Barcelona, Spain, July 9 – Confirmatory findings of paediatric dosage are released today which indicate that T-20, used in conjunction with other anti-retrovirals, is well tolerated by children and adolescents living with HIV. Interim results from this latest study (T20-310), have confirmed that T-20 dosed by body weight reaches children's bloodstreams at a similar rate as those observed in adults. T-20 is anticipated to be a vital component of new cocktail therapies for treatment experienced children as well as adults.

"Our large scale T-20 trials in adults have already confirmed the important role that fusion inhibitors will play in the continued fight against HIV. Today’s news will be welcomed by all those involved in helping HIV-infected children and young adults, who like their adult counterparts, have diminishing treatment options.", said Dr. Eralp Bellibas, Clinical Pharmacologist, Associate Clinical Director, Roche.

Unlike existing AIDS drugs which work once the HIV virus has entered the human cell, T-20 works in a completely new way in that it blocks HIV from entering CD4 cells of the immune system.

The addition of T-20 on top of conventional optimised therapy is expected to become a key treatment component helping physicians optimise therapy in previously treated HIV patients, as it helps the body’s immune cells (CD4 cells) from further depletion by facilitating the reduction of the amount of HIV virus in the blood that can destroy these cells.

In the study presented today, twenty patients, between the ages of 3 and 16 years, who had more than 5000 copies of HIV RNA per millilitre of blood, and had used at least two of the three currently available anti-retroviral classes for a period of three months or more, are participating in the 48 week investigation. The ongoing study includes monitoring for drug levels in the bloodstream, safety and effectiveness. In addition to optimised background therapy, the patients were prescribed two milligrams (mgs) of T-20 for every kilogram of body weight, ensuring their total dosage did not exceed 90mgs- the adult dose under investigation.

The results showed that children and adolescents had T-20 absorption rates similar to the results seen in adults and that twice-daily, subcutaneous injections of T-20 were initially well-tolerated. Local reactions of redness and/or thickening at injection site were the most commonly reported side-effect. Other related side-effects included diarrhoea, decreased appetite and tinnitus.

"We very much hope that T-20 can be used to form a nucleus around which physicians can create an optimal combination of anti-retrovirals for their treatment experienced children as well as adults" said Dr. David Reddy, Disease Area Head, HIV/AIDS, Roche. "The paediatric dosing data from this clinical trial will be included in our application for marketing approval of T-20 in Europe and the US in an effort to make T-20 available to children at the same time as adults. We will continue to work at full speed to bring T-20 to patients and physicians who are looking to strengthen their armamentarium in the constant battle against HIV".

Early Access to T-20

Meeting the Growing Need For a New Class of HIV DrugsOne of the biggest challenges facing people living with HIV is resistance to currently available therapies. Thirty to fifty percent of patients are infected with a strain of the virus that has developed resistance to one or more antiretrovirals, thereby reducing the treatment options available to them. Roche and Trimeris are committed to discovering and developing treatments for patients in need of new options and expect to invest approximately half a billion U.S. dollars to bring fusion inhibitors to people living with HIV/AIDS.

Optimised background therapy

Optimised background therapy consists of an individually chosen anti-HIV drug combination selected from currently available drugs. The TORO studies demonstrate a significant additional reduction in HIV when T-20 is used with optimised background therapy, compared to an optimised background therapy alone.

Long-Term Commitment to HIV Research and Development

Roche and Trimeris are working together to mobilize the considerable resources required to support the rapid development of T-20, the first member of a new class of investigational anti-HIV drugs known as fusion inhibitors. T-20, currently in Phase III clinical trials, is the furthest along in clinical development in the entry inhibitor class. T-1249, a second generation fusion inhibitor being developed by Roche and Trimeris, is in Phase I/II clinical trials. Unlike existing AIDS drugs that work inside the cell and target viral enzymes involved in the replication of the virus, T-20 inhibits fusion of HIV with host cells before the virus enters the cell and begins its replication process. In June 2001, Roche and Trimeris announced a joint research agreement to identify and develop additional HIV fusion inhibitor peptides.

T-20 has fast track designation from the FDA in the U.S. for the treatment of HIV-infected individuals. Fast track is granted to facilitate the development and expedite the review of applications for drugs that are intended to treat serious or life-threatening disease and that demonstrate the potential to address an unmet medical need.

About Trimeris, Inc.

Trimeris Safe Harbor StatementNote: 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 the results presented herein. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the "Risk Factors" section included in Trimeris' Form 10-K for the year ended December 31, 2001 filed with the Securities and Exchange Commission on March 25, 2002.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche’s innovative products and services address needs for the prevention, diagnosis and treatment of disease, thus enhancing people’s well-being and quality of life. For more information on Roche and its commitment to research in HIV, visit the: roche-hiv.com website. All trademarks used or mentioned in this release are legally protected.

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