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"Sales of its HIV drug Fuzeon increased 16 percent in the first quarter, marketed by Roche  
   
   
Approximate Financial Snapshot as of 5/10/07
Shares Outstanding 15.3M
52 Wk Hi/Lo 13.85/

6.45

Market Cap $111.9M
Recent Price $7.32

 

 

5/3/07

TRIMERIS (TRMS)

Website: www.trimeris.com

FUZEON, is the first in a new class of anti-HIV drugs called fusion inhibitors.


Overview

Trimeris (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.

This is an abbreviated profile and we encourage readers interested in learning more about Trimeris to visit the company website at www.trimeris.com.


TRMS Investor Highlights

  • Announced sales of its HIV drug Fuzeon increased 16 percent in the first quarter, driven by growth outside the U.S. First-quarter net sales of the drug grew to $64.3 million, from $55.4 million a year ago.
  • All sales of FUZEON are recorded by F. Hoffmann-La Roche Ltd, ("Roche"), Trimeris' collaborative partner.
  • Has a collaboration agreement with Roche to develop and market Fuzeon and T-1249, a replacement compound. 
  • Announced Roche will return the rights to joint patents and other intellectual property related to next-generation HIV fusion inhibitor peptides to Trimeris that fall under the companies' 2000 research agreement.

Recent News and Press Releases

Trimeris Reports Financial Results for the First Quarter 2007

Trimeris HIV Drug Sales Grow 16 Percent

Trimeris Reports First Quarter 2007 FUZEON(R) Sales Results

For the latest Quote and News on TRMS Click Here.


Fuzeon

Approved in 2003, FUZEON® (enfuvirtide) is the first in a class of anti-HIV drugs called fusion inhibitors. Its “mechanism of action” (or the way it works) is completely different from existing anti-HIV drugs. Instead of working on the inside of T cells (CD4) to stop virus replication, FUZEON works on the outside where it can block entry (“fusion”) to the cell. This unique function gives fusion inhibitors the potential to treat resistant strains of HIV. Additionally, fusion inhibitors are considered less likely to cause unwanted side effects and interfere with other drugs. anti-viral regimen.

The latest HIV treatment guidelines, issued by the US Department of Health and Human Services, currently support the use of FUZEON in combination with other anti-viral drugs to help treatment-experienced patients achieve undetectable viral loads — the ultimate goal of anti-HIV therapy.

Pipeline

The introduction of an entry inhibitor (also known as fusion inhibitor) revolutionized the treatment of HIV. With this breakthrough, patients could fight the virus in a completely different way — from the outside of cells instead of just from the inside. Trimeris' research continues to focus on designing, developing, and commercializing new products that are more effective, potent, and convenient for people affected by viral diseases.

Clinical Trials for T-1249

T-1249 is a second-generation fusion inhibitor for HIV. This compound binds to a slightly different region of the HIV virus than FUZEON® (enfuvirtide). As a result, T-1249 exhibits activity against FUZEON-resistant viruses. In January 2004, the clinical development of T-1249 was put on hold due to challenges in achieving the desired technical profile of the current formulation. The compound's safety, efficacy, and tolerability were in no way related to the decision. TRMS is currently advancing exciting fusion inhibitor drug candidates toward IND and human studies in 2007.

Next-Generation Fusion Inhibitor

Trimeris and Roche entered into a Research Agreement in 2000 to discover and develop Next Generation Fusion Inhibitor ("NGFI") peptide drug candidates. The desired profile for a NGFI peptide is to maintain the highly favorable efficacy and safety profile of FUZEON® (enfuvirtide), while significantly improving patient convenience by reducing the number of injections required for patient administration (i.e., targeting once per week vs. FUZEON twice-daily dosing). Once-weekly dosing is unprecedented for currently approved HIV drugs, which are now dosed either once- or twice-daily.

In addition to having the characteristics indicated above, Trimeris has also focused on creating NGFI compounds that demonstrate a high level of activity against viruses that have developed resistance to FUZEON and, at the same time, to provide a formidable barrier to the virus to impede development of resistance. As such, these drug candidates possess the unique potential to suppress virus replication in a more sustained, effective, and patient friendly manner.

NGFI drug candidates in comparison to FUZEON

Trimeris and Roche have designed and evaluated numerous NGFI drug candidates which could potentially meet the desired product profile described above. Representative compounds from the NGFI program display the following characteristics:

  • Up to 7-fold improvement in potency against wild-type HIV clinical isolates compared to FUZEON
  • Up to 100-fold improvement in potency vs. FUZEON-resistant HIV clinical isolates
  • Much higher genetic barrier to development of viral resistance, as measured in terms of the number of mutations in gp41 required for resistance development
  • Up to a 4-fold improvement in active drug clearance rate from circulation in primates compared to FUZEON
In September, 2006 Trimeris and Roche agreed to amend their Research Agreement to extend the Research Term by an additional two years from January 1, 2007 through December 31, 2008. Research, development, and commercialization costs for the NGFI program will continue to be split equally by Trimeris and Roche, as will any profits from the worldwide sale of products covered under the amended Research Agreement. Trimeris and Roche have selected TRI-1144 as the lead NGFI preclinical compound due to its favorable product profile, including potent antiviral activity against a broad range of HIV clinical isolates and its attractive pharmacokinetic properties in animals. The collaboration is currently focusing its efforts on conducting additional in vitro and in vivo studies with TRI-1144, including the development of extended release formulations for this compound in order to meet the desired frequency of administration.

One Month Chart


Contacts

Trimeris, Inc.

3500 Paramount Parkway
Morrisville, NC 27560
Phone: 919-419-6050
Fax: 919-419-1816


SEC Filings

TRMS filings with the SEC can be found here. All Fillings are current and the Company is fully reporting.


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