Roche and Trimeris Continue to Spearhead Development into New Class of HIV Fusion Inhibitors
Roche and Trimeris announce new analyses from the phase III TORO 1 study which demonstrate that Fuzeon (enfuvirtide, T-20) consistently adds benefit across a range of patients with drug resistant HIV. Fuzeon combined with other antiretroviral agents consistently provides better suppression of HIV in the blood and improvements in the status of the immune system than regimens without Fuzeon for all members of the following patient groups:
Patients with very high levels of virus in their blood (>100,000 copies/mL)
Patients with severely impaired immune systems (<100 CD4 cells /�L)
Patients with different patterns of drug resistance
Across ages
Submissions for marketing authorisations for Fuzeon were filed with the EU and US FDA earlier this September for use in combination with other antiretroviral therapies for HIV-1 infection. Roche and Trimeris also unveil early (phase I/II) data on a second generation fusion inhibitor candidate, T-1249, strengthening the pipeline of drugs that offers hope to treatment-experienced HIV patients.
"Fuzeon opens new doors to an increasing number of treatment experienced patients with limited treatment options" said Dr. Jacob Lalezari, Director of Quest Clinical Research and Assistant Clinical Professor of Medicine at Mount Zion/UCSF, USA. "These new analyses show that whatever drug combination patients have taken previously or whatever the amount of virus in their blood there is a good likelihood that adding Fuzeon will reduce their HIV and increase immune response. Although, not surprisingly however, patients in TORO 1 whose virus was sensitive to a greater number of HIV drugs did achieve a more substantial and durable reduction in HIV than the patients whose virus was sensitive to fewer drugs".
Fuzeon is the front-runner in clinical development of a new class of antiretroviral drugs called "fusion inhibitors". Fuzeon is designed to block HIV replication in a completely different manner than current antiretroviral drugs. Unlike existing anti-HIV drugs that work inside the cell, Fuzeon is designed to block HIV from entering healthy human immune cells. Fuzeon's unique mechanism of action means it is active against HIV that is resistant to the currently available classes of anti-HIV drugs - thereby addressing a growing unmet need in the developed world.
Also presented- Phase II long-term tolerability results
Results pooled from three phase II trials demonstrate that Fuzeon is well tolerated up to 96 weeks. In study T20-205, the incidence and pattern of side effects over the second year were similar to those seen in the first year. Therefore, to date, no new previously unseen side effects associated with long-term use of Fuzeon have been observed. Across the three studies, discontinuations due to injection sites reactions were uncommon comprising approximately 2% of patients, similar to the phase III observations that injection sites reactions are manageable by the great majority of patients.
An important production milestone has recently been achieved by the Roche Colorado manufacturing facility �completion of the first three validation batches of the active ingredient for Fuzeon. These were successfully accomplished despite the enormous challenges of manufacturing such a complex molecule at this scale presents. Fuzeon is one of the most challenging molecules ever chemically manufactured at such a large scale by the pharmaceutical industry. The combination of the efficacy, tolerability and adherence data with the increasing incidence of drug resistance means demand for Fuzeon may be greater than initially anticipated. Therefore, the launch will be carefully managed to ensure continuous drug supply for all patients beginning Fuzeon therapy.
Access to Fuzeon
The Fuzeon International Early Access Programme is designed to ensure that as many patients as possible in need of a new therapy receive Fuzeon before it becomes commercially available. The drug supply will support a total of 1200 patients in the Early Access Programme between October 02 and March 03 and drug will be made available simultaneously across Europe, Australia, Canada and the US. The Early Access Programme will be free of charge to patients and bring the total number of patients on Fuzeon to approximately 3000 by March 2003.
Further Promising News in Fusion Inhibitor Pipeline
Early data (phase I/II) presented for T-1249 show promise as a further novel drug in the fusion inhibitor class. In T1249-101, a 14 day monotherapy study amongst 113 highly treatment experienced, Fusion Inhibitor naive patients, T-1249 was well tolerated, with the most common adverse events related to T-1249 being those associated with injection site reactions. T-1249 also showed characteristics that support once-daily dosing and demonstrated potent, dose-dependent antiretroviral activity. A median maximum change of -2.0 log10 copies/mL was observed in patients receiving T-1249 at a dose of 200 mg/day. The development of T-1249 is approximately three years behind that of Fuzeon.
--Ends--
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-orientated healthcare groups. The company's two core businesses in pharmaceuticals and diagnostics provide innovative products and services, that address prevention, diagnosis and treatment of diseases, thus enhancing people�s health and quality of life.
About Trimeris, Inc.
Trimeris is a development stage, biopharmaceutical company engaged in the discovery and development of novel therapeutic agents that block viral infection by inhibiting viral fusion with host cells. Trimeris' lead product candidate, Fuzeon, which inhibits fusion of the human immunodeficiency virus (HIV) with host cells, is currently in Phase III clinical trials and has received fast track designation from the FDA. Trimeris' second fusion inhibitor product candidate, T-1249, which also inhibits HIV fusion, has received fast track designation from the FDA and is in Phase I/II clinical testing. For more information on Trimeris, Inc., 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 the results presented herein. Factors that could cause of contribute to such differences include, but are not limited to, those discussed in the "Risk Factors" section included in Trimeris� Form S-3 filed with the Securities and Exchange Commission on August 23, 2002 as amended.
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For more information, please contact:
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