PRNewswire - November 18, 2002

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).

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 Phase III 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 due to 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 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 most common adverse events seen more frequently in patients receiving FUZEON plus an individualized background regimen than in patients who received treatment without FUZEON were headache, peripheral neuropathy, dizziness (excluding vertigo), insomnia, depression, appetite decrease, asthenia, myalgia, constipation and pancreatitis. The majority of adverse events were of mild or moderate intensity.

Access to FUZEON

As increasing numbers of patients with HIV are in need of new therapies, it is possible that demand for FUZEON may exceed supply at the projected time of launch in 2003. Roche and Trimeris fully appreciate the compelling need for FUZEON and are working diligently to bring FUZEON to patients with the greatest medical need as early as possible and in the greatest number possible, but also in a manner to ensure continuity of supply for each patient who begins treatment. Considerable investment has already been made and will be further committed to increase capacity for FUZEON production to accommodate the potentially increasing demand for this important medication.

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.

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 Web site at: http://www.rocheusa.com.

About Trimeris, Inc.

Trimeris, Inc. (Nasdaq: TRMS) is a biopharmaceutical company engaged in the discovery and development of novel therapeutic agents for the treatment of viral disease. The core technology platform is based on fusion inhibition aimed at treating disease by preventing viruses from entering host immune cells. Trimeris has two anti-HIV drug candidates in clinical development. FUZEON(TM), currently in Phase III clinical trials, is the most advanced compound in development. A New Drug Application (NDA) and Marketing Authorisation Application (MAA) have been submitted for FUZEON with the US FDA and the EU EMEA, respectively. 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 FUZEON and T-1249 in collaboration with F. Hoffmann-La Roche. For more information about Trimeris, Inc., visit the company's website at http://www.trimeris.com

Trimeris Safe Harbor Statement

Except for any historical information presented herein, matters presented in this release are forward-looking statements that involve risks and uncertainties. The results of Trimeris' previous clinical trials are not necessarily indicative of future clinical trials, and future results could differ materially from past results. For a more detailed description of factors that could cause or contribute to such differences, please see Trimeris' filings with the Securities and Exchange Commission.

SOURCE Hoffmann-La Roche Inc.; Trimeris, Inc. Web Site: http://www.rocheusa.com http://http://www.trimeris.com (TRMS)

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