First commercial scale production successfully completed

As part of the stated commitment to keep interested parties informed on the development of their groundbreaking new HIV drug, Roche and Trimeris now have enough data from the first three months of experience of the commercial manufacturing process of FUZEON (enfuvirtide, previously known as T-20) to provide an update on the progress to date.

Fuzeon is one of the most complex and challenging molecules ever chemically manufactured on a large scale by the pharmaceutical industry.  Roche and Trimeris have demonstrated that production of Fuzeon at large scale is possible and the first commercial scale production of Fuzeon drug substance has now been completed.

Roche's manufacturing plant in Boulder, Colorado in the United States has been working 24 hours a day, seven days a week to meet the challenges required to manufacture this peptide - a complex molecule which requires more than 100 production steps.  Initial commercial scale production yields were lower and cycle times longer than had been projected, however subsequent improvements have been made so that yields have steadily improved to now consistently meet those derived from pilot plant projections.

Plans are also in place to further improve production cycle times.  A rate limiting step has been identified in the manufacturing process, and plans have already been put in place to increase the capacity of this step, including the addition of duplicate equipment.

In 2003: Short-term manufacturing estimates for Fuzeon are based on the current estimated ability to produce around 2 tons of Fuzeon in 2003 - equivalent to up to 20,000 treatment packs (1 treatment pack equals 1 month supply for one patient) per month by year end.  This translates to supply for around 12,000- 15,000 patients on Fuzeon by year end 2003.  This number of patients is lower than would be calculated based upon the manufacturing output for the year due to the fact that approximately half a year 'safety supply' is allocated to every patient to ensure continuity of drug supply.  We believe that a half year safety supply is prudent given our early stage of commercial production and the severity of the illness being treated, however, we plan to evaluate the safety supply requirements as we move forward.

In 2004: Annual production of Fuzeon is planned to increase to around 3.7 tons- equivalent to up to 39,000 treatment packs per month during mid-2004.  After setting aside the required patient safety supplies, this will equate to up to a maximum of 32,000 patients on Fuzeon by year end 2004.  These figures are based upon the assumption that individual patient safety supply of approximately half a year is maintained and projected cycle times and yields remain on track.  As we continue to gain confidence in the process and fill the distribution pipeline, we will evaluate the amount of safety stock required to maintain a continuity of supply.

In 2005: it is expected that safety supplies will already be established and the manufacturing capacity can therefore supply up to 39,000 patients, based upon the improvements described.

"We are pleased to confirm that we are now manufacturing Fuzeon at a commercial scale.  This highly complex peptide has posed unprecedented production challenges and we have had to use cutting-edge technology to be able to manufacture at this scale.  As a result, we are now confident that pending approval, we can begin making this ground-breaking therapy increasingly available to patients during next year." said William M. Burns, Head of Roche Pharmaceuticals.  "In 2003 we will ensure that Fuzeon supplies are carefully managed- given the potential for demand to exceed supply- so that people who are initiated on therapy will receive an uninterrupted supply".

"In the early development stages, many people said that manufacturing a peptide as complex as Fuzeon at large scale could not be done" said Dr. Dani Bolognesi, CEO Trimeris.  "With this announcement we can confirm we have a robust chemical manufacturing process and have reproducibly produced Fuzeon at commercial scale.  This is yet another example of the successful outcomes of our collaboration as we approach approvals and launches of Fuzeon".

About Fuzeon
Fuzeon is a breakthrough in the treatment of HIV - the first for seven years of a new type of anti-HIV drugs with a unique mode of action.  Unlike existing anti-HIV drugs that work inside the cell, Fuzeon is designed to block HIV from entering healthy human immune cells and is active in people with drug resistant HIV.  Fuzeon's novel mechanism of action reduces the likelihood of cross-resistance with other antiretroviral classes while not substantially adding to the toxicity of other agents.  Submissions for marketing authorisations for Fuzeon have been submitted in the EU, US, Australia, Canada and Switzerland.  The 24 week phase III data were better than expected with patients twice as likely to achieve undetectable HIV levels when Fuzeon is combined with other antiretroviral agents compared to taking antiretroviral agents without Fuzeon.  These better than expected results combined with an increasing incidence of resistant virus are expected to initially result in a greater demand for Fuzeon than available drug supply in 2003.

Notes to editors

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 in just 24 hours.  The incidence of drug resistant HIV among already treated patients is increasing at a disturbing rate, with up to 78 percent of patients in North America and Europe 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), another 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.

The viral load measurements in the clinical trials for FUZEON were performed using the AMPLICOR HIV-1 MONITOR version 1.5 assay. This test from Roche Diagnostics is considered to be a highly sensitive measurement of the amount of HIV circulating in a patient's blood ("viral load"). With a limited number of treatment regimens available, the accurate monitoring of viral load levels is essential to establish and monitor the effectiveness of therapeutic regimens and assess the potential onset of drug resistance.  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 therapies- including a paediatric formulation- for these regions and research in HIV, visit the www.roche-hiv.com website.

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

Trimeris, Inc. is a biopharmaceutical company engaged in the discovery and development 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. Trimeris has two anti-HIV drug candidates in clinical development.  FUZEON, 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, please visit the company's website at www.trimeris.com.

Trimeris Safe Harbor Statement
Note: 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. Actual manufacturing results could differ from previous results and current projections.  For a more detailed description of factors that could cause or contribute to such differences, see Trimeris' filings with the Securities and Exchange Commission.
 

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