0.4 million of
operating costs incurred at the Company`s Solon, Ohio manufacturing
facility.
CONSOLIDATED BALANCE SHEET
(unaudited)
(In thousands) March 31, December 31,
2001 2000
Balance Sheet Data:
Cash, cash equivalents and short-term investments $9,176 $8,464
Other current assets 3,183 4,830
Total current assets 12,359 13,294
Long term investments 3,642
Property and equipment, net 3,046 3,197
Other assets, net 1,064 1,043
Total assets $16,469 $21,176
A/P and other accrued expenses $6,112 $3,840
Other current liabilities 692 1,833
Total current liabilities 6,804 5,673
Stockholders` equity 9,665 15,503
Total liabilities & stockholders` equity $16,469 $21,176
MAKE YOUR OPINION COUNT - Click Here
http://tbutton.prnewswire.com/prn/11690X17286277
/CONTACT: Adam D. Gridley, Investor Relations Manager of Gliatech Inc., 216-831-3200, x3019/
geld um ADCON(R)-L ausserhalb und innerhalb der USA wieder auf den MArkt zu bringen-
hoffentlich klappts im Juni
Gliatech to Raise Up To $15-30 million from Paul Capital Partners in A Staged Financing
CLEVELAND, April 26 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA) announced today that the Company has entered into an agreement with Paul Capital Royalty Acquisition Fund, L.P. ("PCRAF") for up to $15 million to be invested in stages, with a future option for up to $15 million of additional funds. The Company has received an initial $5 million cash infusion under this agreement. The Company`s agreement further provides that the Company will receive an additional $2.5 million from PCRAF upon satisfaction of certain conditions, including the commercial relaunch of ADCON(R)-L outside of the U.S. and an additional $7.5 million upon satisfaction of certain conditions, including the commercial relaunch of ADCON(R)-L in the U.S.
In consideration for the first $15 million, PCRAF will receive royalties on ADCON(R) products equal to the greater of i) approximately 2.5% of net sales or ii) certain guaranteed minimum annual royalty payments beginning in 2003 at a rate of $1.6 million annually and increasing in future years until December 31, 2012. The percentage of net sales and guaranteed minimum royalty payment amounts are subject to modification under certain conditions. In addition, PCRAF will receive a warrant to purchase 300,000 shares of common stock of Gliatech at $2.00 per share. Gliatech will have the option for the 12 months following the commercial relaunch of ADCON(R)-L in the U.S., to obtain, subject to the satisfaction of certain other conditions, an additional $15 million from PCRAF on the same general economic terms. Gliatech also has the option to repurchase PCRAF`s royalty interest beginning in 2003.
With the immediate infusion of $5.0 million, Gliatech will have approximately $13 million in cash and short-term investments. As previously stated, Gliatech anticipates commercial relaunch of ADCON(R)-L outside the U.S. in June 2001. This relaunch, along with the satisfaction of certain milestones, will trigger PCRAF`s $2.5 million investment. Gliatech is also working to develop the data necessary to support a submission to the Food and Drug Administration ("FDA") seeking reintroduction of ADCON(R)-L in the U.S, which, together with satisfaction of certain conditions, will trigger PCRAF`s additional $7.5 million investment. A relaunch in the U.S. is subject to the adequacy of the data developed by Gliatech and approval by the FDA under the AIP guidelines.
"We are pleased that Paul Capital shares Gliatech`s vision of becoming a worldwide leader in adhesion prevention, and we appreciate their vote of confidence in our ability to grow the ADCON(R) business," said Steven L. Basta, President of Gliatech. "This financing arrangement offers significant strategic benefits to the Company. The first $5.0 million will support activities required in the near-term for our submission to the FDA to relaunch ADCON(R)-L in the U.S., and the future $10.0 million in milestone funding is expected to support an aggressive relaunch of ADCON(R)-L and additional clinical trials for the ADCON(R) product pipeline. These are key steps toward our goal of winning the adhesion prevention market."
"We believe the structure of the financing is of benefit to our current stockholders and provides strategic advantages. The dilution to current stockholders is minimal and the royalty structure and availability of additional capital allows us to gain operating momentum in the short-term to rapidly grow both the ADCON(R) gel and ADCON(R) solution products toward creating a successful adhesion prevention business," continued Mr. Basta.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R) gel and ADCON(R) solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to treat inflammatory disorders.
Paul Capital Partners is one of the leading purchasers of private equity in the secondary market. The Paul Capital Royalty Acquisition Fund provides liquidity to owners of life sciences royalty interests. Since 1998 Paul Capital Partners and its affiliated entities have invested in or structured more than $250 million in royalty transactions. For company information, visit Paul Capital Partners on the World Wide Web at http://www.paulcapital.com
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, uncertainty of market acceptance of Gliatech`s products, the uncertainty of expenses associated with clinical trials and research efforts which may affect the profitability of Gliatech, the impact of future events on the adequacy of Gliatech`s cash position, the ability of Gliatech to obtain an adequate supply of the materials used in the manufacture of its ADCON(R) products, the uncertainty regarding the relaunch of Gliatech`s products, including the timing thereof, uncertainty of regulatory approvals, the status of the Company with respect to AIP, the timing and content of decisions including review of data by the FDA, including the decisions with respect to sale of ADCON(R)-L, product recalls and the inspectional observations by the FDA, the uncertainty of market conditions, the uncertainty of Gliatech`s ability to satisfy the conditions required for the additional investment by PCRAF and other risk factors detailed in Gliatech`s SEC filings.
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/CONTACT: Adam D. Gridley, Investor Relations Manager of Gliatech Inc., 216-831-3200, x3019/
hoffentlich klappts im Juni
Gliatech to Raise Up To $15-30 million from Paul Capital Partners in A Staged Financing
CLEVELAND, April 26 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA) announced today that the Company has entered into an agreement with Paul Capital Royalty Acquisition Fund, L.P. ("PCRAF") for up to $15 million to be invested in stages, with a future option for up to $15 million of additional funds. The Company has received an initial $5 million cash infusion under this agreement. The Company`s agreement further provides that the Company will receive an additional $2.5 million from PCRAF upon satisfaction of certain conditions, including the commercial relaunch of ADCON(R)-L outside of the U.S. and an additional $7.5 million upon satisfaction of certain conditions, including the commercial relaunch of ADCON(R)-L in the U.S.
In consideration for the first $15 million, PCRAF will receive royalties on ADCON(R) products equal to the greater of i) approximately 2.5% of net sales or ii) certain guaranteed minimum annual royalty payments beginning in 2003 at a rate of $1.6 million annually and increasing in future years until December 31, 2012. The percentage of net sales and guaranteed minimum royalty payment amounts are subject to modification under certain conditions. In addition, PCRAF will receive a warrant to purchase 300,000 shares of common stock of Gliatech at $2.00 per share. Gliatech will have the option for the 12 months following the commercial relaunch of ADCON(R)-L in the U.S., to obtain, subject to the satisfaction of certain other conditions, an additional $15 million from PCRAF on the same general economic terms. Gliatech also has the option to repurchase PCRAF`s royalty interest beginning in 2003.
With the immediate infusion of $5.0 million, Gliatech will have approximately $13 million in cash and short-term investments. As previously stated, Gliatech anticipates commercial relaunch of ADCON(R)-L outside the U.S. in June 2001. This relaunch, along with the satisfaction of certain milestones, will trigger PCRAF`s $2.5 million investment. Gliatech is also working to develop the data necessary to support a submission to the Food and Drug Administration ("FDA") seeking reintroduction of ADCON(R)-L in the U.S, which, together with satisfaction of certain conditions, will trigger PCRAF`s additional $7.5 million investment. A relaunch in the U.S. is subject to the adequacy of the data developed by Gliatech and approval by the FDA under the AIP guidelines.
"We are pleased that Paul Capital shares Gliatech`s vision of becoming a worldwide leader in adhesion prevention, and we appreciate their vote of confidence in our ability to grow the ADCON(R) business," said Steven L. Basta, President of Gliatech. "This financing arrangement offers significant strategic benefits to the Company. The first $5.0 million will support activities required in the near-term for our submission to the FDA to relaunch ADCON(R)-L in the U.S., and the future $10.0 million in milestone funding is expected to support an aggressive relaunch of ADCON(R)-L and additional clinical trials for the ADCON(R) product pipeline. These are key steps toward our goal of winning the adhesion prevention market."
"We believe the structure of the financing is of benefit to our current stockholders and provides strategic advantages. The dilution to current stockholders is minimal and the royalty structure and availability of additional capital allows us to gain operating momentum in the short-term to rapidly grow both the ADCON(R) gel and ADCON(R) solution products toward creating a successful adhesion prevention business," continued Mr. Basta.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R) gel and ADCON(R) solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to treat inflammatory disorders.
Paul Capital Partners is one of the leading purchasers of private equity in the secondary market. The Paul Capital Royalty Acquisition Fund provides liquidity to owners of life sciences royalty interests. Since 1998 Paul Capital Partners and its affiliated entities have invested in or structured more than $250 million in royalty transactions. For company information, visit Paul Capital Partners on the World Wide Web at http://www.paulcapital.com
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, uncertainty of market acceptance of Gliatech`s products, the uncertainty of expenses associated with clinical trials and research efforts which may affect the profitability of Gliatech, the impact of future events on the adequacy of Gliatech`s cash position, the ability of Gliatech to obtain an adequate supply of the materials used in the manufacture of its ADCON(R) products, the uncertainty regarding the relaunch of Gliatech`s products, including the timing thereof, uncertainty of regulatory approvals, the status of the Company with respect to AIP, the timing and content of decisions including review of data by the FDA, including the decisions with respect to sale of ADCON(R)-L, product recalls and the inspectional observations by the FDA, the uncertainty of market conditions, the uncertainty of Gliatech`s ability to satisfy the conditions required for the additional investment by PCRAF and other risk factors detailed in Gliatech`s SEC filings.
MAKE YOUR OPINION COUNT - Click Here
http://tbutton.prnewswire.com/prn/11690X43914407
/CONTACT: Adam D. Gridley, Investor Relations Manager of Gliatech Inc., 216-831-3200, x3019/
@wunram
sieht doch immer noch ganz anständig aus wenn wir jetzt noch mal über 5.50€ kommen würde ich sagen charttechnisch ein kauf
mfg mathes
sieht doch immer noch ganz anständig aus wenn wir jetzt noch mal über 5.50€ kommen würde ich sagen charttechnisch ein kauf
mfg mathes
Folgende Meldung heute bei comdirect, Quelle FON
????????????????????????????????
Montag, 14.05.2001, 12:46
Gliatech-Medikament fällt durch FDA Untersuchung
Die Gliatech Inc. wurde von der U.S. Food and Drug Administration gewarnt, dass Adcon-L, ihr Gel gegen Vernarbungen bei Sicherheitstest nicht bestanden hat. Für die Studien werden weitere Auflagen gemacht.
Die FDA bemängelt ein Versagen bei den Sicherheitstests, das fehlende Einhalten der Richtlinien bei der Anmeldung der Test-Patienten und Fehler bei Änderungen der Studienprotokolle.
Die Richtigkeit der Adcon-L Daten wurde angezweifelt. Deshalb wurde die Genehmigung für eine weitere Anwendung verschoben.
Adcon-L ist das einzige verkaufte Produkt der Gliatech Inc. Das Gel wurde 1998 für die Rückgrat-Chirurgie zugelassen.
Diese Meldung wurde nach Marktschluss veröffentlicht.
Die Aktien verloren 3,28 Prozent und schlossen an der Nasdaq bei 3,83 Dollar.
????????????????????????????????
Montag, 14.05.2001, 12:46
Gliatech-Medikament fällt durch FDA Untersuchung
Die Gliatech Inc. wurde von der U.S. Food and Drug Administration gewarnt, dass Adcon-L, ihr Gel gegen Vernarbungen bei Sicherheitstest nicht bestanden hat. Für die Studien werden weitere Auflagen gemacht.
Die FDA bemängelt ein Versagen bei den Sicherheitstests, das fehlende Einhalten der Richtlinien bei der Anmeldung der Test-Patienten und Fehler bei Änderungen der Studienprotokolle.
Die Richtigkeit der Adcon-L Daten wurde angezweifelt. Deshalb wurde die Genehmigung für eine weitere Anwendung verschoben.
Adcon-L ist das einzige verkaufte Produkt der Gliatech Inc. Das Gel wurde 1998 für die Rückgrat-Chirurgie zugelassen.
Diese Meldung wurde nach Marktschluss veröffentlicht.
Die Aktien verloren 3,28 Prozent und schlossen an der Nasdaq bei 3,83 Dollar.
jetzt gehts wieder vorwärts:
Gliatech Relaunches ADCON(R)-L Outside of the U.S.
CLEVELAND, May 22 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA) announced today that it has relaunched ADCON(R)-L internationally. The Company is producing ADCON(R)-L through its contract manufacturer, European Medical Contract Manufacturing B.V., (EMCM) located in the Netherlands. EMCM today initiated shipment of ADCON(R)-L to Gliatech`s independent medical device distributors.
"We appreciate the patience and support of our distributors during this recall and are encouraged by the continued interest of surgeons and hospitals in this product," stated Steven L. Basta, President of Gliatech. "This is an important milestone in reestablishing ADCON(R)-L internationally as the standard of care for the prevention of scarring and adhesions in the lumbar spine. We are pleased to have met the timeline we promised to our international distribution partners."
This international relaunch is being made through Gliatech`s distributors in each of the following countries and territories: Argentina, Australia, Austria, Belgium, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Korea, Latin America, Luxemburg, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, the Republic of South Africa, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
As previously announced in January 2001, Gliatech implemented a voluntary worldwide recall of the Company`s ADCON(R) gel products as a result of a recall by the supplier of a raw material component of ADCON(R) gel. Relaunch of ADCON(R)-L in the U.S. is subject to the submission and approval of the additional data identified previously as part of the Food and Drug Administration`s Application Integrity Policy status.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R) gel and ADCON(R) solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to treat inflammatory disorders.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, uncertainty of market acceptance of Gliatech`s products, the uncertainty of expenses associated with clinical trials and research efforts which may affect the profitability of Gliatech, the ability of Gliatech to obtain an adequate supply of the materials used in the manufacture of its ADCON(R) products, uncertainty of the success of the relaunch of ADCON(R)-L outside the U.S., uncertainty of regulatory approvals, the status of the Company with respect to AIP, the timing and content of decisions including review of data by the FDA, including the decisions with respect to sale of ADCON(R)-L, product recalls and the inspectional observations by the FDA, the uncertainty of market conditions and other risk factors detailed in Gliatech`s SEC filings.
MAKE YOUR OPINION COUNT - Click Here
http://tbutton.prnewswire.com/prn/11690X93852427
/CONTACT: Adam D. Gridley, Investor Relations Manager of Gliatech Inc., 216-831-3200, x3019/
Gliatech Relaunches ADCON(R)-L Outside of the U.S.
CLEVELAND, May 22 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA) announced today that it has relaunched ADCON(R)-L internationally. The Company is producing ADCON(R)-L through its contract manufacturer, European Medical Contract Manufacturing B.V., (EMCM) located in the Netherlands. EMCM today initiated shipment of ADCON(R)-L to Gliatech`s independent medical device distributors.
"We appreciate the patience and support of our distributors during this recall and are encouraged by the continued interest of surgeons and hospitals in this product," stated Steven L. Basta, President of Gliatech. "This is an important milestone in reestablishing ADCON(R)-L internationally as the standard of care for the prevention of scarring and adhesions in the lumbar spine. We are pleased to have met the timeline we promised to our international distribution partners."
This international relaunch is being made through Gliatech`s distributors in each of the following countries and territories: Argentina, Australia, Austria, Belgium, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Korea, Latin America, Luxemburg, Mexico, The Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, the Republic of South Africa, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
As previously announced in January 2001, Gliatech implemented a voluntary worldwide recall of the Company`s ADCON(R) gel products as a result of a recall by the supplier of a raw material component of ADCON(R) gel. Relaunch of ADCON(R)-L in the U.S. is subject to the submission and approval of the additional data identified previously as part of the Food and Drug Administration`s Application Integrity Policy status.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R) gel and ADCON(R) solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to treat inflammatory disorders.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, uncertainty of market acceptance of Gliatech`s products, the uncertainty of expenses associated with clinical trials and research efforts which may affect the profitability of Gliatech, the ability of Gliatech to obtain an adequate supply of the materials used in the manufacture of its ADCON(R) products, uncertainty of the success of the relaunch of ADCON(R)-L outside the U.S., uncertainty of regulatory approvals, the status of the Company with respect to AIP, the timing and content of decisions including review of data by the FDA, including the decisions with respect to sale of ADCON(R)-L, product recalls and the inspectional observations by the FDA, the uncertainty of market conditions and other risk factors detailed in Gliatech`s SEC filings.
MAKE YOUR OPINION COUNT - Click Here
http://tbutton.prnewswire.com/prn/11690X93852427
/CONTACT: Adam D. Gridley, Investor Relations Manager of Gliatech Inc., 216-831-3200, x3019/
Wer kann mir näheres zu den plötzlichen Kurssteigerungen sagen.
ich leider nicht aber ich finde es sehr erfreulich
mfg
mathes
mfg
mathes
Gliatech Announces Clinical Findings from Large Multi-Center ADCON(R)-L Retrospective Clinical Study
SAN DIEGO, Oct. 1 /PRNewswire/ -- A leading investigator presented a poster today detailing the clinical results of a multi-center retrospective evaluation of ADCON(R)-L, a product of Gliatech Inc. (Nasdaq: GLIA). This information was presented at the Congress of Neurological Surgeons 51st Annual Meeting in San Diego, CA. This retrospective study involved 847 patients at 10 U.S. clinical centers. Surgeons at these centers independently collected and reviewed post-operative clinical information from the medical records for consecutive series of patients who received ADCON(R)-L during single-level, lumbar nerve root decompression.
"We are pleased with the findings from this study," remarked Steven L. Basta, President of Gliatech. "The types of adverse events and incidence rates seen in this study are generally consistent with those expected for patients undergoing lumbar surgery independent of ADCON(R)-L usage."
847 ADCON(R)-L patients` records were retrieved from 10 clinical centers for evaluations, demographic and surgical usage patterns. The entrance criteria were consistent with criteria approved by the Food and Drug Administration ("FDA") for ADCON(R)-L. A total of 819 evaluable patients met such criteria and were included in the final analysis. The study results indicated an overall patient incidence rate of medical events ("ME") of 12.7% including 1.3% pain in limb as the only medical event incidence rate >1.0%. An overall 28.2% patient adverse event ("AE") incidence rate was seen. The surgeons` review of medical and adverse events indicated 83.8% of such events were unrelated to ADCON(R)-L and 16.2% were considered possibly related. No adverse or medical event was considered probably or definitely related to ADCON(R)-L. Reported adverse events included 8.5% pain in limb, 8.3% back pain, 3.9% intervertebral disc herniation, 3.2% radiculitis, 2.1% muscle spasms, 1.3% pain, and 1.1% wound drainage as the AEs observed with an incidence rate >1.0%. Gliatech has submitted all adverse events and relevant medical events observed in this study as Medical Device Reports ("MDRs") to the FDA.
Thirty-five (4.2%) of the patients in this study required reoperations. Recurrent herniation in 23 cases (2.8%) was the major surgical causative factor reported for the reoperations. In addition, five of 819 patients had surgical complications of either a cerebrospinal fluid leak, pseudomeningocele and/or unintended dural tear for an incidence rate of 0.6%.
The data provided in this release are not a substitute for FDA approved labeling relating to ADCON(R)-L and should not be relied upon by surgeons regarding use of this product. Only FDA approved labeling should be used in such a manner by surgeons. This retrospective study funded by Gliatech was conducted on behalf of the Company by Boston Biostatistics, Inc., an independent clinical research organization.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R)-L and ADCON(R)-T/N and ADCON(R) Solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to inhibit inflammation.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, uncertainty of market acceptance of Gliatech`s products, the uncertainty of the success of certain clinical trials, the ability of Gliatech to obtain an adequate supply of the materials used in the manufacture of its ADCON(R) products, uncertainty of the success of the relaunch of ADCON(R)-L outside the U.S., uncertainty of regulatory approvals, the status of the Company with respect to AIP, the timing and content of decisions including review of data by the FDA, including the decisions with respect to sale of ADCON(R)-L, product recalls and the inspection observations by the FDA, the uncertainty of market conditions and other risk factors detailed in Gliatech`s SEC filings.
MAKE YOUR OPINION COUNT - Click Here
http://tbutton.prnewswire.com/prn/11690X94069144
/CONTACT: Adam D. Gridley, Manager, Investor Relations & Business Development of Gliatech Inc., +1-216-831-3200, x3019/
SAN DIEGO, Oct. 1 /PRNewswire/ -- A leading investigator presented a poster today detailing the clinical results of a multi-center retrospective evaluation of ADCON(R)-L, a product of Gliatech Inc. (Nasdaq: GLIA). This information was presented at the Congress of Neurological Surgeons 51st Annual Meeting in San Diego, CA. This retrospective study involved 847 patients at 10 U.S. clinical centers. Surgeons at these centers independently collected and reviewed post-operative clinical information from the medical records for consecutive series of patients who received ADCON(R)-L during single-level, lumbar nerve root decompression.
"We are pleased with the findings from this study," remarked Steven L. Basta, President of Gliatech. "The types of adverse events and incidence rates seen in this study are generally consistent with those expected for patients undergoing lumbar surgery independent of ADCON(R)-L usage."
847 ADCON(R)-L patients` records were retrieved from 10 clinical centers for evaluations, demographic and surgical usage patterns. The entrance criteria were consistent with criteria approved by the Food and Drug Administration ("FDA") for ADCON(R)-L. A total of 819 evaluable patients met such criteria and were included in the final analysis. The study results indicated an overall patient incidence rate of medical events ("ME") of 12.7% including 1.3% pain in limb as the only medical event incidence rate >1.0%. An overall 28.2% patient adverse event ("AE") incidence rate was seen. The surgeons` review of medical and adverse events indicated 83.8% of such events were unrelated to ADCON(R)-L and 16.2% were considered possibly related. No adverse or medical event was considered probably or definitely related to ADCON(R)-L. Reported adverse events included 8.5% pain in limb, 8.3% back pain, 3.9% intervertebral disc herniation, 3.2% radiculitis, 2.1% muscle spasms, 1.3% pain, and 1.1% wound drainage as the AEs observed with an incidence rate >1.0%. Gliatech has submitted all adverse events and relevant medical events observed in this study as Medical Device Reports ("MDRs") to the FDA.
Thirty-five (4.2%) of the patients in this study required reoperations. Recurrent herniation in 23 cases (2.8%) was the major surgical causative factor reported for the reoperations. In addition, five of 819 patients had surgical complications of either a cerebrospinal fluid leak, pseudomeningocele and/or unintended dural tear for an incidence rate of 0.6%.
The data provided in this release are not a substitute for FDA approved labeling relating to ADCON(R)-L and should not be relied upon by surgeons regarding use of this product. Only FDA approved labeling should be used in such a manner by surgeons. This retrospective study funded by Gliatech was conducted on behalf of the Company by Boston Biostatistics, Inc., an independent clinical research organization.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R)-L and ADCON(R)-T/N and ADCON(R) Solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to inhibit inflammation.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, uncertainty of market acceptance of Gliatech`s products, the uncertainty of the success of certain clinical trials, the ability of Gliatech to obtain an adequate supply of the materials used in the manufacture of its ADCON(R) products, uncertainty of the success of the relaunch of ADCON(R)-L outside the U.S., uncertainty of regulatory approvals, the status of the Company with respect to AIP, the timing and content of decisions including review of data by the FDA, including the decisions with respect to sale of ADCON(R)-L, product recalls and the inspection observations by the FDA, the uncertainty of market conditions and other risk factors detailed in Gliatech`s SEC filings.
MAKE YOUR OPINION COUNT - Click Here
http://tbutton.prnewswire.com/prn/11690X94069144
/CONTACT: Adam D. Gridley, Manager, Investor Relations & Business Development of Gliatech Inc., +1-216-831-3200, x3019/
Das könnte das Ende von Gliatech sein:
CLEVELAND, Oct. 15 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA) announced
initial results of the independent re-evaluation of the magnetic resonance
imaging ("MRI" ) data from the U.S. clinical study of ADCON(R)-L. In this re-
evaluation of MRI data from that study, there was no significant difference in
maximum scar scores between the treatment group and the untreated control
group. Gliatech is currently reviewing the data and will discuss these results
and all other available data on ADCON(R)-L with the Food and Drug
Administration ("FDA" ).
In this study, each of two neuroradiologists evaluated the MRI films to
score the amount of post-operative scar evident for each patient six months
after their surgery. The data set of scores by each neuroradiologist was
analyzed as an independent outcome measure. No statistically significant
differences between ADCON(R)-L treated and control patients were evident in
analysis of MRI scar scores rated by either neuroradiologist. The inter-
reader and intra-reader reliability analyses in this re-evaluation indicated
considerable variability in the MRI scar score measurements. The variability
evident in this data may reduce the utility of the MRI re-evaluation in this
study as a valid measure of the effectiveness of ADCON(R)-L. Additional
clinical outcome endpoints, including pain measurements at six months
following treatment, are currently being analyzed by the independent contract
research organization that conducted this study.
"We are disappointed by the results of this MRI re-evaluation," stated
Steven L. Basta, President of Gliatech. "We will discuss with the FDA the
findings of this study and the extensive data available from prior studies and
from years of clinical use to determine the Company`s options regarding
development and commercialization of ADCON(R)-L in the U.S. markets."
The U.S. study, for which this MRI re-evaluation was conducted, was the
second major efficacy study of ADCON(R)-L. In the first efficacy study,
conducted in Europe, results demonstrated that six months following surgery
those patients who received ADCON(R)-L had a statistically significant
reduction in both MRI scar and pain measurements as compared to the untreated
control group. This data was reviewed at the FDA`s Pre-Market Approval (PMA)
panel meeting, and the results of the European study were audited by FDA at
that time. In addition to the European efficacy study, published literature
on ADCON(R)-L has indicated that physicians have observed less scar during
reoperation on patients who received ADCON(R)-L. Gliatech is currently
marketing ADCON(R)-L outside the U.S. in 39 countries through independent
distributors.
The results of this MRI re-evaluation make the reintroduction of ADCON(R)-
L in the U.S. uncertain. Due to this uncertainty, and the capital
requirements of operating the Company, Gliatech intends to consider strategic
and other alternatives available to it. There can be no assurance that the
Company will be able to identify necessary financing or will be able to
conclude strategic alternatives or other alternatives in a timely manner on
terms acceptable to the Company, if at all.
CLEVELAND, Oct. 15 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA) announced
initial results of the independent re-evaluation of the magnetic resonance
imaging ("MRI" ) data from the U.S. clinical study of ADCON(R)-L. In this re-
evaluation of MRI data from that study, there was no significant difference in
maximum scar scores between the treatment group and the untreated control
group. Gliatech is currently reviewing the data and will discuss these results
and all other available data on ADCON(R)-L with the Food and Drug
Administration ("FDA" ).
In this study, each of two neuroradiologists evaluated the MRI films to
score the amount of post-operative scar evident for each patient six months
after their surgery. The data set of scores by each neuroradiologist was
analyzed as an independent outcome measure. No statistically significant
differences between ADCON(R)-L treated and control patients were evident in
analysis of MRI scar scores rated by either neuroradiologist. The inter-
reader and intra-reader reliability analyses in this re-evaluation indicated
considerable variability in the MRI scar score measurements. The variability
evident in this data may reduce the utility of the MRI re-evaluation in this
study as a valid measure of the effectiveness of ADCON(R)-L. Additional
clinical outcome endpoints, including pain measurements at six months
following treatment, are currently being analyzed by the independent contract
research organization that conducted this study.
"We are disappointed by the results of this MRI re-evaluation," stated
Steven L. Basta, President of Gliatech. "We will discuss with the FDA the
findings of this study and the extensive data available from prior studies and
from years of clinical use to determine the Company`s options regarding
development and commercialization of ADCON(R)-L in the U.S. markets."
The U.S. study, for which this MRI re-evaluation was conducted, was the
second major efficacy study of ADCON(R)-L. In the first efficacy study,
conducted in Europe, results demonstrated that six months following surgery
those patients who received ADCON(R)-L had a statistically significant
reduction in both MRI scar and pain measurements as compared to the untreated
control group. This data was reviewed at the FDA`s Pre-Market Approval (PMA)
panel meeting, and the results of the European study were audited by FDA at
that time. In addition to the European efficacy study, published literature
on ADCON(R)-L has indicated that physicians have observed less scar during
reoperation on patients who received ADCON(R)-L. Gliatech is currently
marketing ADCON(R)-L outside the U.S. in 39 countries through independent
distributors.
The results of this MRI re-evaluation make the reintroduction of ADCON(R)-
L in the U.S. uncertain. Due to this uncertainty, and the capital
requirements of operating the Company, Gliatech intends to consider strategic
and other alternatives available to it. There can be no assurance that the
Company will be able to identify necessary financing or will be able to
conclude strategic alternatives or other alternatives in a timely manner on
terms acceptable to the Company, if at all.
hats eigentlich keiner so richtig mitbekommen?? 
Abgenix Licenses From Gliatech Antibody Product Candidates for Cardiovascular and Inflammatory Diseases; IND Planned for 2002
FREMONT, Calif. & CLEVELAND--(BW HealthWire)--Nov. 2, 2001--Abgenix, Inc. (Nasdaq:ABGX) and Gliatech Inc. (Nasdaq:GLIA) today announced an agreement that provides Abgenix with exclusive worldwide rights to human monoclonal antibody therapies against the complement protein properdin as potential treatments for cardiovascular and inflammatory diseases. Abgenix has generated lead antibody product candidates for Gliatech under a January 2000 collaboration and will now assume responsibility for development and commercialization. Abgenix anticipates filing an Investigational New Drug (IND) application to the FDA for an anti-properdin antibody product candidate next year.
Under the terms of the agreement, Abgenix obtains an exclusive license to develop and commercialize anti-properdin antibody therapies for all indications and will be responsible for clinical development, regulatory activities, manufacturing, marketing and sales. Gliatech will receive from Abgenix an upfront license fee of $1.5 million, a commitment for a future equity investment, potential milestone payments for multiple clinical indications, research funding for two years and royalties on net sales of any resulting products. Collectively, these non-royalty payments could reach approximately $40 million over the term of the contract if a product is successfully commercialized.
"An anti-properdin antibody represents a promising approach to the treatment of acute inflammatory conditions which result, for example, from cardiopulmonary bypass surgery, heart attacks and stroke," said R. Scott Greer, chairman and chief executive officer of Abgenix. "Gliatech has done a great deal of pre-clinical work in this field and has generated an important intellectual property position. We are excited to move toward clinical development of the first product candidate."
"Our collaborative work with Abgenix over the past two years has led to the identification of promising clinical candidate antibodies," said Steven L. Basta, president of Gliatech. "We have worked closely in this collaboration, and the XenoMouse(R) technology of Abgenix has been an important tool to create antibodies targeted at the properdin antigen that our research team identified in the inflammatory pathway. We are pleased that Abgenix has chosen this antibody among its portfolio of opportunities to move toward commercialization."
Gliatech has been involved in properdin research and its role in modulating inflammatory response for several years and recently received notice of allowance on its patent covering the antigen as a therapeutic target for inflammatory diseases. Agents which block properdin function may play a unique role in modulating the alternative complement pathway in a manner that avoids broad based immune suppression.
Properdin is a protein of the alternative complement pathway, which is a component of the normal host immune system. When the complement pathway is inappropriately triggered, tissue damage may result. Such is the case with acute damage, for example from stimulation of the complement pathway by cardiopulmonary bypass surgery. Shutting down this inappropriate response may thus provide an important anti-inflammatory therapy for patients undergoing such procedures. In chronic diseases, such as rheumatoid arthritis, the immune system aberrantly recognizes the patient`s own tissue and mounts an autoimmune response. Activation of the complement pathway in such a disease is thought to propagate this attack. An anti-properdin antibody may inhibit this cascade and thus limit tissue damage.
In January 2000, Abgenix and Gliatech established a research collaboration to generate fully human antibodies against properdin using Abgenix`s XenoMouse(R) technology. The companies have discovered monoclonal antibodies to properdin that are in vitro and ex vivo inhibitors of the complement alternative pathway. By selectively blocking the alternative pathway, the negative consequences of inappropriate complement activation can be attenuated without inhibiting other key elements of the normal host immune defense. In pre-clinical models, anti-properdin antibodies reduced damage to heart tissue in models of reduced blood flow and effectively blocked complement activation in models of cardiopulmonary bypass surgery.
Abgenix is a biopharmaceutical company focused on the development and commercialization of human monoclonal antibody therapies for a variety of diseases. The company`s antibody technology platform, which includes XenoMouse(R) and XenoMax(TM) technologies, enables the rapid generation and selection of high affinity, fully human antibody product candidates to disease targets appropriate for antibody therapy. Abgenix leverages its leadership position in human antibody technology by building a large and diversified product portfolio through the establishment of licensing arrangements with multiple pharmaceutical, biotechnology and genomics companies and through the development of its own internal proprietary products. For more information on Abgenix, visit the company`s website at www.abgenix.com.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R)-L and ADCON(R)-T/N and ADCON(R) Solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to inhibit inflammation.
For Abgenix: Statements made in this press release about Abgenix`s technologies, product development activities and collaborative arrangements other than statements of historical fact, are forward looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of clinical trials, the progress of research and product development programs, the regulatory approval process, competitive products, future capital requirements and the extent and breadth of Abgenix`s patent portfolio. Please see Abgenix`s public filings with the Securities and Exchange Commission for information about risks that may affect Abgenix.
For Gliatech: Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of the Company to be different from expectations expressed or implied by such forward-looking statements. Such factors include, but are not limited to, uncertainty of market acceptance of the Company`s products, the uncertainty of the continued development of monoclonal antibodies and other risk factors detailed in the Company`s SEC filings.
CONTACT: Abgenix, Inc.
Ina Cu, 510/608-4662
or
Gliatech Inc.
Adam D. Gridley, 216/831-3200 ext. 3019
Abgenix Licenses From Gliatech Antibody Product Candidates for Cardiovascular and Inflammatory Diseases; IND Planned for 2002
FREMONT, Calif. & CLEVELAND--(BW HealthWire)--Nov. 2, 2001--Abgenix, Inc. (Nasdaq:ABGX) and Gliatech Inc. (Nasdaq:GLIA) today announced an agreement that provides Abgenix with exclusive worldwide rights to human monoclonal antibody therapies against the complement protein properdin as potential treatments for cardiovascular and inflammatory diseases. Abgenix has generated lead antibody product candidates for Gliatech under a January 2000 collaboration and will now assume responsibility for development and commercialization. Abgenix anticipates filing an Investigational New Drug (IND) application to the FDA for an anti-properdin antibody product candidate next year.
Under the terms of the agreement, Abgenix obtains an exclusive license to develop and commercialize anti-properdin antibody therapies for all indications and will be responsible for clinical development, regulatory activities, manufacturing, marketing and sales. Gliatech will receive from Abgenix an upfront license fee of $1.5 million, a commitment for a future equity investment, potential milestone payments for multiple clinical indications, research funding for two years and royalties on net sales of any resulting products. Collectively, these non-royalty payments could reach approximately $40 million over the term of the contract if a product is successfully commercialized.
"An anti-properdin antibody represents a promising approach to the treatment of acute inflammatory conditions which result, for example, from cardiopulmonary bypass surgery, heart attacks and stroke," said R. Scott Greer, chairman and chief executive officer of Abgenix. "Gliatech has done a great deal of pre-clinical work in this field and has generated an important intellectual property position. We are excited to move toward clinical development of the first product candidate."
"Our collaborative work with Abgenix over the past two years has led to the identification of promising clinical candidate antibodies," said Steven L. Basta, president of Gliatech. "We have worked closely in this collaboration, and the XenoMouse(R) technology of Abgenix has been an important tool to create antibodies targeted at the properdin antigen that our research team identified in the inflammatory pathway. We are pleased that Abgenix has chosen this antibody among its portfolio of opportunities to move toward commercialization."
Gliatech has been involved in properdin research and its role in modulating inflammatory response for several years and recently received notice of allowance on its patent covering the antigen as a therapeutic target for inflammatory diseases. Agents which block properdin function may play a unique role in modulating the alternative complement pathway in a manner that avoids broad based immune suppression.
Properdin is a protein of the alternative complement pathway, which is a component of the normal host immune system. When the complement pathway is inappropriately triggered, tissue damage may result. Such is the case with acute damage, for example from stimulation of the complement pathway by cardiopulmonary bypass surgery. Shutting down this inappropriate response may thus provide an important anti-inflammatory therapy for patients undergoing such procedures. In chronic diseases, such as rheumatoid arthritis, the immune system aberrantly recognizes the patient`s own tissue and mounts an autoimmune response. Activation of the complement pathway in such a disease is thought to propagate this attack. An anti-properdin antibody may inhibit this cascade and thus limit tissue damage.
In January 2000, Abgenix and Gliatech established a research collaboration to generate fully human antibodies against properdin using Abgenix`s XenoMouse(R) technology. The companies have discovered monoclonal antibodies to properdin that are in vitro and ex vivo inhibitors of the complement alternative pathway. By selectively blocking the alternative pathway, the negative consequences of inappropriate complement activation can be attenuated without inhibiting other key elements of the normal host immune defense. In pre-clinical models, anti-properdin antibodies reduced damage to heart tissue in models of reduced blood flow and effectively blocked complement activation in models of cardiopulmonary bypass surgery.
Abgenix is a biopharmaceutical company focused on the development and commercialization of human monoclonal antibody therapies for a variety of diseases. The company`s antibody technology platform, which includes XenoMouse(R) and XenoMax(TM) technologies, enables the rapid generation and selection of high affinity, fully human antibody product candidates to disease targets appropriate for antibody therapy. Abgenix leverages its leadership position in human antibody technology by building a large and diversified product portfolio through the establishment of licensing arrangements with multiple pharmaceutical, biotechnology and genomics companies and through the development of its own internal proprietary products. For more information on Abgenix, visit the company`s website at www.abgenix.com.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R)-L and ADCON(R)-T/N and ADCON(R) Solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to inhibit inflammation.
For Abgenix: Statements made in this press release about Abgenix`s technologies, product development activities and collaborative arrangements other than statements of historical fact, are forward looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of clinical trials, the progress of research and product development programs, the regulatory approval process, competitive products, future capital requirements and the extent and breadth of Abgenix`s patent portfolio. Please see Abgenix`s public filings with the Securities and Exchange Commission for information about risks that may affect Abgenix.
For Gliatech: Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of the Company to be different from expectations expressed or implied by such forward-looking statements. Such factors include, but are not limited to, uncertainty of market acceptance of the Company`s products, the uncertainty of the continued development of monoclonal antibodies and other risk factors detailed in the Company`s SEC filings.
CONTACT: Abgenix, Inc.
Ina Cu, 510/608-4662
or
Gliatech Inc.
Adam D. Gridley, 216/831-3200 ext. 3019
Klar hab ich´s mitbekommen.
Erstes Kursziel dürfte der Bereich um 4 EURO sein, aus dem GLIA nach den zurückliegenden desaströsen Meldungen wg. ADCON abstürzte. Da ist also noch Luft.
Gruß Preacher
Erstes Kursziel dürfte der Bereich um 4 EURO sein, aus dem GLIA nach den zurückliegenden desaströsen Meldungen wg. ADCON abstürzte. Da ist also noch Luft.
Gruß Preacher
@all
Warum gehen die gerade jetzt raus, wo es doch wieder interessant wird mit GLIA?? Immerhin handelt es sich einen ~19% Anteil an Gliatech.
Irgend jemand eine Idee??
Wisconsin Investment Board Liquidates Gliatech Holdings
WASHINGTON -(Dow Jones)- State of Wisconsin Investment Board liquidated its holdings in Gliatech Inc. (GLIA), according to an amended Schedule 13G filed Wednesday with the Securities and Exchange Commission.
The Board previously reported owning 1.8 million Gliatech shares for a 19% stake as of June 30, according to a Form 13F.
A Schedule 13G denotes a passive investment stake in a company. Filers aren`t required to provide a reason for any changes in stake and aren`t required to detail any transactions.
The Cleveland company develops biosurgery and therapeutic products to improve surgical outcomes and to treat neurological disorders.
-By Todd Goren, Dow Jones Newswires; 202-628-9782; todd.goren@dowjones.com
Warum gehen die gerade jetzt raus, wo es doch wieder interessant wird mit GLIA?? Immerhin handelt es sich einen ~19% Anteil an Gliatech.
Irgend jemand eine Idee??
Wisconsin Investment Board Liquidates Gliatech Holdings
WASHINGTON -(Dow Jones)- State of Wisconsin Investment Board liquidated its holdings in Gliatech Inc. (GLIA), according to an amended Schedule 13G filed Wednesday with the Securities and Exchange Commission.
The Board previously reported owning 1.8 million Gliatech shares for a 19% stake as of June 30, according to a Form 13F.
A Schedule 13G denotes a passive investment stake in a company. Filers aren`t required to provide a reason for any changes in stake and aren`t required to detail any transactions.
The Cleveland company develops biosurgery and therapeutic products to improve surgical outcomes and to treat neurological disorders.
-By Todd Goren, Dow Jones Newswires; 202-628-9782; todd.goren@dowjones.com
Klär mich mal auf. Wo und wieso wird das wieder interessant mit Gliatech?
@puhvogel
siehe z.B. #41
siehe z.B. #41
Aber mit 1,5 $ kann man nicht so furchtbar viel bewegen, auch wenn ich natürlich nichts dagegen hätte, sie selbst zu bekommen 
.
.
@puhvogel
im August hatte GLIA ein Angebot von Bezugsrechten im Wert von etwa 21 Mio Dollar für das 4 Quartal 2001 bei der SEC angemeldet. Im Oktober wurde diese Ansinnen wieder zurückgezogen. Offensichtlich ist die weitere Finanzierung durch die Abgenix Lizenznahme oder weiteres, das wir nicht kennen gesichert.
Sind ja nicht nur 1,5 Mio
Zitat: Collectively, these non-royalty payments could reach approximately $40 million over the term of the contract if a product is successfully commercialized.
Mal schauen was die Zahlen am 14.11. bringen.
Zugegeben die Geschichte mit Adcon-L ist derzeit unbefriedigend - aber wohl noch nicht endgültig.
Gruss Wunram
im August hatte GLIA ein Angebot von Bezugsrechten im Wert von etwa 21 Mio Dollar für das 4 Quartal 2001 bei der SEC angemeldet. Im Oktober wurde diese Ansinnen wieder zurückgezogen. Offensichtlich ist die weitere Finanzierung durch die Abgenix Lizenznahme oder weiteres, das wir nicht kennen gesichert.
Sind ja nicht nur 1,5 Mio
Zitat: Collectively, these non-royalty payments could reach approximately $40 million over the term of the contract if a product is successfully commercialized.
Mal schauen was die Zahlen am 14.11. bringen.
Zugegeben die Geschichte mit Adcon-L ist derzeit unbefriedigend - aber wohl noch nicht endgültig.
Gruss Wunram
if a product is successfully commercialized.
Wie lange das dauert, weisst Du hoffentlich!
Ich erwarte jetzt dasselbe ,was jüngst mit Ergo Science passiert ist, und das war für die Altaktionäre nicht erquicklich.
http://yahoo.marketguide.com/MGI/news.asp?target=stocks%2Fco…
Wie lange das dauert, weisst Du hoffentlich!
Ich erwarte jetzt dasselbe ,was jüngst mit Ergo Science passiert ist, und das war für die Altaktionäre nicht erquicklich.
http://yahoo.marketguide.com/MGI/news.asp?target=stocks%2Fco…
na freilich weiß ich wie lange eine Markteinführung dauert. Aber es ist doch ein positives Signal oder nicht?
Wenn ich die Geschichte mit Ergo Science richtig verstehe, ist dem ganzen aber auch ein delisting in der Nasdq vorausgegangen. Und wenn ich mir den Chart ansehe, hat sich der Kurs nach der Aktion ja verdoppelt -> halbe Zahl an Aktien beim Aktionär mal doppeltem Kurs = gleiches Kapital oder?? Ich hab nämlich keine Ahnung über die Historie ERGO/ERGG.
Diese Gefahr besteht für GLIA meiner Meinung nach nicht, insbesondere da die Delistingregeln ja bis irgendwann Anfang 2002 ausgesetzt wurden.
Ausserdem musst du mir meinen Optimismus lassen, Ich hab das ganze Elend im August 2000 verfolgt und bin danach in GLIA eingestiegen. Aus dem BAuch heraus mit der Erwartung wenigstens einigermaßen den Anschluss an die Kurse der Jahre 98/99 zu bekommen.
Und insgesamt gesehen hat sich GLIA bis auf den letzten Einbruch Mitte Oktober ja garnicht mal so schlecht in 2001 gehalten. Ich glaube dass ein ernsthaftes Bestreben bei GLIA besteht sich am Markt zu halten und aus den Fehlern der letzte Zeit zu lernen.
Jetzt Mahlzeit
Gruss Wunram
Wenn ich die Geschichte mit Ergo Science richtig verstehe, ist dem ganzen aber auch ein delisting in der Nasdq vorausgegangen. Und wenn ich mir den Chart ansehe, hat sich der Kurs nach der Aktion ja verdoppelt -> halbe Zahl an Aktien beim Aktionär mal doppeltem Kurs = gleiches Kapital oder?? Ich hab nämlich keine Ahnung über die Historie ERGO/ERGG.
Diese Gefahr besteht für GLIA meiner Meinung nach nicht, insbesondere da die Delistingregeln ja bis irgendwann Anfang 2002 ausgesetzt wurden.
Ausserdem musst du mir meinen Optimismus lassen, Ich hab das ganze Elend im August 2000 verfolgt und bin danach in GLIA eingestiegen. Aus dem BAuch heraus mit der Erwartung wenigstens einigermaßen den Anschluss an die Kurse der Jahre 98/99 zu bekommen.
Und insgesamt gesehen hat sich GLIA bis auf den letzten Einbruch Mitte Oktober ja garnicht mal so schlecht in 2001 gehalten. Ich glaube dass ein ernsthaftes Bestreben bei GLIA besteht sich am Markt zu halten und aus den Fehlern der letzte Zeit zu lernen.
Jetzt Mahlzeit
Gruss Wunram
Glückwunsch! Der Anstieg gestern gibt dir recht!
Dennoch ist die Finazsituation extrem angespannt, und 1,5 Millionen reichen da lange nicht aus. Die haben noch Schulden aus diesem Jahr auf dem Buckel! Besitzer von Obgligationen haben Vorrecht vor Aktionären!
On April 26, 2001, the Company entered into a financing agreement with Paul Capital Royalty Acquisition Fund, L.P. ("PCRAF") that provides the Company will initially receive up to $15.0 million in stages. In addition, the Company will also have the option for the 12 months following the commercial relaunch of ADCON(R)-L in the United States, to obtain, subject to the satisfaction of certain other conditions, an additional $15.0 million from PCRAF in the same general economic terms as the initial agreement. As of June 30, 2001, the Company has received $7.5 million of the initial $15.0 million and will receive the remaining $7.5 million upon satisfaction of certain conditions, including, without limitation, the commercial relaunch of ADCON(R)-L in the United States.
In consideration for the first $15 million, PCRAF will receive royalty payments based on future sales of ADCON(R) products equal to the greater of i) approximately 2.5% of net sales or ii) certain guaranteed minimum annual royalty payments beginning in 2003 at a rate of $1.6 million annually and increasing in stages during future years up to $9.0 million annually. Royalty payments to PCRAF end on December 31, 2012. The royalty payments based on the percentage of net sales and the guaranteed minimum annual payment are subject to modification under certain conditions. In addition, PCRAF received a warrant to purchase 300,000 shares of common stock of the Company at $2.00 per share. In the event of a change in control in the Company or upon the occurrence of certain other events as defined in the financing agreement, PCRAF has the option to put its revenue interest back to the Company at a specified rate of return, which is dependent upon the date at which PCRAF exercises this option and the level of investment by PCRAF. The Company also has the option to repurchase PCRAF`s royalty interest beginning in 2003.
Ich finde leider nicht mehr die alten Charts von Ergo, aber die Verwässerung wurde schon vorher angekündigt (etwa im Mai), d.h da ist der Kusrs besonders eingebrochen.
Dennoch ist die Finazsituation extrem angespannt, und 1,5 Millionen reichen da lange nicht aus. Die haben noch Schulden aus diesem Jahr auf dem Buckel! Besitzer von Obgligationen haben Vorrecht vor Aktionären!
On April 26, 2001, the Company entered into a financing agreement with Paul Capital Royalty Acquisition Fund, L.P. ("PCRAF") that provides the Company will initially receive up to $15.0 million in stages. In addition, the Company will also have the option for the 12 months following the commercial relaunch of ADCON(R)-L in the United States, to obtain, subject to the satisfaction of certain other conditions, an additional $15.0 million from PCRAF in the same general economic terms as the initial agreement. As of June 30, 2001, the Company has received $7.5 million of the initial $15.0 million and will receive the remaining $7.5 million upon satisfaction of certain conditions, including, without limitation, the commercial relaunch of ADCON(R)-L in the United States.
In consideration for the first $15 million, PCRAF will receive royalty payments based on future sales of ADCON(R) products equal to the greater of i) approximately 2.5% of net sales or ii) certain guaranteed minimum annual royalty payments beginning in 2003 at a rate of $1.6 million annually and increasing in stages during future years up to $9.0 million annually. Royalty payments to PCRAF end on December 31, 2012. The royalty payments based on the percentage of net sales and the guaranteed minimum annual payment are subject to modification under certain conditions. In addition, PCRAF received a warrant to purchase 300,000 shares of common stock of the Company at $2.00 per share. In the event of a change in control in the Company or upon the occurrence of certain other events as defined in the financing agreement, PCRAF has the option to put its revenue interest back to the Company at a specified rate of return, which is dependent upon the date at which PCRAF exercises this option and the level of investment by PCRAF. The Company also has the option to repurchase PCRAF`s royalty interest beginning in 2003.
Ich finde leider nicht mehr die alten Charts von Ergo, aber die Verwässerung wurde schon vorher angekündigt (etwa im Mai), d.h da ist der Kusrs besonders eingebrochen.
news
Gliatech Provides Clinical and Regulatory Update on Adcon(R)-L
CLEVELAND, Nov. 14 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA) announced today a clinical and regulatory status update on ADCON(R)-L. The Company recently received from the independent clinical research organization ("CRO") conducting the U.S. study additional results regarding pain measurements for ADCON(R)-L patients. Earlier this week, the Company also submitted its Application Integrity Policy ("AIP") Corrective Action Plan (the "AIP CAP") to the U.S. Food and Drug Administration ("FDA"). During the Company`s recent discussions with the FDA, the agency suggested that the Company make a formal submission of all available ADCON(R)-L data, and indicated that upon a review of the data, a FDA Advisory Panel meeting may be called to review the new data and provide recommendations to the FDA on whether the Company will be allowed to recommence distribution of ADCON(R)-L in the U.S. U.S. Clinical Study and FDA Discussions Update
The independent CRO conducting the re-evaluation of the U.S. clinical study has completed additional statistical analyses of the study results. The clinical outcome endpoints in the U.S. clinical study of ADCON(R)-L include the measurement of pain at various points in time postoperatively using three measurement instruments.
A statistically significant reduction in radicular pain was seen at one month postoperatively for ADCON(R)-L patients when compared to control patients, as measured by the Johns Hopkins weighted Activities Related Pain ("wARP") instrument. The Johns Hopkins pain assessment evaluates functional endpoints associated with daily activities of living such as driving or riding in a car, sitting and lifting objects. ADCON(R)-L patients exhibited a statistically significant lower wARP score of 1.47 compared to the control group of 1.81 (p=0.003) at one month. At two months and six months, the ADCON(R)-L patients maintained a numerical advantage but the advantage was not statistically significant.
The Roland and Morris ("RM") Disability Questionnaire demonstrated statistically significant improvements at one month for the ADCON(R)-L treated group as compared to the control group. At one month, the mean RM score for ADCON(R)-L patients was 4.01 compared to 5.80 for the control group (p=0.049). At two months and six months, the ADCON(R)-L treated patients maintained a numerical advantage in the RM score compared to the untreated control group, but the differences were not statistically significant.
A third pain instrument, the visual analog scale, was also used for evaluation. In this assessment, patients were asked to rate their most severe radicular pain within the two weeks prior to each of their office visits. The results indicated that more ADCON(R)-L treated patients experienced less radicular pain (rated by the patient as less than 4 cm on a 10 cm scale) as compared to control patients at one month (81.7% vs. 73.8%, p=0.067).
The pain data from the European clinical trial previously completed with ADCON(R)-L also demonstrated a statistically significant benefit for ADCON(R)- L treated patients as compared to control patients. In the European study, patients in the ADCON(R)-L treatment group had less pain through six months. The European study results on pain reduction were considered by the original FDA Advisory Panel that reviewed ADCON-L in 1997, but the U.S. study was not completed at that time.
Gliatech has also compiled data regarding scar at reoperations for both the ADCON(R)-L and control groups of patients. This data includes prospective data from 29 patients in the European and U.S. clinical studies and data on 38 additional patients from other studies.
Gliatech has reviewed in summary form all available data regarding ADCON(R)-L with the FDA. Based on these discussions, the FDA suggested the Company make a formal submission of the data for a thorough review by the FDA. The Company is considering alternatives for submitting this data including submitting either a supplement to its existing ADCON Pre-Market Approval ("PMA") application or submitting a new PMA application to reflect the currently available data on ADCON(R)-L. The FDA has indicated that it will review the proposed PMA application following resolution of the Company`s AIP status. Following a review of the data, the FDA has indicated that a FDA Advisory Panel meeting may be called to review the new data set and provide recommendations to FDA on whether the Company will be allowed to recommence distribution of ADCON(R)-L in the U.S.
"The reduction in pain for ADCON(R)-L treated patients in both the U.S. and European studies will be a component of the proposed submission to FDA and the expected advisory panel review," stated Steven L. Basta, President of Gliatech. "The purpose of lumbar surgery is to reduce pain, thus we believe that an improvement in this clinical endpoint is directly relevant to patients and will be important in the advisory committee`s review."
After review of the data submitted, the FDA Advisory Panel may recommend that the Company not be allowed to resume distribution of ADCON(R)-L in the U.S., and there can be no assurance that the FDA will reach a decision on this matter in a time frame suitable for the Company`s continued development and commercialization of ADCON(R)-L. AIP Update
As part of its ongoing work related to the Company`s AIP status, our independent auditor, Health Policy Associates ("HPA"), has completed its previously announced audits of selected U.S. clinical study sites and will submit its report to the FDA and Gliatech when available. In addition, at the FDA`s request, HPA has completed its investigation of past package sealing deficiencies described in the warning letter issued in September 1999. The report expresses concern, in HPA`s opinion, regarding communications made by Gliatech to the FDA during 1999 related to this matter. The Department of Justice has included this matter in its ongoing investigation. Current product shipments are being made in a different syringe package format and therefore the prior packaging issues are not applicable to the current commercial product.
Gliatech submitted on November 12, 2001, its AIP CAP for FDA review. Gliatech and the FDA have been working closely to resolve the Company`s AIP status. Gliatech believes that key elements of resolution of the Company`s AIP status involve ongoing audits by HPA, the Company`s implementation of the AIP CAP, which establishes policies and procedures with respect to Gliatech`s data integrity compliance activities, and an AIP inspection of Gliatech by the FDA. About Gliatech Inc.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R)-L, ADCON(R)-T/N and ADCON(R) Solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to inhibit inflammation.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, commercial uncertainty of regulatory approvals of the Company`s ADCON products, including the timing and content of decisions made by the FDA, relating to, among other things, decisions regarding the sale of ADCON-L, the uncertainty of the outcome of FDA`s review of clinical data, product recalls, the import alert and inspectional observations, commercial uncertainty of market acceptance of the Company`s ADCON family of products, delays in product development of additional ADCON products, uncertainty of outcomes of future FDA audits and inspections, the uncertainty of the status of the Company with respect to AIP regulations, the uncertainty of timing and decisions of the FDA Advisory Panel and/or the FDA following a review of the data regarding resuming of sales of ADCON-L in the U.S., the uncertainty of expenses associated with clinical trials and research efforts, which may affect the profitability of the Company, uncertainty due to the early stage of development for the pharmaceutical programs, the ability of the Company to raise additional funding, the ability of the Company to establish and maintain collaborative arrangements with others, the potential market size for ADCON products, the ability of the Company to obtain an adequate supply of the materials used in the manufacture of its ADCON products, the productivity of distributors of ADCON products, shortages of supply of ADCON products from the Company`s sole manufacturer, the lack of supply of raw materials for the Company`s products, uncertainty of future profitability, uncertainties related to the Company`s proprietary rights in its products, the outcome of pending litigation and investigations, technological change and the ability of the Company to fund its capital requirements through cash from operations or the issuance of debt or equity securities, the ability of the Company to consummate strategic collaborations or other strategic alternatives on terms satisfactory to the Company, or at all, and other risk factors detailed in Gliatech`s SEC filings.
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/CONTACT: Adam D. Gridley, Investor Relations Manager of Gliatech Inc., +1-216-831-3200, x3019/
Gliatech Provides Clinical and Regulatory Update on Adcon(R)-L
CLEVELAND, Nov. 14 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA) announced today a clinical and regulatory status update on ADCON(R)-L. The Company recently received from the independent clinical research organization ("CRO") conducting the U.S. study additional results regarding pain measurements for ADCON(R)-L patients. Earlier this week, the Company also submitted its Application Integrity Policy ("AIP") Corrective Action Plan (the "AIP CAP") to the U.S. Food and Drug Administration ("FDA"). During the Company`s recent discussions with the FDA, the agency suggested that the Company make a formal submission of all available ADCON(R)-L data, and indicated that upon a review of the data, a FDA Advisory Panel meeting may be called to review the new data and provide recommendations to the FDA on whether the Company will be allowed to recommence distribution of ADCON(R)-L in the U.S. U.S. Clinical Study and FDA Discussions Update
The independent CRO conducting the re-evaluation of the U.S. clinical study has completed additional statistical analyses of the study results. The clinical outcome endpoints in the U.S. clinical study of ADCON(R)-L include the measurement of pain at various points in time postoperatively using three measurement instruments.
A statistically significant reduction in radicular pain was seen at one month postoperatively for ADCON(R)-L patients when compared to control patients, as measured by the Johns Hopkins weighted Activities Related Pain ("wARP") instrument. The Johns Hopkins pain assessment evaluates functional endpoints associated with daily activities of living such as driving or riding in a car, sitting and lifting objects. ADCON(R)-L patients exhibited a statistically significant lower wARP score of 1.47 compared to the control group of 1.81 (p=0.003) at one month. At two months and six months, the ADCON(R)-L patients maintained a numerical advantage but the advantage was not statistically significant.
The Roland and Morris ("RM") Disability Questionnaire demonstrated statistically significant improvements at one month for the ADCON(R)-L treated group as compared to the control group. At one month, the mean RM score for ADCON(R)-L patients was 4.01 compared to 5.80 for the control group (p=0.049). At two months and six months, the ADCON(R)-L treated patients maintained a numerical advantage in the RM score compared to the untreated control group, but the differences were not statistically significant.
A third pain instrument, the visual analog scale, was also used for evaluation. In this assessment, patients were asked to rate their most severe radicular pain within the two weeks prior to each of their office visits. The results indicated that more ADCON(R)-L treated patients experienced less radicular pain (rated by the patient as less than 4 cm on a 10 cm scale) as compared to control patients at one month (81.7% vs. 73.8%, p=0.067).
The pain data from the European clinical trial previously completed with ADCON(R)-L also demonstrated a statistically significant benefit for ADCON(R)- L treated patients as compared to control patients. In the European study, patients in the ADCON(R)-L treatment group had less pain through six months. The European study results on pain reduction were considered by the original FDA Advisory Panel that reviewed ADCON-L in 1997, but the U.S. study was not completed at that time.
Gliatech has also compiled data regarding scar at reoperations for both the ADCON(R)-L and control groups of patients. This data includes prospective data from 29 patients in the European and U.S. clinical studies and data on 38 additional patients from other studies.
Gliatech has reviewed in summary form all available data regarding ADCON(R)-L with the FDA. Based on these discussions, the FDA suggested the Company make a formal submission of the data for a thorough review by the FDA. The Company is considering alternatives for submitting this data including submitting either a supplement to its existing ADCON Pre-Market Approval ("PMA") application or submitting a new PMA application to reflect the currently available data on ADCON(R)-L. The FDA has indicated that it will review the proposed PMA application following resolution of the Company`s AIP status. Following a review of the data, the FDA has indicated that a FDA Advisory Panel meeting may be called to review the new data set and provide recommendations to FDA on whether the Company will be allowed to recommence distribution of ADCON(R)-L in the U.S.
"The reduction in pain for ADCON(R)-L treated patients in both the U.S. and European studies will be a component of the proposed submission to FDA and the expected advisory panel review," stated Steven L. Basta, President of Gliatech. "The purpose of lumbar surgery is to reduce pain, thus we believe that an improvement in this clinical endpoint is directly relevant to patients and will be important in the advisory committee`s review."
After review of the data submitted, the FDA Advisory Panel may recommend that the Company not be allowed to resume distribution of ADCON(R)-L in the U.S., and there can be no assurance that the FDA will reach a decision on this matter in a time frame suitable for the Company`s continued development and commercialization of ADCON(R)-L. AIP Update
As part of its ongoing work related to the Company`s AIP status, our independent auditor, Health Policy Associates ("HPA"), has completed its previously announced audits of selected U.S. clinical study sites and will submit its report to the FDA and Gliatech when available. In addition, at the FDA`s request, HPA has completed its investigation of past package sealing deficiencies described in the warning letter issued in September 1999. The report expresses concern, in HPA`s opinion, regarding communications made by Gliatech to the FDA during 1999 related to this matter. The Department of Justice has included this matter in its ongoing investigation. Current product shipments are being made in a different syringe package format and therefore the prior packaging issues are not applicable to the current commercial product.
Gliatech submitted on November 12, 2001, its AIP CAP for FDA review. Gliatech and the FDA have been working closely to resolve the Company`s AIP status. Gliatech believes that key elements of resolution of the Company`s AIP status involve ongoing audits by HPA, the Company`s implementation of the AIP CAP, which establishes policies and procedures with respect to Gliatech`s data integrity compliance activities, and an AIP inspection of Gliatech by the FDA. About Gliatech Inc.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R)-L, ADCON(R)-T/N and ADCON(R) Solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to inhibit inflammation.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, commercial uncertainty of regulatory approvals of the Company`s ADCON products, including the timing and content of decisions made by the FDA, relating to, among other things, decisions regarding the sale of ADCON-L, the uncertainty of the outcome of FDA`s review of clinical data, product recalls, the import alert and inspectional observations, commercial uncertainty of market acceptance of the Company`s ADCON family of products, delays in product development of additional ADCON products, uncertainty of outcomes of future FDA audits and inspections, the uncertainty of the status of the Company with respect to AIP regulations, the uncertainty of timing and decisions of the FDA Advisory Panel and/or the FDA following a review of the data regarding resuming of sales of ADCON-L in the U.S., the uncertainty of expenses associated with clinical trials and research efforts, which may affect the profitability of the Company, uncertainty due to the early stage of development for the pharmaceutical programs, the ability of the Company to raise additional funding, the ability of the Company to establish and maintain collaborative arrangements with others, the potential market size for ADCON products, the ability of the Company to obtain an adequate supply of the materials used in the manufacture of its ADCON products, the productivity of distributors of ADCON products, shortages of supply of ADCON products from the Company`s sole manufacturer, the lack of supply of raw materials for the Company`s products, uncertainty of future profitability, uncertainties related to the Company`s proprietary rights in its products, the outcome of pending litigation and investigations, technological change and the ability of the Company to fund its capital requirements through cash from operations or the issuance of debt or equity securities, the ability of the Company to consummate strategic collaborations or other strategic alternatives on terms satisfactory to the Company, or at all, and other risk factors detailed in Gliatech`s SEC filings.
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Zahlen!
ist freilich ein bisschen mau, aber konnte man etwas anderes erwarten?? Ich habe das Gefühl sie werden die Kurve kriegen
Gliatech Announces Third Quarter 2001 Results
CLEVELAND, Nov. 14 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA) announced financial results for the third quarter ended September 30, 2001. Revenues in the third quarter of 2001 were $0.6 million compared to revenues of $6.1 million in the third quarter of 2000. As previously announced on May 22, 2001, the Company successfully relaunched ADCON(R)-L internationally. International net product sales were $0.6 million in the third quarter of 2001 compared to international net product sales of $1.1 million in the third quarter of 2000. Gliatech is currently selling ADCON(R)-L in 34 countries outside of the U.S. No U.S. product sales of ADCON(R)-L have been recorded in 2001.
Cost of products sold decreased to $0.7 million in the third quarter of 2001 compared to $2.4 million in the third quarter of 2000. Research and development costs increased to $2.4 million in the third quarter of 2001 compared to $1.6 million in the third quarter of 2000. Research and development expenses for the quarter included costs related to re-evaluation of the magnetic resonance imaging (MRI) data from the U.S. clinical study of ADCON(R)-L, clinical trial costs related to the 847 patient retrospective U.S. study of ADCON(R)-L, regulatory costs associated with the Company`s Application Integrity Policy (AIP) status and its Corrective Action Plan submission to the Food and Drug Administration (FDA) and complement and H3 research programs including Phase II clinical trial costs of GT-2331. Selling, general and administrative expenses increased to $2.5 million in the third quarter of 2001 compared to $2.3 million in the third quarter of 2000 primarily due to increased professional services, which were partially offset by decreased commission expense. The third quarter of 2000 also included non- recurring costs of $6.8 million related to a terminated merger and severance costs. The Company recorded a net loss in the third quarter of 2001 of $5.4 million, or $(0.56) per share, compared to a net loss of $6.7 million, or $(0.70) per share in the third quarter of 2000.
As of September 30, 2001, Gliatech had approximately $6.3 million of cash, cash equivalents and short-term investments. Subsequent to the end of the quarter, Gliatech received additional cash from its agreement with Abgenix, Inc., as described below. Given the funding requirements of current operations, the Company believes it currently has sufficient cash, cash equivalents and short-term investments on hand to meet operating requirements through approximately March 2002. In August 2001, the Company filed a registration statement on Form S-3 for a proposed rights offering and later withdrew the registration statement due to business and market conditions. The Company is seeking additional financing and considering other strategic alternatives in order to continue operations. The Company is taking significant steps to reduce costs which is expected to include a reduction in the Company`s workforce. There can be no assurance that the Company will be able to identify necessary financing or will be able to conclude strategic alternatives or other alternatives in a timely manner on terms acceptable to the Company, if at all.
ABGENIX PARTNERSHIP
On November 1, 2001, Abgenix, Inc. and Gliatech entered into an agreement that provides Abgenix with exclusive worldwide rights to human monoclonal antibody therapies against the complement protein properdin as potential treatments for cardiovascular and inflammatory diseases. Abgenix has generated lead antibody product candidates for Gliatech under a prior agreement that was entered into in January 2000. Under the November 2001 agreement, Abgenix will now assume responsibility for development and commercialization of these antibodies.
Under the terms of the agreement, Abgenix obtains an exclusive license to develop and commercialize anti-properdin antibody therapies for all indications and will be responsible for clinical development, regulatory activities, manufacturing, marketing and sales. Gliatech has received from Abgenix an upfront license fee of $1.5 million and a commitment for a future equity investment and will receive potential milestone payments for multiple clinical indications, research funding for two years and royalties on net sales of any resulting products. Collectively, the total non-royalty payments could reach approximately $40 million if a product is successfully commercialized. GT-2331 UPDATE
Enrollment in the Phase II clinical trials of GT-2331 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) is continuing. The Phase II study is a multi-dose, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy of GT-2331. The design of this study involves sequential enrollment of escalating dose groups of 30 patients each. Gliatech has completed enrollment of the 5 mg and 10 mg dose groups and is currently enrolling the 15 mg dose group. The potential uses for GT-2331 include ADHD, dementia associated with Alzheimer`s Disease, and sleep disorders such as narcolepsy. CONFERENCE CALL INFORMATION:
There will be a conference call at 4:30pm. EDT today to discuss Gliatech`s third quarter financial results. This call will be broadcast live over the Internet at http://www.videonewswire.com/event.asp?id=1506 and will be archived at Gliatech`s website located at http://www.gliatech.com . A replay of the call will be available until November 18, 2001 by dialing 800.642.1687 (US/Canada) or 706.645.9291 (International/Local) and enter conference ID "2042066". ABOUT GLIATECH INC.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R)-L, ADCON(R)-T/N and ADCON(R) Solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to inhibit inflammation.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, commercial uncertainty of regulatory approvals of the Company`s ADCON products, including the timing and content of decisions made by the FDA, relating to, among other things, decisions regarding the sale of ADCON-L, the uncertainty of the outcome of FDA`s review of clinical data, product recalls, the import alert and inspectional observations, commercial uncertainty of market acceptance of the Company`s ADCON family of products, delays in product development of additional ADCON products, uncertainty of outcomes of future FDA audits and inspections, the uncertainty of the status of the Company with respect to AIP regulations, the uncertainty of timing and decisions of the FDA Advisory Panel and/or the FDA following a review of the data regarding resuming of sales of ADCON-L in the U.S., the uncertainty of expenses associated with clinical trials and research efforts, which may affect the profitability of the Company, uncertainty due to the early stage of development for the pharmaceutical programs, the ability of the Company to raise additional funding, the ability of the Company to establish and maintain collaborative arrangements with others, the potential market size for ADCON products, the ability of the Company to obtain an adequate supply of the materials used in the manufacture of its ADCON products, the productivity of distributors of ADCON products, shortages of supply of ADCON products from the Company`s sole manufacturer, the lack of supply of raw materials for the Company`s products, uncertainty of future profitability, uncertainties related to the Company`s proprietary rights in its products, the outcome of pending litigation and investigations, technological change and the ability of the Company to fund its capital requirements through cash from operations or the issuance of debt or equity securities, the ability of the Company to consummate strategic collaborations or other strategic alternatives on terms satisfactory to the Company, or at all, and other risk factors detailed in Gliatech`s SEC filings.
GLIATECH INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(In thousands, except share and per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2001 2000 2001 2000
Revenues
Product sales $614 $ 6,087 $ 1,708 $19,954
Government grants -- 57 -- 542
Total revenues 614 6,144 1,708 20,496
Operating costs and expenses
Cost of products sold 728 2,386 3,381 4,753
Research and development 2,433 1,564 7,689 7,196
Selling, general and
administrative 2,508 2,320 7,158 8,604
Merger related and
severance costs -- 6,817 -- 7,541
Total operating
costs and expenses 5,669 13,087 18,228 28,094
Operating loss (5,055) (6,943) (16,520) (7,598)
Net interest (expense)
income (326) 266 (225) 808
Net loss $(5,381) $(6,677) $(16,745) $(6,790)
Loss per share
Basic $(0.56) $(0.70) $(1.73) $(0.71)
Diluted $(0.56) $(0.70) $(1.73) $(0.71)
Average shares outstanding
Basic 9,682,637 9,597,912 9,682,637 9,536,819
Diluted 9,682,637 9,597,912 9,682,637 9,536,819
CONSOLIDATED BALANCE SHEET
(unaudited)
(In thousands) September 30, December 31,
2001 2000
Balance Sheet Data:
Cash, cash equivalents and
short-term investments $6,276 $8,464
Other current assets 4,386 4,830
Total current assets 10,662 13,294
Long term investments -- 3,642
Property and equipment, net 2,638 3,197
Other assets, net 1,322 1,043
Total assets $14,622 $21,176
Accounts payable and other accrued expenses $4,933 $3,840
Other current liabilities 2,623 1,833
Total current liabilities 7,556 5,673
Long-term obligations 7,268 --
Stockholders` equity (202) 15,503
Total liabilities & stockholders` equity $14,622 $21,176
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ist freilich ein bisschen mau, aber konnte man etwas anderes erwarten?? Ich habe das Gefühl sie werden die Kurve kriegen
Gliatech Announces Third Quarter 2001 Results
CLEVELAND, Nov. 14 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA) announced financial results for the third quarter ended September 30, 2001. Revenues in the third quarter of 2001 were $0.6 million compared to revenues of $6.1 million in the third quarter of 2000. As previously announced on May 22, 2001, the Company successfully relaunched ADCON(R)-L internationally. International net product sales were $0.6 million in the third quarter of 2001 compared to international net product sales of $1.1 million in the third quarter of 2000. Gliatech is currently selling ADCON(R)-L in 34 countries outside of the U.S. No U.S. product sales of ADCON(R)-L have been recorded in 2001.
Cost of products sold decreased to $0.7 million in the third quarter of 2001 compared to $2.4 million in the third quarter of 2000. Research and development costs increased to $2.4 million in the third quarter of 2001 compared to $1.6 million in the third quarter of 2000. Research and development expenses for the quarter included costs related to re-evaluation of the magnetic resonance imaging (MRI) data from the U.S. clinical study of ADCON(R)-L, clinical trial costs related to the 847 patient retrospective U.S. study of ADCON(R)-L, regulatory costs associated with the Company`s Application Integrity Policy (AIP) status and its Corrective Action Plan submission to the Food and Drug Administration (FDA) and complement and H3 research programs including Phase II clinical trial costs of GT-2331. Selling, general and administrative expenses increased to $2.5 million in the third quarter of 2001 compared to $2.3 million in the third quarter of 2000 primarily due to increased professional services, which were partially offset by decreased commission expense. The third quarter of 2000 also included non- recurring costs of $6.8 million related to a terminated merger and severance costs. The Company recorded a net loss in the third quarter of 2001 of $5.4 million, or $(0.56) per share, compared to a net loss of $6.7 million, or $(0.70) per share in the third quarter of 2000.
As of September 30, 2001, Gliatech had approximately $6.3 million of cash, cash equivalents and short-term investments. Subsequent to the end of the quarter, Gliatech received additional cash from its agreement with Abgenix, Inc., as described below. Given the funding requirements of current operations, the Company believes it currently has sufficient cash, cash equivalents and short-term investments on hand to meet operating requirements through approximately March 2002. In August 2001, the Company filed a registration statement on Form S-3 for a proposed rights offering and later withdrew the registration statement due to business and market conditions. The Company is seeking additional financing and considering other strategic alternatives in order to continue operations. The Company is taking significant steps to reduce costs which is expected to include a reduction in the Company`s workforce. There can be no assurance that the Company will be able to identify necessary financing or will be able to conclude strategic alternatives or other alternatives in a timely manner on terms acceptable to the Company, if at all.
ABGENIX PARTNERSHIP
On November 1, 2001, Abgenix, Inc. and Gliatech entered into an agreement that provides Abgenix with exclusive worldwide rights to human monoclonal antibody therapies against the complement protein properdin as potential treatments for cardiovascular and inflammatory diseases. Abgenix has generated lead antibody product candidates for Gliatech under a prior agreement that was entered into in January 2000. Under the November 2001 agreement, Abgenix will now assume responsibility for development and commercialization of these antibodies.
Under the terms of the agreement, Abgenix obtains an exclusive license to develop and commercialize anti-properdin antibody therapies for all indications and will be responsible for clinical development, regulatory activities, manufacturing, marketing and sales. Gliatech has received from Abgenix an upfront license fee of $1.5 million and a commitment for a future equity investment and will receive potential milestone payments for multiple clinical indications, research funding for two years and royalties on net sales of any resulting products. Collectively, the total non-royalty payments could reach approximately $40 million if a product is successfully commercialized. GT-2331 UPDATE
Enrollment in the Phase II clinical trials of GT-2331 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) is continuing. The Phase II study is a multi-dose, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy of GT-2331. The design of this study involves sequential enrollment of escalating dose groups of 30 patients each. Gliatech has completed enrollment of the 5 mg and 10 mg dose groups and is currently enrolling the 15 mg dose group. The potential uses for GT-2331 include ADHD, dementia associated with Alzheimer`s Disease, and sleep disorders such as narcolepsy. CONFERENCE CALL INFORMATION:
There will be a conference call at 4:30pm. EDT today to discuss Gliatech`s third quarter financial results. This call will be broadcast live over the Internet at http://www.videonewswire.com/event.asp?id=1506 and will be archived at Gliatech`s website located at http://www.gliatech.com . A replay of the call will be available until November 18, 2001 by dialing 800.642.1687 (US/Canada) or 706.645.9291 (International/Local) and enter conference ID "2042066". ABOUT GLIATECH INC.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R)-L, ADCON(R)-T/N and ADCON(R) Solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to inhibit inflammation.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, commercial uncertainty of regulatory approvals of the Company`s ADCON products, including the timing and content of decisions made by the FDA, relating to, among other things, decisions regarding the sale of ADCON-L, the uncertainty of the outcome of FDA`s review of clinical data, product recalls, the import alert and inspectional observations, commercial uncertainty of market acceptance of the Company`s ADCON family of products, delays in product development of additional ADCON products, uncertainty of outcomes of future FDA audits and inspections, the uncertainty of the status of the Company with respect to AIP regulations, the uncertainty of timing and decisions of the FDA Advisory Panel and/or the FDA following a review of the data regarding resuming of sales of ADCON-L in the U.S., the uncertainty of expenses associated with clinical trials and research efforts, which may affect the profitability of the Company, uncertainty due to the early stage of development for the pharmaceutical programs, the ability of the Company to raise additional funding, the ability of the Company to establish and maintain collaborative arrangements with others, the potential market size for ADCON products, the ability of the Company to obtain an adequate supply of the materials used in the manufacture of its ADCON products, the productivity of distributors of ADCON products, shortages of supply of ADCON products from the Company`s sole manufacturer, the lack of supply of raw materials for the Company`s products, uncertainty of future profitability, uncertainties related to the Company`s proprietary rights in its products, the outcome of pending litigation and investigations, technological change and the ability of the Company to fund its capital requirements through cash from operations or the issuance of debt or equity securities, the ability of the Company to consummate strategic collaborations or other strategic alternatives on terms satisfactory to the Company, or at all, and other risk factors detailed in Gliatech`s SEC filings.
GLIATECH INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(In thousands, except share and per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2001 2000 2001 2000
Revenues
Product sales $614 $ 6,087 $ 1,708 $19,954
Government grants -- 57 -- 542
Total revenues 614 6,144 1,708 20,496
Operating costs and expenses
Cost of products sold 728 2,386 3,381 4,753
Research and development 2,433 1,564 7,689 7,196
Selling, general and
administrative 2,508 2,320 7,158 8,604
Merger related and
severance costs -- 6,817 -- 7,541
Total operating
costs and expenses 5,669 13,087 18,228 28,094
Operating loss (5,055) (6,943) (16,520) (7,598)
Net interest (expense)
income (326) 266 (225) 808
Net loss $(5,381) $(6,677) $(16,745) $(6,790)
Loss per share
Basic $(0.56) $(0.70) $(1.73) $(0.71)
Diluted $(0.56) $(0.70) $(1.73) $(0.71)
Average shares outstanding
Basic 9,682,637 9,597,912 9,682,637 9,536,819
Diluted 9,682,637 9,597,912 9,682,637 9,536,819
CONSOLIDATED BALANCE SHEET
(unaudited)
(In thousands) September 30, December 31,
2001 2000
Balance Sheet Data:
Cash, cash equivalents and
short-term investments $6,276 $8,464
Other current assets 4,386 4,830
Total current assets 10,662 13,294
Long term investments -- 3,642
Property and equipment, net 2,638 3,197
Other assets, net 1,322 1,043
Total assets $14,622 $21,176
Accounts payable and other accrued expenses $4,933 $3,840
Other current liabilities 2,623 1,833
Total current liabilities 7,556 5,673
Long-term obligations 7,268 --
Stockholders` equity (202) 15,503
Total liabilities & stockholders` equity $14,622 $21,176
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@all
DELISTING - das Gefühl war wohl falsch - mal sehen ob GLIA jetzt OTC-BB gehandelt wird, und in 2, 3 Jahren die Kurve kriegen.
Gliatech Announces Nasdaq Delisting
/FROM PR NEWSWIRE CLEVELAND 216-566-7777/ [STK] GLIA [IN] MTC [SU]
Gliatech Announces Nasdaq Delisting
CLEVELAND, Jan. 14 /PRNewswire-FirstCall/ -- Gliatech Inc. (Nasdaq: GLIA) today announced that it received a Nasdaq Staff Determination on January 10, 2002, from the Nasdaq Listing Qualifications Department which indicates that Gliatech`s common stock is subject to delisting from the Nasdaq National Market effective January 18, 2002. The letter indicates that the Company fails to comply with either the minimum net tangible asset requirement or minimum stockholders` equity requirement for continued listing as set forth in Marketplace Rule 4450(a)(3), and that its securities are, therefore, subject to delisting from The Nasdaq National Market. In addition Gliatech currently does not meet the requirements for listing on the Nasdaq SmallCap Market.
The Company`s common stock may trade on the OTC Bulletin Board electronic quotation system, or another quotation system or exchange for which the shares of the Company`s common stock may qualify. Corporate Update
As of December 31, 2001, Gliatech had approximately $3.0 million of cash, cash equivalents and short-term investments. As previously disclosed, given the funding requirements of current operations, the Company believes it currently has sufficient cash, cash equivalents and short-term investments on hand to meet operating requirements through approximately March 2002. The Company is seeking additional financing and is currently in active discussions regarding potential funding sources such as equity and debt financing, and is considering other strategic alternatives in order to continue operations. The Company has taken significant steps to reduce costs including a reduction in the Company`s workforce in November of 2001. There can be no assurance that the Company will be able to identify necessary financing or will be able to consummate strategic alternatives or other alternatives in a timely manner on terms acceptable to the Company, if at all.
Gliatech also announced that William A. Clarke and Allan M. Green, M.D., Ph.D., J.D. have resigned from Gliatech`s Board of Directors. The current Board of Director`s composition includes Robert P. Pinkas, Chairman and Acting CEO of Gliatech, Steven L. Basta, President of Gliatech, and Ronald D. Henriksen. "We thank Bill and Allan for their valued service to the Company," stated Robert P. Pinkas. About Gliatech Inc.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R)-L, ADCON(R)-T/N and ADCON(R) Solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to inhibit inflammation.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, commercial uncertainty of regulatory approvals of the Company`s ADCON products, including the timing and content of decisions made by the FDA, relating to, among other things, decisions regarding the sale of ADCON-L, the uncertainty of the outcome of FDA`s review of clinical data, product recalls, the import alert and inspectional observations, commercial uncertainty of market acceptance of the Company`s ADCON family of products, delays in product development of additional ADCON products, uncertainty of outcomes of future FDA audits and inspections, the uncertainty of the status of the Company with respect to AIP regulations, the uncertainty of timing and decisions of the FDA Advisory Panel and/or the FDA following a review of the data regarding resuming of sales of ADCON-L in the U.S., the uncertainty of expenses associated with clinical trials and research efforts, which may affect the profitability of the Company, uncertainty due to the early stage of development for the pharmaceutical programs, the ability of the Company to raise additional funding, the ability of the Company to establish and maintain collaborative arrangements with others, the potential market size for ADCON products, the ability of the Company to obtain an adequate supply of the materials used in the manufacture of its ADCON products, the productivity of distributors of ADCON products, shortages of supply of ADCON products from the Company`s sole manufacturer, the lack of supply of raw materials for the Company`s products, uncertainty of future profitability, uncertainties related to the Company`s proprietary rights in its products, the outcome of pending litigation and investigations, technological change and the ability of the Company to fund its capital requirements through cash from operations or the issuance of debt or equity securities, the ability of the Company to consummate strategic collaborations or other strategic alternatives on terms satisfactory to the Company, or at all, and other risk factors detailed in Gliatech`s SEC filings.
/CONTACT: Adam D. Gridley, Investor Relations Manager of Gliatech Inc., +1-216-831-3200, x3019
DELISTING - das Gefühl war wohl falsch - mal sehen ob GLIA jetzt OTC-BB gehandelt wird, und in 2, 3 Jahren die Kurve kriegen.
Gliatech Announces Nasdaq Delisting
/FROM PR NEWSWIRE CLEVELAND 216-566-7777/ [STK] GLIA [IN] MTC [SU]
Gliatech Announces Nasdaq Delisting
CLEVELAND, Jan. 14 /PRNewswire-FirstCall/ -- Gliatech Inc. (Nasdaq: GLIA) today announced that it received a Nasdaq Staff Determination on January 10, 2002, from the Nasdaq Listing Qualifications Department which indicates that Gliatech`s common stock is subject to delisting from the Nasdaq National Market effective January 18, 2002. The letter indicates that the Company fails to comply with either the minimum net tangible asset requirement or minimum stockholders` equity requirement for continued listing as set forth in Marketplace Rule 4450(a)(3), and that its securities are, therefore, subject to delisting from The Nasdaq National Market. In addition Gliatech currently does not meet the requirements for listing on the Nasdaq SmallCap Market.
The Company`s common stock may trade on the OTC Bulletin Board electronic quotation system, or another quotation system or exchange for which the shares of the Company`s common stock may qualify. Corporate Update
As of December 31, 2001, Gliatech had approximately $3.0 million of cash, cash equivalents and short-term investments. As previously disclosed, given the funding requirements of current operations, the Company believes it currently has sufficient cash, cash equivalents and short-term investments on hand to meet operating requirements through approximately March 2002. The Company is seeking additional financing and is currently in active discussions regarding potential funding sources such as equity and debt financing, and is considering other strategic alternatives in order to continue operations. The Company has taken significant steps to reduce costs including a reduction in the Company`s workforce in November of 2001. There can be no assurance that the Company will be able to identify necessary financing or will be able to consummate strategic alternatives or other alternatives in a timely manner on terms acceptable to the Company, if at all.
Gliatech also announced that William A. Clarke and Allan M. Green, M.D., Ph.D., J.D. have resigned from Gliatech`s Board of Directors. The current Board of Director`s composition includes Robert P. Pinkas, Chairman and Acting CEO of Gliatech, Steven L. Basta, President of Gliatech, and Ronald D. Henriksen. "We thank Bill and Allan for their valued service to the Company," stated Robert P. Pinkas. About Gliatech Inc.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R)-L, ADCON(R)-T/N and ADCON(R) Solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to inhibit inflammation.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, commercial uncertainty of regulatory approvals of the Company`s ADCON products, including the timing and content of decisions made by the FDA, relating to, among other things, decisions regarding the sale of ADCON-L, the uncertainty of the outcome of FDA`s review of clinical data, product recalls, the import alert and inspectional observations, commercial uncertainty of market acceptance of the Company`s ADCON family of products, delays in product development of additional ADCON products, uncertainty of outcomes of future FDA audits and inspections, the uncertainty of the status of the Company with respect to AIP regulations, the uncertainty of timing and decisions of the FDA Advisory Panel and/or the FDA following a review of the data regarding resuming of sales of ADCON-L in the U.S., the uncertainty of expenses associated with clinical trials and research efforts, which may affect the profitability of the Company, uncertainty due to the early stage of development for the pharmaceutical programs, the ability of the Company to raise additional funding, the ability of the Company to establish and maintain collaborative arrangements with others, the potential market size for ADCON products, the ability of the Company to obtain an adequate supply of the materials used in the manufacture of its ADCON products, the productivity of distributors of ADCON products, shortages of supply of ADCON products from the Company`s sole manufacturer, the lack of supply of raw materials for the Company`s products, uncertainty of future profitability, uncertainties related to the Company`s proprietary rights in its products, the outcome of pending litigation and investigations, technological change and the ability of the Company to fund its capital requirements through cash from operations or the issuance of debt or equity securities, the ability of the Company to consummate strategic collaborations or other strategic alternatives on terms satisfactory to the Company, or at all, and other risk factors detailed in Gliatech`s SEC filings.
/CONTACT: Adam D. Gridley, Investor Relations Manager of Gliatech Inc., +1-216-831-3200, x3019
Gliatech wird auch in Deutschland gehandelt.
Was passiert bei einem Delisting an der NASDAQ eigentlich mit diesen Euro-Aktien ??
:O
Was passiert bei einem Delisting an der NASDAQ eigentlich mit diesen Euro-Aktien ??
:O
@orkadian
solange sie OTC-BB gehandelt werden sind die Aktien bei uns auch im freien Handel verfügbar, z.B. Berlin; erst wenns dann noch weiter runter geht im Handelssegment -> OTC (pinksheets), werden sie auch bei uns aus dem "Verkehr" gezogen.
Wunram
solange sie OTC-BB gehandelt werden sind die Aktien bei uns auch im freien Handel verfügbar, z.B. Berlin; erst wenns dann noch weiter runter geht im Handelssegment -> OTC (pinksheets), werden sie auch bei uns aus dem "Verkehr" gezogen.
Wunram
Heute in Berlin sogar auf 0,50 Geld ! Was geht da ab ??
Na SUUUUUPER ! Kennt jemand die Fundamentaldaten?
da bin ich aber mal gespannt! hoffentlich wirds kein Aprilscherz
Gliatech Provides Earnings Release Date and Corporate Update
CLEVELAND, March 14 /PRNewswire-FirstCall/ -- Gliatech Inc. (OTC Bulletin Board: GLIA) today announced that the Company will report its financial results for the fourth quarter and year-ended December 31, 2001 on Monday, April 1, 2002 and will hold a conference call at 10:00 a.m. EST. Investors are invited to listen to the conference call that will be broadcast live over the Internet with Steven L. Basta, President, and other members of Gliatech`s management team.
What: Gliatech Fourth Quarter/Year-End 2001 Earnings Conference Call
When: Monday, April 1, 2002 at 10:00 A.M. EST
Where: http://www.videonewswire.com/event.asp?id=3849
How: Live over the Internet -- Simply log on to the web at the
address above
Contact: Adam D. Gridley
Manager, Investor Relations & Business Development
216.831.3200 x3019
gridleya@gliatech.com
A replay of the call will be available until April 7, 2002 by dialing 888.445.8680 (US/Canada) or 402.998.1332 (International/Local). The playback will also be available on Gliatech`s web site at www.gliatech.com . Corporate Update
As of December 31, 2001, Gliatech had approximately $3.0 million of cash, cash equivalents and short-term investments. Subsequent to year-end, the Company reached a settlement agreement with its business interruption insurance carrier for property damages arising from the January 2001 product recall. The Company received $2.0 million net of legal expenses in settlement of the claim. Under terms of the agreement, the Company has released its insurance carrier from any future insurance claims relating to the product recall. The Company believes that it currently has sufficient cash, cash equivalents and short-term investments on hand to meet operating requirements through mid-May 2002.
The Company is seeking additional financing and is currently in active discussions regarding potential funding sources such as equity and debt financing, and is considering other strategic alternatives in order to continue operations. The issuance of additional equity securities, if any, could result in substantial dilution to the Company`s stockholders. There can be no assurance that the Company will be able to identify necessary financing or will be able to consummate strategic alternatives or other alternatives in a timely manner on terms acceptable to the Company, if at all. Regulatory Update
As previously disclosed, the Company has developed an AIP ("Application Integrity Policy") corrective action plan to address concerns raised by the FDA or the independent auditor regarding internal systems, procedures, training and data integrity. This AIP corrective action plan was submitted to the FDA in November 2001. Subsequently, the Company has responded to several comments from the FDA related to this plan. The corrective action plan and these responses are currently under review by the FDA and the Company expects that the FDA will conduct an inspection of the Company before deciding, at FDA`s sole discretion, if and when the Company will be removed from AIP. About Gliatech Inc.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R)-L, ADCON(R)-T/N and ADCON(R) Solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to inhibit inflammation.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, commercial uncertainty of regulatory approvals of the Company`s ADCON products, including the timing and content of decisions made by the FDA, relating to, among other things, decisions regarding the sale of ADCON-L, the uncertainty of the outcome of FDA`s review of clinical data, product recalls, the import alert and inspectional observations, commercial uncertainty of market acceptance of the Company`s ADCON family of products, delays in product development of additional ADCON products, uncertainty of outcomes of future FDA audits and inspections, the uncertainty of the status of the Company with respect to AIP regulations, the uncertainty of timing and decisions of the FDA Advisory Panel and/or the FDA following a review of the data regarding resuming of sales of ADCON-L in the U.S., the uncertainty of expenses associated with clinical trials and research efforts, which may affect the profitability of the Company, uncertainty due to the early stage of development for the pharmaceutical programs, the ability of the Company to raise additional funding, the ability of the Company to establish and maintain collaborative arrangements with others, the potential market size for ADCON products, the ability of the Company to obtain an adequate supply of the materials used in the manufacture of its ADCON products, the productivity of distributors of ADCON products, shortages of supply of ADCON products from the Company`s sole manufacturer, the lack of supply of raw materials for the Company`s products, uncertainty of future profitability, uncertainties related to the Company`s proprietary rights in its products, the outcome of pending litigation and investigations, technological change and the ability of the Company to fund its capital requirements through cash from operations or the issuance of debt or equity securities, the ability of the Company to consummate strategic collaborations or other strategic alternatives on terms satisfactory to the Company, or at all, and other risk factors detailed in Gliatech`s SEC filings.
MAKE YOUR OPINION COUNT - Click Here
http://tbutton.prnewswire.com/prn/11690X23234353
/CONTACT: Adam D. Gridley, Investor Relations Manager of Gliatech Inc., +1-216-831-3200, x3019/
Gliatech Provides Earnings Release Date and Corporate Update
CLEVELAND, March 14 /PRNewswire-FirstCall/ -- Gliatech Inc. (OTC Bulletin Board: GLIA) today announced that the Company will report its financial results for the fourth quarter and year-ended December 31, 2001 on Monday, April 1, 2002 and will hold a conference call at 10:00 a.m. EST. Investors are invited to listen to the conference call that will be broadcast live over the Internet with Steven L. Basta, President, and other members of Gliatech`s management team.
What: Gliatech Fourth Quarter/Year-End 2001 Earnings Conference Call
When: Monday, April 1, 2002 at 10:00 A.M. EST
Where: http://www.videonewswire.com/event.asp?id=3849
How: Live over the Internet -- Simply log on to the web at the
address above
Contact: Adam D. Gridley
Manager, Investor Relations & Business Development
216.831.3200 x3019
gridleya@gliatech.com
A replay of the call will be available until April 7, 2002 by dialing 888.445.8680 (US/Canada) or 402.998.1332 (International/Local). The playback will also be available on Gliatech`s web site at www.gliatech.com . Corporate Update
As of December 31, 2001, Gliatech had approximately $3.0 million of cash, cash equivalents and short-term investments. Subsequent to year-end, the Company reached a settlement agreement with its business interruption insurance carrier for property damages arising from the January 2001 product recall. The Company received $2.0 million net of legal expenses in settlement of the claim. Under terms of the agreement, the Company has released its insurance carrier from any future insurance claims relating to the product recall. The Company believes that it currently has sufficient cash, cash equivalents and short-term investments on hand to meet operating requirements through mid-May 2002.
The Company is seeking additional financing and is currently in active discussions regarding potential funding sources such as equity and debt financing, and is considering other strategic alternatives in order to continue operations. The issuance of additional equity securities, if any, could result in substantial dilution to the Company`s stockholders. There can be no assurance that the Company will be able to identify necessary financing or will be able to consummate strategic alternatives or other alternatives in a timely manner on terms acceptable to the Company, if at all. Regulatory Update
As previously disclosed, the Company has developed an AIP ("Application Integrity Policy") corrective action plan to address concerns raised by the FDA or the independent auditor regarding internal systems, procedures, training and data integrity. This AIP corrective action plan was submitted to the FDA in November 2001. Subsequently, the Company has responded to several comments from the FDA related to this plan. The corrective action plan and these responses are currently under review by the FDA and the Company expects that the FDA will conduct an inspection of the Company before deciding, at FDA`s sole discretion, if and when the Company will be removed from AIP. About Gliatech Inc.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R)-L, ADCON(R)-T/N and ADCON(R) Solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to inhibit inflammation.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, commercial uncertainty of regulatory approvals of the Company`s ADCON products, including the timing and content of decisions made by the FDA, relating to, among other things, decisions regarding the sale of ADCON-L, the uncertainty of the outcome of FDA`s review of clinical data, product recalls, the import alert and inspectional observations, commercial uncertainty of market acceptance of the Company`s ADCON family of products, delays in product development of additional ADCON products, uncertainty of outcomes of future FDA audits and inspections, the uncertainty of the status of the Company with respect to AIP regulations, the uncertainty of timing and decisions of the FDA Advisory Panel and/or the FDA following a review of the data regarding resuming of sales of ADCON-L in the U.S., the uncertainty of expenses associated with clinical trials and research efforts, which may affect the profitability of the Company, uncertainty due to the early stage of development for the pharmaceutical programs, the ability of the Company to raise additional funding, the ability of the Company to establish and maintain collaborative arrangements with others, the potential market size for ADCON products, the ability of the Company to obtain an adequate supply of the materials used in the manufacture of its ADCON products, the productivity of distributors of ADCON products, shortages of supply of ADCON products from the Company`s sole manufacturer, the lack of supply of raw materials for the Company`s products, uncertainty of future profitability, uncertainties related to the Company`s proprietary rights in its products, the outcome of pending litigation and investigations, technological change and the ability of the Company to fund its capital requirements through cash from operations or the issuance of debt or equity securities, the ability of the Company to consummate strategic collaborations or other strategic alternatives on terms satisfactory to the Company, or at all, and other risk factors detailed in Gliatech`s SEC filings.
MAKE YOUR OPINION COUNT - Click Here
http://tbutton.prnewswire.com/prn/11690X23234353
/CONTACT: Adam D. Gridley, Investor Relations Manager of Gliatech Inc., +1-216-831-3200, x3019/
da isses !
GLIATECH ANNOUNCES 2001 YEAR END AND FOURTH QUARTER RESULTS
Cleveland, OH--April 1, 2002 -- Gliatech Inc. (OTCBB: GLIA.OB) today announced financial results and earnings for the fourth quarter and fiscal year ended December 31, 2001. Total revenues for 2001 decreased to $3.1 million from $23.7 million in 2000. Net product sales decreased to $2.6 million in 2001 compared to $23.1 million in 2000, net of a $2.4 million product recall provision recorded in 2000. The Company recognized $0.1 million of a $1.5 million license fee payment from Abgenix and $0.4 million in research contract revenue in 2001 related to the agreement entered into with Abgenix in November 2001. The Company recognized $0.5 million related to government grants in 2000.
The Company successfully relaunched ADCON(R)-L internationally in May 2001. International net product sales were $2.6 million in 2001 compared to $4.0 million in 2000. The decrease in international net product sales was due to fewer months of product sales and no net product sales of ADCON-T/N in 2001. International net product sales were $0.9 million in the fourth quarter of 2001 compared to $0.7 million in the fourth quarter of 2000.
The Company`s net loss increased to $23.7 million or $2.45 per share in 2001 compared to a net loss of $12.9 million or $1.35 per share in 2000. The increase in the net loss resulted primarily from the lack of U.S. sales in 2001. In 2001, the Company recorded charges of $1.2 million related to costs to exit its leased U.S. manufacturing facility and $0.9 million related to the settlement of an investigation by the Department of Justice.
FINANCIAL STATUS
As of December 31, 2001, Gliatech had approximately $3.0 million of cash, cash equivalents and short-term investments. Subsequent to year-end, the Company reached a settlement agreement with its business interruption insurance carrier for property damages arising from the January 2001 product recall. The Company received $2.0 million net of legal expenses in settlement of the claim. Under terms of the agreement, the Company has released its insurance carrier from any future insurance claims relating to the product recall. The Company believes that it currently has sufficient cash, cash equivalents and short-term investments on hand to meet operating requirements through mid-May 2002.
As previously disclosed, the Company is seeking additional financing. Gliatech has recently executed a non-binding term sheet with a group of investors regarding a proposed private placement of convertible debt, preferred stock and warrants totaling approximately $15 million to be invested in two stages. The issuance of the equity securities associated with this financing if consummated, will result in substantial dilution to the Company`s stockholders, and, upon completion of stage two, result in a change of control of the Company. The structure of the agreement as currently contemplated will require stockholder approval of stage two. Certain significant agreements required for completion of this transaction have not yet been reached. There can be no assurance that the Company will be able to complete the financing or will be able to consummate strategic alternatives or other alternatives in a timely manner on terms acceptable to the Company, if at all. In the event that the Company is unable to consummate this financing or strategic alternatives, the Company may seek court protection under the U.S. Bankruptcy Code.
The securities proposed to be issued in the financing will not be registered under the Securities Act of 1933 and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any offer, solicitation or sale of such securities in any jurisdiction in which such offer, solicitation or sales would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. This press release is issued pursuant to the provisions of Rule 135c under the Securities Act.
REGULATORY UPDATE
As previously disclosed, the Company has developed an AIP ("AIP") corrective action plan to address concerns raised by the FDA or the independent auditor regarding internal systems, procedures, training and data integrity. This AIP corrective action plan was submitted to the FDA in November 2001. Subsequently, the Company has responded to several comments from the FDA related to this plan. The corrective action plan and these responses are currently under review by the FDA and the Company expects that the FDA will conduct an inspection of the Company before deciding, at FDA`s sole discretion, if and when the Company will be removed from AIP.
LITIGATION UPDATE
In March 2002, the Company entered into a written Plea Agreement ("Agreement") with the Department of Justice ("DoJ"). Under the terms of the Agreement, the Company agreed to plead guilty to six misdemeanor violations of the Food, Drug and Cosmetic Act. Pursuant to the Agreement, the Company admitted to (i) failing to submit Medical Device Reports to the FDA regarding four adverse events possibly related to the use of ADCON-L; (ii) a single event of the adulteration of a medical device held for sale relating to Gliatech`s failure to maintain complete complaint files as required by FDA regulations; and (iii) the submission to the FDA of a report pertaining to a medical device that was false and misleading regarding the omission of data from the final report of the U.S. Clinical Study for ADCON-L. All of the conduct at issue occurred prior to March 2000 and relates to matters previously disclosed in press releases and filings with the SEC. The Company has not admitted in the Agreement that there is any causal relationship between ADCON-L and the adverse events discussed in the Agreement. The Company also has not admitted that any of the misdemeanor violations were committed with the intent to defraud or mislead the FDA.
The Agreement proposes a total fine of $1.2 million to be paid in six equal, interest-free installments over a five year period, with the first payment due at the time of sentencing. The Agreement is subject to approval and acceptance by the United States District Court for the Northern District of Ohio. If accepted by the United States District Court, the Agreement resolves the investigation of the Company by the DoJ`s Office of Consumer Litigation and the FDA`s Office of Criminal Investigations.
SBIR GRANT
In January 2002, Gliatech was awarded a Phase I Small Business Innovation Research ("SBIR") Award for $94,000 to evaluate the development of potent and selective inhibitors of the glycine transporter type 1 (GlyT1). The Company has identified a small molecule lead compound in its research program involving the regulation of human glycine transporters. These transporters modulate the levels of the neurotransmitter glycine in the central nervous system. The Company may develop inhibitors of these glycine transporters intended to increase the levels of glycine at the glycine receptor, which may be useful in treating symptoms of schizophrenia.
ABOUT GLIATECH INC.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R)-L, ADCON(R)-T/N and ADCON(R) Solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to inhibit inflammation.
There will be a conference call at 10:00 a.m. EDT today to discuss Gliatech`s fourth quarter financial results. This call will be broadcast live over the Internet at http://www.videonewswire.com/event.asp?id=3849 and will be archived at Gliatech`s website located at http://www.gliatech.com. A replay of the call will be available until April 7, 2002 by dialing 888.445.8680 (US/Canada) or 402.998.1332 (International/Local).
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, commercial uncertainty of regulatory approvals of the Company`s ADCON products, including the timing and content of decisions made by the FDA, relating to, among other things, decisions regarding the sale of ADCON-L, the uncertainty of the outcome of FDA`s review of clinical data, product recalls, the import alert and inspectional observations, commercial uncertainty of market acceptance of the Company`s ADCON family of products, delays in product development of additional ADCON products, uncertainty of outcomes of future FDA audits and inspections, the uncertainty of the status of the Company with respect to AIP status, the uncertainty of timing and decisions of the FDA Advisory Panel and/or the FDA following a review of the data regarding resuming of sales of ADCON-L in the U.S., the uncertainty of expenses associated with clinical trials and research efforts, which may affect the profitability of the Company, uncertainty due to the early stage of development for the pharmaceutical programs, the ability of the Company to raise additional funding, the ability of the Company to obtain stockholder approval, if required, with respect to potential financings or other alternatives, the ability of the Company to establish and maintain collaborative arrangements with others, the potential market size for ADCON products, the ability of the Company to obtain an adequate supply of the materials used in the manufacture of its ADCON products, the productivity of distributors of ADCON products, shortages of supply of ADCON products from the Company`s sole manufacturer, the lack of supply of raw materials for the Company`s products, uncertainty of future profitability, uncertainties related to the Company`s proprietary rights in its products, the outcome of pending litigation and investigation, technological change and the ability of the Company to fund its capital requirements through cash from operations or the issuance of debt or equity securities, the ability of the Company to consummate strategic collaborations or other strategic alternatives on terms satisfactory to the Company, or at all, and other risk factors detailed in Gliatech`s SEC filings.
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT SHARE AND THREE MONTHS ENDED TWELVE MONTHS ENDED
PER SHARE DATA) DECEMBER 31, DECEMBER 31,
2001 2000 2001 2000
---- ---- ---- ----
REVENUES (Unaudited) (Unaudited)
Product sales $ 889 $ 5,558 $ 2,597 $ 25,513
Provision for returns related to recall - (2,400) - (2,400)
----------- ----------- ----------- -----------
889 3,158 2,597 23,113
Government grants and research contracts 486 - 486 542
----------- ----------- ----------- -----------
Total revenues 1,375 3,158 3,083 23,655
OPERATING COSTS AND EXPENSES
Cost of products sold 1,827 2,099 5,208 6,853
Provision for obsolete inventory related to recall - 1,650 - 1,650
----------- ----------- ----------- -----------
1,827 3,749 5,208 8,503
Research and development 1,882 1,883 8,054 8,204
Selling, general and administrative 2,070 3,872 10,744 13,352
Costs to exit leased facility 1,223 1,223
Settlement costs 949 949
Merger related and severance costs - - - 7,541
----------- ----------- ----------- -----------
Total operating costs and expenses 7,951 9,504 26,178 37,600
Loss from operations (6,576) (6,346) (23,095) (13,945)
Interest income 37 218 387 1,026
Interest expense (460) - (1,035) -
----------- ----------- ----------- -----------
NET LOSS $ (6,999) $ (6,128) $ (23,743) $ (12,919)
=========== =========== =========== ===========
Net loss per diluted share $ (0.72) $ (0.63) $ (2.45) $ (1.35)
=========== =========== =========== ===========
Average diluted shares outstanding 9,682,637 9,652,637 9,682,637 9,564,315
=========== =========== =========== ===========
BALANCE SHEET DATAECEMBER 31,
2001 2000
---- ----
(IN Thousands) (Unaudited)
Cash and cash equivalents and $ 3,000 $ 8,464
short-term investments
Other current assets
3,555 4,830
--------- ---------
Total current assets 6,555 13,294
Long term investments 3,642
Property and equipment, net 1,153 3,197
Other assets, net 1,391 1,043
--------- ---------
TOTAL ASSETS $ 9,099 $ 21,176
========= =========
Accounts payable and other $ 5,978 $ 4,855
accrued expenses
Other current liabilities 1,276 818
--------- ---------
Total current liabilities 7,254 5,673
Long-term liabilities 9,058
Stockholders` equity: (7,213) 15,503
--------- ---------
TOTAL LIABILITIES AND STOCKHOLDERS` EQUITY $ 9,099 $ 21,176
========= =========
GLIATECH ANNOUNCES 2001 YEAR END AND FOURTH QUARTER RESULTS
Cleveland, OH--April 1, 2002 -- Gliatech Inc. (OTCBB: GLIA.OB) today announced financial results and earnings for the fourth quarter and fiscal year ended December 31, 2001. Total revenues for 2001 decreased to $3.1 million from $23.7 million in 2000. Net product sales decreased to $2.6 million in 2001 compared to $23.1 million in 2000, net of a $2.4 million product recall provision recorded in 2000. The Company recognized $0.1 million of a $1.5 million license fee payment from Abgenix and $0.4 million in research contract revenue in 2001 related to the agreement entered into with Abgenix in November 2001. The Company recognized $0.5 million related to government grants in 2000.
The Company successfully relaunched ADCON(R)-L internationally in May 2001. International net product sales were $2.6 million in 2001 compared to $4.0 million in 2000. The decrease in international net product sales was due to fewer months of product sales and no net product sales of ADCON-T/N in 2001. International net product sales were $0.9 million in the fourth quarter of 2001 compared to $0.7 million in the fourth quarter of 2000.
The Company`s net loss increased to $23.7 million or $2.45 per share in 2001 compared to a net loss of $12.9 million or $1.35 per share in 2000. The increase in the net loss resulted primarily from the lack of U.S. sales in 2001. In 2001, the Company recorded charges of $1.2 million related to costs to exit its leased U.S. manufacturing facility and $0.9 million related to the settlement of an investigation by the Department of Justice.
FINANCIAL STATUS
As of December 31, 2001, Gliatech had approximately $3.0 million of cash, cash equivalents and short-term investments. Subsequent to year-end, the Company reached a settlement agreement with its business interruption insurance carrier for property damages arising from the January 2001 product recall. The Company received $2.0 million net of legal expenses in settlement of the claim. Under terms of the agreement, the Company has released its insurance carrier from any future insurance claims relating to the product recall. The Company believes that it currently has sufficient cash, cash equivalents and short-term investments on hand to meet operating requirements through mid-May 2002.
As previously disclosed, the Company is seeking additional financing. Gliatech has recently executed a non-binding term sheet with a group of investors regarding a proposed private placement of convertible debt, preferred stock and warrants totaling approximately $15 million to be invested in two stages. The issuance of the equity securities associated with this financing if consummated, will result in substantial dilution to the Company`s stockholders, and, upon completion of stage two, result in a change of control of the Company. The structure of the agreement as currently contemplated will require stockholder approval of stage two. Certain significant agreements required for completion of this transaction have not yet been reached. There can be no assurance that the Company will be able to complete the financing or will be able to consummate strategic alternatives or other alternatives in a timely manner on terms acceptable to the Company, if at all. In the event that the Company is unable to consummate this financing or strategic alternatives, the Company may seek court protection under the U.S. Bankruptcy Code.
The securities proposed to be issued in the financing will not be registered under the Securities Act of 1933 and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any offer, solicitation or sale of such securities in any jurisdiction in which such offer, solicitation or sales would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. This press release is issued pursuant to the provisions of Rule 135c under the Securities Act.
REGULATORY UPDATE
As previously disclosed, the Company has developed an AIP ("AIP") corrective action plan to address concerns raised by the FDA or the independent auditor regarding internal systems, procedures, training and data integrity. This AIP corrective action plan was submitted to the FDA in November 2001. Subsequently, the Company has responded to several comments from the FDA related to this plan. The corrective action plan and these responses are currently under review by the FDA and the Company expects that the FDA will conduct an inspection of the Company before deciding, at FDA`s sole discretion, if and when the Company will be removed from AIP.
LITIGATION UPDATE
In March 2002, the Company entered into a written Plea Agreement ("Agreement") with the Department of Justice ("DoJ"). Under the terms of the Agreement, the Company agreed to plead guilty to six misdemeanor violations of the Food, Drug and Cosmetic Act. Pursuant to the Agreement, the Company admitted to (i) failing to submit Medical Device Reports to the FDA regarding four adverse events possibly related to the use of ADCON-L; (ii) a single event of the adulteration of a medical device held for sale relating to Gliatech`s failure to maintain complete complaint files as required by FDA regulations; and (iii) the submission to the FDA of a report pertaining to a medical device that was false and misleading regarding the omission of data from the final report of the U.S. Clinical Study for ADCON-L. All of the conduct at issue occurred prior to March 2000 and relates to matters previously disclosed in press releases and filings with the SEC. The Company has not admitted in the Agreement that there is any causal relationship between ADCON-L and the adverse events discussed in the Agreement. The Company also has not admitted that any of the misdemeanor violations were committed with the intent to defraud or mislead the FDA.
The Agreement proposes a total fine of $1.2 million to be paid in six equal, interest-free installments over a five year period, with the first payment due at the time of sentencing. The Agreement is subject to approval and acceptance by the United States District Court for the Northern District of Ohio. If accepted by the United States District Court, the Agreement resolves the investigation of the Company by the DoJ`s Office of Consumer Litigation and the FDA`s Office of Criminal Investigations.
SBIR GRANT
In January 2002, Gliatech was awarded a Phase I Small Business Innovation Research ("SBIR") Award for $94,000 to evaluate the development of potent and selective inhibitors of the glycine transporter type 1 (GlyT1). The Company has identified a small molecule lead compound in its research program involving the regulation of human glycine transporters. These transporters modulate the levels of the neurotransmitter glycine in the central nervous system. The Company may develop inhibitors of these glycine transporters intended to increase the levels of glycine at the glycine receptor, which may be useful in treating symptoms of schizophrenia.
ABOUT GLIATECH INC.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R)-L, ADCON(R)-T/N and ADCON(R) Solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to inhibit inflammation.
There will be a conference call at 10:00 a.m. EDT today to discuss Gliatech`s fourth quarter financial results. This call will be broadcast live over the Internet at http://www.videonewswire.com/event.asp?id=3849 and will be archived at Gliatech`s website located at http://www.gliatech.com. A replay of the call will be available until April 7, 2002 by dialing 888.445.8680 (US/Canada) or 402.998.1332 (International/Local).
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, commercial uncertainty of regulatory approvals of the Company`s ADCON products, including the timing and content of decisions made by the FDA, relating to, among other things, decisions regarding the sale of ADCON-L, the uncertainty of the outcome of FDA`s review of clinical data, product recalls, the import alert and inspectional observations, commercial uncertainty of market acceptance of the Company`s ADCON family of products, delays in product development of additional ADCON products, uncertainty of outcomes of future FDA audits and inspections, the uncertainty of the status of the Company with respect to AIP status, the uncertainty of timing and decisions of the FDA Advisory Panel and/or the FDA following a review of the data regarding resuming of sales of ADCON-L in the U.S., the uncertainty of expenses associated with clinical trials and research efforts, which may affect the profitability of the Company, uncertainty due to the early stage of development for the pharmaceutical programs, the ability of the Company to raise additional funding, the ability of the Company to obtain stockholder approval, if required, with respect to potential financings or other alternatives, the ability of the Company to establish and maintain collaborative arrangements with others, the potential market size for ADCON products, the ability of the Company to obtain an adequate supply of the materials used in the manufacture of its ADCON products, the productivity of distributors of ADCON products, shortages of supply of ADCON products from the Company`s sole manufacturer, the lack of supply of raw materials for the Company`s products, uncertainty of future profitability, uncertainties related to the Company`s proprietary rights in its products, the outcome of pending litigation and investigation, technological change and the ability of the Company to fund its capital requirements through cash from operations or the issuance of debt or equity securities, the ability of the Company to consummate strategic collaborations or other strategic alternatives on terms satisfactory to the Company, or at all, and other risk factors detailed in Gliatech`s SEC filings.
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT SHARE AND THREE MONTHS ENDED TWELVE MONTHS ENDED
PER SHARE DATA) DECEMBER 31, DECEMBER 31,
2001 2000 2001 2000
---- ---- ---- ----
REVENUES (Unaudited) (Unaudited)
Product sales $ 889 $ 5,558 $ 2,597 $ 25,513
Provision for returns related to recall - (2,400) - (2,400)
----------- ----------- ----------- -----------
889 3,158 2,597 23,113
Government grants and research contracts 486 - 486 542
----------- ----------- ----------- -----------
Total revenues 1,375 3,158 3,083 23,655
OPERATING COSTS AND EXPENSES
Cost of products sold 1,827 2,099 5,208 6,853
Provision for obsolete inventory related to recall - 1,650 - 1,650
----------- ----------- ----------- -----------
1,827 3,749 5,208 8,503
Research and development 1,882 1,883 8,054 8,204
Selling, general and administrative 2,070 3,872 10,744 13,352
Costs to exit leased facility 1,223 1,223
Settlement costs 949 949
Merger related and severance costs - - - 7,541
----------- ----------- ----------- -----------
Total operating costs and expenses 7,951 9,504 26,178 37,600
Loss from operations (6,576) (6,346) (23,095) (13,945)
Interest income 37 218 387 1,026
Interest expense (460) - (1,035) -
----------- ----------- ----------- -----------
NET LOSS $ (6,999) $ (6,128) $ (23,743) $ (12,919)
=========== =========== =========== ===========
Net loss per diluted share $ (0.72) $ (0.63) $ (2.45) $ (1.35)
=========== =========== =========== ===========
Average diluted shares outstanding 9,682,637 9,652,637 9,682,637 9,564,315
=========== =========== =========== ===========
BALANCE SHEET DATA
ECEMBER 31,2001 2000
---- ----
(IN Thousands) (Unaudited)
Cash and cash equivalents and $ 3,000 $ 8,464
short-term investments
Other current assets
3,555 4,830
--------- ---------
Total current assets 6,555 13,294
Long term investments 3,642
Property and equipment, net 1,153 3,197
Other assets, net 1,391 1,043
--------- ---------
TOTAL ASSETS $ 9,099 $ 21,176
========= =========
Accounts payable and other $ 5,978 $ 4,855
accrued expenses
Other current liabilities 1,276 818
--------- ---------
Total current liabilities 7,254 5,673
Long-term liabilities 9,058
Stockholders` equity: (7,213) 15,503
--------- ---------
TOTAL LIABILITIES AND STOCKHOLDERS` EQUITY $ 9,099 $ 21,176
========= =========
puhvogel hatte wohl doch recht! das wars dann wohl
Gliatech Announces Corporate Update
- Previously Announced Potential Financing Will Not Be Consummated -
CLEVELAND, Ohio, April 30 /PRNewswire-FirstCall/ -- Gliatech Inc. (OTC Bulletin Board: GLIA.OB) today provided the following corporate update on its financial and regulatory status:
Financial Status:
Gliatech announced today that a previously disclosed proposed private placement will not be consummated. As a result, the Company expects to take steps to reduce expenses including a significant reduction in the Company`s workforce. The Company is considering strategic options including the sales of its ADCON(R) product line and pharmaceutical programs to strategic buyers. Gliatech does not expect that the proceeds from any such sales, if consummated, will provide adequate resources to fund the ongoing operations of the Company. The Company is likely to seek court protection under the U.S. Bankruptcy Code in order to manage its financial restructuring options, including the orderly auction and sale of its assets to meet its obligations to its creditors.
As of March 31, 2002, Gliatech had approximately $2.4 million of cash, cash equivalents and short-term investments. The Company believes that it currently has sufficient cash, cash equivalents and short-term investments on hand to meet operating requirements through May 2002.
International Sales:
Gliatech continues to market ADCON(R)-L in countries outside of the U.S. through a network of independent distributors managed by its internal sales organization. The product is currently registered in 41 countries outside of the U.S. Revenues outside of the U.S. in the first quarter of 2002 were approximately $500,000. It is the Company`s intention to work with its international distributors to maintain its international sales activities even if the Company seeks bankruptcy protection.
Pharmaceutical Programs:
Gliatech is currently in discussions with investors and strategic buyers regarding a sale of all or parts of the Company`s pharmaceutical programs, including its Histamine H3 small molecule drug candidates, its anti- inflammation monoclonal antibodies, including the partnership established in November 2001, and its glycine transporter programs.
ADCON(R) Product Family:
Gliatech has had discussions with several strategic buyers regarding a sale of all or parts of the ADCON(R) family of products, including domestic and international rights to its ADCON(R) gel and solution products. The Company has received strong initial indications of interest from various potential buyers, some of whom may be interested in all of the ADCON(R) technology and products or in individual ADCON(R) products for specific territories.
Regulatory Update:
As previously disclosed, the Company has developed an Application Integrity Policy ("AIP") corrective action plan to address concerns raised by the FDA or the independent auditor regarding internal systems, procedures, training and data integrity. This AIP corrective action plan was submitted to the FDA in November 2001. Subsequently, the Company has responded to several comments from the FDA related to this plan. The FDA has completed its review of the AIP corrective action plan and has indicated to the Company that it will conduct an inspection of the Company before deciding, at FDA`s sole discretion, if and when the Company will be removed from AIP. Gliatech has entered into discussions with the FDA regarding the impact of the anticipated changes at the company following the termination of the planned financing. About Gliatech Inc.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R)-L, ADCON(R)-T/N and ADCON(R) Solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to inhibit inflammation.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, commercial uncertainty of regulatory approvals of the Company`s ADCON products, including the timing and content of decisions made by the FDA, relating to, among other things, decisions regarding the sale of ADCON-L, the uncertainty of the outcome of FDA`s review of clinical data, product recalls, the import alert and inspectional observations, commercial uncertainty of market acceptance of the Company`s ADCON family of products, delays in product development of additional ADCON products, uncertainty of outcomes of future FDA audits and inspections, the uncertainty of the status of the Company with respect to AIP status, the uncertainty of timing and decisions of the FDA Advisory Panel and/or the FDA following a review of the data regarding resuming of sales of ADCON-L in the U.S., the uncertainty of expenses associated with clinical trials and research efforts, which may affect the profitability of the Company, uncertainty due to the early stage of development for the pharmaceutical programs, the ability of the Company to raise additional funding, the uncertainties of seeking court protection under the U.S. Bankruptcy Code, the negotiating positions of various constituents and the results of negotiations regarding the potential bankruptcy, the ability of the Company to obtain stockholder approval, if required, with respect to potential financings or other alternatives, the ability of the Company to establish and maintain collaborative arrangements with others, the potential market size for ADCON products, the ability of the Company to obtain an adequate supply of the materials used in the manufacture of its ADCON products, the productivity of distributors of ADCON products, shortages of supply of ADCON products from the Company`s sole manufacturer, the lack of supply of raw materials for the Company`s products, uncertainty of future profitability, uncertainties related to the Company`s proprietary rights in its products, the outcome of pending litigation and investigation, technological change and the ability of the Company to fund its capital requirements through cash from operations or the issuance of debt or equity securities, the ability of the Company to consummate strategic collaborations or other strategic alternatives on terms satisfactory to the Company, or at all, and other risk factors detailed in Gliatech`s SEC filings
Gliatech Announces Corporate Update
- Previously Announced Potential Financing Will Not Be Consummated -
CLEVELAND, Ohio, April 30 /PRNewswire-FirstCall/ -- Gliatech Inc. (OTC Bulletin Board: GLIA.OB) today provided the following corporate update on its financial and regulatory status:
Financial Status:
Gliatech announced today that a previously disclosed proposed private placement will not be consummated. As a result, the Company expects to take steps to reduce expenses including a significant reduction in the Company`s workforce. The Company is considering strategic options including the sales of its ADCON(R) product line and pharmaceutical programs to strategic buyers. Gliatech does not expect that the proceeds from any such sales, if consummated, will provide adequate resources to fund the ongoing operations of the Company. The Company is likely to seek court protection under the U.S. Bankruptcy Code in order to manage its financial restructuring options, including the orderly auction and sale of its assets to meet its obligations to its creditors.
As of March 31, 2002, Gliatech had approximately $2.4 million of cash, cash equivalents and short-term investments. The Company believes that it currently has sufficient cash, cash equivalents and short-term investments on hand to meet operating requirements through May 2002.
International Sales:
Gliatech continues to market ADCON(R)-L in countries outside of the U.S. through a network of independent distributors managed by its internal sales organization. The product is currently registered in 41 countries outside of the U.S. Revenues outside of the U.S. in the first quarter of 2002 were approximately $500,000. It is the Company`s intention to work with its international distributors to maintain its international sales activities even if the Company seeks bankruptcy protection.
Pharmaceutical Programs:
Gliatech is currently in discussions with investors and strategic buyers regarding a sale of all or parts of the Company`s pharmaceutical programs, including its Histamine H3 small molecule drug candidates, its anti- inflammation monoclonal antibodies, including the partnership established in November 2001, and its glycine transporter programs.
ADCON(R) Product Family:
Gliatech has had discussions with several strategic buyers regarding a sale of all or parts of the ADCON(R) family of products, including domestic and international rights to its ADCON(R) gel and solution products. The Company has received strong initial indications of interest from various potential buyers, some of whom may be interested in all of the ADCON(R) technology and products or in individual ADCON(R) products for specific territories.
Regulatory Update:
As previously disclosed, the Company has developed an Application Integrity Policy ("AIP") corrective action plan to address concerns raised by the FDA or the independent auditor regarding internal systems, procedures, training and data integrity. This AIP corrective action plan was submitted to the FDA in November 2001. Subsequently, the Company has responded to several comments from the FDA related to this plan. The FDA has completed its review of the AIP corrective action plan and has indicated to the Company that it will conduct an inspection of the Company before deciding, at FDA`s sole discretion, if and when the Company will be removed from AIP. Gliatech has entered into discussions with the FDA regarding the impact of the anticipated changes at the company following the termination of the planned financing. About Gliatech Inc.
Gliatech Inc. is engaged in the discovery and development of biosurgery and pharmaceutical products. The biosurgery products include ADCON(R)-L, ADCON(R)-T/N and ADCON(R) Solution, which are proprietary, resorbable, carbohydrate polymer medical devices designed to inhibit scarring and adhesions following surgery. Gliatech`s pharmaceutical product candidates include small molecule drugs to modulate the cognitive state of the nervous system and proprietary monoclonal antibodies designed to inhibit inflammation.
Certain statements in this press release constitute "forward-looking statements" that are subject to risks and uncertainties which may cause the actual results of Gliatech to be different from expectations express or implied by such forward-looking statements. Such factors include, but are not limited to, commercial uncertainty of regulatory approvals of the Company`s ADCON products, including the timing and content of decisions made by the FDA, relating to, among other things, decisions regarding the sale of ADCON-L, the uncertainty of the outcome of FDA`s review of clinical data, product recalls, the import alert and inspectional observations, commercial uncertainty of market acceptance of the Company`s ADCON family of products, delays in product development of additional ADCON products, uncertainty of outcomes of future FDA audits and inspections, the uncertainty of the status of the Company with respect to AIP status, the uncertainty of timing and decisions of the FDA Advisory Panel and/or the FDA following a review of the data regarding resuming of sales of ADCON-L in the U.S., the uncertainty of expenses associated with clinical trials and research efforts, which may affect the profitability of the Company, uncertainty due to the early stage of development for the pharmaceutical programs, the ability of the Company to raise additional funding, the uncertainties of seeking court protection under the U.S. Bankruptcy Code, the negotiating positions of various constituents and the results of negotiations regarding the potential bankruptcy, the ability of the Company to obtain stockholder approval, if required, with respect to potential financings or other alternatives, the ability of the Company to establish and maintain collaborative arrangements with others, the potential market size for ADCON products, the ability of the Company to obtain an adequate supply of the materials used in the manufacture of its ADCON products, the productivity of distributors of ADCON products, shortages of supply of ADCON products from the Company`s sole manufacturer, the lack of supply of raw materials for the Company`s products, uncertainty of future profitability, uncertainties related to the Company`s proprietary rights in its products, the outcome of pending litigation and investigation, technological change and the ability of the Company to fund its capital requirements through cash from operations or the issuance of debt or equity securities, the ability of the Company to consummate strategic collaborations or other strategic alternatives on terms satisfactory to the Company, or at all, and other risk factors detailed in Gliatech`s SEC filings
@wunram
kannst Du als experte dazu Deine Meinung sagen ? Danke.
kannst Du als experte dazu Deine Meinung sagen ? Danke.
Kein frisches Geld in Sicht, ganz normale Pleite ist angesagt. Wer bewußt Daten fälscht, darf sich nicht wundern, wenn er (bzw. seine Aktionäre !!) auf die Schnauze fällt !!
:O
:O
haben die jetzt die Pforten zugemacht, einfacht dicht ?
Oder gibts eine hofnung für Aktionäre ?
Wer kann dazu was sagen ?
Danke !
Gruss
Akat
Oder gibts eine hofnung für Aktionäre ?
Wer kann dazu was sagen ?
Danke !
Gruss
Akat
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