Boden bei Trimeris? - 500 Beiträge pro Seite

[Buddah]

meinungen?(zugegeben die lustige witze seite auf n-tv´s videotext 299 hat mich drauf aufmerksam gemacht.da die so einen wert nicht pushen können,erlaube ich mir einen thread aufzumachen)

mfg B.

[t.1]

hallo,
denke TRMS steht noch vor einer große zukunft.letzte zahlen machen doch mut!! ende 2006 wieder über 35 €.

grüße t.1

[blb]

Roche and Trimeris Announce FDA Filing of FUZEON(R) sNDA for Administration with a Needle-Free Injection Device
MONDAY, JULY 18, 2005 4:11 PM
- PR Newswire

NUTLEY, N.J. and MORRISVILLE, N.C., July 18, 2005 /PRNewswire via COMTEX/ -- Roche and Trimeris (TRMS) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of their sNDA to consider inclusion of information about the Biojector 2000 (B2000) needle-free injection device in the FUZEON(R) (enfuvirtide) labeling. The filing is based on data from the T20-405 study, a single-dose, comparative pharmacokinetic study of FUZEON administered via the needle-free device compared to standard needle-syringe administration. Results from this study were presented at the HIV DART meeting in December 2004. FUZEON is the first and only entry inhibitor available for the treatment of HIV; it is approved for use with a needle and syringe.

The companies anticipate that the FDA will provide feedback and a decision on the sNDA later this year.

In a related development, Trimeris and Roche plan to begin enrollment of a new trial -- the FUZEON WAND (FUZEON With A Needle-free Device) study, assessing patient acceptance and experience in administration of FUZEON via the B2000 needle-free device compared to standard needle and syringe administration. Anticipated to start in August 2005, this study will enroll 40 patients, in a month-long, cross-over design evaluation. Endpoints include tolerability, injection site reactions and pharmacokinetics.

The B2000 injection system, manufactured by Bioject Medical Technologies Inc., is a needle-free CO2-powered injector that disperses liquid medication through the skin. The B2000 has been available since 1996 to deliver subcutaneous and intramuscular injections and has been used in vaccine delivery, chronic therapy and other settings, delivering millions of injections worldwide (for more information, please refer to http://www.bioject.com or 800.683.7221).

For more information on FUZEON, patients and physicians can visit http://www.FUZEON.com or call 1-877-4FUZEON.

Facts About FUZEON

FUZEON is the first and only fusion inhibitor for the treatment of HIV. Unlike other HIV drugs that work after HIV has entered the human immune cell, FUZEON works outside the CD4 cell, blocking HIV from entering the cell. For this reason, FUZEON is effective in treatment-experienced patients who have developed resistance to other anti-HIV drugs, though patients may still develop resistance to FUZEON. FUZEON was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in March 2003 on the basis of 24-week data, and was granted traditional (full) approval on Oct. 15, 2004 on the basis of long-term 48-week data.

Injection Site Reactions (ISRs): ISRs are the most common adverse events associated with FUZEON. ISRs occurred in 98% of patients studied and 4% discontinued FUZEON due to ISRs. Signs/symptoms may include pain and discomfort, hardened skin, redness, bumps, itching and swelling. Eleven percent of patients had local reactions that required analgesics or limited usual activities.

Pneumonia: An increased rate of bacterial pneumonia was observed in subjects treated with FUZEON in the Phase III clinical trials compared to the control arm. It is unclear if the increased incidence of pneumonia is related to FUZEON use. Patients with HIV infection should be carefully monitored for signs and symptoms of pneumonia. Risk factors for pneumonia included low initial CD4 cell count, high initial viral load, intravenous drug use, smoking and a prior history of lung disease.

Hypersensitivity Reactions: Systemic hypersensitivity reactions have been associated with FUZEON therapy and may recur on rechallenge. Hypersensitivity reactions have included individually and in combination: rash, fever, nausea and vomiting, chills, rigors, hypotension and elevated serum liver transaminases. Other adverse events that may be immune mediated and have been reported in subjects receiving FUZEON include primary immune complex reaction, respiratory distress, glomerulonephritis and Guillain-Barre syndrome.

Other Adverse Events: The events most frequently reported in patients receiving FUZEON plus an optimized background regimen were diarrhea (32%), nausea (23%) and fatigue (20%). These events were seen at a lower incidence in patients taking a FUZEON-based regimen compared to those receiving an optimized background regimen without FUZEON when taking into account the uneven number of patients in each arm and the length of time they are in that arm. As measured in number per 100 patient-years, the incidence was: diarrhea (38 per 100 patient-years in subjects receiving FUZEON-based regimens vs. 73 per 100 patient-years in patients who did not receive FUZEON), nausea (27 vs. 50, respectively) and fatigue (24 vs. 38, respectively).

Roche in HIV

Roche is at the forefront of efforts to combat HIV infection and AIDS, committed for 15 years to groundbreaking research and development of new drugs and diagnostic technology. The objective is to provide tailored treatment solutions and an improved standard of care worldwide for those people living with HIV. Roche and Trimeris are working together to discover, develop and commercialize the next generation of HIV fusion inhibitors.

About Roche - More Than a Century in the U.S. and the World

Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of the world`s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is one of the world`s leaders in diagnostics, the leading supplier of pharmaceuticals for cancer, as well as a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on many fronts to improve people`s health and quality of life. Roche employs roughly 65,000 people in 150 countries, including approximately 15,000 in the United States.

Roche`s U.S. operations celebrate their American Centennial in 2005. In another milestone this year, Roche was named in January to Fortune magazine`s list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen U.S. sites located in California, Colorado, Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche`s Pharmaceuticals Division offers a portfolio of leading medicines in therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation, dermatology and influenza. Roche`s Diagnostics Division supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our worldwide and U.S. websites (Global: http://www.roche.com and U.S.: http://www.roche.us). For more information on the Roche pharmaceuticals business in the United States, visit the company`s Web site at: http://www.rocheusa.com.

About Trimeris, Inc.

Trimeris, Inc. (TRMS) is a biopharmaceutical company engaged in the discovery, development and commercialization of novel therapeutic agents for the treatment of viral disease. The core technology platform of fusion inhibition is based on blocking viral entry into host cells. FUZEON, approved in the U.S., Canada and European Union, is the first in a new class of anti- HIV drugs called fusion inhibitors. Trimeris is developing FUZEON and future generations of peptide fusion inhibitors in collaboration with F. Hoffmann-La Roche Ltd. For more information about Trimeris, please visit the Company`s website at http://www.trimeris.com.

Trimeris Safe Harbor Statement

This document and any attachments may contain forward-looking information about the Company`s financial results and business prospects that involve substantial risks and uncertainties. These statements can be identified by the fact that they use words such as "expect," "project," "intend," "plan," "believe" and other words and terms of similar meaning. Among the factors that could cause actual results to differ materially are the following: there is uncertainty regarding the success of research and development activities, regulatory authorizations and product commercializations; the results of our previous clinical trials are not necessarily indicative of future clinical trials; and our drug candidates are based upon novel technology, are difficult and expensive to manufacture and may cause unexpected side effects. For a detailed description of these factors, see Trimeris` Form 10-K filed with the Securities and Exchange Commission on March 11, 2005 and its periodic reports filed with the SEC.

SOURCE Roche

Maureen Byrne of Roche, [phone], [e-mail]; or Walter Capone o
Trimeris, [phone], [e-mail]; or Noelle Boyd of Manning Selvage
& Lee, [phone], [e-mail]


http://www.prnewswire.com


Copyright (C) 2005 PR Newswire. All rights reserved.

[blb]

Trimeris Reports Second Quarter 2005 Financial Results; FUZEON(R) (Enfuvirtide) Posts Strong Worldwide Sales Growth; Collaboration Turns Profitable
TUESDAY, JULY 19, 2005 4:02 PM
- BusinessWire

MORRISVILLE, N.C., Jul 19, 2005 (BUSINESS WIRE) -- Trimeris, Inc. (TRMS) today announced the first profitable quarter for the collaboration with Roche. This positive result was primarily driven by the growth in FUZEON sales.

Worldwide net sales of FUZEON were $53.9 million, up 48% from $36.4 million in the second quarter of 2004. All sales of FUZEON are recorded by Roche, Trimeris` collaborative partner.

Compared to the first quarter of 2005, second quarter worldwide sales of FUZEON were $53.9 million, up 27.0% from $42.5 million in the first quarter of 2005. Net sales of FUZEON in the U.S. and Canada were $25.2 million, up 8.2% from $23.3 million in the first quarter of 2005. Net sales of FUZEON outside the U.S. and Canada were $28.7 million, up 50.1% from $19.1 million in the first quarter of 2005.

Worldwide net sales of FUZEON for the six months ended June 30, 2005 were $96.4 million, up 57.5% from $61.2 million for the six months ended June 30, 2004. Net sales of FUZEON in the U.S. and Canada for the six months ended June 30, 2005 were $48.5 million, up 20% from $40.4 million for the six months ended June 30, 2004. Net sales of FUZEON outside the U.S. and Canada for the six months ended June 30, 2005 were $47.9 million, up 130.5% from $20.8 million for the six months ended June 30, 2004. These strong results reflect continued growth in the U.S. and Canada and the launch of new markets outside of the U.S. and Canada.

The Company reported a net loss for the second quarter of 2005 of $3.1 million, or ($0.14 per share), compared with a loss of $16.2 million, or ($0.75 per share) in the second quarter of 2004. For the six months ended June 30, 2005 the Company reported a net loss of $8.6 million, or ($0.39 per share), compared with a loss of $26.1 million, or ($1.21 per share) in the six months ended June 30, 2004. This improved result was primarily driven by the first profitable quarter for the collaboration, increases in royalty revenue and decreases in our operating expenses.

"The first quarter of profitability for the collaboration marks a significant milestone for Trimeris and we are particularly pleased with the expanded adoption and use of FUZEON in North America and our major markets worldwide, " said Steven D. Skolsky, Chief Executive Officer of Trimeris.

A live webcast of our conference call on July 19, 2005 at 5:00 p.m. Eastern Time will be available at http://www.trimeris.com.

About Trimeris, Inc.

Trimeris, Inc. (TRMS) is a biopharmaceutical company engaged in the discovery, development and commercialization of novel therapeutic agents for the treatment of viral disease. The core technology platform of fusion inhibition is based on blocking viral entry into host cells. FUZEON, approved in the U.S., Canada and European Union, is the first in a new class of anti-HIV drugs called fusion inhibitors. Trimeris is developing FUZEON and future generations of peptide fusion inhibitors in collaboration with F. Hoffmann-La Roche Ltd. For more information about Trimeris, please visit the Company`s website at http://www.trimeris.com.

Trimeris Safe Harbor Statement

This document and any attachments may contain forward-looking information about the Company`s financial results and business prospects that involve substantial risks and uncertainties. These statements can be identified by the fact that they use words such as "expect," "project," "intend," "plan," "believe" and other words and terms of similar meaning. Among the factors that could cause actual results to differ materially are the following: there is uncertainty regarding the success of research and development activities, regulatory authorizations and product commercializations; the results of our previous clinical trials are not necessarily indicative of future clinical trials; and our drug candidates are based upon novel technology, are difficult and expensive to manufacture and may cause unexpected side effects. For a detailed description of these factors, see Trimeris` Form 10-K filed with the Securities and Exchange Commission on March 11, 2005 and its periodic reports filed with the SEC.

Trimeris, Inc.
Statements of Operations
(in thousands, except per share amounts)
(unaudited)

Three Months Six Months
Ended June 30, Ended June 30,
------------------ -------------------
2005 2004 2005 2004
------- -------- ------- --------
Milestone revenue $ 430 $ 534 $ 861 $ 1,060
Royalty revenue 2,642 1,109 4,403 1,910
Collaboration income (loss)(a) 1,313 (9,850) 1,277 (12,396)
------- -------- ------- --------
Total revenue and collaboration
income (loss) 4,385 (8,207) 6,541 (9,426)
------- -------- ------- --------

Operating expenses:

Research and development:
Non-cash compensation (b) 99 (2) 208 (53)
Other research and development 5,050 5,382 10,397 11,682
------- -------- ------- --------
Total research and development
expense 5,149 5,380 10,605 11,629
------- -------- ------- --------
General and administrative:
Non-cash compensation (b) 112 12 223 12
Other general and
administrative 2,317 2,818 4,517 5,484
------- -------- ------- --------
Total general and administrative
expense 2,429 2,830 4,740 5,496
------- -------- ------- --------

Total operating expenses 7,578 8,210 15,345 17,125
------- -------- ------- --------

Operating loss (3,193) (16,417) (8,804) (26,551)
------- -------- ------- --------
Other income (expense)
Interest income 318 199 590 460
Gain on sale of equipment 6 - 6 -
Interest expense (185) (2) (368) (5)
------- -------- ------- --------
139 197 228 455
------- -------- ------- --------
Net loss $(3,054)$(16,220) $(8,576) $(26,096)
======= ======== ======= ========

Basic and diluted net loss per
share $ (0.14)$ (0.75) $ (0.39) $ (1.21)
======= ======== ======= ========
Weighted average shares
outstanding 21,727 21,610 21,719 21,596
======= ======== ======= ========


(a) Collaboration income (loss) represents our share of the net operating income (loss) from the sale of FUZEON in the United States and Canada under our collaboration agreement with Hoffmann-La Roche, Inc., our collaborative partner. This net operating income (loss) consists of net sales less cost of goods (gross margin), less selling and marketing expenses and other costs related to the sale of FUZEON. Selling and marketing expenses and other costs exceeded the gross margin from FUZEON sales in the three and six months ended June 30, 2004.

(b) Non-cash compensation is primarily comprised of amortization expense for restricted stock issued to employees and non-cash charges or credits related to stock options granted to non-employees.

Trimeris, Inc.
Condensed Balance Sheets
($ in thousands)

June 30, 2005 December 31,
(unaudited) 2004
--------------- ------------------
Assets
Cash, cash equivalents and
investment securities
available-for-sale $43,100 $48,402
Other current assets 2,954 7,652
-------------- -----------------
Total current assets 46,054 56,054
Property, furniture and
equipment - net 2,287 2,408
Total other assets 8,496 6,358
-------------- -----------------
Total assets $56,837 $64,820
============== =================

Liabilities and Stockholders` Equity
Total current liabilities $6,134 $6,850
Long term portion of deferred
revenue 11,338 11,736
Accrued marketing costs 16,129 15,761
Other liabilities 524 127
-------------- -----------------
Total liabilities 34,125 34,474
-------------- -----------------

Total stockholders` equity 22,712 30,346
-------------- -----------------
Total liabilities and stockholders`
equity $56,837 $64,820
============== =================


FUZEON Net Sales
(Recognized by Roche, our collaborative partner)
($ in millions)
(unaudited)

Three Months Ended,
-----------------------------
June 30, March 31,
2005 2005
-----------------------------

United States and Canada $25.2 $23.3
Rest of World 28.7 19.1
------------ --------------
Worldwide Total $53.9 $42.4
============ ==============


SOURCE: Trimeris, Inc.

Trimeris, Inc.
Andrew Graham, 919-419-6050


Copyright Business Wire 2005

[t.1]

ja freunde das warten und nachkaufen hat sich gelohnt !!

auch wenn der klugscheißerclub es immer noch nicht verstehen möchte.

grüße t.1

[blb]

Na das ging ja schnell!

[t.1]

18.07.2005 23:18
Roche/Trimeris: HIV-Innovation
Roche Holdings und das US-Unternehmen Trimeris (Nachrichten) haben bei der Arzneimittelbehörde FDA eine Neuzulassung für ihr HIV-Präparat „Fuzeon“ beantragt. Dabei soll der Wirkstoff ohne Nadel verabreicht werden. Die nadellose Spritze soll von Biojet Medical Technologies zur Verfügung gestellt werden. „Fuzeon“ ist als Injektion bereits in den USA zugelassen.

Leider kam am 25.11.2005 die Meldung das die FDA noch weitere Daten für BIOJET haben möchte.TRIMERIS möchte dies bis Mitte 2006 bereitstellen.

grüße t.1

[puhvogel]

Hallo t.1: Du bist mit der harnäckigste Anleger , den ich so kenne. Ich kann mir gut vorstellen, dass Deine Engelsgeduld langsam beloht wird.
Es ist scheinbar kaum jemanden aufgefallen, dass die Verkaufszahlen auf einmal angesprungen sind. Es bleibt zu hoffen, dass es sich damit in höheren Revenue-Zahlen ausdrückt, so dass TRMS endlich mal in Richtung Break-even marschiert.

Im Folgenden sind ein paar Daten zusammengefasst (Quartal Q4 2003 - Q4 2005)

Milestones 98
Q4-2003 Q1-2004 Q2-2004 Q3-2004 Q4-2004 Q1-2005 Q2-2005 Q3-2005 Q4-2005
Milestones 989 526 534 546 546 431 430 431
Royalty 443 801 1104 1207 1439 1761 2642 1886
Research 5597 6300 5382 5469 4112 5347 5050 5323

Fuzeon sales
USA 13,30 16,00 24,40 21,10 24,30 23,30 25,20 25,20 35,80
Rest der Welt 4,30 11,10 13,10 17,30 19,10 28,70 28,70 27,10 27,10
Gesamt 17,60 27,10 37,50 38,40 43,40 52,00 53,90 52,30 62,90

PS: Eigentlich gehört dieser Thread ins Biotech-Board

[t.1]

hallo puhvogel,

danke für deine zusammenstellung der zahlen.was aber auch nicht schlecht ist, das der vorstand aktien aufkauft.
aber du hast doch auch schon deine erfahrung gemacht mit den angeblichen "leichen" im depot.am ende hat es sich gelohnt gewartet und nachgekauft zu haben.dir weiterhin viel erfolg beim traden.

[RazorLux]

Hi Leute, wo seid ihr alle? Kein Interesse mehr an Trimeris? Ob überhaupt noch einer investiert ist? Hoffe dass wir nächste Woche mal die 13 Dollar brechen

[Buddah]

vorbörslich 10% im Plus...

[t.1]

meldung von gestern 9.03.2006

208 millionen $ umsatz -profitabel - 54 % steigerung zum vorjahr.

na nun kommen wieder die besseren zeiten !!