Transkaryotic Therapies, Inc. (TKTX) - 500 Beiträge pro Seite

[IWA Japan]

Nachden seit Freitag TKTX mal wieder in aller Munde ist und selbst Deutschlands großes Börsenmagazin „Der Aktionär“ nicht fähi war, das ganze Geschäftfeld von TKTX zu beleuchten, hier mal ein kleiner Überblick:



aktuelle Marktkapitalisierung rund 800 Mio $

TKTX ist in 3 Geschäftsbereichen tätig:
Gen-aktivierte Proteine
Gentherapie
Proteine zur Behandlung seltener Krankheiten („Nischenproteine“)

Hauptprodukt von TKTX ist das GA-EPO, welches sich als Medikament zur Behandlung von Anämie, einem krankhaften Mangel an rotem Blutfarbstoff, in Phase III der klinischen Entwicklung befindet und gewmeinsam mit Aventis entewicklet und vermarktet wird.
Diese fällt in den Bereich der Gen-Aktivierung. Im Unterschied zu herkömmlichen Methoden, die einen Proteinmangel im Körper dadurch begleichen, dass sie Proteine außerhalb des menschlichen Körpers züchten und diese dann injezieren mit den damit verbundenen Risiken. TKTX verfolgt einen anderen Ansatz: Deren Technologie auf diesem Gebiet erlaubt es Ihnen durch Aktivierung bestimmter Gene (wie es ja schon der Name sagt) die Produktion des jeweiligen Proteins direkt im Körper zu ermöglichen.
Das angesprochene Präparat GA-EPO sorgt in diesem Fall dafür, dass die Bildung von roten Blutkörperchen im Körper gesteigert wird. Das Umsatzpotential von solchen EPO-Präparaten wird weltweit auf 3,2 Milliarden $ geschätzt. In Folge der neuartigen Methode könnte sich TKTX davon einen gehörigen Anteil vom Kuchen abschbeiden mit allen Konsequenzen für den Kurs J !
Bevor ich das momentan e große Problem für TKTX anspreche, hier noch die weitere Pipeline:

Im Bereich der Gen-Aktivierung gibt es noch ein weiteres, das sich in Phase I befindet, wobei wiederum mit Aventis zusammengearbeitet wird
Factor VIII Gentherapie wird bei der Behandlung der Bluterkrankheit vom Typ A verwendet und befindet sich in Phase I.
Replagal ist ein Phase II Nischen-Protein zur Behandlung der „Fabry“-Krankheit (wer weiß bitte was das ist?). Dieses wird in Asien durch Sumitomo Pharmaceuticals vermarktet, während dies TKTS in den USA sowie in Europa selbst übernimmt.
Weitere klinische Studien für ein weiteres Gen-aktiviertes Protein sowie ein Nischen-Protein (I2S gegen das Hunter-Syndrom) sind für das Jahr 2000 geplant.

Technologielinks:
Gen-Aktivierung http://www.tktx.com/images/t_technology_ga.gif
Gen-Therapie http://www.tktx.com/images/t_technology_gt.gif
Nischen-Proteine http://www.tktx.com/images/t_technology_np.gif



Das oben angesprochene große Problem für TKTX ist der Biotech-Riese Amgen, der mit EPO-Gen ebenso ein derartiges Präparat bereits auf den Markt gebracht haben und bereits mehrere 100 Mio $ Umsatz je Quartal damit erzielen. Laut Agen Ansicht, die auf Ihre Technologie Patente besitzen, verstößt TKTX genau dagegen, was der Anlass ist zum REchtsstreit.

Wie ich bereits früher gepostet habe, ist die künftige Kursentwicklung von TKTX im Wesentlichen von dieser Entscheidung abhängig. Zwar sind Experten der Meinung, dass die Technologie von TKTX nicht unter die Patente von Amgen fällt, aber dennoch ist es gerade diese Tatsache, die momentan den Kurs von TKTX belastet und auch bestimmt.
Der 35% Kurssprung letzen Freitag ist hier noch nicht als Kaufsignal zu werten, da der Prozess noch nicht entschieden ist. Der Kurssprung wird durch den massiven Kursverlust heute auch wieder relativiert.

Somit sollte mit einem Engagament in TKTX bis zum endgültigen Ausgang des Prozesses gewartet werden, da dann endlich die Unsicherheit aus dem Markt verschwunden ist.
Geht’s der Prozess aus wie von EXperten erwartet, so dürften TKTX goldenen Zeiten ins Haus stehen.

[IWA Japan]

hier noch 2 aktuelle Analysen:

Die Aktienexperten vom Börsenbrief Global Biotech Investing empfehlen die Aktie der Transkaryotic Therapies Inc. (WKN 903363) zum Kauf.

Die Gesellschaft sei in der Erforschung von Proteinen zur Behandlung unter anderem von Krebs tätig. Das erste kommerzielle Produkt, das genaktivierte Erythropoietin werde im kommenden Jahr auf den Markt kommen.

Daneben habe der Konzern eine ganze Reihe weiterer Produkte in der Pipeline mit einem von Analysten geschätzten Marktpotential zwischen 50 und 100 Mio. USD.

TKT habe auf aktuellem Niveau lediglich ein KGV 2002e von 20, und sei mit 200 Mio. USD Cash in der Kasse somit grundsolide.

Der Kursrutsch von 86 auf 26 USD biete eine einmalige Nachkaufgelegenheit, so die Einschätzung der Experten.


Douglas D. Lind, Analyst bei Morgan Stanley Dean Witter, empfiehlt den Kauf von Aktien von Transkaryotic Therapies (WKN 903363) mit Nachdruck.
Weil Transkaryotic Eigentümer einer neuen Proteinerzeugungs – Technologie sei, könne man in fünf Jahren den Sektor beherrschen. Außerdem geht die Entwicklung neuer Proteine immer schneller voran.

Risiken bestehen im Erlass neuer einschränkender Gesetze und in Prüfungsverfahren, die die neuen Proteine noch nicht hinter sich hätten. Ob die hohen Erwartungen erfüllt würden, hänge also trotz der faszinierenden Technologie davon ab, ob sich das Unternehmen in den nächsten Jahren wirtschaftlich sowie in klinischen Tests und Wettbewerbsregulierungen beweisen könne. Der Rechtsstreit mit Amgen könne bis zur Klärung im Spätsommer ebenfalls Schwankungen bewirken.
Nach einem Verlust pro Aktie von 2,25 USD in der vergangenen Geschäftsperiode erwarten Lind und seine Kollegen einen Verlust von 2,67 USD in 2000 und minus 0,36 USD in 2001.
Das 3-Jahres-Kursziel belaufe sich auf 136 USD.

[RCZ]

Item 5. OTHER EVENTS.
On June 9, 2000, Transkaryotic Therapies, Inc. (the "Registrant") sold 9,000 shares of the Registrant`s Series A Convertible Preferred Stock, $0.01 par value per share, for an aggregate price of $90,000,000 to investment funds affiliated with E.M. Warburg, Pincus & Co., L.L.C. (collectively, "Warburg Pincus") pursuant to a Stock Purchase Agreement, dated as of May 18, 2000 (the "Purchase Agreement"), Under the terms of the Purchase Agreement, the 9,000 shares of Series A Convertible Preferred Stock shall convert into approximately 3,213,000 shares of the Registrant`s common stock, $0.01 par value per share, at a conversion price of $28.00 per share.

[winetrader]

Hallo IWA Japan,
Hallo RCZ,

gute Infos!!
Warburg investiert ca. 100 Mio in den Bereich der Nischenproteine von TKTX.
Aventis investiert in Produktionsanlagen im Bereich Genaktivierung.
Noch einige Zahlen von TKTX zur Ergänzung:
Cash: 192 Mio
Verbindlichkeiten: 8 Mio.
Anzahl der Aktien: 23 Mio.
Weiterhin noch eine Klarstellung im Text von Global Biotech Investing:
"Daneben habe der Konzern eine Reihe ... zwischen 50-100 Mio US$."
Diese Zahlen beziehen sich auf jeweils EIN Nischenprotein. Zu ergänzen wäre auch der "orphan drug status", die solche Nischenpräparate zuerkannt bekommen.
Weiterhin erhält die Gentherapie mit der aktuellen Heilung der französischen Babies eine neue Bedeutung!
D.h.: Kurse um die 30 US$ sind absolute Kaufkurse, auch ohne den amerikanischen Markt in Bezug auf GA-EPO!
Denn viele Anleger realisieren nicht, daß sich dieser Streit lediglich auf den amerikanischen Markt bezieht!

Gruß
winetrader

P.S.:
Die aktuelle juristische Entscheidung bezieht sich nur auf ein Patent, jedoch werden dadurch drei weitere patentrechtliche Ansprüche ausgehebelt.

[TolpanBarfuß]

Hallo Winetrader
Kannst du mir mal sagen,woher du die Infos zum Rechtstreit bekommst?
Bei Aktiencheck steht nix davon und der GBI erwähnt das auch nicht.
Welches Marktvolumen wird für GA-EPO prognostiziert,und wieviel % davon entfallen auf die USA?
Ist GA-EPO dasselbe wie das im GBI erwähnte Erythropoietin.
Diesem Wirkstoff wird angeblich ein Marktvolumen von 6 Mrd USD zugetraut(laut GBI).Scheint mir ein bisschen viel!!!
Ich hatteTransk. erst nur als kurzen trade und überlege jetzt ob ich langfristig wieder einsteige.
Schonmal vielen Dank für die bisherigen Infos!
Tolpan aus Kendermoor

[Blomquist]

@IWA Japan, ich hoffe die Infos reichen Dir


Morbus Fabry, Alpha-Galaktosidase-Mangel
Allgemeines
Morbus Fabry ist eine X-Chromosomal-rezessive Erbkrankheit, die zu einer schweren Stoffwechselerkrankung bei den Betroffenen führt.

Bereits Ende des 19. Jahrhunderts wurde diese Erkrankung beschrieben. Und zwar haben der Englische Hautarzt Anderson und der Deutsche Hautarzt Fabry ohne von einander zu wissen, Patienten mit besonders auffallenden Symptomen vorgestellt:

Neben kleinen, rötlichen bis bläulich-schwarzen Gefäßveränderungen, die an einer Reihe von Körperregionen lokalisiert waren, beobachteten sie ausgeprägte Krampfadern und Lymphschwellungen (= Lymphödeme) an den Beinen. Bei weiteren Untersuchungen wurde Eiweiß im Urin (Proteinurie) nachgewiesen. Außerdem wurden Beteiligungen der Augen, des Nervensystems, der Nieren und des Herzens festgestellt.



Ursachen
Der Grund für diese Erkrankung ist ein Defekt des Alpha-Galaktosidase-Gens auf dem „langen Arm“ des X-Chromosoms. Dieses Gen hat einen Umfang von 12 000 Basispaaren. Für die Fachleute sei ohne weitere Erläuterungen erwähnt, dass es 7 Exons enthält. Aufgrund dieses Gendefekts wird die Alpha-Galaktosidase entweder gar nicht oder in einer geringeren Konzentration im Körper synthetisiert. Oder aber die Alpha-Galaktosidase liegt in einer nicht oder weniger aktiven Form vor.

Die Alpha-Galaktosidase ist ein für den Stoffwechsel wichtiges Enzym, es ist für den Abbau der Sphingolipide verantwortlich. Dabei sind Sphingolipide fettähnliche Substanzen, die vor allem Zellmembrankomponente sind. Aufgrund der fehlenden Aktivität der Alpha-Galaktosidase kommt es zu einer starken Ablagerung bestimmter Glykosphingolipide auf der Innenauskleidung der Gefäße (Endothel) oder der Oberflächenzellen vieler Organe oder der glatten Muskulatur (Epithel).

Unter dem Epithel versteht man einen Zellverband der innere oder äußere Körperoberflächen bedeckt.

Symptome
Schmerzsymptome
Die ersten Symptome treten in der Regel im Vorschulalter auf. Dabei klagen die betroffenen Jungen über anfallsartige starke Schmerzen in Händen und Füßen. Diese Schmerzen klingen meist nach einer Dauer von einigen Tagen wieder ab. Neben diesen Schmerzen besteht oft ein unangenehmes Gefühl an Füßen und Händen, das von Dauer ist und durch äußere Temperaturschwankungen verstärkt werden kann. Weiterhin ist die Schweißbildungsregulation gestört. Das führt dazu, dass die Patienten entweder an vermehrter oder verminderter Schweißbildung leiden.

Symptome der Haut
Veränderungen der Haut erscheinen als rötliche bis bläulich-schwarze Gefäßerweiterungen (Gefäßektasien), die, einzeln oder auch in Gruppen angeordnet, meist in der Nabelregion, den Knien, dem Becken sowie Hoden und Penis auftreten.

Diese Hautveränderungen sind meist etwas erhaben und besitzen auf ihrer Oberfläche eine geringe Vermehrung der Hornbildung (Hyperkeratose). Beim Erwachsenen können diese Hautveränderungen allerdings so unauffällig sein, dass sie erst bei einer gründlichen Untersuchung erkannt werden.

Symptome der Augen
Auch die Augen werden bei dieser Erkrankung in Mitleidenschaft gezogen. So treten Hornhautveränderungen bis hin zu starken Trübungen auf. Außerdem können Linsentrübungen, also Katarakte entstehen. Gefäßveränderungen in der Retina und der Bindehaut sind weitere zu erwartende Schäden. Die Gefäße sind geschlängelt und weisen stark ungleichmäßige Durchmesser auf.

Symptome des Herzkreislauf-Systems
Die Beteiligung des Herzkreislauf-Systems ist besonders gravierend. Bei den meisten Patienten ist eine Herz-Klappen-Insuffizienz - meist der Mitralklappen - zu finden. Späte Komplikationen können in dem Auftreten einer Angina pectoris bis hin zu einem Herzinfarkt bestehen. Die Beteiligung des Herzens wird oft noch durch einen von den Nieren hervorgerufenen Bluthochdruck verstärkt.

Symptome der Nieren
Das Versagen der Nieren ist die häufigste Todesursache bei dieser Erkrankung. Die Beteiligung der Nieren beginnt mit Blut sowie Eiweiß im Urin. Dieser Prozess ist fortschreitend und führt bis zu einer Dialysepflicht oder zu einer Nierentransplantation.

Frauen als Überträgerinnen
Frauen, die über zwei X-Chromosomen verfügen, sind generell als Überträgerinnen anzusehen, aber sie können trotzdem auch selber erkranken. Das ist wie folgt zu verstehen:

In den ersten Lebenswochen eines weiblichen Embryos wird eines der beiden X-Chromosomen gleichsam abgeschaltet. Welches der beiden Chromosomen abgeschaltet wird entscheidet der Zufall. Auf diese Weise ist bei Frauen später nur ein X-Chromosom aktiv. Bei Morbus Fabry-Trägerinnen ist von den beiden X-Chromosomen eines intakt, während das andere über den vorher beschriebenen Defekt verfügt. Durch das „zufallsbedingte“ Abschalten kann es daher passieren, dass z.B. 60% der defekten und 40% der intakten Chromosomen abgeschaltet worden sind, also noch 60% intakt sind. Es kann aber auch zu anderen Verhältnissen zwischen intakten und defekten Chromosomen kommen.

Je nach Enzym kann ein bestimmtes Verhalten zwischen „intakt und nicht intakt“ ausreichen, um die betroffene Person erkranken zu lassen. Bei dieser Erkrankung kommen Fälle vor, bei denen die Mädchen (Frauen) fast dieselben Symptome zeigen wie erkrankte Jungen (Männer). Aber viele Trägerinnen des defekten Gens zeigen dagegen keine Symptome.

Häufigkeit
Da keine wirklich verlässlichen Daten vorliegen, ist man auf Hochrechnungen und Schätzungen angewiesen. Die auf diese Weise gewonnenen Häufigkeiten liegt zwischen 1:35 000 bis 1:40 000.

Diagnose
Bei einem Verdacht auf das Vorliegen des Morbus Fabry kann dieser Verdacht durch die Messung der Aktivität der Alpha-Galaktosidase entweder bestätigt oder ausgeschlossen werden. Ein Verdacht auf das Vorliegen des Morbus Fabry ergibt sich entweder durch eine Familienanamnese oder durch das Auftreten der unter Symptome genannten Beschwerden. Diese klinischen Symptome sind außerdem eine notwendige und wichtige Ergänzung der Laborbefunde.

Therapie
Bis vor kurzem gab es keine kurative (= heilende) Therapie, man konnte lediglich die Symptome lindern bzw. therapieren, bis hin zu einer Nierentransplantation. Aber seit kurzem steht gentechnisch erzeugte Alpha-Galaktosidase zur Verfügung. Bis Mitte des Jahres 2000 war dieses neue Medikament noch nirgends zugelassen, obwohl bereits seit 1998 recht erfolgreiche Studien - vor allen in den USA – betrieben werden. Dort liegt auch ein Antrag bei der FAD auf Zulassung vor.

Prognose
Wenn die therapeutische Anwendung der Alpha-Galaktosidase zugelassen worden ist, kann davon ausgegangen werden, dass eine deutliche Verbesserung der Therapie, dann auch als kausale Therapie erfolgen wird . Bis jetzt aber ist die Lebensqualität der betroffenen Menschen erheblich beeinträchtigt und das mittlere Lebensalter mit 40-45 Jahren deutlich reduziert.

[IWA Japan]

@blomquist: Vieln Dank, aber so ausführlich wäre es nicht nötig gewesen

@winetrader: 1.Ich denke, die Tatsache dass sich die 50-100 Mio auf jedes Medikament beziehen, sollte aus dem Text hervorgehen
2. Habe wirklich vergessen zu schreiben, dass sich dieser Patentstreit nur auf die USA bezieht, deshalb danke für die Ergänzung.
Bedenke aber, dass ich mein Urteil vor diesem Hintergrund der ausschließlichen Beziehung auf die USA getroffen habe!

Grund: Zum einen sollte in den USA zumindest am Anfang das größte Umsatzpotential geben.
2. Die USA ist hier der wichtigste Markt, glaube, wenn TKTX den STreit verliert, sich die Amis eher abwenden von TKTX und sie interssieren sich zumindest kurzzeitig nicht mehr für den REst von TKTX.
Deshalb würde ich TKTX bei negativem Prozessende nicht kaufen!

[winetrader]

Hallo IWA Japan,

der amerikanische Markt ist für Umsatz und Kursentwicklung einer Aktie sehr wichtig!
Das Problem ist bei einem positiven Rechtsstreit den Kursen nicht hinterher zu laufen.
Ich denke zu Preis um 30 US$ kauft man die Firma ohne Genaktivierung!
Falls zu ungunsten von TKTX entschieden wird könnte man nochmals billiger nachkaufen (oder nauch nicht). Aber, und das ist ein entscheidender Vorteil, falls TKTX "gewinnt", sitzt man in der Rakete schon mal drin.
Mein Rat ist und bleibt gleich; mit einer "verschmerzbaren Menge" sich mal positionieren und in Ruhe abwarten.

Und an TolpanBarfuß:
Medical Strategy und englischsprachige Suchmaschinen nutze ich für meine Informationssuche. (man kann das nicht research nennen)

Und an Blomquist: Gute Infos!!! Danke!

Gruß
winetrader

[winetrader]

Company Press Release
SOURCE: Transkaryotic Therapies, Inc.
TKT Submits Biologics License Application for Replagal(TM) to Treat Fabry Disease
CAMBRIDGE, Mass., June 16 /PRNewswire/ -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX - news) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval of Replagal(TM) (agalsidase alfa), its enzyme replacement therapy for the treatment of Fabry disease. If approved by the FDA, Replagal(TM) would represent the first treatment option available to patients with Fabry disease. TKT also plans to submit a Marketing Authorization Application (MAA) for Replagal(TM) to the European Medicines Evaluation Agency in the second half of 2000.

``Today marks an important achievement for TKT and underscores our commitment to develop innovative enzyme replacement therapies. This is the first in what I hope will be a series of regulatory filings for products to treat a variety of rare disorders,`` said Richard F Selden, M.D., Ph.D., President and Chief Executive Officer of TKT. ``My colleagues and I are gratified that through our clinical program we have had the opportunity to make an impact on the lives of those afflicted with Fabry disease.``

The submission of TKT`s BLA for the treatment of Fabry disease is based on clinical data from two independent trials conducted at the National Institutes of Health (NIH) and Royal Free Hospital in the United Kingdom. TKT`s BLA also includes long-term data from twenty-five patients treated for approximately one-year as part of a maintenance study at the NIH. Approximately 50 patients with Fabry disease have been treated with Replagal(TM) enzyme replacement therapy in TKT`s clinical development program. TKT has received both Fast Track and Orphan Drug designation for Replagal(TM).

Twenty-six patients with Fabry disease participated in the 24-week, randomized, double-blind, placebo-controlled study at the NIH. All twenty-five patients who completed the study at the NIH elected to receive Replagal(TM) as part of a maintenance study, and many of these patients have been on therapy for one year or longer. Fifteen patients with Fabry disease participated in the 24-week, randomized, double-blind, placebo controlled study conducted at the Royal Free Hospital. Fourteen of the fifteen patients participating in the U.K. study remain on therapy as part of an ongoing maintenance study. In both studies, patients received either Replagal(TM) or placebo by intravenous infusion every two weeks. Data from these studies will be presented at major medical meetings this year.

Fabry disease is an inherited rare genetic disorder caused by deficient activity of the lysosomal enzyme alpha-galactosidase A. In Fabry disease, ceramidetrihexoside (CTH) accumulates in various organs and tissues of the body due to the deficiency of alpha-galactosidase A. The deposits of this material can result in extreme pain, serious renal and cardiovascular disease, and stroke. Currently, affected individuals have a significantly reduced quality of life and a greatly shortened life expectancy.

Transkaryotic Therapies, Inc. (TKT) is a biopharmaceutical company dedicated to the development and commercialization of products based on its three proprietary development platforms: Gene-Activated(TM) proteins, Niche Protein(TM) products, and Gene Therapy. The Company`s gene activation technology is a proprietary approach to the large-scale production of therapeutic proteins, which does not require the cloning of genes and their subsequent insertion into non-human cell lines. TKT`s Niche Protein product platform is based on protein replacement for the treatment of rare genetic diseases, a group of disorders characterized by the absence of certain metabolic enzymes. The Company`s Gene Therapy technology, known as Transkaryotic Therapy(TM), is focused on the commercialization of non-viral, ex vivo gene therapy products for the long-term treatment of chronic protein deficiency states.

This press release contains forward-looking statements that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward- looking statements. Without limiting the foregoing, the words, ``believes,`` ``anticipates,`` ``plans,`` ``expects,`` ``intends,`` and similar expressions are intended to identify forward-looking statements. Important factors that could cause actual results to differ materially from the expectations described in these forward-looking statements are set forth under the caption ``Certain Factors That May Affect Future Results`` in the Company`s Annual Report on Form 10-K for the year ended December 31, 1999 which is on file with the Securities and Exchange Commission and incorporated herein by reference. These important factors include risks as to whether TKT`s products will advance in the clinical trials process, the timing of such clinical trials, whether the clinical trial results will warrant continued product development, and, in particular with this release, whether the Company`s products will receive approval from the U.S. Food and Drug Administration or equivalent regulatory agencies, and, if such products receive approval, whether they will be successfully marketed; the results of any patent litigation in which the Company is involved or may become involved; competition; and the Company`s dependence on collaborators.

Gene-Activated(TM), Niche Protein(TM), Replagal(TM), TKT(TM), and Transkaryotic Therapy(TM) are trademarks of Transkaryotic Therapies, Inc.

Please visit our web site at www.tktx.com for additional information about Transkaryotic Therapies, Inc.

[IWA Japan]

@winetrader: Dein PRinzip ist verständlich, aber ich warte solche Unsicherheiten meist ab, da ich bei so etwas schon zu oft "Glück" hatte!

[gholzbauer]

Heute gibts was auf die Mütze! Der Artikel ist aber schwammig, welche "defenses" sind gemeint? Der Kurs geht auf Tauchstation, 28$ nur noch.
Kann sich zwar schnell wieder ändern, doch die Nervösen verlassen das Boot.

Amgen Wins Preliminary Ruling in Transkaryotic Patent Fight
By Anna Marie Stolley and Kerry Dooley

Boston, July 21 (Bloomberg) -- Amgen Inc. won a preliminary victory in its patent dispute with Transkaryotic Therapies Inc. over the best-selling anemia drug Epogen.

U.S. District Judge William Young limited Transkaryotic`s defenses to claims that it infringed Amgen`s patent for Epogen. The judge postponed until at least September a final ruling in the patent fight.

``My gut tells me that if there`s other evidence, I`d like to hear it,`` said Young. He has said he will hold further hearings in the case after Sept. 5.

Young reserved judgment on whether Transkaryotic infringed Amgen`s patents. The judge has been trying the case without a jury since May.

Amgen shares rose 4 11/16, or 6.3 percent, to 78 3/4 in midday trading. Shares of Transkaryotic fell 5 5/8, or 16 percent, to 29 3/8.

At stake is an estimated $4 billion in annual U.S. sales for Epogen. Amgen developed a method for copying erythropoietin, which healthy kidneys make to stimulate red-blood cell production. The final product, Epogen, is given to kidney dialysis patients, who often become anemic.

Amgen contends that Transkaryotic and Aventis SA predecessor Hoechst Marion Roussel Inc. are infringing its patents by developing another version of erythropoietin.

The case, closely watched by patent attorneys, investors and drugmakers, could permit up-and-coming gene therapy companies such as Transkaryotic to more easily challenge the dominance of established pharmaceutical makers such as Amgen, patent experts say.

Amgen argues that Transkaryotic should not be allowed to capitalize on its success by misappropriating patented inventions.

Thousand Oaks, California-based Amgen, the world`s biggest biotechnology company, sued Cambridge, Massachusetts-based Transkaryotic in April 1997.

In addition to putting Epogen on the market, Amgen licenses the drug to Johnson & Johnson, which sells it in the U.S. as Procrit for anemia stemming from causes other than kidney damage. In Europe, Johnson & Johnson sells the same drug as Eprex.

Transkaryotic has yet to put a drug on the market. It is also developing a drug for the rare metabolic disorder, Fabry disease.

[pollyanna]

Glaubt ihr wirklich ein Zwerg wie Transkaryotic ist in der Lage Amgen vom Markt zu verdrängen?
Ganz zu schweigen von Hoffman La Roche, die auch einen hohen Marktanteil bei EPO haben.

Und was bedeutet der Gewinn des Rechtsstreits langfristig?
Was heißt denn Genaktivierung? Nur eigene Gene können angeschaltet werden.
Wieviel Krankheiten gibt es denn die durch fehlende eigene Proteine entstehen?
Das sind doch alles Nischenkrankheiten.

Ich lasse mich gerne eines besseren belehren.

Gruß pollyanna

[puhvogel]

gholzbauer: Unter defenses verstehe ich Klageeinwände.
Da geht es wohl um juristische Tricks/Mittel, mit denen die Klage von Amgen abgeschwächt werden sollte. Diese Einwände wurde vom Richter nun abgewiesen.
In Amerika hat man es vor Gerichten als "Kleiner" oft besser als "Großer". Da gibt es Anwaltsbüros , die spezialisieren sich auf solche Fälle, denn von den großen kann man mehr Geld erbeuten als von den kleine Firmen/Leuten
Der Puhvogel

[gholzbauer]

Hallo puhvogel,
mir gings nicht um die Übersetzung von defenses, sondern darum, daß TKTX deren mehrere in den Prozeß eingebracht hat, daß davon sicherlich einige auf schwachen Füßen standen und zu erwarten war, daß die schwächsten ausgeschlossen werden würden. D.h. diese Beschränkung war zu erwarten und die Kursreaktion könnte überzogen sein. Ich versuche nur herauszufinden, wie die bzw. welche der verschiedenen "defenses" beschränkt wurden.
@ pollyanna, TKTX arbeitet mit Aventis zusammen, und das ist sicher kein Zwerg. Dennoch denke ich, daß der Richter und die Prozeßbeteiligten sich eventuell mehr auf die Seite Amgens schlagen könnten, weil dieser Prozeß die Grundlagen des Biotech-Patentrechts berührt und eine Einflußnahme von politischer Seite oder von Interessengruppen nicht ausgeschlossen werden kann, auch wenn das in der Öffentlichkeit stets dementiert werden wird.

[winetrader]

Hallo an alle,

selbstverständlich war auch meine Wenigkeit über den Kursverlauf am Freitag enttäuscht bzw. geschockt. Was war passiert? Man geht gerade einmal ein paar Tage geschäftlich außer Haus und dann so was!
Nachfolgend ein (englischer ) Text, der etwas Aufschluß bringt.
Nachdem ich dies laß war meine Welt wieder in Ordnung.
Ich stelle diesen Text jetzt einfach mal hier rein und hoffe somit eine informative Diskussion angeregt zu haben. Wer Fragen zur Übersetzung hat kann ruhig fragen. Mir ist bekannt, daß nicht jeder hier im board mit solchen Texten umgehen kann, aber leider habe ich nicht die Zeit eine vollständige Übersetzung vorlegen zu können.
----------------------------------------------------------------------
Transkaryotic takes a hit in its patent trial

Judge, seeking more evidence, stops short of ruling in Amgen`s favor

By Ronald Rosenberg, Globe Staff, 7/22/2000




US District Judge William Young yesterday narrowed the patent infringement trial between Amgen Inc. and Transkaryotic Therapies Inc. by weakening TKT`s argument that Amgen`s patents were invalid. Young ruled the Cambridge company failed to prove that the discoveries and prior inventions found in its rival`s patents were widely known.


The decision was hailed by some as a victory for Amgen. But Young stopped short of making any of the findings on patent infringement that Amgen sought.


``My gut tells me that if there`s other evidence, I`d like to hear it,`` said Young, who will reconvene the trial next Friday and may recess the case until Sept. 5 when Amgen continues its rebuttal arguments.


Investors reacted to the judge`s comments by boosting Amgen shares, which hit a 52-week high closing at $78, up $3.9375, while TKT shares fell $3.875 to $31.125 on heavy volume.


The widely followed case has spotlighted the strength and breadth of biotech patents.


At issue is whether TKT is infringing on three key Amgen patents for erythropoietin, the biggest-selling biotech drug - $4 billion in US sales last year - that is universally used to stimulate red blood cell production. Amgen, of Thousand Oaks, Calif., markets the drug under the brand name Epogen, primarily to treat anemia for kidney dialysis patients. The drug is made by cloning a human gene and splicing it into Chinese hamster ovary cells.


TKT claims it has developed EPO using ``gene activation`` technology, which turns on a ``switch`` inside human cells that activates the dormant gene responsible for making EPO.


Amgen maintains TKT is violating its patents, which TKT said are overly broad, invalid, and were obtained fraudulently.


Yesterday, Young presented his views using a whiteboard drawing with a big circle and two smaller nonoverlapping circles to illustrate how he is grappling with whether a commonality exists between Amgen`s use of animal cells to make EPO and TKT`s approach using human cells.


``He is asking whether Amgen`s EPO patents teach how to make EPO using human cells, and if they do there is infringement by TKT, but for the moment he is not sure of this,`` said Kathy Williams, cochairperson of the patent law practice of Palmer & Dodge, who has been attending the trial.


Yesterday some courtroom observers and Wall Street analysts said Young`s ruling weakened TKT`s case, but all agreed the small company has plenty of other defenses.


``The case is still wide open, although the odds still favor Amgen,`` said Elise Wang, PaineWebber`s senior biotechnology analyst. ``Based on the things the judge has said and the way he has led the discussions with witnesses, there is a sense that he is leaning more to Amgen`s side of things. But until he makes a final ruling, it is still tough to handicap.``


But attorney Williams said Young`s ruling did not impact TKT`s infringement and validity claims. She said Young has taken a conservative approach, throwing out two of TKT`s weakest issues - prior inventions and anticipation that others in the scientific field knew of the technology.


``This is not a big victory for Amgen,`` said Williams. Young ``wants to hear more evidence before he makes final decisions on validity and infringement, and that includes hearing witnesses from the US Patent Office and from Amgen.``


TKT claims Amgen committed fraud on the Patent Office and, in an unusual move, the firm plans to call Michael Boren, Amgen`s inside patent counsel, who in the 1980s drafted the company`s patents. His revisions of the early drafts of Amgen`s patents, particularly on the use of the term ``human EPO,`` and the role of the Patent Office will be questioned.


``TKT has gotten the judge to think about the right issues,`` said Dr. Jonas Alsenas, a former ING Baring biotechnology analyst who is now portfolio manager at ING Furman Selz Asset Management Co. Alsenas believes TKT will prevail in the trial.


This story ran on page C01 of the Boston Globe on 7/22/2000.
© Copyright 2000 Globe Newspaper Company

[Braininvestor]

Hallo TKTX-ler!

Gehen im Moment wieder auf Tauchstation,so ich verstanden habe wg.eines möglichen Patentstreites mit Genzyme um das Medikament gegen Fabry dissease.Aber Prozesse ersetzen in den USA oftmals den Wettbewerb, besondersw in der Biotechbranche ist das mehr als üblich, weil es da um richtig viel Geld geht.

EIN BESONDERES HALLO AN ****GHOLZBAUER***
Ich bin es Jenszocker vom Consorsboard (das ist dort im Moment einfach nur schlecht=> plappern alle nur die B.F.-Tipps nach und heitern das Board mit Fragen : Wo finde ich den Biotechindex?)

Sollte die Zulasung des EPO-Medikaments erfolgen und der Prozeß in den USA verloren werden, so bleibt doch immer noch der europäische Markt für TKTX übrig, oder Gholzbauer???

BB biotech hat eine große Position in TKTX (ca 7-8%) und die haben ein feines Näßchen für die Megabranche.

Hast du deine TKTX noch Ghlozbauer, ich bleibe drin, kann doch nur noch aufwärts gehen oder??

Außerdem erscheint mir die Plaatformtechnologie von TKTX als sehr interesssant. Na bis dann!

Jenszocker alias Braininvestor

[winetrader]

Hallo an alle,
Hallo an Braininvestor,

nachfolgend der dazugehörige Text: Besonderes Interesse für TKTX besteht leider nicht. Auch mit dem oben von mir dargestellten Text scheinen die meisten nichts anfangen zu können. Zwar rückt dieser Bericht aus Bosten (!) den Prozess in ein korrekteres Licht, aber keiner versteht ihn. Davon muß ich ausgehen, denn bisher kam keine Antwort. Ich hoffe dieser Text kann besser verstanden werden.
----------------------------------------------------------------------
TKT Announces Patent Infringement Suit by Genzyme Relating to Replagal(TM)
CAMBRIDGE, Mass., July 25 /PRNewswire/ -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX - news) today announced that Genzyme Corporation has brought suit against TKT in the United States District Court of Delaware in Wilmington claiming that TKT`s activities relating to Replagal(TM) (agalsidase alfa) infringe one or more claims of U.S. Patent No. 5,356,804. Replagal(TM) is TKT`s investigational enzyme replacement therapy for the treatment of Fabry disease. TKT was the first company to conduct human clinical testing for this disorder and submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration seeking marketing approval of Replagal(TM) on June 16, 2000.


(DIESEN TEXT SOLLTE MAN SICH BESONDERS GENAU ANSCHAUEN!!!!!)

Richard F Selden, M.D., Ph.D., President and Chief Executive Officer of TKT stated, ``We strongly believe that TKT`s activities relating to Replagal(TM) do not infringe the `804 patent, and, in addition, that the patent is not valid. We intend to vigorously defend this lawsuit and expect to prevail. It is a shame that Genzyme has chosen to compete based on a frivolous lawsuit rather than on the merits of their products. Furthermore, with over 5,000 rare diseases affecting 20 million Americans, Genzyme is clearly wasting resources that could be better allocated toward helping patients.``

Transkaryotic Therapies, Inc. (TKT) is a biopharmaceutical company dedicated to the development and commercialization of products based on its three proprietary development platforms: Gene-Activated(TM) proteins, Niche Protein(TM) products, and Gene Therapy. The Company`s gene activation technology is a proprietary approach to the large-scale production of therapeutic proteins, which does not require the cloning of genes and their subsequent insertion into non-human cell lines. TKT`s Niche Protein product platform is based on protein replacement for the treatment of rare genetic diseases, a group of disorders characterized by the absence of certain metabolic enzymes. The Company`s Gene Therapy technology, known as Transkaryotic Therapy(TM), is focused on the commercialization of non-viral, ex vivo gene therapy products for the long-term treatment of chronic protein deficiency states.

This press release contains forward-looking statements that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward- looking statements. Without limiting the foregoing, the words, ``believes,`` ``anticipates,`` ``plans,`` ``expects,`` ``intends,`` and similar expressions are intended to identify forward-looking statements. Important factors that could cause actual results to differ materially from the expectations described in these forward-looking statements are set forth under the caption ``Certain Factors That May Affect Future Results`` in the Company`s Annual Report on Form 10-K for the year ended December 31, 1999 which is on file with the Securities and Exchange Commission and incorporated herein by reference. These important factors include risks as to whether TKT`s products will advance in the clinical trials process, the timing of such clinical trials, whether the clinical trial results will warrant continued product development, and whether the Company`s products will receive approval from the U.S. Food and Drug Administration or equivalent regulatory agencies, and, if such products receive approval, whether they will be successfully marketed; the results of any patent litigation in which the Company is involved or may become involved; competition; and the Company`s dependence on collaborators.

Gene-Activated(TM), Niche Protein(TM), Replagal(TM), TKT(TM), and Transkaryotic Therapy(TM) are trademarks of Transkaryotic Therapies, Inc. Please visit our web site at www.tktx.com for additional information about Transkaryotic Therapies, Inc.


CONTACT:
Justine E. Koenigsberg
Manager, Corporate Communications
[phone]

SOURCE: Transkaryotic Therapies, Inc.

[gholzbauer]

Daß GENZ gegen TKTX klagt, ist mir neu. Ich halte beide Werte, hoffe aber, daß TKTX sich durchsetzt, da GENZ bereits profitabel ist und diese Umsätze nicht unbedingt braucht, für TKTX wäre jedoch damit die Profitabilität schneller zu erreichen.

Hallo Braininvestor/Jenszocker,
mich nervt das Anemos-Board gewaltig!
Immer noch long TKTX, klar. Hast Du den Artikel im Aktionär Nr. 30/2000 über TKTX gelesen? Bombenschlecht! Kein Hinweis auf die verschiedenen Patentsituationen in USA und Europa, und bei den Nischenprodukten schreiben sie über ein Hunter-Medikament in der präklin. Phase, während das Fabry-Medikament womöglich kurz vor der Zulassung steht! Einfach lächerlich! Ich bin durch BBBiotech auf TKTX gestoßen (wie auch auf Aurora, CV Therapeutics und Ariad), und bei BBBiotech ist man immer noch zuversichtlich, was den US-Prozeß angeht. Europa gilt als klar für Aventis und TKTX. Hoffentlich kommts auch so. Wenn nicht, haben wir noch die Basispatente, in der Tat interessant, aber sehr langfristig!
Grüße, gholzbauer.

[gholzbauer]

Dow Jones Newswires
Amgen Patent Trial Recesses After Round Of Questioning
By BETH M. MANTZ

Of DOW JONES NEWSWIRES

BOSTON -- The patent infringement trial between Amgen Inc. (AMGN) and defendants Transkaryotic Therapies Inc. (TKTX) and Aventis SA (AVE) grounded to a halt Monday morning after the defendants questioned witness Dr. Joseph Eschbach of the Northwest Kidney Center in Seattle.

Although the trial hasn`t ended, the court has recessed until early September. At that time, the defendants will call their last two witnesses to try to prove that Amgen`s patents for its anemia drug Epogen are invalid and that Amgen secured the patents through improper methods.

U.S. District Court Judge William Young has a lot of information to sift through, including the testimony of Eschbach, a nephrologist and lead investigator of Amgen`s clinical trials of Epogen, which began in 1985.

Amgen called Eschbach to refute the earlier statements of Dr. Allan Erslev, a witness for the defendants.

Eschbach said other scientists` research prior to the filing of Amgen`s patents on its recombinant erythropoietin drug demonstrated only biological activity, not therapeutic effect.

Eshbach said erythropoietin`s biological response is determined by an increase in reticulocyte count - the number of immature red blood cells in a volume of blood - and an increase in iron activity in the blood. He said therapeutic effect is determined by an increased level of hematocrits - mature red blood cells in a volume of blood - and how the patient feels.

While many physicians consider an increase in reticulocytes necessary for correcting anemia, simply obtaining an increase in reticulocytes after administering an erythropoietin drug isn`t enough to bring about a therapeutic effect, according to Eschbach. But such an effect is more likely with a sustained rise in reticulocytes, he added.

In June, Erslev testified that a boosted reticulocyte count was the equivalent of a therapeutic effect. Erslev, a medical professor at Thomas Jefferson Medical College in Philadelphia, first uncovered erythropoietin`s ability to stimulate the production of red blood cells.

Eschbach`s testimony referred to an experiment conducted by Eugene Goldwasser, who tested erythropoietin purified from human urine in three patients. The experiment didn`t elicit a sufficient therapeutic benefit, but did boost reticulocytes. The witness considered Goldwasser`s test a failure because it didn`t show an increase in mature red blood cells and deemed the biological response not statistically significant.

On cross examination, Transkaryotic and Aventis began to chip away at Eschbach`s answers by bringing the courtroom`s attention back to the heart of this case: Amgen`s patents.

The defendants directed the witness to patent No. 5,547,933, which lists increased reticulocyte count, a rise in hematocrits levels and other results in its description of therapeutic effect. The patent doesn`t refer to or define biological activity.

The patent also doesn`t require all of the effects to occur for therapeutic levels to be achieved, nor does it rank them in a hierarchy. Moreover, the patent doesn`t make Eschbach`s distinctions, attorneys pointed out.

While acknowledging the patent`s lack of clarity, Eschbach tried to limit the impact from that acknowledgement by asserting that a scientific expert at the time of the patent filings would know the difference. That would mean, he contended, that it was unnecessary for the patent to include such an explanation.

Courtroom observers applauded Transkaryotic`s and Aventis` strategy to focus on the patents themselves.

Noting that Eschbach "made a good witness and would not back down or let himself be taken out of context," regular trial attendee Kathleen Williams, a biotech patent attorney for Palmer & Dodge LLP in Boston, said, "the question is how does the patent define therapeutic efficacy - that is what is relevant."

After Eschbach stepped down from the stand, Judge Young made clear that the trial isn`t closed to new evidence, and noted that Amgen has the right to counter issues raised by the defendants` remaining witnesses when they are questioned in early September.

-Beth M. Mantz; Dow Jones Newswires; 201-938-5287

[gholzbauer]

Hallo IWA
Dein 3Sat-Konkurrenzdepot ist geradezu obszön konservativ. :-)
gholzbauer

[IWA Japan]

Hallo gholzbauer,
sehr richtig.

Grund: warte erstmal ab, was aber womöglich auch falsch sein kann

[IWA Japan]

habe ich mich in den Regeln geirrt. Muss man nicht von Beginn an dabei sein, nachträgliches einsteigne ist doch nicht mehr zulässig?

[gholzbauer]

Ich habe am Freitag das Abschicken der Orders vor 12 Uhr verpaßt. Um 12.11 Uhr fiel es mir ein ...
Da werd ich jetzt wohl mit Regelverstoß dabeisein, verd...
Vielen anderen erging es scheinbar auch so.
Heute wollte ich Orders geben, da sie aber scheinbar erst ab Freitag gültig werden, warte ich noch bis Do oder Fr, um die Limits dann zu setzen.
Wer zu spät kommt, blablabla.

gholzbauer

[IWA Japan]

wie gesagt, hab 1. auch die Uhrzeit vergessen und da ich vormittags arbeiten müsste, konnt ich nur noch Don Abend machen,
2. hab ich ganz vergessen mir was zu überlegen und auf die Schnelle ist mir nix besseres eingefallen

[RCZ]

!

Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an [e-mail]

[winetrader]

Hallo an alle,

die Zuschauer im Gerichtssaal haben zur Strategie, bzw. zum Kreuzverhör von TKTX applaudiert!!!
Das muß man sich auf der Zunge zergehen lassen.
Und im September kommen zwei Zeugen von TKTX.
Wenn das nicht gut aussieht, dann fress ich einen Besen!
Da wächst ein weiterer "big player" heran!

winetrader

[gholzbauer]

Mit "Applaudieren" ist wohl nicht gerade Klatschen im Gerichtssaal gemeint, sondern positive Kommentare.
Weiß jemand, ob BBBiotech sich zum Stand der Dinge geäußert hat?

gholzbauer

[winetrader]

Vielleicht war mit "applaudieren" nur bildlich gesprochen worden. Dennoch inhaltlich doch das gleiche.
Ich möchte deine Frage erweitern:
"Wie verhält sich der Pictet Biotechfond, der eine hervorragende Researcharbeit leistet?"
(Mir gefällt nicht der Strukturaufbau von BB Biotech!)
Ich glaube auch der Lacuna Biotechfond hat TKTX im Depot.

Gruß
winetrader

[gholzbauer]

Ich frage mich, ob die BRL/LLY/Prozac-Geschichte ein Omen für TKTX/AMGN ist.
Der Nachahmer setzt sich gegen den Original-Hersteller durch.
Der Kurssprung bei TKTX könnte noch größer ausfallen als bei BRL.
Und AMGN ginge a la LLY auf Tauchstation.
Eine Entscheidung zu Gunsten TKTX könnte allerdings für den restlichen Biotechmarkt ein bitterer Tag werden, da AMGN unbestritten der Leithammel ist.
Hmmmmm?

[IWA Japan]

!

Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an [e-mail]

[Division2]

Für die Leute die es interessiert.

Der TD-Letter von dieser Woche hat folgende Themen:

- Transkaryotic Therapies
- teamwork information managment AG
- November AG-Update


Nachzulesen unter: http://www.trading-division.de


Gruß
Division2

[Pariah]

@Division2
Danke für den Tip.Bin erst heute auf TKTX aufmerksam geworden. Dieser Thread hat mir wirklich weitergeholfen. Mal sehen, was ich sonst noch so finden werde. Übrigens:BB Biotech ist äußerst zuversichtlich, was den weiteren Verlauf der Klage angeht.

THANXXX
Pariah

[winetrader]

Hallo,

im September letzte Zeugenanhörung. Danach kann es aber nochmals einige Woche hinziehen bis das Urteil gefällt ist. Diese Bedenkzeit räumte judge Young schon ein.
Spannender als ein Krimi! Schade, daß keine Biologen die Thematik des Prozesses im deutschsprachigen Raum datailierter diskutieren. Oder weiß jemand wo diese Thematik deutschsprachig "zerpflückt" wird?

Gruß
winetrader

[gholzbauer]

Die Dinge spitzen sich zu.
Nicht vergessen: wird der Prozeß verloren, geht TKTX stark nach unten (evtl. mit Optionen absichern!), aber 2001 steht die Zulassungs-Entscheidung in Europa an. Hier ist die Zulassung wahrscheinlicher als in den USA.


U.S. Options-Transkaryotic vols pop, volume up
CHICAGO, Sept. 1 (Reuters) - Implied volatility nearly doubled and volume rose on Friday in pre-holiday trading in options on biopharmaceutical company Transkaryotic Therapies Inc. (NASDAQ: TKTX) as the stock lost ground.

Implied vols for the near-the-money options popped upward to around 265 percent, nearly twice Thursday`s 135 percent closing level. The stock`s one-month historical volatility stood at roughly 81 percent.

"It`s (implied volatility) probably up almost 100 (vol points) from yesterday," said a designated primary market maker with TradeNet at the Chicago Board Options Exchange. "We`ve seen some buying of premium in September."

He said traders the last couple of days have bought September 45 and 50 calls, but he also saw buyers of puts at lower strikes as well.

The DPM said the increased options activity suggested the market expects a "significant" move in the stock in either direction as it weighs the potential for a resolution soon in the patent infringement trial between Amgen Inc. (NASDAQ: AMGN) and Transkaryotic over Amgen`s Epogen anemia drug.

The trial recessed on July 31 and is expected to resume on Sept. 5 at the earliest.

Amgen sued TKT in 1997 seeking to defend its patents covering the making and selling of Epogen, a drug that uses erythropoietin to boost red blood cells and combat anemia.

Options volume also increased by late Friday morning to its highest level in at least one trading month, with some 935 calls and 170 puts already traded on the CBOE and American Stock Exchange combined.

That compared to an average daily turnover during the last month of about 190 contract options contracts.

Stock of Massachusetts-based Transkaryotic had risen since early August, when it hovered in the upper-$20 area.

At 11:40 a.m. CDT (1640 GMT) on Friday, the stock was down 4 at 39-3/8 on Nasdaq market volume of 200,500 shares.

[winetrader]

So langsam geht es wieder los!!!!


U.S. Options-Transkaryotic vols pop, volume up
CHICAGO, Sept. 1 (Reuters) - Implied volatility nearly doubled and volume rose on Friday in pre-holiday trading in options on biopharmaceutical company Transkaryotic Therapies Inc. (NasdaqNM:TKTX - news) as the stock lost ground.

Implied vols for the near-the-money options popped upward to around 265 percent, nearly twice Thursday`s 135 percent closing level. The stock`s one-month historical volatility stood at roughly 81 percent.

``It`s (implied volatility) probably up almost 100 (vol points) from yesterday,`` said a designated primary market maker with TradeNet at the Chicago Board Options Exchange. ``We`ve seen some buying of premium in September.``

He said traders the last couple of days have bought September 45 and 50 calls, but he also saw buyers of puts at lower strikes as well.

The DPM said the increased options activity suggested the market expects a ``significant`` move in the stock in either direction as it weighs the potential for a resolution soon in the patent infringement trial between Amgen Inc. (NasdaqNM:AMGN - news) and Transkaryotic over Amgen`s Epogen anaemia drug.

The trial recessed on July 31 and is expected to resume on Sept. 5 at the earliest.

Amgen sued TKT in 1997 seeking to defend its patents covering the making and selling of Epogen, a drug that uses erythropoietin to boost red blood cells and combat anaemia.

Options volume also increased by late Friday morning to its highest level in at least one trading month, with some 935 calls and 170 puts already traded on the CBOE and American Stock Exchange combined.

That compared to an average daily turnover during the last month of about 190 contract options contracts.

Stock of Massachusetts-based Transkaryotic had risen since early August, when it hovered in the upper-$20 area.

At 11:40 a.m. CDT (1640 GMT) on Friday, the stock was down 4 at 39-3/8 on Nasdaq market volume of 200,500 shares.

[RCZ]

TRANSKARYOTIC THERAPIES 893735100
NAS TKTX.NAS 49,50 10,25 Mio. +7,625 (+18,21%) 06.09.
20:20

(irgendeiner muß es ja tun, wenn IWA seine Smilies nicht postet)

[RCZ]

[image2000]

Boston, Sept. 6 (Bloomberg) -- An Amgen Inc. lawyer testified before a federal judge today that the company`s application for a patent covering its top-selling anemia drug Epogen was based on the ``best information`` available at the time.

Michael Borun, under questioning by an attorney for rival drugmaker Transkaryotic Therapies Inc., denied knowingly providing patent examiners with false information.

``It`s not false,`` Borun testified, in a testy exchange with Transkaryotic`s lawyer, Herbert Scwartz. ``It`s the information we had at the time.``

Amgen, the world`s largest biotechnology company, is suing to block Transkaryotic from selling its own version of Epogen, a drug used to stimulate red-blood cell production in kidney dialysis patients who become anemic. The drug is a form of the human protein erythropoietin.

Transkaryotic contends Amgen`s patents on Epogen should not be enforced because they were obtained through what`s legally known as inequitable conduct, by intentionally withholding highly material information. This argument is among the key defenses that Transkaryotic has raised in response to Amgen`s patent- infringement allegations.

Borun, an outside patent lawyer for Amgen who helped prepare the company`s applications for patents on Epogen, testified via a television hook-up before U.S. District Judge William Young, who will decide the case. Borun lives in the Chicago area and was unavailable to fly to Boston to testify in person. Cambridge, Massachusetts-based Transkaryotic is expected to present its final defense witnesses tomorrow, with closing arguments to follow.

[winetrader]

Guten Morgen an alle,

das sieht immer besser aus. Heute ist nochmal TKTX dran. Meines Wissens nach dürfte das auch nochmal interessant werden. Dann wird Judge Young eine Entscheidung zu finden haben. Das kann aber u. U. nochmals einige Wochen dauern. Wenn TKTX wirklich gewinnt, dann ...

winetrader

[gholzbauer]

AMGN: der Kaiser ohne Kleider!

[jumanii]

Guten Tag,

eine frage an IWA Japan u. gholzbauer. Euere Meinung zu GLGC mit den gestrigen Rating
von 40$ würde mich Interssieren! Danke im voraus

mfg

[gholzbauer]

MotleyFool.com - Fool Plate Special
Amgen Blood Feud Nears End
By Tom Jacobs

After three years, biopharmaceutical giant Amgen`s (Nasdaq: AMGN - news) highly publicized patent case against gene therapy pioneer Transkaryotic Therapies (Nasdaq: TKTX - news) may end this week. This grudge match over $4 billion-a-year drug Epogen accuses Transkaryotic of patent infringement. Widely billed as a make-or-break case for each company, it`s a speed bump for Amgen, but a likely roadblock for Transkaryotic.

What`s the dispute?
Amgen`s Epogen is a protein that boosts red blood cells and combats anemia in dialysis patients. Amgen inserts a cloned gene into hamster ovaries (now there`s a delicacy!), which grow the protein. Transkaryotic`s proprietary gene therapy method is different: It delivers a DNA sequence into a human cell so that the body produces its own protein.

Amgen maintains that its patents cover any use of the Epogen protein for dialysis-related anemia, regardless of the manufacturing method. This is the remaining key defense in the trial for Transkaryotic and its partner, Aventis (NYSE: AVE - news): If Amgen`s patents don`t describe the human production method, then Transkaryotic hasn`t infringed on them. At stake could be Epogen`s $4 billion in annual revenues, currently split almost 50-50 between Amgen and Drip Port holding Johnson & Johnson (NYSE: JNJ - news), which licenses and sells Epogen under other names in Europe and in the U.S. for non-dialysis-related uses.

Risks for Amgen
A victory for either company promises obvious benefits: Either Amgen vanquishes a competitor for the remaining six years of its Epogen patent protection, or Transkaryotic scores a potentially huge new revenue stream. But a loss will likely harm Amgen only in the short term: Epogen may still beat Transkaryotic`s version on price, and Amgen is developing NESP, a once-a-week version of Epogen, that could conquer anybody`s two-to-three times a week version.

This chart shows that the market either favors Amgen`s chances of victory or predicts less harm from a loss. Since the trial started in March, Transkaryotic`s stock is down sharply and is unchanged from three years ago, while Amgen flirts with all-time highs.

Risks for Transkaryotic
Is the market right about risks for Transkaryotic? Yep, if a loss means that only the patent holder itself could take advantage of biotech advances in gene therapy for a patented drug. Then Transkaryotic and its colleagues would face a future as niche players -- selling proprietary gene therapy technology to existing patent holders -- unless Transkaryotic and others can discover or license their own protein drugs.

Transkaryotic could also apply its technology to successful drugs after their patent protection runs out. In the Epogen case, Transkaryotic might not even lose the whole banana, because some argue that European coverage for the Epogen protein patents does not include Transkaryotic`s product. So while defeat clearly lowers the ceiling for Transkaryotic investors, the company has $269 million in the bank, minuscule debt and a good chance at a future in a profitable niche -- despite Genzyme`s (Nasdaq: GENZ - news) new lawsuit against the company for another gene therapy drug.

Because a decision and likely appeal will delay any final result, Foolish investors must look beyond this case to the long term. They know that betting on a court`s decision is not the way to invest. Instead, they should examine the products in the companies` drug pipelines and the future for their business models. That always beats gazing at a legal crystal ball.


For more things Foolish, go to the The Motley Fool`s complete site! We aim to inform, educate and help you make good money, Fool. Also, check out the FoolMart, the place to shop for Foolish investing tools. Become a Fool for Motley Fool stock features, updates, contests, and product discounts!

[gholzbauer]

Playing the Biotech Games
By Lissa Morgenthaler
Special to TheStreet.com
9/6/00 5:03 PM ET





When it comes to games, the Olympics have nothing on the stock market.

I was in a group conversation with a doctor some years ago when we started in on the stock market. I don`t know what triggered it, but suddenly she said, "You play games" in tones full of contempt. I was just sitting there --- this broadside seemingly came out of nowhere. I could have responded, "Yes, and when you have a bad day, somebody dies."

But I didn`t. (Very nice of me.)

This is, incidentally, a lady who has made a lot of money from the stock market. But she may not understand the connection between the market and human health.

So what games are we playing today?

Hmmmm. Last week`s game was end-of-quarter markups for many mutual funds, and doublings of biotech IPOs that have come out of their quiet period. (August is the end of the quarter for mutual funds like ours that run on a November fiscal year, which many of them do. Whatever we hold that day is what will appear in our reports to shareholders. So when you see stocks squirt upward on the last day of November, February, May and August, remember what`s really going on. Nobody wants to be busted by Cramer!)

TSC`s Ian McDonald wrote a great piece Aug. 30 about the rash of new health care funds that have started in the past several months. (Judging by the number of calls I`ve been getting from recruiters, Ian`s numbers are low.) This is in the context of a biotech stock sector in which at least $10 billion in new funds has flowed into what was 350 public companies. Add in 50-plus IPOs in the past nine months --- 25 of them last month -- and you can see why the latest game has been to buy the IPO stocks when they come out of the quiet period (i.e., when analysts start publishing on them).

At least, that was the game. Now, because the sector`s hot and folks like Ben Holmes have been reminding people when quiet periods end, the game is to buy these biotech IPOs a few days in advance of the first reports. Under this heading, I had a very entertaining conversation with a top analyst last week. He told me which companies he would initiate coverage on this week when the quiet periods end. Not only that, his salesman later told me much the same thing.

Incredible.

If I may digress briefly, there was another little game last week that I didn`t understand at the time but would very much like to. Gabe Hoffman made a point in Columnist Conversation last Thursday about Protein Design Labs Inc.`s (PDLI:Nasdaq - news - boards) plunge: The recent 8-K and S-3 filings caused some analysts to lower their estimates. But for a stock with a $4 billion market cap to drop $17 in the last 1 1/2 hours of trading on Aug. 31 meant $675 million had to evaporate on a day when everything else in biotech was going up.

Protein Design Labs was virtually the only red on my screen that afternoon, and it was so red. (On nearly 4 million shares, I might add, which is more than double the normal daily volume for that stock.) Who wanted it out of their portfolio for the end of the quarter so badly that they were willing to tank it in such a fashion? As of the June filing, Fidelity had 4 million shares, Invesco had 2.7 million, etc. But I doubt they were the guilty parties. Alternatively, who wanted to make someone else look bad and therefore started a run on one of their target`s major holdings?

Dis one I don`t get. But I would like to.

Now, on to this week`s games.

Game One is the unwinding of last week`s silliness in marking up biotech stocks. Len Yaffe at Banc of America Securities (the former Montgomery Securities) tanked pharmaceuticals Tuesday when he pointed out that drug companies will have a tough time growing 10% this year. Len is a super guy and very funny, but he was pointing out the obvious here. Anyone who doesn`t know about the lack-of-growth crisis in pharma has been under a rock for the past several years. (Cramoo, why do you keep buying these lames when you can have much more fun in biotech?)

Meanwhile, Gore and Bush can be accused of piling on as they duke it out over who will be more generous on prescription-drug benefits. (How`s that for a mixed sports metaphor?) Bush may have outlined his little drug plan Tuesday, but it`s not like anyone didn`t know these two were going to hammer drug stocks this fall while whaling on each other. If the winner follows through, the net effect will be drug price controls. This should primarily affect drugs paid for by Medicare, which caters almost entirely to the over-65 crowd.

By contrast, biotech drugs are most often used by people in their 40s and 50s, are seldom reimbursed by Medicare and are therefore unlikely to get hit with price controls. Moreover, biotech has yet to sprout much in the way of generic versions of lifesaving drugs: For example, if you have cancer and you need Amgen`s (AMGN:Nasdaq - news - boards) Epogen at the moment, that`s pretty much your only option. But this privileged status hasn`t prevented biotech stocks from being sideswiped in this latest rout, dropping 8% in the past two days.

Moreover, the small but sovereign state of Maine recently implemented drug price controls, so everybody who sells anything drug-related is nervous about a social trend forming.

Or as my pappy the World War II captain says, "When they raid the house of ill reputie, they take the piano player, too."

Game Two this week is Amgen. Final witnesses are being heard or have been heard in Amgen`s patent-infringement case against Transkaryotic Therapies (TKTX:Nasdaq - news - boards) for that self-same drug Epogen, which is used to treat anemia. I`m in the small minority that thinks Transkaryotic will win, but I`m not putting big money on it. If Transkaryotic does win, the pro-Amgen types will say it doesn`t matter anyway because Amgen has a full pipeline coming onstream and its long-acting version of erythropoietin (NESP) is about to supersede Epogen anyway. Besides, Transkaryotic will appeal.

However, Amgen is 25% of the Nasdaq Biotech Index by weight --- and when Amgen hiccups, the IXB swoons. Moreover, this case is extremely important because pharmaceutical companies can come up with many variations on a drug, and thus generic drug companies flourish. But nature optimized each of the estimated 10,000 to 1 million proteins in your body. A "variation" on that protein`s structure generally won`t cut it. So there haven`t really been any generic biotech companies per se --- and this ruling could open the door to a flood of them.

This week`s final game may be the most immediate: the BioCentury/Carson Group conference. Coming this Thursday (Sept.7), it`s the first biotech financial conference of the fall season. It is especially fun because it`s not sponsored by a brokerage firm; hence, every sell-side analyst can attend.

At first glance, the conference looks harmless enough. But last year, this conference was the venue in which Genentech and Idec Pharmaceuticals (IDPH:Nasdaq - news - boards) let it be known that sales of their monoclonal antibody Rituxan were light. That revelation started a biotech sag that lasted until late October. This year, it may work in reverse. The stocks are conveniently tanking in advance.

As of last Friday, the AMEX Biotech Index (BTK) was up 100.78% year to date while the Nasdaq Biotech Index was up 56.55%. Which meant they were vulnerable to some well-deserved profit-taking. Any bad news that gets muttered at the conference has already been somewhat discounted, and any good news could turn these stocks around.

Incidentally, have you noticed that these two indices made one whopping round trip this year? (Much like the Internet stocks, which bottomed on April 13, 1998, and then proceeded to double over the succeeding months.) But the fact that the AMEX Biotech Index was up so much more than the Nasdaq Biotech Index makes it clear how narrow much of this advance has been. It`s only in the past two weeks that the Nasdaq index has really gotten off its haunches and started moving, as momentum shifted from New York Stock Exchange stocks back to the Nasdaq.

The final question for today is, are those double tops we see forming in the AMEX and IXB biotech indices? Or will biotech blast back up and through? I think the overwhelming number of medical and financial conferences this autumn, with the associated news flow they typically generate, will ultimately drive these stocks higher despite all the efforts of Bush and Gore combined.

But there is no doubt that a lot of big general funds were 9% in health care a year ago and are now 25% in health care. Upshot: They`re unlikely to allocate much more to the sector unless the economy goes down the toilet. And with $10 billion or more coming off lockup this fall, not to mention as many more biotech IPOs as investment bankers can jam out the door, I expect we`ll see a wee bit more supply than demand.

GBS, where are you when we need you?

[gholzbauer]

Amgen, TKT expected in U.S. patent trial Friday
By Christopher Noble

BOSTON, Sept 7 (Reuters) - Rival biotechnology firms Amgen Inc. and Transkaryotic Therapies Inc. (TKT), locked since May in a patent infringement trial over Amgen`s blockbuster anemia drug Epogen, rested their cases on Thursday ahead of closing arguments set for Friday.

After the arguments, with each side allotted one hour to sum up, U.S. District Court Judge William Young will retire for an undisclosed period of time before issuing his ruling in the widely watched case.

Young said he would move "expeditiously" but indicated the decision would take time because the case was so complex and far-reaching.

"It`s pretty clear to me that I am not going to decide this case from the bench tomorrow," he told the court. "I have a lot of work to do."

The trial has been closely watched because of its expected impact on patents in the biotech industry, which relies on strong enforcement to recoup the often enormous expense of developing a new drug.

Shares in the two firms have fluctuated during the course of the trial as investors reacted to preliminary rulings by the judge. In a typical example, TKT`s shares shot higher on Wednesday while Amgen`s fell. On Thursday, the share movements reversed, with TKT closing down $5-1/2 at $41-1/2 and Amgen`s finishing the day up $3-15/16 at $72.

Young`s ruling will determine whether Transkaryotic (NASDAQ: TKTX) can sell a drug that uses erythropoietin (EPO) to fight anemia by increasing red blood cell counts.

Amgen (NASDAQ: AMGN) makes Epogen by inserting a human gene into hamster cells which then produce EPO. TKT, whose EPO drug is called Dynepo, makes EPO without animals by inserting a promoter into human genes, which then stimulates the human cells to produce the substance.

Amgen sued TKT and Franco-German drug giant Aventis in 1997 for infringing five patents relating to Epogen. TKT, in its defense, has said that Amgen`s patents are invalid, overly broad and were obtained dishonestly.

The stakes are enormous. Epogen generated about $1.8 billion in sales for Amgen in 1999 and worldwide revenues were some $4 billion including sales through Amgen`s licensing partner Johnson & Johnson (NYSE: JNJ).

If Young rules for Amgen, it will reaffirm the strength of early biotech patents and delay the introduction of generic biological drugs for years, said one biotech analyst, who declined to be named.

Others played down the importance of such a decision, saying it would affect mostly older patents and in any case would not fundamentally alter the biotech patent landscape.

"At the end of the day this is a case that hinges on the specifics of the case at hand," said Eric Schmidt, an analyst with SG Cowen.

Some experts have taken the position that TKT, having introduced a genuinely new way of making EPO, should be allowed to proceed. But others counter that if TKT is rewarded for what is essentially an end run around Amgen`s production method, it will discourage costly original research.

If the judge decides in TKT`s favor, it would most directly affect the earliest biotech patents, which were much broader than most patents issued now.

"Amgen`s patents are old, among the first biotech patents," said the analyst who requested anonymity. "You just don`t get patents that broad anymore."

Schmidt said that despite his view, he expected the case to have a significant effect on the companies` share prices.

"Fundamentally, it means very little for the industry. There might be a handful of proteins affected," he said.

"But probably the perception, because this is such a focused case, could be worse than that and you could have a broader sell-off of the group,` he said.

[winetrader]

Hallo gholzbauer,

du beobachtest TKTX und bist im Goldboard zu finden. Sehr schön, gefällt mir!!! Scheinbar gleiche Gedanken?!
Wie siehst du die aktuelle Situation?
Die in deinem letzten Bericht gepostete news war für den Fall gestern und dein vorletztes posting für den Anstieg bei TKTX verantwortlich.
Verdammt große Unsicherheit im Markt. Es wird immer mehr Leuten bewußt welche Tragweit dieser Prozess haben kann.
Was wird heute Judge Young sagen?
Wann erwartest du das endgültige Urteil?
Bist du investiert? In AMGN? :-)
Ich frage mal und hoffe nicht zu direkt gewesen zu sein.

Gruß
winetrader

[MR. Montana]

bin noch nicht in tktx investiert, würde aber eigentlich sehr gerne rein.

die frage, die sich mir stellt ist folgende: wenn tktx den prozeß verliert, ist die aktie trotzdem ein kauf, ist sie
also auch im falle eines verlustes (proz.) ein strong buy? meines wissens nach bezieht sich der epo-streit doch nur auf
die usa, nicht aber auf europa?

wie stehen die chancen für einen vergleich? das wäre doch eigentlich auch schon für tktx sehr gut.

Meinungen erwünscht,

ciao,

Montana

[gholzbauer]

Ahoi winetrader,
ich bin in TKTX investiert, AMGN ist mir angesichts des großen Prozeß-Risikos zu teuer. Wenn AMGN gewinnt, wird der Effekt auf den Kurs nicht allzu groß sein, vielleicht ein 10$-Sprung, aber das dürfte es dann gewesen sein. TKTX dagegen hat bei einer entsprechenden Entscheidung ein mittelfristiges Potenzial von mehreren 100%. Nach GA-EPO werden noch andere, ähnliche Produkte ("GA-Neupogen" z.B.) folgen, wenn der Weg erst mal frei ist.
Wenn TKTX verliert, wird es wohl die erste Biotech-Aktie, bei der ich dann stärker in die Verlustzone geraten werde. Aber spätestens in der Nähe von 10$ (wenn es schlimm kommt) werde ich verbilligen, da das Fabry-Medikament und die anderen Nischen-Medikamente nicht uninteressant sind, ebenso die Grundpatente in der Gentherapie.
Und einen besonderen Joker im Ärmel hat TKTX noch, nämlich ein Basis-Patent auf transgene Mäuse, die von fast allen Biotechgesellschaften verwendet werden. Dieses Patent bekam TKTX erst vor ein paar Monaten zugesprochen und könnte evtl. dazu benutzt werden, sich an AMGN zu rächen ...

[winetrader]

Ja, das Rückschlagspotenzial bei negativem Ausgang für TKTX wird enorm sein. Aber nur kurzfristig. LAngfristige Anleger können eigentlich nichts verkehrt machen.
Eine neue, bessere Technolgie kann man nicht verhindern!!!
AMGNs Vorgehensweise ist ein Selbstschutz um Entwicklungskosten wieder rein zu holen. Das ist ja eigentlich verständlich!
Aber TKTX wird auch ohne den amerikanischen Markt seinen Weg gehen!!!
Sollte TKTX verlieren, und nach dem gestrigen Kursverlauf sehe immer noch TKTX-Vorteile, ergibt sich nochmals gute Nachkauf- bzw. Einstiegskurse!
Wie beurteilst du die aktuelle Situation? So aus deinem Bauch heraus!

Gruß
winetrader

[P.Bateman]

!

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[winetrader]

Man warte auf das Urteil von Judge Young.
Aufgrund der schwierigen Materie wird er eine entsprechende Zeit benötigen. Dies kann einige Tage, aber auch Wochen bedeuten. Das Urteil ist , unabhängig vom Kursverlauf der Aktien, noch völlig offen!! Biotechspezialisten sehen TKTX im Vorteil, die Analysten erkennen einen Vorteil für Amgen aus dem Verlauf des Prozesses. Analysten können ja, wir alle wissen (Alan Greenspan), sehr genau zwischen die Zeilen schauen.
Unten der letzte dazugehörige Pressebericht:
----------------------------------------------------------------------

Amgen, TKT drug patent trial ends, judge to rule later
By Christopher Noble

BOSTON, Sept 8 (Reuters) - Rival biotechnology firms Amgen Inc. and Transkaryotic Therapies Inc. summed up their cases on Friday, trading accusations of greed and dishonesty as the four-month patent infringement trial over Amgen`s blockbuster anaemia drug Epogen wound to a close.

``There is a common thread here, and that thread is greed,`` argued Herbert Schwartz, one of Transkaryotic`s (NasdaqNM:TKTX - news) lawyers.

Amgen (NasdaqNM:AMGN - news) was ``building a wall of patents to try to stop anyone from making any kind of EPO,`` said Schwartz.

EPO is the abbreviation for erythropoietin, the protein that is the active ingredient in Epogen, which fights anaemia by boosting red blood cell counts. TKT has made its own EPO drug, Dynepo, using a different method to make the protein.

U.S. District Judge William Young took the case under advisement. From the bench, he said he will rule expeditiously.

The case started in 1997 when Amgen sued TKT and Franco-German drug giant Aventis for infringing five patents covering Epogen. TKT has said that Amgen`s patents are invalid, overly broad and were obtained dishonestly.

The stakes are enormous. Epogen generated about $1.8 billion in sales for Amgen in 1999 and worldwide revenues were some $4 billion including sales through Amgen`s licensing partner Johnson & Johnson (NYSE:JNJ - news).

The case has been closely watched because strong patents allow biotech firms to recoup their often enormous financial outlays and secure backing from investors for future projects.

Shares in Amgen and TKT have fluctuated during the case according to the day-to-day ups and downs of the trial. On Friday, TKT was trading down $1-1/8 at $40-3/8, while Amgen was flat on the day at $72.

In his closing remarks, Amgen lead attorney Lloyd Day sought to draw Judge Young`s attention to precedents that supported his client, the world`s largest biotech company.

He asserted that Amgen`s patent claims were clear and that precedent showed Young must use them as the basis for his opinion.

``Look to the claim,`` he urged Young. ``If the claim is clear and unambiguous...you apply the claim as written,`` he said.

He accused TKT of taking material out of context to support its accusations. He argued TKT, the Cambridge, Mass.-based company, was the greedy party because it was trying to cash in on Amgen`s original work.

[JSK]

Sollte TKTX verlieren, gibt es einen kräftigen, aber nur kurzen Rückschlag. Diesen sollte man zum Einstieg nutzen. Auch ohne Epo hat TKTX genug in der Pipeline. Für alle Neueinsteiger ist ein negativer Ausgang des Verfahrens eine einmalige Chance... . That´s life ...

[gholzbauer]

something not completely different:
Ich bin gespannt, wie viele Olympiateilnehmer mit Epogen-Doping erwischt werden. Tests darauf sollen durchgeführt werden. Ich frage mich aber, wie man einen nur leicht über den Normalstand erhöhten Epogen-Level feststellen will.

[winetrader]

Einige Chinesen sind ja vorsorglich schon einmal zu Hause gebieben!

winetrader

[gholzbauer]

+10% trotz schwacher Nasdaq.
Aber keine News, seit Tagen unheimliche Stille.

[m.lynched]

Ich glaube der Kurs wird zur Zeit von Glücksrittern gemacht.

Zwei Meinungen aus einem US-Board:



By: wolfee $$$
Reply To: 145 by Rodhot $$$
Tuesday, 12 Sep 2000 at 8:47 PM EDT
Post # of 149

Rodhot.
My position is long. A small one. My style is shoot first and ask questions later. This isn`t an investment, it`s a lotto ticket.
The risk/reward betting on TKTX looks good enough to me to take a gamble.



By: Rodhot $$$
Reply To: 146 by wolfee $$$
Friday, 15 Sep 2000 at 4:55 PM EDT
Post # of 149

Wolfee,I can appreciate a portfolio having some high risk investments[lotto-tickets], but why are you choosing the long
side instead of the short side. I`ve been waiting until an announcement is made as to the date of a Court decision until
entering into the waters and in the interim am looking for as much information as possible to be better informed. You had
seemed to indicate that this is a no brainer and that TKTX would prevail, and quite honestly Ifound that contrary to what I
know at this time.
The closing arguments by Amngen were perceived by the investment community as being sufficient to protect their turf, but
I`m troubled by the premiums in the calls and puts as they indicate that the smart money is betting on a TKTX victory.
I`ve been investing soley on options for nearly ten years and have averaged about a 50% return per year, and it has come
about by doing good research and betting the smart money, and thats why I have deferred to you for whatever information
you have that supports your view, as I`m not comfortable about this one yet.
Goodfortunes.

[gholzbauer]

TKT Files Complaint Seeking Declaratory Judgment Against Genzyme
CAMBRIDGE, Mass., Sep 19, 2000 /PRNewswire via COMTEX/ -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX chart, msgs) today announced the Company has filed a complaint against Genzyme Corporation seeking declaratory judgments of patent non-infringement and invalidity in the U.S. District Court of Massachusetts in Boston. In the complaint, TKT asserted that the Company`s activities relating to Replagal(TM) (agalsidase alfa), an investigational enzyme replacement therapy for the treatment of Fabry disease, do not infringe U.S. Patent No. 5,356,804 and that the patent is invalid.

"Genzyme filed a groundless lawsuit in Delaware two months ago amid much publicity, but has not commenced the suit by serving process on TKT," said Richard F Selden, M.D., Ph.D., President and Chief Executive Officer of TKT. "We believe Genzyme resorted to this tactic in order to persuade opinion leaders, patients, and potential partners not to work with TKT. These actions are improper and unacceptable, and we intend to put an end to Genzyme`s pre- approval marketing campaign as soon as possible." Dr. Selden added, "It is a shame that Genzyme has chosen to compete based on a frivolous lawsuit rather than on the merits of their product."

On July 25, 2000, Genzyme brought suit against TKT in the United States District Court of Delaware in Wilmington claiming that TKT`s activities relating to Replagal(TM) infringe one or more claims of U.S. Patent No. 5,356,804. The suit has not commenced because Genzyme has refused to serve process on TKT. Serving process is the notice provided to a party that allows a lawsuit to proceed.

[Cowboy00]

An alle TKTX-Interessierte:

Ich will Euch auf ein Interview der Trading-Division mit BB Biotech hinweisen. Ihr könnt es Euch unter www.trading-division.de im Bereich Interviews ansehen.

Nun fragt Ihr Euch was das mit TKTX zu tun hat, TKTX ist immerhin eine Beteiligung von BB und macht einen großen Teil ihres Portfolios aus. Daher könnte es ja sein, dass Herr Krebs von BBB im Gespräch mit mir eine Prognose für den Prozess gestellt hat....

Seht selbst!

Gruß Cowboy

[Pariah]

Mann..Mann..Mann !!! Judge Young läßt sich ja ganz schön feiern.

[bruder]

!

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[winetrader]

Hallo,

das ist die Ruhe vor dem Sturm!
So ruhig wie in den letzten Tagen war es noch nie im dazugehörigen amerikanischen YAHOO-board.
Einzige Zuversicht in diesen spannenden Tagen ist die Tatsache, daß TKTX ordentlich klotzt und ein neues headquarter baut.
Das stimmt zuversichtlich.
Wenn TKTX gewinnt...

winetrader

[winetrader]

Heute könnte noch das das ausstehende Gerichtsurteil zu Gunsten von TKTX gesprochen werden. Das wäre ein Hammerschlag für AMGN.
Ich stehe innerlich nun mal zu TKTX und bin auch dementsprechend investiert.
Mir gefällt einfach nicht die Selbstgefälligkeit einiger AMGN.-Investoren. Bei ca. 70 Mrd. Kapitalisierung, eine Menge Holz, lastet ein entsprechender Druck auf AMGN.
Wenn jetzt der Hauptumsatzträger in Amerika einen entsprechenden Mitbewerber bekäme, dann ...
Naja, ich denke aber wir werden noch eine Weile warten müssen!
Auf jeden Fall steht mit meinem posting TKTX mal wieder ganz oben im board und erinnert einige Biotechler, daß da noch was im Busch ist!

winetrader

[ricox]

@ winetrader

Kannst Du mal schildern, was das mit dem "Hauptumsatzträger in Amerika" auf sich hat? Etwa ein Medikament, das Amgen vertreibt, aber auf das Transkaryotic die Vermarktungsrechte eingeklagt hat? So was?

Dank im Voraus

Gruß,
ricox

[gholzbauer]

ricox,
Richtig, Epogen ist das. 4 Mrd $ Umsatz von Amgen und Johnson&Johnson.
TKTX und Aventis wollen eine eigene Version auf den Markt bringen. Unterschied ist die Herstellungweise.
Amgen bringt demnächst allerdings eine verbesserte Version auf den Markt.

[winetrader]

Diese verbesserte Version bringt u.U. nicht den entscheidenden Vorteil.
Die Genaktivierung ist elegant, kostengünstiger und effektiver in der Herstellung!!
Und wenn man beobachetet was während der "juristischen Wartezeit" so alles geschieht bei Aventis und TKTX, bekommt man den Eindruck, daß die Jungs total unbeeindruckt an die Sache ran gehen.
Für GA-EPO wird von Seite Aventis bereits alles vorbereitet und TKTX bauen eben mal schon ein neues headquarter. (benutze gerne das amerikanische Wort, denn es hat was dominantes! )
Die sind sich ihrer Sache ganz schön sicher!
Wird von den Analysten ein falsches Spiel gespielt um bei AMGN genügend Nachfrage zu erhalten, damit man sich noch von größeren Aktienpaketen ohne negative Kursbeeinflussung trennen kann??
Sehr wahrscheinlich nicht!!!
Ich bin nun mal ein Querdenker (deshalb manchmal im Goldboard, GHOLZBAUER )
Aber die Biotechfachleute geben immer noch TKTX bessere Chancen.
Ich hoffe das Geheimnis lüftet sich bald und alle TKTXler machen eine Flasche Champagner auf!
@ricox:
EPOGEN ist der Hauptumsatzträger bei AMGN. TKTX ist in der lage ein GenAktiviertes Epogen (GA-EPO) zu erzeugen.
Im bestehenden Rechtsstreit klagt AMGEN gegen TKTX!!!! Nicht umgekehrt! Dabei beruft man sich auf AMGN-Patente, die TKTX bei der genaktivierten Herstellung angeblich verletzt.
Man muß wissen, daß die Patentformulierungen früher sehr weit gefasst wurden, vielleicht auch weil zu dem früheren zeitpunkt noch nicht nach neustem Forschungsstand formuliert werden konnte. Dadurch aber heute nicht mehr juristisch unbedingt haltbar sind. Besteht man auf diese zur Sicherheit weit gefaßten Patente könnte damit die Weiterentwicklung der Biotechnologie gehemmt werden. Das Amgenlager argumentiert umgekehrt. Sie behaupten, daß durch eine Patentierung die Sicherheit gegeben werden muß die großen Investitionen der Entwicklung eines Medikaments unabhängig vom Fortschritt abzusichern! Auch verständlich.
Meiner Meinung nach wird TKTX momentan juristisch von allen Seiten beschossen(denn es gibt weiteren "Ärger" bei einem Nischenprotein von TKTX) weil die Kläger Angst haben sich am Markt mit TKTX zu duellieren!
Hier verweise ich auf die Vorteile der Herstellungsmethode über die Genaktivierung, die scheinbar von der Branche gefürchtet wird.
Vielleicht wollte AMGEN im Vorfeld des Urteils unbedingt eine bessere Version auf den Markt bringen?!
Egal!
Abschließend: Der Streit bei EPOGEN bezieht sich lediglich auf den amerikanischen Markt, gilt aber als richtungsweisend für die gesamte Biotechbranche.


winetrader

[winetrader]

Transkaryotic Therapies muß immer wieder einmal im board ganz oben stehen!
Schreibt AMGN, daß Epogen zukünftig möglicherweise weniger verkauft wird, straft man TKTX mit seinem GA-EPO ebenfalls ab? Das ist falsch! AMGN baut nur vor!
Denn man versucht den uneingeschränkten Optimismus, den man in den letzten Monaten AMGN im Falle dieses Rechtsstreites zukommen lies, etwas zu dämpfen!!!!!
Ich fand es damals unverantwortlich bei TKTX kurstechnisch die Unsicherheit des Prozessausganges voll einzupreisen und gleichzeitig AMGN von einem Hoch ins andere Hoch laufen zu lassen!
Man behauptete, daß ein negativer Ausgang dem AMGN-Kurs wenig anhaben wird!
Wo sind diese Personen heute? Wer glaubt heute noch daran?
Man hätte, von Seite der Analysten, mit etwas mehr Vorsicht Empfehlungen aussprechen sollen.
Für die gesamte Biotechbranche hoffe ich, daß AMGN sich schnell fängt und eine kursrechtfertigende Perspektive veröffentlicht, damit sich die damaligen Aussagen einiger "Spezialisten" relativieren.

winetrader

[gholzbauer]

AMGN würde ich auch auf dem ermäßigten Niveau nicht mal mit der Kneifzange anfassen. 2004 glaub ich läuft der Patentschutz für Epogen ab, spätestens dann ist auch der US-Markt für TKTX klar, und was die nächsten 2 Jahre die Marktreife schaffen soll, ist nicht sooo toll, bezogen auf die Mkp. von AMGN (bei Kurs 55$ ca. 55 Mrd.$). Bin gespannt, welche Marktanteile das neue EPO (NESP) gewinnen wird.

[gholzbauer]

Zur Erinnerung: es läuft noch der Fabry-Wettlauf mit Genzyme.

Genzyme General Says Fabrazyme(TM) BLA Will Not Need December Advisory Committee Review
CAMBRIDGE, Mass., Nov 1, 2000 /PRNewswire via COMTEX/ -- Genzyme General (Nasdaq: GENZ chart, msgs) announced today that the U.S. Food and Drug Administration (FDA) has said that there is no need for a December advisory committee review of Genzyme`s Biologics License Application (BLA) for Fabrazyme(TM) (agalsidase beta).

The FDA frequently uses advisory committees to provide guidance regarding clinical issues related to marketing applications.

Fabrazyme is Genzyme`s investigational enzyme replacement therapy for patients with Fabry disease. The Fabrazyme BLA has been accepted for priority review by the FDA. ction on U.S. marketing authorization is expected by mid- January.

[gholzbauer]

Transkaryotic leads as biotechs slip

By Ted Griffith, CBS.MarketWatch.com
Last Update: 1:51 PM ET Nov 3, 2000 NewsWatch
Latest headlines

NEW YORK (CBS.MW) -- Biotechnology shares slipped in afternoon action, with shares of Transkaryotic Therapies among the decliners after some analysts made favorable comments about rival Genzyme Corp.

The Amex Biotechnology Index ($BTK: news, msgs) slipped 1.4 percent and the Nasdaq Biotechnology Index ($IXBT: news, msgs) lost 0.2 percent.

Transkaryotic (TKTX: news, msgs) declined 6.5 percent, or $2.81, to trade at $40.56 in recent action. Shares of Genzyme`s primary division, Genzyme General (GENZ: news, msgs), gained $6.06, or 7.6 percent, to $86.06. Earlier, Genzyme General shares touched a 52-week high of $86.75.

In June, both Transkaryotic and Genzyme applied to the Food and Drug Administration seeking marketing clearance for a treatment for a rare genetic condition called Fabry disease. Analysts expect that ultimately, only one of the companies, both of which are based in Cambridge, Mass., will be granted permission to sell the Fabry disease treatment.

Genzyme said late Wednesday the FDA has indicated there is no need for a December advisory committee review of the company`s application for clearance to sell the treatment, Fabrazyme. Genzyme said it expects the agency to make its decision on the marketing clearance application by mid-January.

Edge to Genzyme or Transkaryotic?

At least one analyst interpreted Wednesday`s announcement as favorable to Genzyme and issued positive comments about the company.

In a note to clients, PaineWebber analyst Elise Wang said that Genzyme "may have an advantage" over Transkaryotic in the effort to gain FDA approval. Among other things, Wang said, Genzyme`s studies have included more patients than Transkaryotic`s.

Another analyst, though, gave the edge to Transkaryotic. Pacific Growth Equities analyst Thomas Dietz said in a note to clients that Transkaryotic`s drug has "a distinct advantage," reflecting what he said has been its effectiveness in patient testing.

Elsewhere, shares of Affymetrix (AFFX: news, msgs), which had opened lower, recovered and resumed their ascent Friday, gaining $6.19 to $85.63 in recent action.

Shares of Affymetrix gained 32 percent Thursday following news that the company scored a legal victory in a patent dispute with Oxford Gene Technology, an English biotech.

Shares of Human Genome Sciences (HGSI: news, msgs), which also gained significant ground this week, rose 63 cents to $99.06. Human Genome Sciences announced this week two separate collaborations with other companies aimed at developing new treatments for cancer and autoimmune diseases.

[gholzbauer]

UPDATE 1-Amgen anemia drug seen boosting sales, EPS through `05
(Adds CEO comment in paragraph 4, byline. Updates stock price)
By David Brinkerhoff


NEW YORK, Nov 8 (Reuters) - Biotech giant Amgen Inc. (NASDAQ: AMGN) on Wednesday forecast that the anticipated launch of its next generation drug to treat anemia, Aranesp, will speed up earnings and sales growth over the next five years.

Executives from the Thousand Oaks, Calif., company told analysts at a meeting in New York that they projected sales and earnings per share at a compound average growth rate in the low 20 percent range over the next five years.

The company said growth would be driven by expected sales of Aranesp, the company`s yet-to-be-approved, once-a-week version of its current blockbuster drug, Epogen, for anemia.

"Aranesp is a huge opportunity and Amgen is well prepared to capitalize on it," Kevin Sharer, Amgen`s chief executive, said. He said the worldwide anemia treatment market, currently estimated at $5 billion, is projected to double over the next five years.

Officials expected total company sales to reach up to $9 billion in 2005. They also projected the launch of at least five new products in new markets valued at $13 billion in 2001-2005.

"This is not an everything-goes-right forecast, we can have a few things that go wrong," Sharer said, referring to the $9 billion sales figure. "It`s not totally conservative either," he added.

For 2001, total product sales are expected to grow in the mid- to high teens percent range, and earnings per share are expected to grow in the mid-teens range, excluding non-recurring items, Amgen said.

Combined sales growth in 2001 of Aranesp and Epogen is expected to be in the high teens to low 20 percent ranges, and sales growth of Neupogen, a medicine to counteract low white blood cell count in cancer and AIDS patients, is expected to be in the high single-digit percent range.

Shares rose about $2-9/16, or about 4 percent, to $64-3/8 in afternoon Nasdaq trade.

(updates throughout with details, analysts comments)

By David Brinkerhoff and Deena Beasley


NEW YORK/LOS ANGELES, Nov 8 (Reuters) - Biotechnology giant Amgen Inc. (NASDAQ: AMGN) on Wednesday said strong sales of Aranesp, its yet-to-be-approved next-generation anemia treatment, will rev up the company`s earnings growth over the next five years.

Amgen, based in Thousand Oaks, Calif., said its annual sales would reach $8 billion-$9 billion by 2005, compared with just over $3 billion this year.

The company`s shares were up $2-7/16, or 4 percent, at $64-1/4 early on the Nasdaq.

Amgen Chief Executive Kevin Sharer told analysts at a meeting in New York that he projects growth of sales and earnings per share at a compound average rate in the low 20 percent range over the next five years.

For 2001, Amgen said product sales are expected to grow by a percentage in the mid- to high teens, and earnings per share, excluding one-time items, will grow in the mid-teens range, a rate slightly short of the Wall Street consensus estimate.

Analysts on average had called for the company to earn $1.26 a share next year, up nearly 18 percent from a projected $1.07 this year, according to First Call/Thomson Financial.

The company said growth would be driven by expected sales of Aranesp, the company`s once-a-week version of its current blockbuster anemia drug, Epogen. Amgen filed for U.S. Food and Drug approval of Aranesp late last year and expects to be cleared to launch the drug in the first half of next year.

"Aranesp is a huge opportunity and Amgen is well prepared to capitalize on it," Sharer said. He said the worldwide anemia treatment market, currently estimated at $5 billion, is projected to double over the next five years.

Unlike Epogen, which is also marketed by Johnson & Johnson (NYSE: JNJ) in Europe and in the U.S. non-dialysis market under the brand name Procrit, Amgen retained all marketing rights to Aranesp.

"We think Aranesp is a potential $1.5 billion product and it appears that Amgen believes that as well," said Dennis Harp, an analyst at Deutsche Banc Alex. Brown.

UBS Warburg analyst Elise Wang said in a report issued Wednesday that the cancer treatment market represents a major market opportunity for Aranesp. "We believe that the oncology setting accounts for a significant portion of Johnson & Johnson`s Procrit/Eprex sales of approximately $2.5 billion," she said.

Amgen also projected the launch of at least five new products in new markets valued at $13 billion in 2001-2005.

"This is not an everything-goes-right forecast, we can have a few things that go wrong," Sharer said, referring to the $9 billion sales figure. But, he added: "It`s not totally conservative either."

Combined sales growth in 2001 of Aranesp and Epogen are expected to be in the high teens to low 20-percent ranges. Sales growth of Neupogen, an Amgen lead drug that is used to counteract low white blood cell count in cancer and AIDS patients, is expected to be in the high single-digit percent range.

Harp said he was also encouraged by comments from Amgen regarding a pending decision on the company`s patent infringement suit against Transkaryotic Therapies Inc. (NASDAQ: TKTX)Inc. and Aventis SA .

"They remain confident that they will prevail. On the outside chance they don`t, the company said it expects to prevail in the marketplace with Aranesp, which is superior to Epogen in terms of dose and will reach the market before the TKT product is approved," Harp said.

Amgen sued Transkaryotic and Aventis, which claim that their method for making Epogen, by inserting a promoter into human genes, is not covered by Amgen`s broad patents. The judge in the Boston trial, which concluded in September, is expected to issue a decision any day.

TKT and Aventis do not have a product in development that can match Amgen`s Aranesp, Harp said.

Amgen also said it expects to receive word on its FDA application for Kineret, a treatment for rheumatoid arthritis, by the second half of next year and plans to file applications for its prostate cancer treatment abarelix and for SD/01, a second-generation version of white blood cell booster Neupogen, sometime next year.

[winetrader]

An AMGN`s Stelle würde ich auch versuchen die Luft aus dem fokusierten Rechtsstreit zu nehmen. Besonders wenn man vielleicht intern davon ausgeht den Prozess verlieren zu können.
Dennoch geht es um eine Grundsatzfrage, die, wenn sie positiv für TKTX ausfällt, ein enormes Potenzial bedeutet. Dies bezieht sich nicht auf GA-EPO, denn dieses Produkt wird auf jeden Fall außerhalb von Amerika vermarktet. Es ist die enorme pipeline von Produkten, die durch Genaktivierung entwickelt sind und zukünftig entwickelt werden, die dann darauf warten problemlos an den Markt zu kommen.
Vielleicht wartete Young bis zu dieser Meldung von Amgen. Damit es nicht zu bitter wird!

winetrader

[P.Bateman]

Guten Morgen,
muß man erst mal klar kommen mit der neuen Version.
Aber zum Thema,wer kann helfen:TKTX am Freitag in US gegen den Trend ca. 10% Plus,gibt es News oder ist das nur Zocke?
TKTX-Interessierte bitte melden.
Schönen Tag und hoffentlich eine bessere Woche,Pat

[P.Bateman]

Keiner interessiert?
Wie gesagt,TKTX gestern gegen den Trend gut 10%Plus,heute gegen den Trend nochmal leicht positiv,umgerechnet jetzt wieder ca.€50.Zufall?Mir soll`s recht sein,aber vielleicht
tausche ich sie morgen gegen MLNM,wer hätte gedacht,daß die mal das gleiche kosten?
Schöne Träume
Pat

[winetrader]

Hallo P.Bateman,

bei TKTX kann man zur Zeit nichts sagen.
Jeder wartet aufs Christkind!Oder orakeln.
Es könnte jederzeit soweit sein.
Aber der aktuelle Kursverlauf hat nichts damit zu tun. Ich denke nicht, daß im Vorfeld Informationen nach außen dringen.

winetrader

[P.Bateman]

Hi,
ich habe sie gerade für €49 mit 30% Gewinn verkauft,mir wird das alles zu heiß...
Buchgewinne sind ja gut und schön, aber...Meine Entscheidung, PDLI für €158 zu verkaufen war ja
auch nicht soooo falsch.Vielleicht hole ich mir heute noch ein Päckchen MLNM...?

Bis bald,Pat

[winetrader]

Vor Steuer oder nach Steuer?

TKTX ist als langfristiges Basisinvestment zu sehen. Unabhängig von diesem Prozessausgang.
TKTX stellt, meiner meinung nach, bereits die zweite Generation in Bezug auf Biotechtechnologien dar.
TKTX hat die Zukunft noch komplett vor sich. Bisher in der 22-jährigen Beriebsgeschichte haben die Jungs nur "Drecksarbeit" (Grundlagenforschung) gemacht.
Ab jetzt wird es wesentlich interessanter!

winetrader

[gholzbauer]

TKT Announces Issuance of U.S. Patent Covering Alpha-L-Iduronidase Enzyme for the Treatment of Hurler Syndrome (MPS I)
CAMBRIDGE, Mass., Nov 21, 2000 /PRNewswire via COMTEX/ -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX chart, msgs) today announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 6,149,909 entitled, "Synthetic Alpha-L-Iduronidase and Genetic Sequences Encoding Same." The patent is based on work performed by Dr. John Hopwood and colleagues, who cloned the gene and cDNA for alpha-L- iduronidase and characterized the protein. The patent claims are related to the purified alpha-L-iduronidase made from cells transfected with DNA encoding the protein. The protein is useful in the investigation, diagnosis, and treatment of Hurler syndrome, also know as mucopolysaccharidosis I (MPS I). The patent was issued to Women`s and Children`s Hospital in North Adelaide, Australia and licensed to TKT through an exclusive worldwide license agreement.

"We are committed to developing treatments for rare genetic disorders, and Dr. Hopwood`s work offers real hope to patient`s with Hurler, Hurler-Scheie, and Scheie syndromes," stated Richard F Selden, M.D., Ph.D., President and Chief Executive Officer of TKT.

MPS I is an inherited rare genetic disorder caused by deficient activity of the protein alpha-L-iduronidase. Alpha-L-iduronidase is present in the lysosome of cells, where it helps break down large biomolecules called mucopolysaccharides. In patients affected by MPS I, these mucopolysaccharides accumulate in organs and tissues of the body, particularly in the central nervous system, liver, spleen, heart and skeleton ultimately lending to cell death and progressive tissue and organ damage. It is estimated that 1 in 25,000 births will result in some form of MPS in the United States.

A copy of U.S. Patent No. 6,149,909 is available on the World Wide Web at http://uspto.gov.

[gholzbauer]

Ist nicht so gut heute.


TKT Provides Update on Dynepo(TM) Regulatory Status in the United States
CAMBRIDGE, Mass., Nov 22, 2000 /PRNewswire via COMTEX/ -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX chart, msgs) today announced that the U.S. Food and Drug Administration (FDA) has required that data be provided on additional manufacturing runs of Dynepo(TM). Dynepo is being developed by Aventis Pharma, the pharmaceutical company of Aventis S.A., in collaboration with TKT. The FDA`s requirement is based on a recent change in the Dynepo manufacturing process, an increase in scale from the 2000 liter to 5000 liter bioreactors. Though the product has been successfully manufactured at the 5000 liter scale, additional process validation data will be submitted. The amount of new data will necessitate that it be submitted as part of a new Biologics License Application (BLA), which is expected to occur in approximately six months.

"We have a clear understanding of the additional data the FDA has requested, and we believe we can provide this data in a timely manner. This is the first significant delay in the Dynepo development program, and we will diligently assist our colleagues at Aventis to provide the required validation data," said Richard F Selden, M.D., Ph.D., President and Chief Executive Officer of TKT. "Though understandably disappointed, we remain optimistic that Dynepo will become an accepted tool in the treatment of anemia."

[gholzbauer]

Ich bin angenehm überrascht, daß die heutige Nachricht den Kurs nicht dauerhaft unter 30$ gedrückt hat. In dem schwierigen Börsenumfeld hätte ich eine Erholung von 28$ auf 38$ während des Börsenverlaufs nicht erwartet.

[gholzbauer]

Droht hier schon der nächste Streit zwischen TKTX und GENZ?
Vgl. mein Posting vom 21.11.

SOURCE: BioMarin Pharmaceutical Inc.
Genzyme and Biomarin Announce PHASE III Trial of Aldurazyme(TM) For MPS-I
CAMBRIDGE, Mass., and NOVATO, Calif., Nov. 22 /PRNewswire/ -- Genzyme General (Nasdaq: GENZ - news) and BioMarin Pharmaceutical Inc. (Nasdaq and Swiss SWX New Market: BMRN) announced that they are initiating a pivotal Phase III trial of Aldurazyme (TM) (laronidase), and expect to treat the first patient in the trial by early December. The product, recombinant alpha-L-iduronidase, is an enzyme replacement therapy for patients with MPS-I, also known as Hurler, Hurler-Scheie and Scheie diseases. Genzyme and BioMarin have received Orphan Drug designation and Fast-Track status for Aldurazyme from the U.S. Food and Drug Administration.

In an initial clinical trial, Aldurazyme has shown safety and promising clinical results. If the Phase III trial confirms the initial safety and efficacy profile of the drug, the companies will submit for marketing approval in the U.S., Europe, Canada and other countries in order to provide Aldurazyme therapy to the thousands of patients who currently suffer from this life- threatening disease.

In 1998, Genzyme and BioMarin formed BioMarin/Genzyme LLC to develop and commercialize Aldurazyme throughout the world.

BioMarin specializes in the development and commercialization of therapeutic enzyme products. Since inception in 1997, BioMarin has applied its proprietary enzyme technology to develop products for lysosomal storage diseases and for the treatment of serious burns. Glyko, Inc., a BioMarin subsidiary, provides analytical and diagnostic products and services in the area of carbohydrate biology.

Genzyme General develops and markets therapeutic products and diagnostic products and services. Genzyme General has three therapeutic products on the market and a strong pipeline of products in development focused on the treatment of genetic disorders. Genzyme General is a division of the biotechnology company Genzyme Corporation.

....

[fun-ta]

Nachricht nur zur Info:
In der kommenden Ausgabe vom Aktionär:
-trtx lehrt Konkurrenz das fürchten
-enormes Potential am Markt
-risikobereite Anleger denken ans einsammeln

[fun-ta]

Hallo
gibts Neuigkeiten zum Unternehmen, weiß jemand was???
Morgan Stanley hat am Freitag wieder ein Strong Buy ausgesprochen, ich hoff doch mal da tut sich was!!

[gholzbauer]

Ich weiß nicht neues.
Auf dem TKTX-Yahoo-Board gibt es ebenfalls nix.
Alle warten auf den Richterspruch.

[winetrader]

Ich werde beim Beobachten der AMGN-news den Verdacht nicht los, daß man mit dem Nachfolgeprodukt von Epogen und den in der pipeline befindlichen Wirkstoffen vom Richterspruch ablenken bzw. als weniger wichtig (für AMGN!) darstellen möchte.
Mir kommt es ebenso vor, daß man vereinbart haben könnte, sich mit dem Richterspruch Zeit zu lassen, damit AMGN mit den neuen Präparaten eine mit etwas Abstand neue Position beziehen kann.
Denn ein negativer Ausgang für AMGN bedeutet momentan im Biotechbereich nur für TKTX steigende Kurse!!!

winetrader

[gholzbauer]

Weiter unten stehendes in Kurzform:
``We are very excited by the clinical activity we have seen this early on in the program, but it is important to emphasize to the hemophilia community that we still have a great deal of work ahead to develop a safe and effective treatment.``



Monday December 4, 6:45 pm Eastern Time
Press Release
SOURCE: Transkaryotic Therapies, Inc.
TKT Reports Encouraging Results in First Human Investigation Of Hemophilia A Gene Therapy
- Data Presented at American Society of Hematology Meeting -
SAN FRANCISCO, Dec. 4 /PRNewswire/ -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX - news) reported today Phase I results of the first clinical trial evaluating Factor VIII gene therapy in patients with hemophilia A. Data from six patients participating in the study demonstrated that non-viral delivery of Factor VIII using patients` genetically modified cells is safe and well-tolerated. Furthermore, four of the first six patients showed clinical benefit with two patients having no spontaneous bleeds for close to a year following treatment. The results were presented by Dr. David A. Roth from Beth Israel Deaconess Medical Center and Harvard Medical School at the 42nd Annual Meeting of the American Society of Hematology.

``We have seen encouraging biochemical and clinical results in patients, which suggests this approach may become a practical option for the treatment of hemophilia. These results are exciting since we were cautious in the number of cells returned to the patient initially and in the amount of Factor VIII the cells were producing, yet several experienced an improvement in their hemophilia,`` said David A. Roth, M.D., Director, Hemophilia Clinical Research, Beth Israel Deaconess Medical Center and Assistant Professor of Medicine, Harvard Medical School. ``Since the initiation of this program, we have taken a conservative approach with this new technology, and accordingly, I am pleased to note that the therapy not only shows clinical activity but also has been very well-tolerated.``

The Phase I open-label study was initiated in December 1998 at Beth Israel Deaconess Medical Center in Boston, Massachusetts to assess the safety of Factor VIII gene therapy in twelve patients with hemophilia A, utilizing Transkaryotic Therapy(TM). Following implantation of 100 to 400 million genetically-modified cells, four of six patients demonstrated decreased bleeding frequency and/or Factor VIII usage. In addition, two patients, while still having occasional trauma-related bleeds, have not experienced spontaneous bleeds for close to one year for the first time in their lives, while occasional injury-related bleeds may have occurred. There were no serious adverse events related to the study material or the implantation procedure. Only minor anticipated adverse experiences related to the implantation procedure were observed.

``We are very hopeful that our non-viral approach to gene therapy will be appropriate for long term delivery of Factor VIII in patients with hemophilia A,`` stated Richard F Selden, M.D., Ph.D., President and Chief Executive Officer of TKT. ``We are very excited by the clinical activity we have seen this early on in the program, but it is important to emphasize to the hemophilia community that we still have a great deal of work ahead to develop a safe and effective treatment.``

About Transkaryotic Therapy

In Transkaryotic Therapy, the Company`s non-viral gene therapy system, a small sample of a patient`s cells are removed in an outpatient procedure and sent to the Company`s manufacturing facility where the cells are genetically- engineered to produce the desired protein for extended periods of time. After the cells and the protein have been tested to ensure both safety and functionality, an appropriate number of genetically-engineered cells are returned to the physician and injected back into the patient.

TKT believes Transkaryotic Therapy is well suited to allow safe and long-term delivery of therapeutic proteins for the treatment of chronic protein deficiency states, including anemia, hemophilia, hypercholesterolemia, and diabetes. This technology is designed to take advantage of a patients` ability to synthesize therapeutic proteins for extended periods, potentially providing improved therapeutic outcome, a reduction of side effects due to overdosing or underdosing of conventional proteins, improved patient compliance, and significant reductions in cost due to less frequent administration.

About Hemophilia A

Hemophilia A is an X-linked, hereditary bleeding disorder caused by the absence or defect of a blood clotting protein Factor VIII. As a result, when a person with hemophilia A has a bleeding episode, the bleeding may be prolonged due to the body`s inability to form blood clots. Patients affected with hemophilia A experience acute, debilitating, and often life threatening bleeding episodes and may suffer from spontaneous internal, joint, or soft tissue bleeding episodes due to Factor VIII deficiency. It is estimated that approximately 50,000 individuals worldwide are affected with hemophilia A.

[fun-ta]

Weiß jemand was neues??
Bin über jede Nachricht dankbar!!!

[gholzbauer]

Friday December 8, 8:29 am Eastern Time
Press Release
SOURCE: Transkaryotic Therapies, Inc.
TKT Regains Rights to Second Gene-Activated(R) Protein From Aventis Pharma
CAMBRIDGE, Mass., Dec. 8 /PRNewswire/ - Transkaryotic Therapies, Inc. (Nasdaq: TKTX - news) today announced it has reacquired worldwide commercial rights to GA-II, a second Gene-Activated® protein in development, from Aventis Pharma, the pharmaceutical company of Aventis S.A. (NYSE: AVE - news). Financial terms were not disclosed.

``GA-II is a top priority program at TKT, and we are pleased to have reached agreement with Aventis to reacquire rights to the product. We have benefited from Aventis` expertise in moving the protein from basic research to preclinical testing and into clinical development, and I believe we have the ability to aggressively move this program into pivotal trials and beyond,`` said Richard F Selden, M.D., Ph.D., President and Chief Executive Officer of TKT. ``Aventis has been and continues to be instrumental in the development of our lead Gene-Activated protein, Dynepo(TM), and we very much appreciate their effort on both Gene-Activated protein programs.``

Frank Douglas, M.D., Ph.D., Executive Vice President, Head Drug Innovation and Approval of Aventis Pharma said, ``Based on our collaboration over the past five years we believe that TKT is well positioned to bring this program forward. We wish TKT success in the future development of this product.``

In December 1999, Aventis Pharma filed an Investigational New Drug Application to commence Phase I clinical testing of GA-II. The Phase I study in healthy volunteers was recently completed, and TKT expects to begin Phase II testing of the protein next year. TKT`s approach is based on the activation of genes encoding therapeutic proteins in human cells rather than the cloning and transfer of these genes. TKT believes that its approach will allow it to develop and commercialize a number of therapeutic proteins, including potentially improved versions of many that are currently marketed.

Transkaryotic Therapies, Inc. (TKT) is a biopharmaceutical company dedicated to the development and commercialization of products based on its three proprietary development platforms: Gene-Activated® proteins, Niche Protein(TM) products, and Gene Therapy. The Company`s gene activation technology is a proprietary approach to the large-scale production of therapeutic proteins, which does not require the cloning of genes and their subsequent insertion into non-human cell lines. TKT`s Niche Protein product platform is based on protein replacement for the treatment of rare genetic diseases, a group of disorders characterized by the absence of certain metabolic enzymes. The Company`s Gene Therapy technology, known as Transkaryotic Therapy(TM), is focused on the commercialization of non-viral, ex vivo gene therapy products for the long-term treatment of chronic protein deficiency states.

This press release contains forward-looking statements that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward- looking statements. Without limiting the foregoing, the words, ``believes,`` ``anticipates,`` ``plans,`` ``expects,`` ``intends,`` and similar expressions are intended to identify forward-looking statements. Important factors that could cause actual results to differ materially from the expectations described in these forward-looking statements are set forth under the caption ``Certain Factors That May Affect Future Results`` in TKT`s Annual Report on Form 10-K for the year ended December 31, 1999 and updated in TKT`s Quarterly Report on Form 10-Q for the quarter ended September 30, 2000, which are both on file with the Securities and Exchange Commission and incorporated herein by reference. These important factors include risks as to whether TKT`s products, such as GA-II, will advance in the clinical trials process, the timing of such clinical trials, whether the clinical trial results will warrant continued product development, and whether TKT`s products, such as GA- II, will receive approval from the U.S. Food and Drug Administration or equivalent regulatory agencies, and, if such products receive approval, whether they will be successfully marketed; the results of any patent litigation in which TKT is involved or may become involved; competition; and TKT`s dependence on collaborators.

Gene-Activated® is a registered trademark and Niche Protein(TM), TKT(TM), and Transkaryotic Therapy(TM) are trademarks of Transkaryotic Therapies, Inc. Dynepo(TM) is a trademark of Aventis Pharma. Please visit our web site at www.tktx.com for additional information about Transkaryotic Therapies, Inc.


CONTACT:
Justine E. Koenigsberg
Manager, Corporate Communications
[phone]

SOURCE: Transkaryotic Therapies, Inc.

[winetrader]

Hallo,

in Bezug auf das posting vom 5.12.00 von gholzbauer, den ich auch aus dem Goldboard kenne , wird einmal mehr gezeigt, daß TKTX zu Recht zu den Biotechunternehmen der zweiten Generation zählt!!!
Unabhängig von dem schwebenden Gerichturteil, bei dem, lt. Aussage von Judge Joung, dieses Jahr noch das Recht gesprochen werden soll, werden alle langfristige TKTX-Aktionäre noch viel Spaß mit diesem Wert haben!!!

winetrader

[fun-ta]

So langsam wirds aber ungemütlich!!
Wie siehts aus kommt das Urteil noch dieses Jahr??
Positives scheint es im Moment nicht zu geben!!

[gholzbauer]

Was jetzt zusätzlich auf den Kurs drückt, ist die Ankündigung (vorgestern), daß TKTX für bis zu 500 Mio. $ neue Aktien ausgeben will.

[gholzbauer]

Das hier meinte ich:

Wednesday December 13, 5:30 pm Eastern Time
Transkaryotic to sell $500 mln of stock, adopts rights plan
CAMBRIDGE, Mass., Dec 13 (Reuters) - Biotech firm Transkaryotic Therapies Inc. (NasdaqNM:TKTX - news) on Wednesday said it would sell up to $500 million of stock in the future and announced the adoption of a shareholder rights plan that would start if a party buys 20 percent of company stock.

The company said the adoption of the rights plan, known as a ``poison pill``, was not in response to any unsolicited offer.

Under the plan, a dividend of one preferred stock purchase right is being declared for each common share owned by shareholders of record as of the close of business on December 26.

Initially, the rights will automatically trade with underlying common shares and cannot be exercised unless a person acquires, or starts a tender offer to buy, 20 percent or more of Transkaryotic common shares.

If exercised, each right entitles shareholders to buy a fractional share of preferred stock for $289. If someone acquires 20 percent or more of Transkaryotic common shares, each right would entitle a holder to purchase company shares with a market value of two times the exercise price of the right.

[TheFrog]

Schauen sie doch einfach mal rein: www.brokerstalk.de.vu

[winetrader]

Würde ein Unternehmen, welches erwartet, daß der Kurs augfrund eines Urteils rutschen könnte, so etwas zu diesem Zeitpunkt veröffentlichen???
NEIN!
AMGN und TKTX wissen bzw. ahnen sehr genau was kommen wird.
TKTX gewinnt! 100%!!
Das wird jeden Tag sicherer!!!!
Seit geraumer Zeit wird der Kurs exakt in einer Bandbreite gehalten.
Nach meinem Verständnis soll der Ausstoß dieser zusätzlichen Aktien nur in bestimmten Fällen geschehen.
TKTX hält sich somit eine Option, die nach meinem Verständnis, ein guter Schutz gegen eventuelle Übernahmen ist.
Der eigentliche Schlüssel bei TKTX ist nicht dieses fokusierte GA-EPO sondern die jetzt Erfolg versprechende Gentherapie.


winetrader

[fun-ta]

Also keine Panik und drin bleiben????!

[gholzbauer]

Noch haben sie ca. 150-170 Mio.$ Cash.
Man wird sicher einen Kursanstieg für die Ausgabe weiterer Aktien abwarten, z.B. nach einer Dynepo(GA-EPO)-Zulassung oder nach einer Zulassung des Fabry-Medikaments.
Die 500 Mio. werden vermutlich über einen längeren Zeitraum verteilt und zum Großteil bei Fonds u.ä. untergebracht.
Deshalb besteht kein Grund zur Panik.

[winetrader]

@fun-ta:
Kurzfristanleger machen mit TKTX einen heißen Ritt.
Aber wer einen langfristigen Horizont hat, der kann nicht nur halten, sondern auch kaufen.
Auch wenn der Kurs einbrechen sollte, wird langfristig TKTX ein sehr gutes Biotechunternehmen der zweiten Generation sein.
Die aktuellen Aktionen im Haus von TKTX interpretiere ich als sehr optimistisch, nein bullish!
Es macht den Anschein, daß TKTX sich alleine weiterentwickeln will. Die letzten Entscheidungen, incl der Bau einer neuen Zentrale, verstehe ich als eine gewisse Eigenständigkeit! Dazu paßt die letzte news 100%-ig.
Meine vielleicht etwas extra-bullische Einschätzung:
"TKTX hat das Potenzial für eine zweite AMGN. Wer kauft und hält wird reich!"
Ich weiß, sehr mutig, vielleicht auch etwas verrückt, aber dieses Unternehmen hat drei hochinteressante Produktplattformen, die, meiner Meinung nach, diese Behauptung rechtfertigt!
Also nochmals zu deiner Frage:
"Auf jeden Fall drin bleiben!"

winetrader

[puhvogel]

Sind die neuen Aktien nicht als Giftpille gedacht?

[gholzbauer]

Ich glaube, die poison pill ist noch außerhalb der 500 Mio. geplant.
In den letzten Monaten haben sich viele Biotech-Unternehmen Aktienausgaben genehmigen lassen bzw. angekündigt (oft off-the-shelf registration), um bei einem erneuten Boom sofort Geld am Markt einsammeln zu können, anstatt dies erst langwierig als secondary IPO durchzuführen.

[winetrader]

Am gestrigen NASDAQ-Aktienhandel ereignete sich in den letzten Handelsstunden ein möglicherweise interessantes Kursszenario bei AMGN und TKTX.
Dabei standen die Schlußkurse der beiden Werte bei:
+ 6% bei TKTX
- 6% bei AMGN
Der Kursverlust bei Amgen fand sogar in den letzten 20 Minuten der Handelszeit statt.
Sehr wahrscheinlich nur eine technische Reaktion aus dem Optionsscheingeschäft. Aber, möglicherweise...

winetrader

[fun-ta]

Hat den keiner ne gute Nachricht so kurz vorm Neuen Jahr??

[gholzbauer]

Vielleicht. Bei Genzyme verzögert sich die Markteinführung des Fabry-Medikaments vorraussichtlich um 4-6 Monate. Gut für TKTX, denke ich. GENZ habe ich im Laufe der letzten Wochen fast alle verkauft, jetzt drücke ich natürlich für TKTX die Daumen.

[gholzbauer]

Biotech stocks move up


By Ted Griffith, CBS.MarketWatch.com
Last Update: 9:54 AM ET Dec 28, 2000


NEW YORK (CBS.MW) - Biotechnology stocks were climbing in early action Thursday with the stock of Genzyme reclaiming a little of the ground it lost Wednesday.
The Amex Biotechnology Index ($BTK: news, msgs) rose 1.6 percent and the Nasdaq Biotechnology Index gained 0.9 percent.

Shares of Genzyme edged up 50 cents to $90.25. Genzyme (GENZ: news, msgs) shares fell Wednesday after the company said the U.S. Food and Drug Administration has asked for more information about Genzyme`s treatment for a rare genetic disease. The FDA`s request is expected to delay a final decision by the federal agency on Genzyme`s treatment for Fabry disease.

Shares of Transkaryotic Therapies (TKTX: news, msgs) slipped $1.56 to $33.88 in early action after posting substantial gains Wednesday. Transkaryotic is also trying to win FDA approval to sell a Fabry disease treatment.

[winetrader]

Wieder einmal weisen Analysten darauf hin, daß Amgen nicht mehr so stark von den Erlösen von Epogen abhängig ist!!!
Man stehe nicht mehr als Zwei-Produkt-Unternehmen am Markt, sondern hat sich aufgrund etlicher Beteiligungen ein wesentlich breiteres Standbein aufgebaut. Bis 2003 kann man sogar mit Einnahmen im onkologischen Bereich rechnen!
Na, dann wird es doch langsam Zeit, daß Herr Young das Urteil sprechen darf, oder?
Schließlich wissen doch jetzt alle Amgen-Aktionäre, daß Amgen Epogen nicht mehr braucht bzw. mit dem Nachfolgeprodukt wesentlich besser positioniert ist!

winetrader

[mr.lukoil]

Moin moin,

es gab mal wieder erfreuliche Nachrichten, die gestern wohl im negativen Umfeld untergegangen sind. Wie ja scheinbar der thread auch. Heute gab es ja mal wieder einen Ruck nach oben.


TKT Files IND to Begin Clinical Testing of Iduronate-2-Sulfatase for the Treatment of Hunter Syndrome

CAMBRIDGE, Mass., Jan. 2 /PRNewswire/ -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX) today announced that it has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) to commence a Phase I/II clinical trial of Company`s Niche Protein(TM) product, iduronate-2-sulfatase (I2S), an enzyme replacement therapy for the treatment of Hunter syndrome.

"Today`s IND filing is an important milestone for TKT that demonstrates the commitment and motivation of many individuals to advance this program for the many patients in need of treatment." said Thomas J. Schuetz, M.D., Ph.D., Vice President, Clinical Affairs of TKT. "TKT is very much looking forward to beginning clinical testing of the safety and clinical activity of enzyme replacement therapy as a potential treatment for Hunter syndrome. I am hopeful that through careful development of this program we will have an opportunity to make a real difference in the lives of these young patients."

As a first step in developing a treatment for Hunter syndrome, TKT will conduct a Phase I/II clinical trial designed to assess the safety, pharmacokinetic profile, and clinical activity of I2S enzyme replacement therapy. Twelve patients with Hunter syndrome will be enrolled in the dose- escalating study and will be randomized to receive I2S or placebo for six months. Dr. Joseph Muenzer, Associate Professor of Pediatrics at the University of North Carolina at Chapel Hill is the principal investigator of the study. TKT expects to complete Phase I/II testing in approximately 1 year.

Hunter syndrome is an inherited rare genetic disorder caused by deficient activity of I2S. I2S is present in the lysosomes of cells, where it helps break down large biomolecules called glycosaminoglycans. Patients affected by Hunter syndrome suffer from a variety of symptoms including skeletal deformities, obstructive airway disease, cardiac failure, and, in severe cases, neurologic decline can occur. TKT estimates that approximately 5,000 patients worldwide are affected by Hunter syndrome. In severe cases, the life expectancy for patients with Hunter syndrome is typically 10-15 years of age, however, in mild cases, patients can survive into the fifth or sixth decade of life. Currently, there is no effective treatment.

Weiß jemand, wann endlich mit einer Entscheidung von Richter young im Patentstreit mit amgen zu rechnen ist????

Grüße


lukoil

[mr.lukoil]

Niemand mehr an tktx interessiert??? Oder ausgestoppt worden? Wo ist IWA JAPAN???

[mr.lukoil]

Scheinen die gleichen Schwierigkeiten wie bei genzyme aufzutreten:Transkaryotic Therapies says Replagal not approved

CAMBRIDGE, Mass., Jan 3 (Reuters) - Biotech firm Transkaryotic Therapies Inc. <TKTX.O> said Wednesday it received a letter from the U.S. Food and Drug Administration (FDA) seeking additional data about its Replagal therapy for treatment of a genetic disorder known as Fabry disease.

"While we are disappointed that the FDA did not approve Replagal at this time, we are working diligently to respond quickly to their requests for additional data," Richard Selden, Transkaryotic Therapies` president and chief executive, said in a statement.

The Cambridge, Mass.-based firm said it received a complete review letter from the FDA concerning its biologics license application for Replagal, or agalsidase alfa, an investigational enzyme replacement therapy for the treatment of Fabry disease.

Fabry disease is an inherited rare genetic disorder caused by deficient activity of a lysosomal enzyme, and affects an estimated 5,000 people worldwide, Transkaryotic Therapies said.

Shares of Transkaryotic Therapies finished up 7 percent, or $2-7/16, at $36-9/16 on the Nasdaq Wednesday. The stock has a 52-week high of $87 and a 52-week low of $22-1/2. Gregory Cresci, New York Newsroom [phone]


Wahrscheinlich reagiert der Markt auf die schlechten Nachrichten deutlich, nachdem er schon bei guten nicht so recht reagiert hat.

Irgendwann vielleicht mal was erfreuliches? Vielleicht sind das ja auch die Schmerzen vor dem Geldverdienen.

so long

mr.lukoil

[fun-ta]

Immer noch keine Entscheidung oder ähnliche gute News??

So long

[fun-ta]

Da es hier ganz schön ruhig wird um die Aktie hier wieder mal ein paar Infos:
Morgan Stanley Dean Witter

Transkaryotic Therapies "Strong Buy" Datum : 12.01.2001
Zeit :13:53


Die Aktie des Biotechnologieunternehmens Transkaryotic Therapies (WKN
903363) wird von den Analysten von Morgan Stanley Dean Witter zum Kauf
empfohlen. Das Unternehmen biete Therapiemöglichkeiten zur Behandlung von
Stoffwechseldefekten.
Transkaryotic Therapies sei besonders auf die Forschung und Entwicklung
von „Nischenkrankheiten“ fokussiert, und biete in diesem
Bereich sehr erfolgreiche Produkte und Gentherapieprogramme an. So rechnen
die Analysten speziell in diesem Zusammenhang mit einer positiven
Entwicklung im Jahr 2001.

Ebenso aussichtsreich sei die neuartige Gentherapiemethode zur Behandlung
der Bluterkrankheit, Hämophilie A, wobei die Phase I der klinischen
Studien kürzlich bekannt gegeben und von den Experten in der
„American Society of Hematology“ sehr positiv aufgenommen
seien.

Etwas negativ sei der Rechtsstreit mit Amgen zu beurteilen, wobei man
jederzeit mit einem Urteil rechnen könne. Das Kursziel auf Sicht der
nächsten drei Jahre liege bei 136 USD, der Gewinn pro Aktie liege im Jahr
2000 bei –2.10 USD und werde im Jahr 2001 auf –1.16 USD
geschätzt.



Ach ja am Freitag Plus 13,4 % (very nice)

[Braininvestor]

Friday January 19, 7:24 pm Eastern Time
Judge: Amgen Patents Were Infringed
By JUSTIN POPE
Associated Press Writer
BOSTON (AP) -- A federal judge ruled Friday that Transkaryotic Therapies Inc. violated a series of valid patents belonging to Amgen Inc. (NasdaqNM:AMGN - news) in its development of a potentially lucrative anti-anemia drug.

Shares of Amgen shot up 21 percent in after-hours trading following the ruling, rising to $72.75 after finishing the regular session at $60, down $3.32, on the Nasdaq Stock Market.

In a 235-page ruling, U.S. District Court William Young concluded that five claims on two of Amgen`s patents were ``valid, enforceable and literally infringed,`` and three claims on another patent were ``valid, enforceable and infringed under the doctrine of equivalents.``

Spokesmen from the two companies did not immediately return phone messages seeking comment.

``For now, Amgen`s dodged a bullet and a cloud that`s been hanging over their stock for the last year will be lifted,`` said Eric Schmidt, biotechnology analyst at SG Cowen Securities Inc. in New York.

The decision concerned the drug Epogen, which is known generically as erytrhopoietin, and accounted for $1.8 billion in sales in 1999 for the Thousand Oaks, Calif.-based Amgen -- more than half of the company`s revenue.

Amgen makes Epogen by putting cloned human genes into hamster ovary cells. Cambridge-based TKT had developed another method to produce a similar drug by inducing human cells to make the protein in a laboratory culture.

TKT was counting on the technology to produce other drugs, though the ruling is not expected to affect its attempts with partner Aventis (NYSE:AVE - news) to break into the European and Japanese markets, worth perhaps $1 billion each.

Schmidt said TKT is almost certain to appeal.

``Appeal may only cost these parties $15-to-20 million, which is about a day`s worth of Epogen sales,`` he said.

``(TKT) is far from being out of business,`` Schmidt added. ``They do have some other things going on ... but no one is going to give them any credit for the erytrhopoietin franchise until an appeals court rules.``

Shares of TKT fell $1 to $34 in trading before being halted, also on the Nasdaq.

Part of Friday`s complex ruling turned on the definitions of terms such as ``vertebrate cells,`` which was central to several claims involving two of Amgen`s patents. Amgen contended the term refers to ``cells originating from an animal having a backbone.`` TKT countered the term only applies to non-human cells, which would have cleared the way for TKT`s method of using human cells.

``Because humans are vertebrates, TKT`s construction betrays the plain and ordinary meaning of the claim term,`` Young ruled, siding with Amgen.

On the Net:

http://www.mad.uscourts.gov/inet/r0119post.pdf

Mies, aber bei Zulassung Marktvolumen in Europa und Japan jeweils 1 Milliarde Dollar

Braininvestor

[Braininvestor]

Die Stellungnahme von TKTX:



Return to News Bureau


U.S. DISTRICT COURT ISSUES RULING IN ERYTHROPOIETIN PATENT LITIGATION™
Cambridge, MA, January 19, 2001

Transkaryotic Therapies, Inc. (Nasdaq: TKTX) today announced that Judge William G. Young of the U.S. District Court of Massachusetts has issued an opinion in a patent infringement suit Amgen brought against Aventis Pharma and TKT involving Dynepo™, the companies` Gene-Activated® erythropoietin being developed in the United States and Europe for the treatment of anemia.

Judge Young ruled in favor of Amgen on a number of issues. He held that claims 2 through 4 of Amgen`s U.S. Patent No. 5,621,080, while not literally infringed, were valid and infringed under the doctrine of equivalents. He held that four of the five claims, claims 1,3,4, and 6, of Amgen`s U.S. Patent No. 5,756,349 were valid and literally infringed. He also held that claim 1 of Amgen`s U.S. Patent No. 5,955,422 was valid and literally infringed.

Judge Young ruled in favor of TKT and Aventis on a number of issues. He held that Amgen`s U.S. Patent No. 5,547,933 was not infringed, and that it would be invalid if it were infringed. He held that Amgen`s U.S. Patent No. 5,618,698 was not infringed. He held that claim 7 of Amgen`s U.S. Patent No. 5,756,349 was not infringed. He held that Amgen`s U.S. Patent No. 5,621,080 was not literally infringed.

"Although we are disappointed by today`s ruling, we are grateful for Judge Young`s long and intensive efforts on this case. We remain confident that our position is strong and intend to appeal this decision," stated Richard F Selden, M.D., Ph.D., President and Chief Executive Officer of TKT. "Furthermore, we congratulate Amgen on the initial ruling in the case, but we look forward to competing with them to provide patients with the best possible product after a successful appeal."

Dynepo is a novel human erythropoietin for the treatment of anemia. Clinical development testing of Dynepo as a treatment for anemia of renal failure in dialysis and pre-dialysis patients has been completed, and Aventis Pharma has been pursuing marketing authorization in the both the U.S. and Europe.

A copy of the opinion is available on the District Court of Massachusetts` website at http://www.mad.uscourts.gov.

TKT will host a conference call at 10:00 am EST Monday, January 22, 2001 to discuss the recent decision in the Dynepo patent litigation. Participants may access the call by dialing 800-789-2340 in the U.S. or 706-634-0776 outside of the U.S. This call will also broadcast live over the Internet at http://www.tktx.com/f_investor.htm. Please dial in 5 to 10 minutes prior to the scheduled conference call time.

The conference call will be archived on the Internet for 24 hours for those who are unable to hear it live. A replay of the call will also be accessible by telephone after 12:00 pm EST Monday, January 22, 2001 through midnight EST on Tuesday, January 23, 2001. To replay the call, dial 800-642-1687 in the United States and 706-645-9291 internationally, using access code 888986.

Transkaryotic Therapies, Inc. (TKT) is a biopharmaceutical company dedicated to the development and commercialization of products based on its three proprietary development platforms: Gene-Activated® proteins, Niche Protein™ products, and Gene Therapy. The Company`s gene activation technology is a proprietary approach to the large-scale production of therapeutic proteins, which does not require the cloning of genes and their subsequent insertion into non-human cell lines. TKT`s Niche Protein product platform is based on protein replacement for the treatment of rare genetic diseases, a group of disorders characterized by the absence of certain metabolic enzymes. The Company`s Gene Therapy technology, known as Transkaryotic Therapy™, is focused on the commercialization of non-viral, ex vivo gene therapy products for the long-term treatment of chronic protein deficiency states.



Braininvestor

[winetrader]

Hallo an alle TKTX-ler in dieser schweren Stunde.

Hätte in den nächsten Jahren schnell aufwärts gehen können, wenn...
Aber der jetzige Kurs preist einen negativen Ausgang des Patentstreites voll ein.
Man sollte sich auch einmal genau das rating von SC. Cowen anschauen, die in der Biotechbranche meines Erachtens durch einen sehr qualifizierten Berater-/Analystenstab Beachtung zu schenken ist.
Beide Werte, AMGN und TKTX bleiben unverändert in deren rating!!!! (=buy)
Damit wird meine obige (Kurs-)Aussage verdeutlicht und rechtfertigt einen eher enttäuschenden Kursanstieg bei AMGN!!
Das Urteil bezieht sich auch (nur) auf den amerikanischen Markt.
Weiterhin ist die GA*-Technologieplattform nur ein Bereich im Unternehmen. Nischenproteine und die immer interessanter werdende Gentherapie sind weitere hochinteressante Bereiche bei TKTX!!
Die jetzigen Kurse sind für langfristige Anleger sehr interessant.
Kurz- und mittelfristig wird TKTX u.U. zu einem Zockerpapier und soll nur von wirklich überzeugten TKTX-ler dauerhaft gehalten werden.
Dennoch, auch ich bin enttäuscht, werde aber bei weiteren Kursverlusten und einer darauffolgenden Bodenbildung möglicherweise nochmals nachkaufen, denn TKTX hat know how und enormes Potenzial!
Sollte der heutige Kurs, ca. 20 US$, wirklich das Ende der Fahnenstange sein, dann interpretiere ich das als eine gewisse Stärke und würde für eine mittelfristige Sicht nicht unbedingt negativ eingestellt sein.
Aber dennoch ist ein kleiner Traum geplatzt und die Amerikaner interessiert es weniger ob TKTX außerhalb der Staaten dieses Präperat verkaufen darf oder nicht.
Ob dieses Urteil wirklich so gut für die Biotechbranche ist, ist ebenfalls anzuzweifeln, denn die in früheren Jahren oftmals sehr breit definierten Patente lassen neuen innovativen Biotechunternehmen wenig Luft. Für die aktuellen Big player im Biotechbereich bestimmt ein Vorteil, aber nicht unbedingt zum Wohle der Menschheit.

winetrader

[gholzbauer]

Dumm gelaufen für TKTX (und BBBiotech), aber wenn AMGN den Prozeß verloren hätte, würde mein Depot vermutlich noch weit mehr unter einer allgemeinen Biotech-Schwäche leiden.
Daß der Prozeß so deutlich verloren ging, wirft einen dunklen Schatten auf GA-II (vermutlich Neupogen), vielleicht auch auf die rechtliche Position von Dynepo in Europa und Japan.
Ich werde die nächsten Tage meine TKTX für das Finanzamt umschaufeln, bleibe jedoch langfristig dabei, vielleicht mit etwas verringerter Gesamtzahl.
Ärgerlich fand ich, daß TKTX heute in Deutschland bis ca. 15:30 ausgesetzt waren. Wenn das einreißt, können wir die deutschen Börsenöffnungszeiten doch gleich vollständig an New York anpassen.

[OneYear]

aber das ganz grosse schlachtfest blieb aus.
tktx wird sich wieder erholen imho.
so long

[gholzbauer]

Monday April 30, 12:00 pm Eastern Time
RESEARCH ALERT-DB Alex Brown raises Transkaryotic
NEW YORK, April 30 (Reuters) - Deutsche Banc Alex. Brown said on Monday that it raised its rating on biotech company Transkaryotic Therapies Inc. (NasdaqNM:TKTX - news) to strong buy from market perform, based on increased visibility for Replagal sales in Europe.

Deutsche Banc Alex. Brown set a $28 price target on Transkaryotic, based on the stock trading 50 times the 2005 estimate, discounted at an annual trate of 35 percent.

Analyst Dennis Harp said in a research note that the investment bank is forecasting the European approval and launch of Replagal in the second half of the year, with sales of $7 million in 2001, $47 million in 2002, $90 million in 2003, $114 million in 2004 and $132 million in 2005.

U.S. approval of Raplagel is expected at some point in 2001 and U.S. sales could reach $158 million by 2005, the firm said in a research note.

Transkaryotic shares rose $1.96 or more than 12 percent to $17.81. The stock has a 52-week trading range of $12.50 to $56.13.

[gholzbauer]

Replagal führt uns zum Erfolg.

Ich hoffe, daß es möglichst viele "Spezialisten", die unter 15 $ noch glaubten, bei TKTX short gehen zu müssen, böse erwischt hat.

[gholzbauer]

Noch was am Rande.
BBBiotech hat im Quartal I/2001 die Beteiligung an TKTK fast halbiert, dafür ihre Actelion-Beteiligung fast vervierfacht.

TKTX in $, Nasdaq:






Verzockt, würde ich sagen.

[gholzbauer]

Thursday May 17, 12:00 pm Eastern Time
RESEARCH ALERT-Transkaryotic price target raised
NEW YORK, May 17 (Reuters) - Deutsche Banc Alex. Brown on Thursday said it raised its price target on biotech company Transkaryotic Therapies Inc. (NasdaqNM:TKTX - news) to $34 from $28 a share, citing increased visibility of trials for its heart treatment drug, Replagal.

The firm said the company`s drug show cardiac improvement in patients with Fabry`s disease, a condition which causes heart disease, kidney failure or stroke.

The broker expects sales of Replagal in Europe of $7 million in 2001, $47 million in 2002, $90 million in 2003, $114 million in 2004 and $132 million in 2005.

The broker, who expects the drug to be approved in the U.S. this year, said the results of a randomized, double blind, placebo-controlled trial of Replagal demonstrated that the product is safe and effective in reversing cardiomyopathy, a disorder that prevents the heart muscles from pumping effectively, commonly associated with Fabry`s disease.

Shares rose $1.75, or 6.4 percent, to $28.93 on Nasdaq in morning trade. The company`s 52-week range is $12.50 to $56.13.

[sorry-baby]

Hallo gholzbauer !

Bin seit über einem Jahr dabei, habe als Langfristanleger alle
Rücksetzer mitgemacht, auch bei meinen anderen Bios.....
Ich bin überzeugt, daß wir bis zum Winter wieder bei ungefähr
55 US§ stehen...ohne etwas von der Charttechnik zu verstehen,
sieht er für mich einfach vorbildlich aus.....Richtung Norden..

Viel Glück
sorry-baby

[gholzbauer]

55$ ist vielleicht ein bißchen hoch gegriffen. Ich wäre mit 40$ dieses Jahr und 60$ nächstes Jahr schon zufrieden, es sei denn, Genzyme könnte bei Fabry deutlich geschlagen werden. Ein Erfolg im Amgen-Prozeß wäre die große Chance für TKTX gewesen, mit der Beschränkung auf die Nischenproteine ist die Story relativ lahm. Ich bleibe aber bis auf weiteres dabei.


P.S. Bei Actelion bin ich jetzt übrigens long.

[sorry-baby]

Hallo !

Habe soeben bei boerse-go gelesen, daß TKTX gestern erneut
ein strong-buy erhalten hat...von Growth Pacific

Viel Glück
sorry-baby

[shaman]

Thursday June 7, 7:03 am Eastern Time
Press Release
SOURCE: Transkaryotic Therapies, Inc.
New England Journal Of Medicine Article on TKT`s Non-Viral Gene Therapy System Demonstrates Promising Clinical Effects in Patients With Severe Hemophilia A
CAMBRIDGE, Mass., June 7 /PRNewswire/ --Investigators at Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts reported results from the first human investigation of hemophilia A gene therapy. The study, which appears in today`s issue of the New England Journal of Medicine (NEJM), demonstrates that Transkaryotic Therapies, Inc.`s (Nasdaq: TKTX - news) non-viral ex vivo gene therapy system delivering Factor VIII to patients with severe hemophilia A was safe and well-tolerated over one year of monitoring in the first six treated patients. The report also provides evidence that the delivery of Factor VIII using TKT`s non-viral gene therapy system may be a practical treatment option for this patient population and may be effective in reducing the occurrence of spontaneous bleeding, a frequent and potentially lethal symptom in patients with severe hemophilia.

The paper describes the results from a Phase I clinical trial conducted in six patients with severe hemophilia A. After administration of the patients` own genetically-engineered cells expressing Factor VIII, patients were monitored for twelve months. Following the procedure, four of the six patients had increased Factor VIII activity levels. The increase in Factor VIII activity correlated with a decrease in bleeding and/or a reduction in the use of Factor VIII replacement therapy to treat bleeding. Furthermore, two of the patients had no spontaneous bleeding episodes for nearly one year following implantation of the genetically-engineered cells.

``We are pleased that there were no side effects related to the use of genetically modified cells expressing Factor VIII,`` said David A. Roth, M.D., principal investigator of the study and lead author of the NEJM article. ``We are also very excited by the clinical activity we have seen this early on in the program since we were cautious in the number of cells returned to the patient initially and in the amount of Factor VIII the cells were producing at the time the cells were administered.``

``We are encouraged that our research in hemophilia and gene therapy may have a dramatic effect on the way we treat this disease,`` said Richard F Selden, M.D., Ph.D., President and Chief Executive Officer of TKT. ``We believe that delivering our non-viral approach has the potential to be a safe and effective treatment option. If further clinical testing confirms the results seen to date, it may be possible to prevent bleeding episodes entirely.``

The Phase I open-label study was initiated in November 1998 at Beth Israel Deaconess Medical Center in Boston, Massachusetts under the direction of David A. Roth, M.D., Director, Hemophilia Clinical Research and Assistant Professor of Medicine at Harvard Medical School. The study was designed to assess the safety of Factor VIII gene therapy over two years in twelve patients with hemophilia A. All twelve patients are currently enrolled in the study.

The paper was authored by David A. Roth, M.D., Nicholas E. Tawa, Jr., M.D., Ph.D. and Joanne M. O`Brien, R.N., of Beth Israel Deaconess Medical Center and Douglas A. Treco, Ph.D. and Richard F Selden, M.D., Ph.D. of Transkaryotic Therapies, Inc.

About Transkaryotic Therapy(TM)

In Transkaryotic Therapy, TKT`s non-viral gene therapy system, a small sample of a patient`s cells is removed in an outpatient procedure and sent to the Company`s manufacturing facility where the cells are genetically- engineered to produce the desired protein for extended periods of time. After the cells and the protein have been tested to ensure both safety and functionality, an appropriate number of genetically-engineered cells is returned to the physician and implanted back into the patient. For hemophilia A, the cells are injected into the fatty tissue of the abdomen.

TKT believes Transkaryotic Therapy is well suited to allow safe and long- term delivery of therapeutic proteins for the treatment of chronic protein deficiency states, including anemia, hemophilia, hypercholesterolemia, and diabetes. This technology is designed to take advantage of a patient`s ability to synthesize therapeutic proteins for extended periods, potentially providing improved therapeutic outcomes, a reduction of side effects due to overdosing or underdosing of conventional proteins, improved patient compliance, and significant reductions in cost due to less frequent administration.

About Hemophilia A

Hemophilia A is an X-linked, hereditary bleeding disorder caused by the absence or defect of a blood clotting protein, Factor VIII. As a result, when a person with hemophilia A has a bleeding episode, the bleeding may be prolonged due to the body`s inability to form blood clots. Patients who are affected with hemophilia A experience frequent spontaneous bleeding, most commonly into their joints and soft tissues, with bleeding into vital organs that may also be life-threatening. Bleeding episodes may be painful, and over time, recurrent joint bleeding may result in debilitating destruction of the joints. Currently, patients with hemophilia A are dependent on injections of Factor VIII produced by genetic engineering or purified from human plasma, to help control a bleeding episode. It is estimated that approximately 50,000 individuals worldwide are affected with hemophilia A.

About TKT

Transkaryotic Therapies, Inc. (TKT) is a biopharmaceutical company dedicated to the development and commercialization of products based on its three proprietary development platforms: Gene-Activated® proteins, Niche Protein(TM) products, and Gene Therapy. The Company`s gene activation technology is a proprietary approach to the large-scale production of therapeutic proteins, which does not require the cloning of genes and their subsequent insertion into non-human cell lines. TKT`s Niche Protein product platform is based on protein replacement for the treatment of rare genetic diseases, a group of disorders characterized by the absence of certain metabolic enzymes. The Company`s Gene Therapy technology, known as Transkaryotic Therapy(TM), is focused on the commercialization of non-viral, ex vivo gene therapy products for the long-term treatment of chronic protein deficiency states.

This press release contains forward-looking statements that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward- looking statements. Without limiting the foregoing, the words, ``believes,`` ``anticipates,`` ``plans,`` ``expects,`` ``estimates,`` ``intends,`` ``should,`` ``could,`` ``will,`` ``may,`` and similar expressions are intended to identify forward- looking statements. There are a number of important factors that could cause the Company`s actual results to differ materially from those indicated by such forward-looking statements set forth under the caption ``Certain Factors That May Affect Future Results`` in the Company`s Quarterly Report on Form 10-Q for the quarter ended March 31, 2001 which is on file with the Securities and Exchange Commission and incorporated herein by reference. These include, without limitation, the following: (1) whether any of the Company`s Gene- Activated protein, Niche Protein or gene therapy product candidates will advance in the clinical trial process, (2) whether such clinical trials will proceed in a timely manner, (3) whether the clinical trial results will warrant continued product development, (4) whether the required regulatory filings, such as Investigational New Drug applications and Biologics License Applications, are made in a timely manner, (5) whether the Company`s products will receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies, (6) if such products receive approval, whether they will be successfully distributed and marketed, (7) whether patent litigation in which the Company is involved or may become involved are resolved in a manner adverse to the Company, (8) the effects of competitive products on the Company`s proposed products, and (9) the Company`s dependence on third parties, including collaborators, manufacturers and distributors.

Gene-Activated® is a registered trademark and Niche Protein(TM), Replagal(TM), TKT(TM), and Transkaryotic Therapy(TM) are trademarks of Transkaryotic Therapies, Inc.

Please visit our web site at www.tktx.com for additional information about Transkaryotic Therapies, Inc.


CONTACT:
Justine E. Koenigsberg
Director, Corporate Communications
[phone]

SOURCE: Transkaryotic Therapies, Inc.

[gholzbauer]

TKTX 10:55 AM 26.72 -5.24 -16.40%

[gholzbauer]

10:30AM Transkaryotic (TKTX) 28.88 -3.12: Sources at SG Cowen telling Briefing.com that TKTX will price a 2.5 mln secondary offering tonight.


Halb so wild, denke ich.
Ungleich wichtiger wird die FDA-Entscheidung sein.

[gholzbauer]

Monday October 22, 9:47 am Eastern Time
Genzyme`s Fabrazyme drug approval pushed back by FDA
NEW YORK, Oct 22 (Reuters) - Genzyme General (NasdaqNM:GENZ - news) must provide more information to regulators before they approve its Fabrazyme drug for Fabray disease, according to the U.S. Food and Drug Administration.

Genzyme received a letter from the FDA on Friday that is neither an approval nor a rejection but a request for more information.

The result is a blow to Genzyme because it is in a race with Transkaryotic Therapies Inc. (NasdaqNM:TKTX - news) to bring a treatment for Fabray disease to the U.S. market first. Whoever wins will receive so-called ``orphan`` drug status, which protects it against competition for seven years.

Analysts said the FDA`s decision was not unexpected. Some physicians, they said, are concerned that Genzyme`s data does not show improvement in the symptoms of Fabray disease, which include pain in hands and feet, and ultimately renal and cardiac failure.

The data, they said, show a decrease in the level of a substance which they believe cause the symptoms.

In August, both Genzyme and Transkaryotic Therapies won regulatory approval for their Fabray drugs in Europe. The two Cambridge, Massachusetts-based companies are competing for a market that industry experts estimate to be 5,000 or more world-wide.

[gholzbauer]

Transkaryotic jumps, biotechs mixed

By Ted Griffith, CBS.MarketWatch.com
Last Update: 9:55 AM ET Oct. 23, 2001


NEW YORK (CBS.MW) -- Shares of Transkaryotic Therapies moved out ahead of other biotechnology stocks in early trading Tuesday, following positive comments from an analyst about the biotech firm`s treatment for a rare genetic illness called Fabry disease.

Shares of Transkaryotic (TKTX: news, chart, profile) surged $2.18, or nearly 7 percent, to $35.05 in early trading. In a note to clients, SG Cowen biotechnology analysts said that Transkaryotic`s treatment for Fabry disease is selling well in Europe and appears to have an advantage over a competing treatment made by Genzyme. The SG Cowen analysts upgraded their rating on Transkaryotic stock from "buy" to "strong buy."

Shares of Genzyme General (GENZ: news, chart, profile), the primary division of Genzyme Corp., rose $1.75 to $50.45.

The overall biotech sector was mixed. The Amex Biotechnology Index (BTK: news, chart, profile) rose 0.3 percent and the Nasdaq Biotechnology Index (NBI: news, chart, profile) dipped 0.2 percent.

Ted Griffith is a reporter for CBS.MarketWatch.com

[gholzbauer]

11% im Plus heute. Ich bleibe aber vorerst bei meinen Kurszielen 40$ 2001, 60$ 2002.

---------------


Tuesday October 23, 8:32 am Eastern Time
Press Release
SOURCE: Transkaryotic Therapies, Inc.
TKT Awarded U.S. Patent Relating to Protein Production and Delivery For Gene Therapy
CAMBRIDGE, Mass., Oct. 23 /PRNewswire/ -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX - news) today announced that the U.S. Patent and Trademark Office has issued Patent No. 6,303,379 entitled, ``In Vivo Protein Production and Delivery System for Gene Therapy.`` The patent covers the transfection of cells relating to the delivery of therapeutic proteins. This technology offers several advantages to conventional gene therapy approaches including safety, ease of administration, dose precision, and cost effectiveness.

``The issuance of this patent further strengthens TKT`s intellectual property portfolio in the area of non-viral gene therapy,`` said Mary S. Consalvi, Vice President and Chief Intellectual Property Counsel at TKT. ``Utilizing this novel technology, we have the potential to treat a variety of human diseases and conditions, among them anemia, diabetes, hemophilia, hypercholesterolemia, and multiple sclerosis, through the production and delivery of therapeutic proteins.``

A copy of the patent described above is available on the World Wide Web at http://www.uspto.gov.

[Siby]

Hallo gholzi...,

wenns so weiter geht,kannste neue Kursziele ausdenken.

Gruß

[gholzbauer]

Ich erhöhe meine Kursziele um jeweils 10$


Transkaryotic Takes European Lead in Race to Treat Rare Disease

By Adam Feuerstein
Staff Reporter
10/29/2001 07:12 PM EST


Transkaryotic Therapies (TKTX:Nasdaq - news - commentary - research - analysis) is on track to grab two-thirds of the European market for a new treatment for Fabry disease, and this could spell trouble for rival Genzyme General (GENZ:Nasdaq - news - commentary - research - analysis).

Both companies received European approval to sell their Fabry drugs on Aug. 3. Since then, doctors and patients seem to be heavily favoring Transkaryotic`s drug, Replagal, because it has demonstrated superior efficacy and safety, and it is easier to administer, according to a survey conducted by SG Cowen.

Transkaryotic and Genzyme are locked in a neck-and-neck race to get their drugs approved in the U.S. European preferences are significant in that they offer a clue to how the drugs will perform financially once approval here is granted.

Fabry is a rare, painful and fatal genetic disorder that affects only about 5,000 people worldwide. But at an estimated treatment price of as much as $175,000 annually, Fabry represents an $875 million market.

SG Cowen quizzed doctors and Fabry referral centers in Europe and found sentiment leaning heavily in Replagal`s favor, says analyst Eric Schmidt. Schmidt and his team believe that according to their findings, about 1,500 European patients will seek treatment for Fabry disease by 2005, with two-thirds using Replagal.

"We called everyone in Europe that matters on this, and the sentiment for Replagal was strong," says Schmidt, who on Monday raised his Transkaryotic rating to strong buy from buy. SG Cowen has performed underwriting work for the company.

Transkaryotic and Genzyme are free to sell their Fabry drugs in Europe, but this might not be the case in the United States. The Food and Drug Administration is supposed to render its decision under "orphan" drug status rules, which means that one drug will be given exclusive rights to the U.S. market for seven years. The FDA could, however, disregard the orphan drug laws if it finds both drugs approvable but one more effective than the other.

There are no clear answers as to how, or when, the FDA will make its decision. On Oct. 22, Genzyme acknowledged that it must submit additional information about its drug, Fabrazyme, before regulators will render a decision. This is the second time the FDA has asked for additional data about Fabrazyme, and this is typically an ominous sign.

But Morgan Stanley analyst Caroline Copithorne actually saw a silver lining for Genzyme in the FDA request. In a research note, she said the FDA response "clarifies the additional steps necessary for approval in the U.S. and eliminates this source of potential uncertainty."

Copithorne raised her Genzyme rating to strong buy from outperform, based partly on the FDA request and partly on strong Genzyme third-quarter results. Her firm hasn`t done underwriting for Genzyme.

SG Cowen`s Schmidt sees it differently, believing that the FDA twice requesting more data about Fabrazyme is a just a polite way of saying they don`t like the drug.

"I don`t think it`s likely that Fabrazyme gets approval first," Schmidt says. (Bill Tanner, another SG Cowen analyst, does rate Genzyme strong buy, based on the company`s existing drug portfolio. SG Cowen doesn`t do underwriting for the company.)

Transkaryotic executives have been mostly mum about a timetable for an FDA decision on Replagal. Like Genzyme, Transkaryotic also has had to submit additional data on its drug, but neither the company nor the FDA has disclosed whether the responses were adequate or accepted.

In related news, Transkaryotic reported Monday a third-quarter net loss of $15.9 million, or 60 cents per share. Analysts polled by Thomson Financial/First Call were expecting a third-quarter loss of 77 cents per share.

Shares of Transkaryotic were up 19 cents to $38.03 in Monday trading. Genzyme shares fell $1.54, or 2.8%, to $52.78.

[gholzbauer]

Monday November 5, 5:51 pm Eastern Time
Genzyme, Transkaryotic set for Fabry drug hearing
(UPDATE: Updates with comments from Genzyme clinical research executive, adds background)

By Toni Clarke

NEW YORK, Nov 5 (Reuters) - Two biotechnology companies vying to be the first to bring a drug for the rare Fabry disease to the United States will face off in a patent infringement hearing on Thursday that could largely decide the outcome of their dispute.

Cambridge, Massachusetts-based Genzyme General Corp. (NasdaqNM:GENZ - news), together with the Mount Sinai School of Medicine, have sued Transkaryotic Therapies Inc. (NasdaqNM:TKTX - news), claiming its Replagal drug infringes a patent associated with Genzyme`s Fabrazyme.

Genzyme is seeking to block Replagal from being launched in the United States, and an as yet to be determined amount in damages. A trial is set for the first quarter of 2002.

The so-called Markman hearing, scheduled in the U.S. District Court for the District of Delaware on Thursday, will define the meaning of certain claims in Genzyme`s patent, potentially setting the parameters for the trial itself.

``You can win or lose a case on a Markman hearing,`` said Paul Clark, partner in the law firm Clark & Elbing, which specializes in biotechnology.

At stake is a market that analysts estimate could reach $800 million by 2005, from almost nothing today. Both Fabrazyme and Replagal are sold in Europe. Whichever drug first gains U.S. approval will receive ``orphan`` drug status, which gives it protection from competitors for seven years.

Fabry disease, which affects some 5,000 people worldwide, is characterized by a buildup of fat in blood vessels that feed the heart, kidney, brain and other organs. The excess fat can eventually cause the organs to collapse.

MAMMALIAN CELLS

Genzyme claims its drug and Transkaryotic`s are essentially the same, and that differences between them comes down to dose levels. Infusions of Fabrazyme take two to three hours and are up to five times as strong as Replagal infusions, which take just 40 minutes to administer.

In response to Genzyme`s patent claims, Transkaryotic maintains that its technology is qualitatively different from that used by Genzyme, and that its drug is simply more efficient.

``We don`t do what they do and we don`t make what they make,`` said Dan Geffken, Transkaryotic`s chief financial officer.

Ravi Thadhani, assistant professor of medicine at Harvard Medical School and staff nephrologist at Massachusetts General Hospital, has studied Fabry disease extensively, with the help of a research grant from Transkaryotic`s.

``In my opinion the molecules are different,`` he said. ``One is made in human cells and the other in Chinese hamster ovary cells. I would be surprised if Genzyme had a strong case of infringement.``

Thadhani`s view is echoed by numerous physicians and researchers, but has yet to be supported by hard evidence, something that irritates Genzyme.

``I hear these views all the time in corridors at conferences, but I have yet to hear these differences presented in a peer review form,`` said Mark Goldberg, senior vice president of clinical research at Genzyme. "It`s very frustrating.

Genzyme said its patent covers all types of mammalian cell, whether human or animal.

``Mount Sinai was the first to invent a mammalian cell line that makes large quantities of the enzyme that treats Fabry disease,`` said Tom DesRosier, Genzyme`s chief patent counsel. ``When you get a patent on a product, then you can block others from making and using it no matter how they make it.``

Even if Genzyme wins the case, it is possible victory could be compromised, since some experts claim Replagal may be the more effective product, something Genzyme denies.

While both show effectiveness when analyzed under a microscope, only Replagal shows effectiveness in patients, Thadhani and others have said.

Genzyme says its trial showed a stabilization in kidney function and an improvement in pain. Goldberg said ``it would take years`` for either Replagal or Fabrazyme to show true clinical benefit, in the sense of significant improvement in symptoms. Right now, stabilization of kidney function counts as a clinical improvement, he said.

QUICKER INFUSION

Jan Medina, an analyst at ABN Amro Inc., said the only definitive way of comparing the two drugs would be to run a head-to-head trial. But he said some conclusions can be drawn from existing data.

``My sense is that Fabrazyme has a bit of an edge in the more severe patients, while Replagal has an edge in less severe patients,`` he said. Medina has an ``add`` recommendation on Genzyme`s stock. He doesn`t follow Transkaryotic.

Others see bigger divergences.

``The difference in infusion time speaks to a potential difference in the molecules,`` which would bolster Transkaryotic`s legal case, said Daniel Dubin, president of MedaCorp., a healthcare consulting firm. ``Replagal is probably more effective and it`s clearly easier to use.``

Last month the U.S. Food and Drug Administration told Genzyme it must provide it with more information if it is to receive approval to market Fabrazyme in the United States. Transkaryotic said it is still in discussions with the FDA about its own regulatory filing.

[gholzbauer]

Das sollte dem Kurs heute Unterstützung geben.



Thursday November 29, 7:34 am Eastern Time
Press Release
SOURCE: Transkaryotic Therapies, Inc.
TKT Announces Favorable Outcome in Markman Hearing in Replagal(TM) Patent Litigation
- TKT to Move for Summary Judgment -
CAMBRIDGE, Mass., Nov. 29 /PRNewswire/ -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX - news) announced today that the Honorable Gregory M. Sleet of the U.S. District Court of Delaware has issued an opinion from the ``Markman hearing`` favorably construing the claims of U.S. Patent No. 5,356,804 in an infringement suit Genzyme Corporation and Mount Sinai School of Medicine brought against TKT. Next week TKT intends to move for summary judgment that Replagal(TM) does not infringe this patent.

Richard F Selden, M.D., Ph.D., President and Chief Executive Officer said, ``We are delighted with the Court`s construction of the claims involved in this case. Based on the Court`s decision, we continue to believe that TKT does not infringe this patent and, furthermore, believe that the Court should grant our motion for summary judgment.``

Markman hearings are typically held prior to the commencement of a patent infringement trial to determine the meaning of certain words or phrases in the claims of the patent in question. At this Markman hearing, the Court construed the key disputed phrase ``chromosomally integrated`` from the `804 patent to mean a combination of ``the chromosome of the host cell and an exogenous nucelotide sequence encoding human alpha-galactosidase A with a promoter and selectable marker.`` TKT`s technology for making Replagal is not based on such a combination. In addition, many other claim terms were also construed in TKT`s favor, and the Court incorporated its definition of ``chromosomally integrated`` into a number of the claim terms.

On July 25, 2000, Genzyme and Mt. Sinai School of Medicine brought suit against TKT in the U.S. District Court of Delaware in Wilmington claiming that TKT`s activities relating to Replagal (agalsidase alfa) enzyme replacement therapy for Fabry disease infringe one or more claims of the `804 patent. TKT answered and counterclaimed that the `804 patent was invalid and was not infringed by TKT. The Markman hearing was held on November 8, 2001. If the case continues, a jury trial in this action is scheduled to begin in March 2002.

[gholzbauer]

Friday December 14, 3:39 pm Eastern Time
Press Release
SOURCE: Genzyme General
Genzyme Moves Toward Appeal in Patent Infringement Suit Against TKT
CAMBRIDGE, Mass., Dec. 14 /PRNewswire/ -- Genzyme Corp. announced today that the U.S. District Court in Delaware has, at the company`s request, clarified certain claim constructions in its Markman ruling of November 29, 2001. Based on this clarification, Genzyme will concede non-infringement in its patent lawsuit against Transkaryotic Therapies Inc. in order to expedite an appeal of the Markman ruling to the Court of Appeals for the Federal Circuit.

Genzyme is suing TKT for patent infringement in connection with the manufacture of Replagal(TM), TKT`s enzyme replacement therapy for Fabry disease. The suit alleges infringement of U.S. patent No. 5,356,804, which is exclusively licensed to Genzyme by Mount Sinai School of Medicine. The patent is directed to methods of making alpha-galactosidase in mammalian cells, as well as the genetically-engineered cells themselves. Alpha-galactosidase is the enzyme that is deficient in patients with Fabry disease. Genzyme`s unextended patent protection expires in October 2011.

Genzyme General (Nasdaq: GENZ - news), a division of Genzyme Corp., is developing Fabrazyme (agalsidase beta), an enzyme replacement therapy for patients with Fabry disease. Fabrazyme is approved in the European Union, and Genzyme is pursuing authorization to market the product in the United States and elsewhere.




Monday December 17, 8:50 am Eastern Time
Press Release
SOURCE: Transkaryotic Therapies, Inc.
TKT Announces Victory in Genzyme Patent Litigation - No Infringement; Trial Cancelled -
CAMBRIDGE, Mass., Dec. 17 /PRNewswire/ -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX - news) today announced that the Honorable Gregory M. Sleet of the U.S. District Court of Delaware has informed the parties he will dismiss the patent litigation Genzyme Corporation and Mount Sinai School of Medicine brought against TKT. The suit, brought last year, claimed that TKT`s activities relating to Replagal(TM) (agalsidase alfa) enzyme replacement therapy for the treatment of Fabry disease infringe one or more claims of U.S. Patent No. 5,356,804. The order came in response to a motion by Genzyme asking the Court to clarify its recent ``Markman`` ruling construing the term ``chromosomally integrated.``

``We are pleased with the decision that our Replagal product does not infringe their patent,`` said Richard F Selden, M.D., Ph.D., President and Chief Executive Officer of TKT. ``The fact that the Court decided to dismiss this case before completing briefing on our motions for summary judgment of non-infringement and invalidity confirms our belief that this was a frivolous case. The important thing now is that our time, resources and energy can be focused on improving the lives of patients with Fabry disease.``



--------------

[gholzbauer]

As of Jan 3, 5:46 PM

10:08AM Transkaryotic Therapies (TKTX) 43.55 +0.25: The biotech sector has been among the leaders of the recent three-month market advance. In fact, the Biotech Index or BTK is among the few sector indices currently trading consistent with early July levels. Shares of Transkaryotic Therapies have outperformed even the BTK, and are currently well within striking distance of their 52-week high. The company develops gene therapies that activate malfunctioning genes, inducing them to produce proteins necessary for proper operation. Instead of relying on cloned genes, Transkaryotic is researching a way to graft `healthy` DNA sequences directly onto genes, which then reproduce properly. TKTX is getting a lift today on the company`s announcement that its enzyme replacement therapy designed to treat Hunter syndrome has been assigned orphan drug status in both Europe and the United States. Generally, if a product with orphan drug designation subsequently receives the first marketing approval for the designated indication, the product is entitled to orphan drug exclusivity. In Europe, orphan drug designation grants up to ten years of marketing exclusivity for serious disorders affecting not more than 185,000 people. In the United States, orphan drug designation provides up to seven years of marketing exclusivity for disorders affecting less than 200,000 people. A look at the three-month chart on TKTX illustrates one other point that caught our attention. The chart is currently carving out a cup-and-handle formation which is among the more bullish technical patterns. In addition, the top of the cup and the handle both approximate its 52-week high (at 45.27) which means once the break higher does take place there will be little facing it in the way of resistance. Over the very near term, look for 45.00 to 45.27 to represent notable resistance while 42.00 should serve as a relatively solid floor. If the pattern follows through with the expected break higher, we would be looking at a near to intermediate-term swing target of about 48.00. Yet if TKTX should fail support at 42.00 on a closing basis, it would be time to reassess our bullish near-term outlook. -- Mike Ashbaugh, Briefing.com

[faku]

hallo Transkaryotic - aktionäre
gibts davon übrhaupt welche ???
ich bin mit meinen aktien extrem glücklich,denn ich habe bei 24€ nachgekauft
wie siehts bei euch aus
kursziel nach den neuesten meldungen ??

[faku]

hi
ist der absturz zu erklären ??
oder einfach ne schlechte bio - aktien zeit ??

[Deichkind01]

Servus faku,
wo gabs denn das Papeie für 24 € ?. Und ja es ist eine schlechte Zeit für Bio. aber schau doch mal: 883040 wenn Du Dein Geld los werden willst.
Gruß

[gholzbauer]

Im Chart hat sich die Möglichkeit eines stärkeren Rückganges bereits im Januar abgezeichnet, als die kurzfristigen Durchschnittslinien (30 Tage bzw. 38 Tage) bei gut 40$ nach unten durchbrochen wurden. Die allgemein schlechte Stimmung für Biotech hat die letzten paar Tage ihr übriges getan. Erst bei einer Bodenbildung/Trendwende sollte man zurückkaufen.

[debull]

Die anhaltende Schwäche von TKTX und der Aufschwung von GENZ
am Freitag geben mir zu denken. Sollte die Stimmung in der
FDA i.S. Fabry-Medikament doch in Richtung GENZ schwenken?

[gholzbauer]

Bei GENZ war es wohl hauptsächlich eine Reaktion nach den relativ starken Verlusten der letzten Zeit.
Einen einzelnen Handelstag würde ich nicht überbewerten.

Was hältst du von GZTC bei 3,6$, debull?
Wäre schon wieder nur noch knapp über Cash.
Bis 5$ oder 6$ sollten sie wieder laufen können.

[debull]

@gholzbauer
GZTC scheint günstig bewertet. Für 2002 und 2003 werden
aber weitere Verluste erwartet.
Die Börse ist unberechenbar. Warum sollte nicht irgendein Gerücht die Kurse hochtreiben. Den Abwartstrendkanal haben sie ja verlassen.

Eigentlich kaufe ich nur Werte, die Gewinne machen. Wenn ich von diesem Prinzip abweiche und mich von Spekulationsfieber verbunden mit
ein Quentchen Gier leiten lasse, geht das in die Hose -
siehe TKTX.

Die FDA könnte langsam wirklich eine Entscheidung treffen.

[gholzbauer]

Wednesday April 17, 12:00 pm Eastern Time
Reuters Business
Genzyme sees FDA OK of Fabrazyme later this year

NEW YORK, April 17 (Reuters) - Biotechnology firm Genzyme General (NasdaqNM:GENZ - news) said on Wednesday that its expects U.S. regulators to approve its treatment for Fabry disease later this year.

``Our reasoning is, based on discussions with the FDA, that it is a reasonable projection to say we will get approval of Fabrazyme later this year,`` said Henri Termeer, Chairman and Chief Executive of Genzyme Corp., parent corporation of Genzyme General.

Fabrazyme is an experimental drug to treat Fabry disease, a rare genetic disorder caused by the lack of an enzyme.



---------------


TKT hält sich anders als GENZ sehr bedeckt, was die Gespräche mit der FDA betrifft.
Sollte TKTXs Replagal bei der Zulassung GENZs Fabrazyme zuvorkommen, wäre es der Coup schlechthin.

[debull]

Die Lage im Biotech-Bereich ist aktuell bescheiden: Nur wenige Aktien haben seit Jahresanfang zulegen können, die überwiegende Mehrzahl ist dagegen gefallen. Vor diesem Hintergrund ist ein Minus von 13,3 Prozent, wie es Transkaryotic Therapies (TKT) aufzuweisen hat, gar kein schlechtes Ergebnis.

Die Zahlen für das erste Quartal sind insgesamt recht positiv. Die Verluste sind deutlich höher ausgefallen als im entsprechenden Vorjahresquartal: Mit minus 18,47 Mio. Dollar ist ein Anstieg von 31,6 Prozent festzustellen. Dabei hat in den ersten drei Monaten 2001 ein Sondererlös in Höhe von 2,79 Mio. Dollar zur Verbesserung des Ergebnisses beigetragen. Außerdem liegt der Verlust pro Aktie mit 54 Cent exakt in der von Analysten prognostizierten Höhe.

Gute Fortschritte machen die Umsätze. Insgesamt hat TKT Erlöse in Höhe von 6,6 Mio. Dollar erzielt, wovon nur 552,000 Dollar auf Lizenzvereinbarungen entfallen. Der Löwenanteil stammt aus Produktverkäufen, namentlich von Replagal. Das Mittel zur Behandlung der seltenen Fabry-Krankheit hat 6,06 Mio. Dollar erwirtschaftet. Da im ersten Quartal 2001 kein Vergleichswert vorliegt, weil Replagal erst im Herbst 2001 in Europa die Zulassung erhalten hat, dient das vierte Quartal des Vorjahres als Maßstab: Gegenüber diesem Zeitraum beträgt die Steigerung 124 Prozent.

Die Umsätze sind noch viel zu niedrig, um die hohen Kosten für Forschung und Entwicklung zu schultern. TKT hat in den ersten drei Monaten in diesem Bereich unvermindert stark investiert: Die Aufwendungen sind um 24 Prozent auf 20,4 Mio. Dollar gestiegen, was auf umfangreich! e klinische Tests zurückgeht. Auch im Bereich Verwaltung, Marketing und Sonstiges sind die Kosten um 30 Prozent auf 6,4 Mio. Dollar in die Höhe geschnellt. Diese Mehrausgaben hängen mit der Vermarktung von Replagal in Europa und der Vorbereitung des Markteintrittes in den USA zusammen.

Dort liefert sich die Gesellschaft ein Rennen mit dem Biotech-Giganten Genzyme, das Fabrazyme als Konkurrenz ins Feld schicken will. Bislang sieht es so aus, als ob Replagal die Nase vorn haben wird. Das Unternehmen ist optimistisch, dass die Zulassung erfolgen wird. Daniel Geffken, Finanzvorstand von TKT, meint, es sei mehr die Frage „wann“, denn die Frage „ob“. Anders als in Europa, wo auch Fabrazyme zugelassen worden ist, erwartet Geffken, dass man sich in den USA den begehrten „Orphan-Drug-Status“ nicht mit Fabrazyme nicht teilen muss.

Für das gesamte Geschäftsjahr ! erwartet Geffken unverändert Vekaufserlöse von Replagal in Höhe von 35 bis 45 Mio. Dollar. Der Verlust wird mit 70 bis 80 Mio. Dollar am oberen Ende der bisherigen Prognose liegen. Analysten erwarten ein Minus je Aktie von 2,09 Dollar, wobei die Schätzungen von minus 2,07 bis minus 2,11 Dollar reichen.

Autor: Alexander Apel (© wallstreet:online AG) 13:43 03.05.2002

[gholzbauer]

Monday July 8, 1:38 pm Eastern Time

Press Release

SOURCE: Transkaryotic Therapies, Inc.

TKT Announces Meeting of FDA Advisory Committee to Review Replagal(TM) BLA for Fabry Disease

- Endocrinologic and Metabolic Drugs Advisory Review Scheduled for September 27, 2002 -

CAMBRIDGE, Mass., July 8 /PRNewswire-FirstCall/ -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX - News) today announced that the Company`s Biologics License Application (BLA) for Replagal(TM) (agalsidase alfa), an enzyme replacement therapy for the long-term treatment of Fabry disease, will be considered before the U.S. Food and Drug Administration`s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee. The advisory panel will meet to discuss Replagal on September 27, 2002.

"We are pleased that the FDA is taking this next, important step in the review of our BLA," said Richard F Selden, M.D., Ph.D., President and Chief Executive Officer of TKT. "We look forward to the opportunity to make Replagal available to patients in the United States."

Advisory committees provide the FDA with independent advice on marketing applications. The FDA generally follows the recommendations of its advisory committees, but is not bound to do so.

Since August 2001, Replagal has been approved for commercial use in over 20 countries, including the European Union, the Czech Republic, Iceland, Israel, New Zealand, Norway, and Switzerland.

...

-----


TKTX 2:16pm 38.053 +4.133 +12.18%
GENZ 2:16pm 18.952 -0.918 -4.62%
^BTK 2:15pm 318.98 -6.56 -2.02%

[gholzbauer]

Oops...


Monday July 8, 2:16 pm Eastern Time

Press Release

SOURCE: Genzyme Corp.

Genzyme Announces FDA Panel Will Review Fabrazyme BLA

CAMBRIDGE, Mass., July 8 /PRNewswire-FirstCall/ -- Genzyme General (Nasdaq: GENZ - News), a division of Genzyme Corp., today announced that its biologics license application for Fabrazyme® (agalsidase beta) will be reviewed by the U.S. Food and Drug Administration`s Endocrinologic and Metabolic Drugs Advisory Committee on September 26.

Fabrazyme is an investigational enzyme replacement therapy intended for the treatment of Fabry disease, a rare and potentially fatal genetic disorder. Genzyme looks forward to the opportunity to present its application to the advisory committee and is confident in a positive outcome. Fabrazyme has been approved for use in the 15 member states of the European Union and in several other countries.

Genzyme General develops and markets therapeutic products and diagnostic products and services. Genzyme General has five therapeutic products on the market and a strong pipeline of products in development focused on the treatment of genetic disorders and other chronic debilitating diseases with well-defined patient populations. Genzyme General is a division of the biotechnology company Genzyme Corporation.

Genzyme® and Fabrazyme® are registered trademarks of Genzyme Corporation. All rights are reserved.

This press release contains forward-looking information, including statements about the outcome of the advisory panel meeting. Actual results may differ materially depending on numerous factors.

Genzyme`s press releases and other company information are available at www.genzyme.com and by calling Genzyme`s investor information line at 1-800- 905-4369 within the United States or 1-703-797-1866 outside the United States.



TKTX 2:21pm 36.06 +2.14 +6.31%
GENZ 2:21pm 20.669 +0.799 +4.02%

[gholzbauer]

Hallo Leute,
ich habe meinen TKTX-Anteil bei ca. 40 E bzw. $ stark zurückgefahren.
Zur Zeit überwiegen wohl die Risiken.
Aus der EPO-Ecke rechne ich eher mit schlechten Nachrichten, s. unten angefügter Text. Bei positiver Überraschung könnte man vermutlich immer noch einsteigen, analog Orphan Medical (wichtige Zulassung bekommen und nur 10% gestiegen).
Andernfalls würde ich sie erst zu 25$ zurückkaufen.
Andere Biotechs erscheinen mir aktuell interessanter.
Z.B. LGND um die 7$ und GENZ deutlich unter 20$.






Transkaryotic Therapies interessant

Quelle:
SUNDAY-MARKET
Datum:
24.06.02


Dem äußerst spekulativ ausgerichteten Anleger empfehlen derzeit die Analysten von "sunday-market" die Aktien von Transkaryotic Therapies zum Kauf. Erbkrankheiten würden oft nur auf dem Fehlen eines einzigen Enzyms beruhen wie z. B. bei der seltenen Fabry-Krankheit. Hier funktioniere ein für den Fettabbau notwendiges Protein nicht, was zu einer Ablagerung von unvollständig abgebauten Fetten im Gewebe führe. Viele Patienten würden im 40. bis 50. Lebensjahr an Herzinfarkt, Schlaganfall oder Nierenversagen sterben. Transkaryotic Therapies Inc. (TKT) habe sich auf die Behandlung derartiger Erbkrankheiten spezialisiert. Den Fabry-Patienten werde Replagal, ein "Ersatzenzym" verabreicht, das zwar die Krankheit nicht heilen, aber zumindest die Symptome lindern könne. Die Zahl der Fabry- Patienten werde in Europa auf etwa 5. 000 geschätzt weswegen der sog. Orphan-Drug-Status in Europa erteilt worden sei. Dieser schütze das Medikament u. a. sieben Jahre vor Konkurrenzprodukten. Allerdings sei in Europa der ungewöhnliche Schritt getan worden, diesen Status zugleich an zwei Präparate zu vergeben. Auch Genzyme habe ein sehr ähnliches Präparat (Fabrazyme) entwickelt und die Zulassung dafür beantragt. So müssten sich erstmals zwei Konkurrenten um einen geschlossenen Markt streiten. Da pro Patient rund 160. 000 Dollar pro Jahr an potenziellem Umsatz erwirtschaftet werden sollten, ergebe sich auch bei der kleinen Zahl ein ansehnliches Potenzial. Für die USA stehe die Zulassung und die Orphan-Drug- Entscheidung noch aus. Bei der zweiten Produktlinie von TKT sei Streit mit etablierten Pharma- und Biotech-Firmen vorprogrammiert. Der 20 Milliarden-US-Dollar-Markt gentechnisch hergestellter Proteine - man denke an Insulin, Interferon, Interleukin etc. - sei durch Patente hermetisch gegen Neulinge aus der Biotech-/Pharma-Branche abgeriegelt. Um diesen Schutzwall zu knacken, habe sich TKT ein völlig neues Verfahren zur Herstellung therapeutischer Proteine überlegt. So werde Amgens Blockbuster Epogen bei TKT nicht von gentechnisch manipulierten Zellen (Hefe oder Bakterien) produziert, sondern von genaktivierten menschlichen Zellen. Obwohl Dynepo, TKTs Äquivalent zu EPO, bereits in der EU zugelassen worden sei, könne mit der Vermarktung, die Aventis übernehmen solle, nicht begonnen werden. In England und den USA hätten die Patentklagen von Amgen in erster Instanz Erfolg gehabt. Die Urteile im von TKT angestrengten Berufungsverfahren würden nach der Sommerpause erwartet. Zwei Fragen seien für die Zukunft von TKT besonders entscheidend: Erstens, wer werde den Orphan-Drug-Status für das Fabry-Medikament in den USA erhalten, TKT oder Genzyme? Eine salomonische Regelung der FDA wie in der EU scheine eher unwahrscheinlich. Zweitens, wie werde der Patentstreit gegen Amgen ausgehen? Insbesondere letztere Entscheidung könnte TKT bei positivem Ausgang schnell zu einem Big Player der Biotechnologie-Branche machen. Der Markt rechne mit positivem Ausgang, ansonsten wäre eine Marktkapitalisierung von knapp 1,4 Milliarden US-Dollar bei einem Umsatz von weniger als 50 US-Dollar Millionen in diesem Jahr und geschätzten 120 Millionen US-Dollar im nächsten Jahr kaum zu verstehen. Ein akzeptables Kurs-Umsatzverhältnis von 3 angesetzt, müsste TKT in den nächsten Jahren seinen Umsatz verzehnfachen. Äußert spekulativ veranlagte Investoren können sich nach Ansicht der Analysten von "sunday-market" einige Stücke von TKT ins Depot nehmen. Kräftige Ausschläge nach oben oder unten sollten einkalkuliert werden. Der Stoppkurs sollte bei 29 US-Dollar platziert werden.

[debull]

Bin gestern auch raus. Scheinen mir doch sehr hoch bewertet.

[gholzbauer]

TKTX 8:27am 43.42 +4.54 +11.68%

Was`n jetz los?
Auffällig starke vorbörsliche Aktivitäten für TKTX.
Ob der Quartalsbericht heute eine Überraschung bringt?

[puhvogel]

London, July 31 (Bloomberg) -- Transkaryotic Therapies Inc. won a U.K. appeal of a judgment that said the U.S. biotechnology company`s anemia treatment infringed on a patent for Amgen Inc.`s marketing-leading Epogen, a law firm said.

A U.K. appeals court said Amgen`s patent is valid, but decided Transkaryotic`s Dynepo didn`t infringe, the U.K. law firm Bristows said in an e-mailed statement. Amgen will likely appeal the ruling, the firm said.

[gholzbauer]

marketwatch.com

Amgen (AMGN: news, chart, profile), the fourth-most heavily weighted Nasdaq 100 stock, slumped $3.09, or 6.8 percent, to $42.40 after rival biotech firm Transkaryotic Therapies (TKTX: news, chart, profile) said it had scored a legal victory in its ongoing patent dispute with the company. Pre-open volume in Amgen as of 9:00 a.m. ET was 2 million shares.

Transkaryotic surged $3.12, or 8 percent, to $42.02.





AMGN wird bestimmt nochmal in Berufung gehen.
übrigens:
TKTX gewinnt aktuell 100 Mio MktCap
AMGN verliert 3500 Mio

[gholzbauer]

Jetzt sind TKTX ebenfalls im Minus.
Wenn das Urteil zu Ungunsten von Transkaryotic (und Aventis) ausgefallen wäre, hätte TKTX vermutlich 10$ oder mehr verloren.
Es lohnt sich im derzeitigen Marktumfeld tatsächlich nicht, Risiken einzugehen.

[gholzbauer]

Boah, da haben wir aber Glück gehabt.
Nachbörslich unter 16$.
Die Puts hätte ich mir nach der Terminverschiebung etwas genauer ansehen sollen!
Ich glaube, TKTX kommen möglicherweise die nächsten Tage noch auf den Cashwert (ca. 8$) herunter.
Unter 10$ geh ich evtl. wieder long.

[panik]

TKT Reports Preliminary Results From New Clinical Study of Replagal(TM)
Wednesday November 27, 7:56 am ET
- FDA Complete Response Letter Defers Decision on Replagal and Provides Additional Guidance on Renal Pathology Surrogate Endpoint as Basis for Replagal Approval -


CAMBRIDGE, Mass., Nov. 27 /PRNewswire-FirstCall/ -- Transkaryotic Therapies, Inc. (Nasdaq: TKTX - News) today announced preliminary data from an 80 patient double-blinded, placebo-controlled Phase III study of Replagal(TM) (agalsidase alfa), its enzyme replacement therapy for Fabry Disease. Preliminary review of the six-month data did not show a statistically significant difference between treated and placebo patients for the primary endpoint of renal function, as measured by glomerular filtration rate. Additional analyses of these data and data for other endpoints are ongoing.
ADVERTISEMENT


"Based on our earlier clinical data, we believed that Replagal would demonstrate a statistically significant effect on kidney function after six months of treatment. In hindsight, we believe renal benefits might have been observed more readily over a longer treatment period," said Richard F Selden, M.D., Ph.D., President and Chief Executive Officer of TKT. "Although the results of the current clinical study are disappointing, we continue to believe Replagal is saving lives, and we believe that longer term data from these patients will confirm Replagal`s efficacy."

TKT also announced receipt of a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration ("FDA") in accordance with the previously disclosed deadline for the FDA`s review. As expected, the CRL indicates that the FDA believes the data are inadequate for final approval action at this time, primarily because of continuing questions concerning efficacy, but also indicates that the FDA plans "to discuss the data at the Endocrinologic & Metabolic Drugs FDA Advisory Committee and seek their input regarding its interpretation." The meeting is scheduled for January 14, 2003.

The CRL included a small number of well-defined issues and provided guidance as to the steps TKT should take in order to bolster its case for an accelerated approval based on a histopathological surrogate endpoint. "We believe our data will demonstrate that renal pathology correlates with renal function, and, accordingly, is an appropriate surrogate marker. We look forward to the opportunity to make our case for Replagal in January based on both clinical and surrogate endpoints," Dr. Selden added.

Replagal is approved in 25 countries, but there is currently no approved therapy for this life-threatening disease in the United States. To date, TKT has submitted to the FDA five clinical studies covering Replagal exposures for periods of up to 2.5 years. The Company believes that its FDA submissions demonstrate that Replagal is well-tolerated and has a positive effect in several areas, including kidney pathology and function, cardiac structure and function, and metabolism.

About Replagal(TM) Enzyme Replacement Therapy

Replagal is a human alpha-galactosidase A protein, produced by genetic engineering technology, intended for long-term treatment of patients with Fabry Disease. It works by replacing the deficient alpha-galactosidase A with active enzyme to stop or reverse the disease process. Patients receive 0.2 mg/kg of Replagal every other week over a 40-minute intravenous infusion and many patients receive Replagal at home rather than in a hospital setting. Replagal is approved for commercial use in 25 countries, including the 15 countries of the European Union. In the United States, Replagal is an investigational product.

About Fabry Disease

Fabry Disease is an inherited rare genetic disorder caused by deficient activity of the lysosomal enzyme alpha-galactosidase A, affecting both males and females, which results in premature mortality in the fourth or fifth decade of life due to kidney disease, heart disease and stroke. In patients with Fabry Disease, globotriaosylceramide (Gb3) accumulates in various organs and tissues of the body due to the deficiency of alpha-galactosidase A. Many cells are damaged by Gb3 including epithelial cells of the kidney, myocardial cells, cells of the autonomic nervous system, and endothelial, perithelial, and smooth muscle cells in the large blood vessels. As a result, the deposits of this material can result in severe kidney damage, cardiovascular disease, stroke, and extreme pain. Due to its rarity and vast array of symptoms, diagnosis is often difficult and affected individuals have a significantly reduced quality of life and a greatly shortened life expectancy. TKT estimates that Fabry Disease affects approximately 5,000 patients worldwide.

About TKT

TKT is a leading biotechnology company developing and commercializing human proteins for a broad range of diseases, with a major focus on rare genetic diseases. TKT currently markets one product, Replagal(TM) (agalsidase alfa) for the treatment of Fabry Disease in the European Union and certain other countries and has four products in clinical testing. TKT is headquartered in Cambridge, Massachusetts and has a majority owned subsidiary in Sweden, TKT Europe-5S AB, which is responsible for European sales and marketing activities. Additional information on TKT is available on the Company`s website at www.tktx.com.

This press release contains forward-looking statements, including statements regarding the possible approval of Replagal, the timing of an advisory panel meeting to consider Replagal, and other statements containing the words "believes," "anticipates," "plans," "expects," "will" and similar expressions. These forward-looking statements are based on the Company`s opinion and expectations as of the date hereof and are subject to risks and uncertainties that could cause actual results to differ materially. Important factors that could cause results to differ include, but are not limited to, the outcome or changes in timing of the advisory committee meeting; when the FDA will approve Replagal, if at all; whether Replagal clinical data will be deemed sufficient to support regulatory approval of Replagal in the U.S.; whether future trials will need to be conducted; whether competing products will reduce any market opportunity that may exist; the impact of competing products on the market for the treatment of Fabry disease, including with respect to the market acceptance of Replagal, and other factors set forth under the caption "Risk Factors" in the Company`s Quarterly Report on Form 10-Q for the quarter ended September 30, 2002 which is on file with the Securities and Exchange Commission and are incorporated herein by reference. The Company does not undertake any obligation to update any forward-looking statements

Replagal(TM) is a trademark of Transkaryotic Therapies, Inc.

Contact:
Justine E. Koenigsberg
Director, Corporate Communications
[phone]

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Source: Transkaryotic Therapies, Inc.