Roche - Media News

Basel, 28 May 2003

European Commission approves Fuzeon, first HIV-fusion inhibitor, for use in the fight against HIV
Go-ahead for Fuzeon in Europe following the recent FDA approval

Roche and Trimeris announce today that the European Commission has approved the groundbreaking anti-HIV drug Fuzeon (enfuvirtide, formerly known as T-20) for use in the European Union. Fuzeon is the first in a new class of anti-HIV medication, known as ‘fusion inhibitors’; this is the first new class of HIV therapy to be approved since 1996. Fuzeon has been developed jointly by Roche and Trimeris Inc.

Fuzeon attacks HIV in a totally different way compared to existing HIV medications. Fuzeon blocks the fusion of HIV with human cells while existing drugs act once the cell is infected. As a result of the very different mechanism of action, Fuzeon is active against HIV strains that have become resistant to current therapies.

"It was twenty years ago this year that HIV was identified as the causative agent of AIDS" said Mr. William Burns, Head of Roche Pharmaceuticals. "Over the last two decades there have been significant advances in the treatment of HIV, however the virus continues to try to outsmart us. The approval of Fuzeon by the European Medicines Evaluation Agency today represents a landmark advance in the fight against HIV, bringing with it new hope for HIV-infected people living in Europe."

"For me and my colleagues at Trimeris, who have seen Fuzeon from its discovery to becoming a therapeutic option, today's announcement of the European approval is a moment of great excitement" said Dr. Dani Bolognesi, CEO of Trimeris Inc. "The rapid European approval demonstrates the clinical benefit and favorable safety profile of Fuzeon shown in the two pivotal phase III studies as well as the compelling need for this new therapy."

Clinical data
The regulatory submission for Fuzeon was based on data from two 24-week Phase III pivotal studies of approximately 1,000 patients, TORO (T-20/ Fuzeon vs. Optimised Regimen Only) 1, conducted in North America and Brazil, and TORO 2, conducted in Europe and Australia. These studies showed that treatment-experienced patients receiving Fuzeon as a part of an optimised background regimen (individualised combination of anti-HIV drugs) experienced greater immunologic improvements and were twice as likely to achieve undetectable plasma levels of HIV (HIV-1 RNA of <400 copies/mL) compared to patients receiving an individualised regimen alone. In addition, those patients with less advanced disease and two or more active drugs in their background regimen were more likely to achieve undetectable levels of HIV. Preliminary 48-week data was also provided to the European Authorities in support of the approval of Fuzeon. The final 48-week data will be presented at an international AIDS conference later this year.

“When I was diagnosed with HIV I thought that my life had come to an end. I was the first patient in the UK to be enrolled in a Fuzeon study, at a time when my treatment options had become limited. I now feel extremely positive about my future and I am pleased, following today’s announcement, that other HIV positive patients across Europe are now able to benefit from this new class of drugs”, said James Locke, a HIV-patient who was first diagnosed in 1984.

Fuzeon indication
The indication for Fuzeon in the European Union 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 patients 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 European Union approval announcement follows the granting of a positive opinion in March by the Committee for Proprietary Medicinal Products. The Food and Drug Administration (FDA) approved Fuzeon in March in the United States and the approval in Switzerland, which was announced last week. Submissions for marketing authorisations have also been made in Australia and Canada.

Safety of Fuzeon
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, 3 percent of patients at 24 weeks discontinued treatment with Fuzeon as a result of injection site reactions.
An increased rate of some bacterial infections, primarily pneumonia, was seen in patients treated with Fuzeon. It is unclear if this increased incidence is related to Fuzeon use. 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.

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. Increased access to Fuzeon will be in step with increased supply output. Significant investments have been made and will be further committed to increase capacity for Fuzeon production, which is expected to be fully realized early in 2004. Roche undertake to work diligently with local reimbursement bodies and health care providers to ensure the widest possible access for patients with drug resistant HIV. Fuzeon is expected to be launched in individual countries across Europe over the next few months.


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 50 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.

The viral load measurements in the clinical trials for Fuzeon were performed using the AMPLICOR HIV-1 MONITOR® TEST, version 1.5. 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 protease inhibitors for these regions and research in HIV, visit

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market and is the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche employs roughly 62,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai.

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

About Trimeris
Trimeris, Inc. (Nasdaq: TRMS) is a biopharmaceutical company engaged in the discovery, development and commercialisation 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, recently approved by the FDA and now in the European Union, is the first in a new class of anti-HIV drugs called fusion inhibitors. 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 Roche. For more information about Trimeris, please visit the company’s website.

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 authorisations and product commercialisations; 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 27, 2003 and its periodic reports filed with the SEC.

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© 2003 F. Hoffmann-La Roche Ltd