TRIMERIS STUDIE VON T20 ERFOLGREICH ! - 500 Beiträge pro Seite

[t.1]

Roche and Trimeris Announce 24-Week Results From First Phase III Study Of HIV Fusion Inhibitor T-20
4/18/02





- Pivotal Study Meets Primary Endpoint -

NUTLEY, N.J. and DURHAM, N.C., Apr 18, 2002 /PRNewswire-FirstCall via COMTEX/ -- Roche and Trimeris, Inc. (Nasdaq: TRMS) today announced positive 24-week results from the first pivotal Phase III study of T-20, the furthest in clinical development of an investigational class of antiretrovirals called fusion inhibitors. The results from this first study (TORO 1: T20-301) as well as the results from a second ongoing study (TORO 2: T20-302) will form the basis of the submission to regulatory authorities.
In the TORO 1 study, T-20 administered in combination with an individualized antiretroviral treatment regimen was shown to provide a significant additional decrease in the amount of virus in the blood as compared to an individualized antiretroviral treatment regimen alone. TORO 1 was conducted in 491 HIV-1 infected patients who were treatment-experienced and/or had documented resistance to each of the three classes of currently available antiretrovirals. At baseline, patients had a median HIV RNA level of over 5 log10 copies/mL and extensive prior exposure to multiple anti-HIV drugs. Patients who received T-20 as part of their combination regimen achieved a reduction in HIV levels of 1.697 log10 copies/mL compared to 0.763 log10 copies/mL for those who were randomized to the control arm, calculated in accordance with the study protocol. The primary efficacy endpoint for the study, the difference in the magnitude of decrease in HIV between the two arms, was 0.934 log10 copies/mL and was statistically significant (p<0.0001). Roche and Trimeris expect to present these data in detail at scientific conferences in the next several months.

"These Phase III results demonstrate that T-20 enhanced the activity of combination therapy over 24 weeks," said William M. Burns, Head of Pharmaceuticals, Roche. "These results are even better than the positive results of earlier studies had led us to expect, and we are delighted to share this information today."

"Roche and Trimeris are extremely pleased with the results from this trial. This important milestone brings T-20 one step closer to patients in need of new options to treat their HIV disease," commented Dr. Dani Bolognesi, Chief Executive Officer of Trimeris, Inc.

Safety Results

Through 24 weeks, the incidence of grade 3 and 4 laboratory abnormalities and clinical adverse events was similar between the T-20 and control arms. Additionally, drug discontinuation at 24 weeks was approximately 10 percent overall and was very similar in both arms. While most patients on the T-20 arm experienced injection site reactions, only 3 percent of patients discontinued the study as a consequence. Other adverse events (>10 percent), where the incidence was greater on the T-20 arm than on control, were insomnia, headache, peripheral neuropathy, and dizziness. It was not possible to establish a causal relationship between these other adverse events and T-20.

Study Design

TORO 1 (T-20 vs. Optimized Regimen Only), previously known as T20-301, and TORO 2 (previously known as T20-302) are randomized, open-label trials that enrolled approximately 1,000 patients at 112 centers worldwide. TORO 1 is being conducted in North America and Brazil, while TORO 2 is being conducted in Australia, Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, Switzerland and the United Kingdom. Patients in the trials were treatment-experienced and/or had documented resistance to each of the three classes of currently-available antiretrovirals. In addition, each patient was required to have a plasma HIV-RNA level of greater than 5,000 copies/mL. Patients are expected to undergo treatment for 48 weeks, with an optional 48-week treatment extension.

At entry, genotypic and phenotypic resistance testing was used to aid in the selection of an antiretroviral regimen, consisting of three to five drugs, including if appropriate, up to two newly approved or investigational drugs. After selection of the regimen, patients were randomized 2:1 to receive either the regimen in combination with T-20 or the regimen alone. Patients randomized to T-20 receive T-20 administered as one 90 mg subcutaneous self-injection twice-daily.

Early Access to T-20

In November 2001, Roche and Trimeris announced the initiation of the T-20 open-label safety study (T20-305) to provide T-20 to 450 patients around the world. The study is ongoing and is being conducted in Australia, Brazil, Europe, and North America. An expansion of this trial over the next several months will continue to make T-20 available prior to approval for patients with advanced HIV disease who are unable to construct a viable antiretroviral regimen with currently approved agents. Additionally, Roche and Trimeris are committed to starting early access programs in the second half of this year when increased drug supply is expected to be available.

Meeting the Growing Need For a New Class of HIV Drugs

One of the biggest challenges facing people living with HIV is resistance to currently available therapies. Thirty to fifty percent of patients are infected with a strain of the virus that has developed resistance to one or more antiretrovirals, thereby reducing the treatment options available to them. Roche and Trimeris are committed to discovering and developing treatments for patients in need of new options and expect to invest approximately half a billion U.S. dollars to bring fusion inhibitors to people living with HIV/AIDS.

Long-Term Commitment to HIV Research and Development

Roche and Trimeris are working together to mobilize the considerable resources required to support the rapid development of T-20, the first member of a new class of investigational anti-HIV drugs known as fusion inhibitors. T-20, currently in Phase III clinical trials, is the furthest along in clinical development in the entry inhibitor class. T-1249, a second generation fusion inhibitor being developed by Roche and Trimeris, is in Phase I/II clinical trials. Unlike existing AIDS drugs that work inside the cell and target viral enzymes involved in the replication of the virus, T-20 inhibits fusion of HIV with host cells before the virus enters the cell and begins its replication process. In June 2001, Roche and Trimeris announced a joint research agreement to identify and develop additional HIV fusion inhibitor peptides.

T-20 has fast track designation from the FDA in the U.S. for the treatment of HIV-infected individuals. Fast track is granted to facilitate the development and expedite the review of applications for drugs that are intended to treat serious or life-threatening disease and that demonstrate the potential to address an unmet medical need.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world`s leaders in pharmaceuticals, diagnostics and vitamins. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people`s health, well-being and quality of life. Among the company`s areas of therapeutic interest are: dermatology; genitourinary disease; infectious diseases, including influenza; inflammation, including arthritis and osteoporosis; metabolic diseases, including obesity and diabetes; neurology; oncology; transplantation; vascular diseases; and virology, including HIV/AIDS and hepatitis C.

For more information on the Roche pharmaceuticals business in the United States, visit the company`s website at: http://www.rocheusa.com.

About Trimeris, Inc.

Trimeris is a development stage, biopharmaceutical company engaged in the discovery and development of novel therapeutic agents that block viral infection by inhibiting viral fusion with host cells. Trimeris` lead product candidate, T-20, which inhibits fusion of the human immunodeficiency virus (HIV) with host cells, is currently in Phase III clinical trials and has received fast track designation from the FDA. Trimeris` second fusion inhibitor product candidate, T-1249, which also inhibits HIV fusion, has received fast track designation from the FDA and is in Phase I/II clinical testing.

For more information on Trimeris, Inc., visit the company`s Web site at www.trimeris.com

Trimeris Safe Harbor Statement

[starbull]

Hallo,
jetzt noch in Frankfurt günstig kaufen! Die Nachricht ist in den USA erst heute Nacht bekannt geworden!She. Yahoo.
Viel Glück allen!

[t.1]

@starbull
das ist genau so wie du schreibst.wie man sieht geht es schon kräftig los erster kurs wohl um 52-54$
grüße t.1

[Leraunt]

Hallo,


ich habe von Trimeris vorher noch nix gehört,.. daher die Frage: lohnt es sich och, zu diesne Kursen einzusteigen?
Denn aufgrund der NAchricht lönnte doch ein kleiner Hype entstehen... Und wenn nicht kann man sie ja liegen lassen, wenn in einem Jahr die Milliarden sprudeln sollten solche Kurse doch ein Witz sein. Denn laut Onvista sind sie glaube ich etwa 800 - 900 Mio € Wert.

Wie sind die Meinungen?

Grüße. Leraunt

[t.1]

Trimeris to Present at the Deutsche Bank Securities Annual Health Care Conference
4/30/02



DURHAM, N.C., Apr 30, 2002 /PRNewswire-FirstCall via COMTEX/ -- Trimeris, Inc. (Nasdaq: TRMS) announced today that it will present at the Deutsche Bank Securities Health Care Conference on Tuesday, May 7, 2002 at 11:30 a.m. EDT. The conference is being held at the Baltimore Marriott Waterfront Hotel in Baltimore, Maryland. Trimeris` presentation will be webcast live for investors and available for replay for 14 days following the conference. The webcast can be accessed from either www.db.com/conferences or www.trimeris.com.
Trimeris is a development stage biopharmaceutical company engaged in the discovery and development of novel therapeutic agents that block viral infection by inhibiting viral fusion with host cells. Trimeris` lead product candidate, T-20, which inhibits fusion of the human immunodeficiency virus (HIV) with host cells, is currently in Phase III clinical trials and has received fast track designation from the FDA. Trimeris` second fusion inhibitor product candidate, T-1249, has also received fast track designation from the FDA and is in Phase I/II clinical testing. For more information about Trimeris, please visit the Company`s website at www.trimeris.com.

[t.1]

Trimeris akkumulieren
14.05.
--------------------------------------------------------------------------------

sunday-market

Dem spekulativ ausgerichteten Anleger empfehlen derzeit die Analysten von "sunday-market" die Aktien von Trimeris (WKN 910178) zu akkumulieren.

Seit Beginn der AIDS-Epidemie hätten sich bis heute insgesamt fast 40 Millionen Menschen mit HIV infiziert. Damit der gefürchtete Virus nach der Aufnahme in die Blutbahn in eine menschliche Zelle eindringen und sie infizieren könne, benötige er eine geeignete Andockstelle. Der wichtigste unter diesen sogenannten Rezeptoren sei für HIV der CD4-Rezeptor. Dieser sei vor allem auf Lymphozyten zu finden, einer Untergruppe der weißen Blutkörperchen, die für die Immunabwehr wichtig seien. Erst nach dem Andocken und Eindringen in die Zelle würden sich die Viren vermehren und ihre Wirtszelle abtöten. Die Immunabwehr werde durch das Absterben der Lymphozyten geschwächt.

Alle bisherigen Medikamente, die sich gegen das AIDS-Virus richten würden, würden versuchen die Vermehrung der Viren innerhalb der Wirtszelle zu unterbinden. In den frühen 90er Jahren hätten die Gründer von Trimeris jedoch die Entdeckung gemacht, das spezielle Proteine das Andocken und Eindringen des HI-Virus in die Wirtszelle - auch Fusion genannt - verhindern könnten. Die Türen für das HIV in die Wirtszellen würden so einfach geschlossen. Seither arbeite Trimeris mit knapp 100 Mitarbeitern an der Entwicklung von zwei Fusionsinhibitoren, die gegen die Immunschwächekrankheit helfen sollten.

Im April seien die letzten Testreihen für das noch T-20 genannte Medikament mit besseren Ergebnissen abgeschlossen worden, als es angesichts der Resultate früherer Studien zu erwarten gewesen sei. Die Zulassung solle nun in der zweiten Jahreshälfte beantragt werden. Da das Projekt den sogenannten "fast-track"-Status von der US-Zulassungsbehörde FDA erhalten habe, könnte die Zulassung innerhalb von sechs Monaten erteilt werden und die Vermarktung 2003 beginnen. Der zweite Kandidat, T-1249 mit ähnlichem Wirkprinzip wie T-20, befinde sich noch in der ersten klinischen Phase.

Bereits 1999 hätten Trimeris und Roche eine Vereinbarung über die Vermarktung getroffen. Danach würden Trimeris und Roche das Produkt nach der Zulassung in Nordamerika gemeinsam vermarkten, während der Pharma-Riese die Rechte in allen anderen Märkten alleine halte. Kosten und Einnahmen in USA und Kanada würden geteilt, für die restliche Welt erhalte Trimeris Tantiemen. Nach Angaben von Roche könnte T-20 und das Nachfolgeprodukt Erlöse zwischen 500 Millionen und einer Milliarde US-Dollar erzielen.

Für Trimeris würde die Zulassung von T-20 der Durchbruch sein. Zwar müsse man für 2002 und 2003 weiterhin mit hohen Verlusten rechnen. Mit Beginn der Vermarktung von T-20 könnte sich die Lage für Trimeris jedoch grundlegend ändern. Marktkapitalisierungen wie sie Cephalon (3,3 Milliarden US-Dollar) oder gar Gilead (6 Milliarden US-Dollar) aufweisen würden, wären dann möglich. Aktuell belaufe sich der Wert von Trimeris auf 0,8 Milliarden US-Dollar. "Türen schließen! Abfahrt!" heiße es jedoch erst nach dem Okay der FDA. Ansonsten wäre "Türen schließen! Der Letzte macht das Licht aus!" angesichts der finanziellen Lage angebrachter. Spekulative Investoren könnten einige Stücke einsammeln.

grüße t.1

[puhvogel]

Der Autor hat unrecht. Die Ergebnisse einer Studie (Toro 2) stehen noch aus. Insofern ist eben noch nicht alles in Butter, auch wenn ein Scheitern der zweiten Studie erfahrungsgemäss eher unwahrscheinlich aber eben nicht unmöglich ist.
Nutley, NJ and Durham, NC (April 18, 2002)—Roche and Trimeris, Inc. (Nasdaq: TRMS) today announced positive 24-week results from the first pivotal Phase III study of T-20, the furthest in clinical development of an investigational class of antiretrovirals called fusion inhibitors. The results from this first study (TORO 1: T20-301) as well as the results from a second ongoing study (TORO 2: T20-302) will form the basis of the submission to regulatory authorities.

@t20: De facto hat sich ein Investment im Vorfeld der Studienergebnisse nicht gelohnt. Bei einem Scheitern wäre der Kurs angesichts der mauen Pipeline und dünnen Kasse um mindestens um 70 % nach unten abgerauscht. So konnte man die Aktie trotz der überraschend guten Studiendaten nur mit 10% Aufpreis einsammeln, als man Gewissheit hatte.
Das Chance/Risiko-Verhältnis stimmt jetzt viel mehr als noch vor einem Monat.

[t.1]

@puhvogel
es ist nicht richtig was du schreibst!
wenn du dir die mühe machst und unter der aktie den begrif BIOPHARMAHERSTELLER wählst und dann unter PERFOMENCE LISTE nachsehen würdest mußt du folgendes feststellen!!!
MITTELFRISTIG
3 MONATE= 24,55%
1 MONAT = 21,78%
1 WOCHE = 8,51 %
PLATZ 3 IN DER GESAMMTLISTE

LANGFRISTIG

6 MONATE = 29,86 %
9 MONATE = 51,52 %
1 JAHR = 33,33 %

PLATZ 5
das ist in dieser börsenzeit schon recht ordentlich
PS wer vor der bekannt gabe gekauft hat konnte an einem tag so wie ich in diesem trade gepostet habe 30% an einem tag erreichen .
der juli bringt noch schöne kurssteigerungen....für TRIMERIS.(TORO 2)
grüße t.1 (nicht t20)

[t.1]

kleiner zahlentausch
langfristig 9 monate = 25,98 %
1 jahr = 24,55 %
KANN SCHON MAL VORKOMMEN NACH 10 STUNDEN NACHTDIENST.
t.1

[puhvogel]

Die zweite Studie war auch erfolgreich.
Der Überraschungeffekt dürfte sich aber in Grenzen halten

Roche and Trimeris Announce 24-Week Results From Second Pivotal Study of HIV Fusion Inhibitor T-20

- Second of Two Phase III Studies Meets Primary Endpoint;
Companies Will Proceed with Filing US and EU Registration Packages In the Second Half of 2002 -

NUTLEY, N.J., and DURHAM, N.C., May 16 /PRNewswire-FirstCall/ -- Roche and Trimeris, Inc. (Nasdaq: TRMS) today announced positive 24-week results from the second pivotal Phase III study of T-20 (TORO 2), just four weeks after
reporting similarly positive 24-week results from the first Phase III study of T-20. Together, the results from TORO 2, as well as the results from the first study, TORO 1, will form the basis of the submission to regulatory
authorities.
T-20 is the furthest in clinical development in an investigational class of antiretrovirals called fusion inhibitors. Unlike currently approved classes of antiretrovirals that work inside the cell and target viral enzymes involved in the replication of the virus, clinical trials have shown that T-20 inhibits fusion of HIV with host cells before the virus enters the cell and begins its replication process.
The results from the TORO 2 study show that T-20 administered in combination with an optimized antiretroviral treatment regimen provides a significant additional decrease in the amount of virus in the blood as compared to an optimized antiretroviral treatment regimen alone. TORO 2 was conducted in 504 HIV infected patients in Europe and Australia who were treatment-experienced and/or had documented resistance to each of the three classes of currently available anti-HIV drugs.
At baseline, patients had a median HIV RNA level of over 5 log(10) copies/mL and extensive prior exposure to multiple anti-HIV drugs. At 24 weeks, patients who received T-20 as part of their combination regimen achieved a mean reduction in HIV levels of 1.43 log(10) copies/mL compared to a mean of 0.65 log(10) copies/mL for those who were randomized to the control arm, calculated in accordance with the study protocol. The primary efficacy endpoint for the study, the difference in the magnitude of decrease in HIV between the two arms at 24 weeks, was 0.78 log(10) copies/mL and was statistically significant (p<0.0001). Roche and Trimeris expect to present these data in detail at scientific conferences in the next several months.
"This is the second large pivotal study to demonstrate that T-20 significantly enhances the activity of combination therapy in treatment-experienced HIV patients over 24 weeks. The excellent results from TORO 2 confirm and build upon those from TORO 1, the first pivotal study," said Georges Gemayel, Vice President, Specialty Care, Roche. "Taken together, these data represent a significant milestone in our commitment to deliver new options for people living with HIV."
"The positive results from TORO 2 are both clinically and statistically significant. It is remarkable that both TORO studies consistently demonstrate the substantial treatment effect of T-20 across a diverse, treatment-experienced patient population from a number of countries. The Roche and Trimeris collaboration plan to proceed with filing registration packages for T-20 in the US and EU early in the second half of the year," said Dani Bolognesi, Chief Executive Officer, Trimeris. "This important milestone brings T-20, the first member of a new class of antiretrovirals, yet another step closer to patients in need."

Safety Results
Through 24 weeks, as in TORO 1, overall clinical adverse events aside from injection site reactions were similar between T-20 and control groups. Other adverse events (>10%) occurring more frequently in the T-20 group were
headache, fever, and asthenia. It was not possible to establish a causal relationship between these other adverse events and T-20. Grade 3 laboratory abnormalities were more frequent in the T-20 group, and Grade 4 laboratory
abnormalities were more frequent in the control group. In TORO 2, discontinuation at 24 weeks was 17 percent in the T-20 group and 5 percent in the control group. Patients experiencing virologic failure in the control
group could switch to a T-20 regimen and not discontinue the study. While most patients on the T-20 arm experienced injection site reactions, only 3 percent of patients discontinued the study as a consequence.

Early Access to T-20
In November 2001, Roche and Trimeris announced the initiation of the T-20 open-label safety study (T20-305) to provide T-20 to 450 patients around the world. The study is ongoing and is being conducted in Australia, Brazil,
Europe and North America. Roche and Trimeris are committed to starting early access programs in the second half of this year when increased drug supply is expected to be available.

Study Design
TORO 2 (T-20 vs. Optimized Regimen Only), previously known as T20-302, and TORO 1 (previously known as T20-301) are randomized, open-label trials that enrolled approximately 1,000 patients at 112 centers worldwide. TORO 2 is
being conducted in Australia, Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, Switzerland and the United Kingdom, TORO 1 is being conducted in North America and Brazil. Patients in the trials were treatment-experienced and/or had documented resistance to each of the three classes of currently-available antiretrovirals. In addition, each patient was required to have a plasma HIV-RNA level of greater than 5,000 copies/mL.
Patients are expected to undergo treatment for 48 weeks, with an optional 48-week treatment extension. At entry, genotypic and phenotypic resistance testing was used to aid in the selection of an antiretroviral regimen, consisting of three to five drugs, including if appropriate, up to two newly approved or investigational drugs. After selection of the regimen, patients were randomized 2:1 to receive either the regimen in combination with T-20 or the regimen alone. Patients randomized to T-20 receive T-20 administered as one 90 mg subcutaneous self-injection twice-daily.

[puhvogel]

@t1: Was Trimeris in irgenwelchen Zeiträumen gewonnen hat interessiert mich nicht. Interessant ist nur, ob man vor eventuellen positiven Ergebnissen einsteigt oder nicht.
Schlusskurs am 17. April, dem Tag vor der Ergebnis : 39.25 $
Dann schoss das Ding auf bis zu 52 $, um dann auf zwischenzeitlich auf 42.83 $ (7.5.2002) zu fallen.

Das sind kanpp 10 % gegenüber einem potentiellen 70 % Fall bei vollem Risiko, (eigentlich wäre mehr gerechtfertigt) wenn die Studie gescheitert wäre. Und sag mir nicht, dass Studien nicht scheitern können! Du wusstest ja nicht mal, dass da noch eine zweite Studie (die oben ) noch folgte.

[t.1]

@puhvogel
nur zur info ich kaufe die aktie schon 2 jahre lang.
zweitens bin ich in der info weiterleitung bei TRMS eingetragen.das kann man auf deren hompage veranlassen.in meinem ersten posting ist übrigens von (toro 2 zu lesen.)
nur eine kleine randbemerkung,ich bin seit der ersten aktie von dieser AG mit ganzem herzen dabei und verfolge alles zu diesem thema und umfeld.
grüße t.1

[t.1]

Study Design

TORO 1 (T-20 vs. Optimized Regimen Only), previously known as T20-301, and TORO 2 (previously known as T20-302) are randomized, open-label trials that enrolled approximately 1,000 patients at 112 centers worldwide. TORO 1 is being conducted in North America and Brazil, while TORO 2 is being conducted in Australia, Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, Switzerland and the United Kingdom. Patients in the trials were treatment-experienced and/or had documented resistance to each of the three classes of currently-available antiretrovirals. In addition, each patient was required to have a plasma HIV-RNA level of greater than 5,000 copies/mL. Patients are expected to undergo treatment for 48 weeks, with an optional 48-week treatment extension.
EIN AUSZUG AUS TRADE #1 vom 18.04.02

[Chris8888]

War das jetzt die TORO 2 Studie,dachte die kommt erst im Juli beim HIV Meeting in Barcelona?

[t.1]

@chris888
bin ich auch von ausgegangen,vorstand ist wohl sehr stolz auf ihre arbeit und ergebnise und konnten es wohl nicht abwarten.letzte hürde FDA ist in meinen augen so sicher wie das amen in der kirche.nicht so eine geldvernichtungs biotechfirma wie INTRABIOTICS wo placebo genausogut ist wie das super medikament von den(sollten besser ODOL herstellen das hat aufjedenfall eine wirkung).
grüße t.1

[t.1]

Study Results Demonstrate Safety and Antiviral Activity of T-1249
7/3/02




NUTLEY, N.J. and DURHAM, N.C., Jul 3, 2002 /PRNewswire-FirstCall via COMTEX/ -- Roche and Trimeris, Inc. (Nasdaq: TRMS) today announced final results of a Phase I/II study demonstrating that T-1249, a second-generation fusion inhibitor candidate, was well-tolerated and exhibited antiviral activity in HIV patients. Unlike existing anti-HIV drugs that work inside the cell and target viral enzymes involved in the replication of the virus, the fusion inhibitors T-1249 and T-20 are designed to block fusion of HIV with host cells before the virus enters the cell and begins its replication process. T-20, currently in Phase III clinical trials, is the most clinically advanced fusion inhibitor under investigation.
"The results of this study show that the favorable tolerability and antiviral activity trends observed at lower doses of T-1249 continued in doses of up to 200 mg once-daily," said Dr. Dani Bolognesi, Chief Executive Officer, Trimeris. "This clinical progress in the development of a second fusion inhibitor candidate is encouraging news for treatment-experienced HIV patients, who are in need of new therapies."

Results from T1249-101

The Phase I/II study evaluated the safety, pharmacokinetics and antiviral activity of T-1249 monotherapy in fusion inhibitor-naive, heavily treatment- experienced patients. The initial study included six cohorts dosed by subcutaneous injection once-daily (QD) and twice-daily (BID) (6.25 to 50 mg total daily dose); subsequently, the study was amended to add four cohorts (50 to 200 mg QD). Of 115 patients entering the study, 113 (98 percent) completed the 14-day dosing period. Dose-dependent decreases in HIV viral load were observed, including a median maximum change of -2.0 log(10) copies/mL in patients receiving T-1249 at a dose of 200 mg/day.

No treatment-related, clinically important laboratory abnormalities occurred and no dose-limiting toxicities were identified. Three serious adverse events possibly related to T-1249 occurred: grade 4 neutropenia (25 mg QD, previously reported), hypersensitivity reaction (25 mg BID, previously reported), and fever associated with injection site reaction (150 mg QD).

Meeting the Growing Need For a New Class of HIV Drugs

One of the biggest challenges facing people living with HIV is resistance to currently available therapies. Thirty to fifty percent of patients are infected with a strain of the virus that has developed resistance to one or more antiretrovirals, reducing the treatment options available to them. Roche and Trimeris are committed to discovering and developing treatments for patients in need of new options and are planning to invest approximately half a billion U.S. dollars to bring fusion inhibitors to people living with HIV/AIDS.

Long-Term Commitment to HIV Research and Development

Roche and Trimeris are working together to mobilize the considerable resources required to support the rapid development of T-20 and T-1249, the first members of a new class of investigational anti-HIV drugs known as fusion inhibitors. T-20, currently in Phase III clinical trials, is the furthest along in clinical development in the fusion inhibitor class, while T-1249 is currently being evaluated in Phase I/II clinical trials. In June 2001, Roche and Trimeris announced a joint research agreement to identify and develop additional HIV fusion inhibitor peptides.

T-20 and T-1249 have fast track designation from the FDA in the U.S. for the treatment of HIV-infected individuals. Fast track is granted to facilitate the development and expedite the review of applications for drugs that are intended to treat serious or life-threatening disease and that demonstrate the potential to address an unmet medical need

wiso der kurs auf diese nachricht fällt bei hohen umsätzen ist mir nicht klar.
@puhvogel hast du eine ahnung?
grüße t.1

[extremrelaxer]

Es wurde immerwieder kritisiert, dass Roche die Entwicklung von T20 hinauszögern würde. Wartet Roche vielleicht auf den Konkurs von Trimetris (nur geringe Cash-Reserven), um dann die Rechte an der Vermarktung von T20 in den USA vollkommen übernehmen zu können???
Ich kann mir die Kursentwicklung der letzten Tage nicht anders erklären!

Andere Erklärungen?

[puhvogel]

Ich habe das schon erwartet: Die wollen an neues Geld, worauf der Kurs regelmässig von den zukünftigen Käufern verkloppt wird.
Vorsichtig, trotz der exzellenten Ergebnisse von T-20 und der guten Nachrichten.

[t.1]

@puhvogel
kannst du bitte zu deinem standpunkt deutlicher werden ,KZ ect.beispiel z.b.
noch etwas zu T 20 der verkaufspreis liegt nun auch vor 15000 $ soll das medikament kosten . wie in der TAZ heute zu lesen war wurde daraufhin die veranstalltung von TRIMERIS gestört un die infostände von ROCHE und TRIMERIS umgeworfen.leute wurden angepöbelt.NUR zur info T 20 ist das schwierigste PROTEIN was ROCHE jemals hergestellt hat und das hat seinen preis.
grüße t.1

[extremrelaxer]

Was soll 15.000 $ kosten? Eine Medikamentenpackung, eine Monats-/Jahrestherapie oder die Behandlung auf Lebenszeit?

Danke für Antworten im voraus!

Grüsse, ER

[t.1]

schätzungen von bear stearns zu t20:
2003: 190 mio$
2004: 460 mio$
2005: 670 mio$

trimeris erhält 50% der erlöse in den usa und 10% von denen in europa.
die behandlung kostet für einen patienten 10000 $ pro jahr.

nun sind aber die zahlen raus und die behandlung kostet PRO JAHR UND PATIENT 15000 $ .die oberen zahle der schätzungen sind also höher anzusetzen.
grüße t.1

[t.1]

Roche and Trimeris Submit New Drug Application for FUZEON(TM), First Fusion Inhibitor to be Reviewed by FDA
9/17/02




NUTLEY, N.J. and DURHAM, N.C., Sep 17, 2002 /PRNewswire-FirstCall via COMTEX/ --
Roche and Trimeris, Inc. (Nasdaq: TRMS) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval to market FUZEON(TM) (enfuvirtide), formerly known as T-20. FUZEON is the frontrunner in a new class of anti-HIV drugs called "fusion inhibitors," developed for the treatment of HIV-1 infection in combination with other antiretroviral agents. Roche and Trimeris have requested priority review status from the FDA, which if granted would enable FUZEON to be reviewed within six months. In parallel with the filing, Roche and Trimeris confirmed the successful completion of the next major manufacturing milestone at the Roche Colorado manufacturing facility -- validation of the first three commercial batches of active ingredient for FUZEON. The companies also plan to file for FUZEON approval in Europe before the end of September.

Unlike existing anti-HIV drugs that work inside the cell, FUZEON has a unique mode of action that is designed to block HIV from entering the human immune cell. Consequently, FUZEON is active against HIV that is resistant to the currently available classes of anti-HIV drugs.

The regulatory submissions for FUZEON are based on 24-week data from two large, international Phase III trials, which indicate that patients on FUZEON plus an individualized background regimen of other antiretroviral drugs were twice as likely to achieve undetectable levels of HIV in the blood as compared to patients who received an individualized background regimen alone. FUZEON also provided a significant increase in immune cells at 24 weeks.

"Managing the treatment experienced patient has become increasingly complex and requires careful consideration of adherence, tolerability and resistance issues. The incidence of drug resistant HIV among already treated patients is growing dramatically. In fact, up to 78 percent of patients receiving treatment in North America and Europe are infected with a strain of the virus that has developed resistance to one or more anti-HIV drugs," said Dr. Daniel Kuritzkes, Director of AIDS Research, Brigham and Women`s Hospital, and Associate Professor of Medicine, Harvard Medical School. "It is clear that the need for new drugs such as FUZEON, which work in completely new ways to block HIV, will become ever more urgent."

"These filings are important steps for Roche," said Georges Gemayel, Vice President, Roche. "Drug resistance among patients with HIV has become one of the greatest medical challenges we are facing in this epidemic today. This is why new therapies are needed to help manage the changing face of this disease. FUZEON was one of the most difficult scientific and manufacturing challenges we have faced, but despite these challenges we have developed FUZEON at the fastest pace possible in response to this increasing patient need. We proceeded in parallel across Europe and North America and pending approval, anticipate launches early next year."

"FUZEON was designed from the outset to block HIV replication in a completely different manner than current antiretroviral drugs, while not substantially adding to the toxicity of other agents. FUZEON`s unique mode of action is designed to block HIV before entering the human cell and if approved, it will represent the first of a new class of anti-HIV drug in seven years," said Dr. Dani Bolognesi, CEO, Trimeris. "These milestones are the latest result of the ongoing joint development program between Roche and Trimeris."

Manufacturing Progress

FUZEON is one of the most challenging molecules ever chemically manufactured on such a large scale by the pharmaceutical industry. It takes 106 manufacturing steps to produce the active drug substance alone, which is around ten times more than that of a protease inhibitor. To coincide with the fast-paced clinical development program, the Roche Colorado manufacturing plant has been working 24 hours a day, seven days a week in the commercial scale-up of FUZEON. As a result, Roche and Trimeris have successfully completed the next major manufacturing milestone -- validation of the first three commercial batches of active ingredient for FUZEON. In addition, continued investments are being made in the ongoing development of the manufacturing facility.

Phase III 24-Week Results

The NDA filing for FUZEON is based on 24 week results from two international Phase III clinical trials, TORO 1 and TORO 2. TORO is an acronym for "T-20 vs Optimized Regimen Only."

In TORO 1, the first Phase III trial, conducted in North America and Brazil, 37 percent of patients who were treated with FUZEON in combination with an individualized background regimen had undetectable blood levels (less than 400 copies/mL) of HIV at 24 weeks, compared to 16 percent who received an individualized background regimen alone (p<0.0001). Combination therapy with FUZEON further reduced HIV viral load to less than 50 copies/mL in 20 percent of patients as compared to 7 percent who took combination therapy alone (P=0.0002). Patients in the FUZEON arm experienced a mean CD4+ cell increase of 76 cells/mm3, as compared to 32 cells/mm3 in the control arm (p<0.0001). Results from TORO 2, the second Phase III clinical trial, conducted in Europe and Australia, were consistent with findings from TORO 1. In TORO 2, 28 percent of patients who were treated with FUZEON in combination with an individualized background regimen had undetectable blood levels (less than 400 copies/mL) of HIV at 24 weeks, compared to 14 percent receiving an individualized background regimen alone (p<0.0001). Combination therapy with FUZEON further reduced HIV viral load to less than 50 copies/mL in 12 percent of patients as compared to 5 percent who took combination therapy alone (P=0.0099). Patients in the FUZEON arm experienced a mean CD4+ cell increase of 65 cells/mm3, as compared to 38 cells/mm3 in the control arm (p=0.023).

More About FUZEON

FUZEON, a fusion inhibitor, is administered as a twice-daily subcutaneous injection. Local injection site reactions were the most frequent adverse events associated with the use of FUZEON. In clinical studies, 98 percent of patients had at least one local injection site reaction; however, these reactions were seldom treatment limiting, with only three percent of patients discontinuing treatment with FUZEON.

The addition of FUZEON to background antiretroviral therapy generally did not increase the frequency or the severity of the majority of adverse events. The absolute difference in the most common adverse events seen between FUZEON plus an individualized background regimen of antiretroviral drugs and individualized background regimen alone was less than five percent. The events most frequently reported in patients receiving FUZEON plus an individualized background regimen were, headache, peripheral neuropathy, dizziness (excluding vertigo), insomnia, depression, appetite decrease, asthenia, myalgia, constipation and pancreatitis. All these events were seen more frequently in patients receiving FUZEON plus an individualized background regimen than in patients who received treatment without FUZEON. The majority of adverse events were of mild or moderate intensity.

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FUZEON(TM) Granted Priority Review Status by U.S. FDA

First HIV fusion inhibitor will have a target six month review period -

NUTLEY, N.J. and DURHAM, N.C., October 11 /PRNewswire-FirstCall/ -- Roche and Trimeris, Inc. (Nasdaq: TRMS) today announced that the U.S. Food and Drug Administration (FDA) has notified the companies that the New Drug Application (NDA) for FUZEON(TM) (generic: enfuvirtide, formerly known as T-20) is fileable and has been granted priority review status. Designed for the treatment of HIV-1 in combination with other antiretroviral agents, FUZEON is the most clinically advanced in an investigational class of anti-HIV drugs called "fusion inhibitors."

The priority review designation establishes a target six-month review period for the FUZEON NDA, which was submitted by Roche and Trimeris on September 16, 2002. The FDA will, therefore, take an action on the NDA by March 16, 2003 (the user fee action date). According to FDA policies and procedures, priority designation is granted to medications that, if approved, address unmet medical needs, offering a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease.

Unlike existing anti-HIV drugs that work inside the cell, FUZEON has a unique mechanism of action and is designed to block HIV before it enters the human immune cell. Consequently, FUZEON is active against HIV that is resistant to the currently available classes of anti-HIV drugs.

"The NDA submission for FUZEON was based on 24-week results of innovative and rigorous Phase III clinical trials in treatment-experienced patients. The granting of priority review status by the FDA is a critical milestone in bringing FUZEON to patients," said Georges Gemayel, Vice President Specialty Care, Roche.

"If approved, FUZEON will represent a significant advance in the treatment of HIV," said Dr. Dani Bolognesi, Chief Executive Officer, Trimeris. "Due to drug resistance and tolerability issues, the population of treatment- experienced patients in need of new therapies continues to grow. FUZEON has the potential to help address this unmet need.

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11.11.2002
Trimeris "buy"
Punk Ziegel & Co.

Rating-Update:

Die Analysten vom Investmenthaus Punk Ziegel & Co stufen die Aktie von Trimeris (WKN 910178) unverändert mit "buy" ein. Das Kursziel sehe man bei 89 US-Dollar.

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Second Pivotal Study Demonstrates Benefit of FUZEON(TM) Across Range of Treatment-Experienced HIV Patients

-Separate Study Shows Subcutaneous Administration Manageable for Most Patients

at 24 Weeks-

GLASGOW, Scotland, Nov. 18 /PRNewswire-FirstCall/ -- Roche and Trimeris, Inc. (Nasdaq: TRMS) today announced data from a second pivotal Phase III study (TORO 2) demonstrating that FUZEON(TM) (enfuvirtide), in combination with other antiretrovirals, provided benefit to treatment-experienced HIV patients at 24 weeks regardless of patient demographics, baseline disease stage or treatment history. In addition, a survey of treatment-experienced patients participating in the FUZEON pivotal studies found that twice-daily subcutaneous administration was manageable for the majority of patients through 24 weeks of treatment with patient education and support. These data were presented at the Sixth International Congress on Drug Therapy in HIV Infection being held in Glasgow, Scotland, Nov.17-21.

Regulatory submissions for FUZEON were filed in the U.S. and European Union in September for the treatment of HIV-1 infection in combination with other antiretroviral agents. FUZEON was granted priority review status in the U.S. in October, establishing a target six-month review period. Unlike existing anti-HIV drugs that work inside the cell, FUZEON has a unique mechanism of action that is designed to block HIV before it enters the human immune cell. Consequently, FUZEON is active against HIV that is resistant to the currently available classes of anti-HIV drugs.

"The studies on FUZEON presented today in Glasgow are yet another important milestone for FUZEON," said Dr. Dani Bolognesi, CEO, Trimeris. "These data further support and confirm the robustness of the Phase III 24-week clinical data for FUZEON."

New Analysis of TORO 2, Second Pivotal Study

The new subgroup analyses of TORO 2 (T-20/FUZEON vs. Optimized Regimen Only), presented in an oral session at Glasgow, show that response of patients receiving FUZEON plus individualized background regimen surpassed that of patients on the individualized regimen alone across the subgroups studied. The benefit of adding FUZEON to an individualized background regimen was consistent across gender, age, race, baseline CD4 cell count and baseline viral load.

The benefit of FUZEON was correlated with the sensitivity of the patients` virus to his or her individualized treatment regimen; patients whose virus was sensitive to a greater number of drugs demonstrated greater suppression of the virus. Among patients who exhibited a range of phenotypic sensitivity to drugs in their background regimens ranging from sensitivity to none of the drugs to sensitivity to five or more drugs, HIV RNA reductions for patients who received FUZEON plus an individualized background regimen arm ranged from -0.96 log10 to -1.73 log10, while viral suppression among a similar range of patients on an individualized background regimen only ranged from -0.13 log10 to -0.91 log10.

Patient Acceptance of Self-Injection of FUZEON After 24 Weeks

Data collected from a survey of 584 patients in two ongoing, multinational Phase III studies (TORO 1 and TORO 2), also presented today, suggest that subcutaneous delivery of FUZEON was manageable for a majority of patients after 24 weeks of treatment.

"Results of this patient survey indicate that motivated patients who received instruction and ongoing support were able to manage self-injection without substantial changes in their daily routines," said Dr. James A. Thommes, Medical Director, Roche.

The subcutaneous injection survey assessed whether the subcutaneous delivery of FUZEON influenced a patient`s ability to conduct normal activities of daily living (ADL). A total of 99.3 percent of patients completed the survey after eight weeks and 24 weeks of treatment; eight-week data were reported at the XIV International AIDS Conference, and results are similar at 24 weeks. After 24 weeks, most patients reported little or no impact of subcutaneous delivery on familiar routines of work (85 percent), sleep (90 percent), social life (84 percent), travel (68 percent), intimacy (77 percent), privacy (70 percent) or appearance (75 percent).


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Update on the Manufacture of Investigational HIV Drug FUZEON
12/18/02





- First commercial scale production successfully completed -

NUTLEY, N.J., and DURHAM, N.C., Dec 18, 2002 /PRNewswire-FirstCall via COMTEX/ --
As part of the stated commitment to keep interested parties informed on the development of their investigational HIV drug, Roche and Trimeris now have enough data from the first three months of experience of the commercial manufacturing process of FUZEON(TM) (enfuvirtide, previously known as T-20) to provide an update on the progress to date.

FUZEON is one of the most complex and challenging molecules ever chemically manufactured on a large scale by the pharmaceutical industry. Roche and Trimeris have demonstrated that production of FUZEON at large scale is possible and the first commercial scale production of FUZEON drug substance has now been completed.

Roche`s manufacturing plant in Boulder, Colorado in the United States has been working 24 hours a day, seven days a week to meet the challenges required to manufacture this peptide -- a complex molecule which requires more than 100 production steps. Initial commercial scale production yields were lower and cycle times longer than had been projected; however, subsequent improvements have been made so that yields have steadily improved to now consistently meet those derived from pilot plant projections.

Plans are also in place to further improve production cycle times. A rate limiting step has been identified in the manufacturing process, and plans have already been put in place to increase the capacity of this step, including the addition of duplicate equipment.

In 2003: Short-term manufacturing estimates for FUZEON are based on the current estimated ability to produce around metric two tons of FUZEON in 2003 - equivalent to up to 20,000 treatment packs (one treatment pack equals one month supply for one patient) per month by year end. This translates to supply for approximately 12,000 to 15,000 patients on FUZEON by year end 2003. This number of patients is lower than would be calculated based upon the manufacturing output for the year due to the fact that approximately half a year "safety supply" is allocated to every patient to ensure continuity of drug supply. We believe that a half-year safety supply is prudent given our early stage of commercial production and the severity of the illness being treated; however, we plan to evaluate the safety supply requirements as we move forward.

In 2004: Annual production of FUZEON is planned to increase to around 3.7 metric tons -- equivalent to up to 39,000 treatment packs per month during mid-2004. After setting aside patient safety supplies, this will equate to up to a maximum of 32,000 patients on FUZEON by year-end 2004. These figures are based upon the assumption that individual patient safety supply of approximately half a year is maintained and projected cycle times and yields remain on track. As we continue to gain confidence in the process and fill the distribution pipeline, we will evaluate the amount of safety stock required to maintain a continuity of supply.

In 2005: It is expected that safety supplies will already be established and the manufacturing capacity can therefore supply up to 39,000 patients, based upon the improvements described.

"We are pleased to confirm that we are now manufacturing FUZEON at a commercial scale. This highly complex peptide has posed unprecedented production challenges and we have had to use cutting-edge technology to be able to manufacture at this scale. As a result, we are now confident that, pending approval, we can begin making this ground-breaking therapy increasingly available to patients during next year," said Georges Gemayel, Vice President, Roche. "In 2003 we will ensure that FUZEON supplies are carefully managed -- given the potential for demand to exceed supply -- so that people who are initiated on therapy will receive an uninterrupted supply."

"In the early development stages, many people said that manufacturing a peptide as complex as Fuzeon at large scale could not be done," said Dr. Dani Bolognesi, CEO, Trimeris. "With this announcement we can confirm we have a robust chemical manufacturing process and have reproducibly produced FUZEON at commercial scale. This is yet another example of the successful outcomes of our collaboration.

FUZEON is the most clinically advanced in an investigational class of anti-HIV drugs known as fusion inhibitors. Unlike existing anti-HIV drugs that work inside the cell, FUZEON has a unique mechanism of action that is designed to block HIV before it enters the human immune cell. Consequently, FUZEON is active against HIV that is resistant to the currently available classes of anti-HIV drugs. Regulatory submissions for FUZEON were filed in the U.S. and European Union in September for the treatment of HIV-1 infection in combination with other antiretroviral agents. FUZEON was granted priority review status in the U.S. in October, establishing a target six-month review period. Marketing authorizations have also been submitted in Switzerland, Canada, and Australia.

Launch of FUZEON

Because demand for FUZEON is expected to exceed supply at launch, Roche and Trimeris will carefully manage allocation of FUZEON, and are working with HIV physician and patient groups to develop a progressive launch plan. The details of this plan will be announced when FUZEON is closer to launch.

Pivotal Study Results

Regulatory submissions for FUZEON were based on data from two 24-week Phase III pivotal studies of approximately 1,000 patients, TORO 1 (T-20/FUZEON vs. Optimized Regimen Only), conducted in North America and Brazil, and TORO 2, conducted in Europe and Australia. These studies showed that treatment-experienced patients receiving FUZEON plus an individualized combination of standard anti-HIV drugs both experienced greater immunologic improvements and were twice as likely to achieve undetectable plasma levels of HIV, than patients who received an individualized drug combination without FUZEON.

Further analyses of TORO 1 and TORO 2 showed that response of patients in the FUZEON arm surpassed that of patients on the individualized regimen alone across all subgroups studied. The benefit of adding FUZEON to an individualized background regimen was consistent across gender, age, race, baseline immune cell (CD4) count and baseline viral load. The magnitude of viral suppression in both treatment arms, however, depended on the number of active drugs in the individualized background regimen. There was greater viral suppression in patients who had more agents in their background regimen to which the virus was sensitive

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unverständlich wie anleger ihre TRMS für 36€ bzw 37,50 $ verkaufen.wer nicht lesen und übersetzen kann sollte die finger von ami aktien lassen.TRMS hat genau das bestätigt was jeder innerlich erhofft hat der in diesen wert investiert hat.die daten stimmen und das kann nur noch nach oben gehen heute.
grüße t.1

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Replay Available of Conference Call Regarding the Manufacture Of Investigational HIV Drug Fuzeon
12/18/02





DURHAM, N.C., Dec 18, 2002 /PRNewswire-FirstCall via COMTEX/ --
Trimeris, Inc. (Nasdaq: TRMS) today announced that a telephone replay is available of its conference call held earlier today regarding the manufacture of its investigational drug FUZEON. To access, please call [phone] (U.S.) or [phone] (international). The conference ID number is 7263525. The replay is available approximately two hours after the call through 11:59 p.m. Eastern Time, December 20, 2002. The information provided on the teleconference is only accurate as of the time of the conference call, and Trimeris takes no responsibility for providing updated information. A webcast of the conference call is available at http://www.trimeris.com and will be archived for replay for 48 hours after the cal

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TRMS zieht kräftig los 10% real in zwei handelstagen ....es gibt eben doch noch leute mit verstand an der börse.(ES WAR FÜR KLUGE ANLEGER SOGAR MEHR DRIN 37,50$ BIS HEUTE 44,32$) es werden sich noch einige die augen reiben im MÄRZ dann werden wir kurse in dem 70$ bereich als normal erachten.

grüße t.1