Fuzeon approved for marketing and reimbursement in Switzerland
Fuzeon leads first novel class of anti-HIV drugs to become available since 1996
Roche announced today that Fuzeon (enfuvirtide), the first in a novel class of drugs against HIV-1 infection, has been granted marketing authorisation by Swissmedic and has received reimbursement approval from the Federal Insurance Office.
Fuzeon is indicated for use in combination with other antiretroviral (anti-HIV) medicinal products for the treatment of HIV-1 infection in treatment-experienced patients with evidence of viral replication despite ongoing therapy. Switzerland is the first country in Europe to issue a marketing authorisation for Fuzeon. The drug will be available from the beginning of June 2003.
Fuzeon is the first fusion inhibitor, representing the first new class of anti-HIV treatments in seven years. Unlike all other anti-HIV medications currently on the market, Fuzeon prevents the virus from entering human immune cells. This blocks the replication of the HIV, which is capable of destroying the immune systems of people infected with the virus.
Commenting on Swiss approval of the product, Beat Lieberherr, General Manager of Roche Pharma (Switzerland) Ltd, said: 'Today is a very important day for everybody who is affected directly or indirectly by HIV. For these people Fuzeon offers a new option in the fight against this insidious infection at a time when development of viral resistance is forcing more and more patients with HIV infection to look for therapeutic alternatives. We at Roche are very pleased that with Fuzeon we can give the medical profession another new and very effective weapon in the fight against AIDS.'
According to Professor Manuel Battegay from Basel University Hospital, 'With its novel mechanism of action, Fuzeon stops HIV from entering healthy cells and thus protects them against infection. Since it combats viral replication differently to other drugs on the market, it is also active against strains of HIV that are resistant to currently available medications.
The safety and efficacy of this new drug have been documented in major comparative studies involving treatment-experienced patients with advanced HIV infection. In clinical terms, Fuzeon represents an important step forward in HIV treatment since it opens up new avenues for HIV-infected people with limited therapeutic options.'
Findings from pivotal studies
The regulatory submission for Fuzeon was based on data from two 24-week phase III pivotal studies involving approximately 1,000 patients. These data were corroborated by the results after 48 weeks of treatment. The TORO 1 study ('TORO' stands for 'T-20/Fuzeon vs. Optimised Regimen Only') was conducted in North America and Brazil, while TORO 2 was conducted in Europe and Australia.
These studies showed that treatment-experienced patients receiving Fuzeon as part of an optimised background regimen (individualised combination of anti-HIV drugs) experienced greater immunological improvement; they were also twice as likely to achieve undetectable plasma levels of HIV (400 copies of HIV-1 RNA per ml) than patients receiving an individualised regimen alone. The likelihood of achieving undetectable HIV levels was even greater in patients with two or more active anti-HIV drugs in their background regimen.
In view of the implications of these findings for public health, the New England Journal of Medicine (NEJM) has posted the clinical results of the TORO 1 study with Fuzeon on its website (www.nejm.org) even before the data are published in one of the forthcoming issues of the Journal.
Supply and distribution of Fuzeon
Since the process used to manufacture Fuzeon is complex and initial demand is likely to be high, the global availability of the drug will be limited during the introductory phase. A managed distribution programme will therefore be adopted in Switzerland to ensure the uninterrupted supply of Fuzeon to patients who have begun therapy. The consumer price for Fuzeon in Switzerland will be 2712.60 Swiss Franks for one month treatment per patient.
Notes:
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 http://www.roche-hiv.com.
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 at www.trimeris.com.
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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Your Roche Media Team
F. Hoffmann-La Roche AG
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