First new class of anti-HIV medication to be approved since 1996

A positive opinion has been adopted by the European Committee for Proprietary Medicinal Products (CPMP), the scientific committee of the EMEA (European Agency for the Evaluation of Medicinal Products), recommending the granting of a marketing authorisation for Fuzeon (enfuvirtide) which has been developed by Roche and Trimeris. The proposed indication for Fuzeon is for " use in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes, protease inhibitors, non-nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens. In deciding on a new regimen for patient who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate. " The CPMP's positive opinion will now be proposed for approval by the European Commission.

This announcement follows approval of Fuzeon last week by the Food and Drug Administration (FDA) in the United States. Submissions for marketing authorisations have also been made in Australia, Canada and Switzerland.

Fuzeon's unique mode of action is not comparable to conventional anti-HIV drugs, as it blocks the virus before entering the human immune cell.

"This is excellent news for European HIV patients who are becoming resistant to currently available treatments" commented William M. Burns, Head of Roche Pharmaceuticals. "Fuzeon is yet another example of Roche's long-standing commitment to advancing the treatment of HIV and represents a major advance in the fight against HIV."

Fuzeon was studied in two large, international phase III studies - TORO 1 (T-20 vs. Optimised Regimen Only) and TORO 2. These studies confirmed the activity of Fuzeon at 24 weeks of therapy against drug resistant forms of the virus. Treatment-experienced patients receiving Fuzeon plus an individualised regimen of standard anti-HIV drugs were twice as likely to achieve undetectable levels of HIV in the blood (less than 400 copies/mL; 32.7%; 216/661 patients) than patients who received an individualised drug regimen without Fuzeon (15.0%; 50/334 patients). These 24 week data, as well as the preliminary 48 week data, showed that in treatment experienced patients with few remaining options, the addition of Fuzeon to an individualised combination of anti-HIV medicines reduced the amount of virus in the blood and increased the number of CD4 cells more than the use of an individualised combination of anti-HIV medicines alone.

Safety Results
Fuzeon 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 the TORO studies, 98 percent of patients had at least one local injection site reaction. In this treatment-experienced patient population, three percent of patients discontinued treatment with Fuzeon as a result of injection site reactions.

The addition of Fuzeon to background antiretroviral therapy generally did not increase the frequency or the severity of the majority of adverse reactions. The majority of adverse reactions were of mild or moderate intensity. Hypersensitivity reactions have occasionally been associated with Fuzeon therapy and in rare cases have recurred on re-challenge. A preliminary analysis of longer term safety data has identified an increased rate of some bacterial infections, primarily pneumonia, in patients treated with Fuzeon.

Fuzeon supply and access
There is a significant and growing need for new antiretrovirals that are active against strains of HIV that are resistant to the currently available medications. As Fuzeon represents the first new class of HIV therapy to be introduced since 1996, there is likely to be a considerable demand for the drug which may exceed initial supplies. In view of the potential for demand to exceed supply, Roche and Trimeris will carefully manage available drug to ensure that people who initiate therapy have uninterrupted supply.

Currently in Europe there are patients receiving Fuzeon through Early Access Programmes and clinical studies. Roche and Trimeris are committed to ensuring that all these patients as well as those who start therapy following approval have a guaranteed supply of Fuzeon. Increased access to Fuzeon will be in step with increased supply output.

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Resistance to HIV drugs
It is estimated that in a single untreated person the virus can mutate to form around a billion new and potentially different versions of HIV every day. The incidence of drug resistant HIV among already treated patients is increasing at a disturbing rate. It was recently reported in one study that up to 78 percent of patients in North America are infected with a strain of the virus that has developed resistance to one or more anti-HIV drug.

Roche in HIV
Roche is at the forefront of efforts to combat HIV infection and AIDS, committed since 1986 to groundbreaking research and development of innovative new drugs and diagnostic technology. Saquinavir was the first Protease Inhibitor (PI) and was first introduced by Roche in 1995 in the US.

As a consequence of Roche's continuous research and development, the combination of boosted saquinavir with ritonavir (1000/100 mg twice daily) has shown encouraging results in the MaxCmin 1 trial with high efficacy and an excellent safety and tolerability profile. Saquinavir/r was approved in the EU in August 2002. Viracept (nelfinavir), a leading PI is supplied by Roche outside the US and Canada. In first-line HIV therapy, Viracept delivers consistent long-term efficacy and safety. When used first line, Viracept also allows the subsequent use of both NNRTIs and other PIs for most patients due to its unique resistance pattern. Fuzeon and T-1249 are being co-developed by Roche and Trimeris.

Roche is a committed partner of the Accelerating Access Initiative to increase access to HIV care in sub-Saharan Africa and the world's Least Developed Countries. For more information on Roche policy and pricing of HIV protease inhibitors for these regions and research in HIV, visit www.roche-hiv.com.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals and diagnostics. Roche's innovative products and services address prevention, diagnosis and treatment of diseases, thus enhancing people's well being and quality of life. In 2002 Roche's core businesses recorded sales of 26.5 billion Swiss francs and employed some 61,900 people worldwide.

About Trimeris
Trimeris, Inc. (Nasdaq: 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, just approved by the FDA, is the first in a new class of anti-HIV drugs called fusion inhibitors. A Marketing Authorisation Application (MAA) has also been submitted for Fuzeon in the European Union. Trimeris' second fusion inhibitor product candidate, T-1249, has received fast track status from the FDA and is in Phase I/II clinical testing. Trimeris is developing FuzeonT-1249 in collaboration with F. Hoffmann-La Roche Ltd. For more information about Trimeris, please visit the company's website at www.trimeris.com.

All trademarks used or mentioned in this release are legally protected.

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 S-3 filed with the Securities and Exchange Commission on September 27, 2002 and its periodic reports filed with the SEC.

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