Press Release


Contacts:		Pamela Van Houten
		Roche
		(973) 562-2231

		Robin Fastenau
		Trimeris, Inc.
		(919) 419-6050

		Debbie Venech
		Manning Selvage & Lee
		(212) 468-3878

NUTLEY, N.J., and DURHAM, N.C. (May 17, 2004) – International consensus guidelines for Fuzeon^® (enfuvirtide), the first and only fusion inhibitor available for the treatment of HIV, were published today in AIDS¹, the official journal of the International AIDS Society. The international guidelines are the first to focus solely on optimizing the use of Fuzeon in treatment-experienced HIV patients.

The guidelines provide a framework for physicians in deciding when to include Fuzeon in HIV treatment regimens for their patients. The consensus panel recommends that patients are most likely to experience maximum treatment success when Fuzeon is introduced earlier in the paradigm, after second-line failure as part of a third or fourth antiretroviral regimen. However, the consensus panel agrees that Fuzeon benefits treatment-experienced patients across all sub-groups studied, including those taking few or no other active drugs.

“Because of its unique mechanism of action, Fuzeon is a vitally important option for the increasing number of treatment-experienced patients with HIV drug resistance or intolerance. By providing clear advice on timing of Fuzeon initiation and patient support during therapy, these new consensus guidelines have clarified the place of this drug in current HIV treatment regimens and may enable more treatment-experienced patients to benefit from it,” stated Dr. Mike Youle, Royal Free Hospital, London.

The guidelines also suggest that as the first of a new class of drugs and a self-injectable antiretroviral, Fuzeon is best used when a training and support program for healthcare professionals and patients is in place. Roche and Trimeris have recently launched two patient support programs, the Outbound Nursing Call program and the Visiting Nurse Support Program. These programs will augment the existing Fuzeon treatment hotline and in-office training efforts by HIV healthcare providers. For more information on these programs, physicians and patients can call 1-877-4FUZEON.

The guidelines’ consensus group was comprised of nine leading experts from around the world in the area of HIV and several have had direct experience with Fuzeon from both clinical trials and subsequent clinical use. The guidelines were derived from a roundtable discussion supported by funding from Roche.

Fuzeon was granted accelerated approval on the basis of 24-week data by the U.S. Food and Drug Administration in March 2003, and is also approved in the European Union, Switzerland and Canada. Fuzeon leads the first class of anti-HIV drugs with a unique mechanism of action to be introduced in seven years. 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 (enfuvirtide) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts in controlled studies of Fuzeon of 24 weeks’ duration. Subjects enrolled were treatment-experienced adults; many had advanced disease. There are no studies of Fuzeon in antiretroviral-naive patients. There are no results from controlled trials evaluating the effect of Fuzeon on clinical progression of HIV-1.

Injection Site Reactions (ISRs): ISRs are the most common adverse events associated with Fuzeon. In two controlled Phase III studies at 24 weeks, TORO 1 and TORO 2, 98 percent of patients had at least one local injection site reaction. Signs/symptoms may include pain and discomfort, induration, erythema, nodules and cysts, pruritus, and ecchymosis. Nine 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: 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 (26.8%), nausea (20.1%) and fatigue (16.1%). These events were seen at a lower incidence than in patients receiving an optimized background regimen without Fuzeon: diarrhea (33.5%), nausea (23.7%) and fatigue (17.4%). This list of side effects is not complete because Fuzeon is still being studied.

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.

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 and diagnostics. 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.

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(R), 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.

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,” “anticipate”, “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 12, 2004 and its periodic reports filed with the SEC.

1. Clotet B, Raffi R, Cooper D et al. Clinical management of pre-treated, HIV-infected patients with the fusion inhibitor enfuvirtide: consensus recommendations. AIDS 2004; 18: 1137-1146.