Synageva BioPharma (GEVA)

[rsox]

there is an internet address towards the middle of this page that leads to the guidelines of the dhhs with regards efuzeon

DHHS guidelines - clear recommendations for FUZEON use with
boosted PIs

The importance of FUZEON in the management of HIV has been
recognised by the US Department of Health and Human Services (DHHS).
Their newly updated HIV/AIDS treatment guidelines support the use of
FUZEON with an active boosted PI for the management of treatment
experienced patients. The guidelines state that adding a drug with
activity against drug-resistant virus (e.g. a boosted PI such as
TMC114/r) and a drug with a new mechanism of action (e.g. an HIV
entry inhibitor such as FUZEON) can provide significant
antiretroviral activity.

These data come at a pivotal time as Tibotec has launched this
month an international expanded access programme for TMC114/r. This
will enable patients that are rapidly running out of new treatment
options early access to this investigational agent, which has been
seen to be highly promising when used in combination with FUZEON.

The updated DHHS guidelines (October 6, 2005) are available at
online: http://aidsinfo.nih.gov/guidelines/. <<<<<<<<<<<<<<<<<<<<<

TMC114 is an investigational product

Growing Body of Evidence, RESIST 1&2 / POWER 1&2 / TORO 1&2 -
Collectively the data from all six studies, in over 2,500 patients,
establish a new paradigm in the management of triple
class-experienced patients.

[rsox]

continued from previous post...

This adds to the growing body of evidence for the powerful "FUZEON
effect" which has been seen across the RESIST 1 & 2, POWER 1 & 2 and
TORO 1 & 2 studies, where adding FUZEON was seen to almost double the
number of patients reaching undetectable, when combined with one of
the latest boosted PIs such as lopinavir/r, tipranavir/r or TMC
114/r.

Doctors underestimate significant "FUZEON effect"

Surprisingly, of the 560 doctors surveyed onsite this week at the
IAS conference, three quarters (75%) underestimated the "FUZEON
effect" seen in both RESIST(2) and POWER(3) studies.

Latest data adds to growing Body of Evidence - Latest Boosted
Protease Inhibitors (lopinavir/r, tipranavir/r and TMC 114/r) all
work best in combination with FUZEON

RESIST Phase III tipranavir trials

- Over 24 weeks, almost double the proportion of patients who
received FUZEON plus tipranavir/r showed a 90% drop in viral load
compared with patients not receiving FUZEON

POWER Phase II TMC114 dosing trials

- Over 24 weeks in the combined TMC114 trials, almost double the
proportion of patients who received FUZEON plus TMC114/r achieved a
viral load below 50 copies/ml compared with patients not receiving
FUZEON

- A remarkable 67% of the patients receiving FUZEON plus TMC114/r
reached an undetectable viral load

TORO Phase III FUZEON trials

- Over 24 weeks, double the proportion of patients who received
FUZEON plus lopinavir/r achieved an undetectable viral load (<50
copies/ml) compared with patients not receiving FUZEON

Collectively the data from all six studies, in over 2,500
patients, establish a new paradigm in the management of triple
class-experienced patients.

Why FUZEON is effective in face of HIV resistance

FUZEON is still the first and only anti-retroviral drug to work
outside the human immune cell (CD4), blocking the HIV virus from
entering. All other currently available HIV drugs fight the HIV virus
once it has entered the cell. FUZEON's unique mode of action means
that FUZEON has no cross-resistance with currently available drugs
and that it is an effective treatment, in combination with other
anti-HIV drugs, for patients facing resistance.

New combination improves quality of life

Spike, a 48 year old person living with HIV from London, whose
blood levels of HIV reached undetectable within six months of taking
FUZEON and boosted tipranavir and has remained undetectable ever
since, explains "This new combination of treatments has really
improved my quality of life. Getting back to undetectable and seeing
my CD4 count increase from 20 to 268 has changed my outlook on life.
I believe I can plan for the future, which I didn't even consider
doing before starting this regimen. I have much more energy now than
I had before, which is exhilarating since I have been held back for
so long." Spike has been living with HIV since it was detected in his
body in 1986 and works as a freelance designer and night-club
promoter.

The use of FUZEON is continuing to grow, despite initial
reluctance from patients and physicians to using an injection, and
more patients are now successfully starting and remaining on
treatment. Roche continues to roll out educational initiatives to
support patients and physicians with the administration and use of
FUZEON.

References:

(1) Grinsztejn B et al. IAS 2005 Abstract WePe 16.7B07

(2) Cooper D et al. CROI 2005 Abstract 560

(3) Katlama C et al. CROI 2005 Abstract 164LB

ots Originaltext: Roche Pharmaceuticals
Im Interne

[rsox]

here is a little reading on the so called fuzeon affect that the execs at trimeris were boasting about at the jan 31 fuzeon sales update...

27.07.2005 - 12:39 Uhr
Rio De Janeiro, Brazil (ots/PRNewswire) -

- Giving Patients Facing HIV Resistance Their Best Chance to
Achieve Undetectable Viral Loads

Data presented at IAS build a compelling case for FUZEON
(enfuvirtide, formerly known as T-20) to be combined with the newest
drugs to give patients facing resistance their best chance of
achieving undetectable viral load - the optimal treatment goal for
all people living with HIV.

"Undetectable viral load should be the ultimate treatment goal for
all triple-class experienced patients. FUZEON combined with the
latest drugs now makes this much more achievable," explained Dr Mike
Youle the Royal Free Hospital, London. "We are seeing a consistent
FUZEON effect with these new drugs and I believe these data must
change the way we manage triple class experienced patients facing HIV
resistance and failing to reach undetectable viral load."

Studies presented this week show that when FUZEON was given in
combination with the novel HIV medication, tipranavir, an impressive
70% of FUZEON naïve patients achieved a ten-fold reduction in their
viral load and furthermore they also had double the increase in
immune cell count(1), compared to patients receiving tipranavir/r
without FUZEON.

[RonnieD]

I'm also looking at TRMS and think it's near time to take a position. I like the zero debt and cash on hand combo along with Fuzeon which by next quarter should begin to make them look significantly more attractive to the investment community . I would say the stock appears cheap right now.

[rsox]

fuzeon sales are starting to show an uptick......

>> trimeris today announced worldwide net sales of FUZEON for the first quarter were $55.4 million, up 31 percent from $42.5 million for the first quarter of 2005. Net sales of FUZEON in the U.S. and Canada for the first quarter of 2006 were $27.4 million, up 17 percent from $23.3 million in the first quarter of 2005. Net sales of FUZEON outside the U.S. and Canada for the first quarter were $28.0 million, up 47 percent from $19.1 million for the first quarter of 2005. <<

[rsox]

Hi mskatie, what do you think about this release scheduled for the 25th....would they be reporting on this if the news wasnt going to be good on it?

Trimeris to Release First Quarter 2006 FUZEON Sales Results on Tuesday April 25, 2006
Friday April 21, 4:05 pm ET

MORRISVILLE, N.C.--(BUSINESS WIRE)--April 21, 2006--Trimeris, Inc. (NASDAQ: TRMS - News) today announced that it will release FUZEON sales results for the first quarter of 2006 on Tuesday, April 25, 2006, at 4:00 P.M. Eastern Time. Trimeris' announcement will be followed by a conference call at 4:15 P.M., led by Steven D. Skolsky, Chief Executive Officer, and other members of senior management.

[mskatiescarletohara]

Glaxo, Gilead, Merck part of team to fight HIV
Tuesday March 14, 2:06 pm ET

GlaxoSmithKline, Gilead Sciences Inc., and Merck & Co. have joined an international partnership to increase the number of HIV drugs available to children in Third World countries.

First Lady Laura Bush on Monday announced a collaborative effort on the part of the U.S. government, pharmaceutical companies and the United Nations to maximize the use of pediatric HIV drugs currently available and to speed up the development of new treatments.

The project will be part of the President's Emergency Plan for AIDS Relief and will attempt to identify obstacles that prevent or slow the distribution of HIV drugs to children in developing countries.

Gilead and Merck, which have Triangle operations, and Glaxo, which has co-U.S. headquarters in Research Triangle Park, join a number of large pharmaceutical companies in the initiative, including Abbott Laboratories, Bristol-Myers Squibb, and Pfizer. Generic drug makers involved in the project include Aspen Pharmacare, Aurobindo Pharma, Cipla, Emcure and Ranbaxy.

Glaxo is working to develop a scored tablet form - or tablets that can be divided into smaller, uniform doses - of its anti-HIV treatments Epivir, Ziagen and Combivir.

Officials at the World Health Organization and the United Nations Children's Fund claim that access to tablet forms of HIV drugs could be easier to store and distribute in Third World countries and could simplify the process of administering the drugs.

California-based Gilead operates an office in Durham, and Merck, which is based in Whitehouse Station, N.J., has plans to construct a $300 million vaccine plant in Durham that is expected to employ about 200 workers.

GlaxoSmithKline (NYSE: GSK - News) employs about 5,600 Triangle workers.

[mskatiescarletohara]

Drug maker trims losses
Trimeris profitable in fourth quarter

http://www.newsobserver.com/104/story/416494.html

Sabine Vollmer, Staff Writer

Analysts had expected Trimeris to become profitable in the fourth quarter, but just barely.

The Morrisville drug company surprised them.

Record sales of Fuzeon, the HIV/AIDS drug developed by Trimeris and its Swiss partner Roche, helped generate a profit of $3.8 million, or 17 cents per share. That exceeded analysts' most optimistic expectations.

Trimeris, which reported fourth-quarter and annual results late Thursday, is finally catching up to the high hopes that investors had when Fuzeon came to market in the spring of 2003.

"We've achieved an important milestone," Steven Skolsky, Trimeris' chief executive, told analysts during a conference call Thursday evening. "That's a significant turning point. That's a big achievement."

He predicted that the company will be profitable this year.

Trimeris shares closed at $11.74 Thursday, up 1 cent. In late trading after the financial results came out, the stock traded as high as $13.11.

New drugs in pipeline

But analysts weren't sure whether Trimeris would continue to generate profits after this year. The company plans to begin testing at least one of two follow-up HIV/AIDS drugs in humans in 2007.

Both experimental drugs could be even more potent than Fuzeon and require only once-weekly injections.

Fuzeon must be injected twice daily. That and its price tag -- about $22,000 a year -- initially hurt the drug's acceptance among patients and doctors.

Skolsky declined to predict how much research and development costs would rise once Trimeris starts costly human trials.

"Overall, ... [Trimeris] is still a wait-and-see story," said Sharon Seiler, an analyst with Punk Ziegel. The question remains whether Fuzeon sales will pick up enough to make up for increased research spending, Seiler said.

Trimeris, which employs about 100, generated fourth-quarter revenue of about $8 million. The figure includes about $5 million from Trimeris' collaboration with Roche. Under the collaboration agreement, the partners split costs to market Fuzeon and profits from sales in North America. Trimeris receives royalty payments on Fuzeon sales elsewhere.

The company reported revenue of $536,000 in the fourth quarter of 2004.

Trimeris lost $8.1 million last year, down from a $40.1 million loss in 2004.

[mskatiescarletohara]

[mskatiescarletohara]

Positive Pre-Clinical Data on Two New Investigational HIV Fusion Inhibitors Presented at Major Scientific Meeting
Thursday February 9, 4:30 pm ET

NUTLEY, N.J. and MORRISVILLE, N.C., Feb. 9 /PRNewswire-FirstCall/ -- New data presented in an oral session at the 13th Conference on Retroviruses and Opportunistic Infections (CROI) this week support the continued development of two next-generation HIV fusion inhibitor peptide candidates, Roche and Trimeris, Inc. (Nasdaq: TRMS - News) announced today. The peptides, TRI-999 and TRI-1144, were discovered by Trimeris scientists and selected by the companies for progression into full pre-clinical development last month. The new data show potent antiviral activity and durable control of HIV replication in vitro, with desirable pharmacokinetic properties in vivo.

Roche and Trimeris currently market FUZEON® (enfuvirtide), the first and only fusion inhibitor available for the treatment of HIV. Its launch in 2003 represented the first completely novel approach to fighting HIV -- blocking viral entry into human immune cells -- since 1996. Since its approval, FUZEON has increasingly become recognized as a foundation for combination regimens with newly-available agents that enable the restoration of virologic control in treatment-experienced patients. The goal for the next generation of fusion inhibitors is to improve upon the efficacy demonstrated by FUZEON, while increasing patient convenience via simpler, more patient-friendly administration, with a target of once-weekly dosing.

The studies presented at CROI included evaluations of these peptides in three key areas:

* Potency against FUZEON-sensitive viruses: Both TRI-1144 and TRI-999
demonstrated potent in vitro activity against a panel of 12 clinical
isolates with varying degrees of sensitivity to FUZEON. Potency
against this panel of FUZEON-sensitive viruses was up to seven times
greater than that of FUZEON.

* Activity against FUZEON-resistant viruses and genetic barrier to
resistance: TRI-1144 and TRI-999 demonstrated substantial improvements
in activity compared to FUZEON (greater than 150 to 250-fold,
respectively) against viruses with FUZEON-related resistance. In
addition, acquisition of resistance to the two new peptides was very
difficult to derive in vitro, as evidenced by prolonged and repeated
exposure to the virus in passaging studies. Together, these results
suggest a substantially higher genetic barrier to development of
resistance for TRI-1144 and TRI-999.

* Pharmacokinetic properties: TRI-999 and TRI-1144 demonstrated slow,
extended clearance properties in monkeys, equal to six- and four-fold
greater than FUZEON, respectively, as well as subcutaneous
bioavailability of 85 to 90 percent.

"The dynamic combination of potency, durability, and extended clearance properties of TRI-999 and TRI-1144 warrants their progression into further pre-clinical studies," Dani Bolognesi, PhD, Chief Scientific Officer, Trimeris. "Together with Roche, we look forward to accelerating the development of these next-generation fusion inhibitors which have the potential to alter the existing HIV treatment paradigm and further extend the advantages of fusion inhibition to benefit patients living with HIV."

"Roche's commitment to improving the lives of people with HIV through innovation in research and development is as strong as ever," said James A. Thommes, M.D., Senior Medical Director, Roche. "This commitment is reflected in the promising work with Trimeris to develop the next generation of fusion inhibitor peptides, as well as our joint efforts to demonstrate the role of FUZEON as the foundation of fully suppressive regimens for treatment-experienced patients, and to provide alternatives for self-administration of FUZEON."

Facts About FUZEON

Administered via one 90 mg subcutaneous injection twice-daily, 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.

Recently updated Antiretroviral Treatment Guidelines from the U.S. Department of Health and Human Services (DHHS) established the use of FUZEON and an active ritonavir-boosted PI and to achieve undetectable HIV in treatment-experienced patients. These new guidelines cited several recent clinical trials of new boosted PIs in treatment-experienced patients, demonstrating better and more prolonged virologic response in patients taking FUZEON as part of a regimen that includes these new boosted PIs.

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 over 48 weeks. 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.

[mskatiescarletohara]

Trimeris Reports First Profitable Quarter - Significant Growth and Continued Profitability Forecasted for 2006
Thursday March 9, 4:00 pm ET

Worldwide Sales of FUZEON(R) Exceed $200 Million
Next Generation Fusion Inhibitor Program in Full Preclinical Development

MORRISVILLE, N.C.--(BUSINESS WIRE)--March 9, 2006--Trimeris, Inc. (NASDAQ: TRMS - News) today announced 2005 financial results reporting an 80% reduction in losses from prior year and the first profitable quarter for the company. These results were primarily driven by record worldwide sales of FUZEON, reaching $208 million, a growth of 54% - in its second full year since launch. The Company expects continued profitability and significant growth for 2006 through expansion in FUZEON sales and strong fiscal management with continued investment in its pipeline assets.


The Company reported a net profit for the fourth quarter of 2005 of $3.8 million, or $0.17 per share, compared with a loss of $5.7 million ($0.27 per share) in the fourth quarter of 2004. For the year ended 2005, the Company's net loss totaled $8.1 million ($0.37 per share), compared with a loss of $40.1 million ($1.86 per share) for 2004.

The decrease in net loss for 2005 compared to 2004 is primarily due to the increase in gross profit from the sale of FUZEON and decreases in operating expenses. Cash, cash equivalents and investment securities available-for-sale totaled $36.9 million at December 31, 2005 compared to $48.4 million at December 31, 2004.

"Attaining profitability is a significant and transforming event for Trimeris," said Steven D. Skolsky, Chief Executive Officer of Trimeris. Mr. Skolsky added, "Continued investment in the growth of FUZEON, efficient use of resources, and the progression of the next generation fusion inhibitor program will be the foundation for significant growth and continued profitability through 2006."

A live webcast of our conference call on March 9, 2006 at 5:00 p.m. Eastern Time will be available at http://www.trimeris.com.

About Trimeris, Inc.

Trimeris, Inc. (Nasdaq: TRMS - News) 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.