Roche and Trimeris announce the submission of a New Drug Application to the US FDA for Fuzeon (enfuvirtide T-20) for HIV-1 infection in combination with other antiretroviral agents and the plan to submit the Marketing Authorisation Application to the EU by the end of September. Moreover, Roche and Trimeris also announce that the completion of the next manufacturing milestone at the Roche Colorado manufacturing facility � completion of three validation batches � has been successfully achieved.
The submissions are based on the outstanding phase III results, which generated considerable interest when presented at the International Aids Congress in Barcelona in July. The data are better than expected and show that heavily treatment experienced patients are twice as likely to achieve undetectable HIV levels plus have an improved immunological status when Fuzeon is combined with other antiretroviral agents compared to taking antiretroviral agents without Fuzeon.
Fuzeon is the frontrunner in a new class of anti-HIV drugs called "fusion inhibitors". Unlike existing anti-HIV drugs that work inside the cell, Fuzeon has a unique mode of action and is designed to block HIV before entering the human immune cell. Fuzeon is active against HIV that is resistant to the currently available classes of anti-HIV drugs. As a result of the better than expected activity and tolerability data, Fuzeon offers new hope to patients with limited treatment options.
"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 drugs". said Dr. Daniel Kuritzkes, Director of AIDS Research, Brigham and Women's Hospital, Associate Professor of Medicine, Harvard Medical School. "It is clear that the need for new drugs such as Fuzeon which work in completely new ways to block HIV will become ever more urgent."
William M. Burns, head of Roche�s Pharma Division, said "These filings are important steps for Roche. HIV is a constantly evolving virus, so it is no wonder that drug resistance has become one of the greatest HIV medical challenges physicians and patients are facing in the developed world today. Patients are now living with new and different types of HIV and need dramatically different therapies to help manage their disease. Fuzeon was one of the most difficult scientific and manufacturing challenges we have faced, but despite these challenges we have developed Fuzeon at the fastest pace possible in response to this increasing patient need. We proceeded in parallel across Europe and North America and now anticipate launches from the first quarter next year."
"Fuzeon was designed from the outset to block HIV replication in a completely different manner than current antiretroviral drugs, while not substantially adding to the toxicity of other agents. Fuzeon's unique mode of action is designed to block HIV before entering the human cell and if approved, it will represent the first of a new class of anti- HIV drug in seven years," said Dr. Dani Bolognesi, CEO, Trimeris. "These milestones are the latest result of the ongoing joint development programme between Roche and Trimeris."
Fuzeon is one of the most challenging molecules ever chemically manufactured at such a large scale by the pharmaceutical industry. One hundred and six manufacturing steps are required to produce the active drug substance alone, which is around ten times more than that of a protease inhibitor. To coincide with the fast paced clinical development program, the Roche Colorado manufacturing plant has been working 24 hours a day, seven days a week in the commercial scale-up of Fuzeon. Because of this dedication, the next major milestone for commercial manufacturing - completion of three validation batches - has been achieved and therefore, the process of bringing the commercial plant on hand for launch remains firmly on track. In addition, continued investments are being made in the ongoing development of the manufacturing facility to meet potential increased demand for Fuzeon.
Resistance to HIV drugs
It is estimated that in a single person the virus can mutate to form around a billion new and 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.
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.
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 Web site 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.
All trademarks used or mentioned in this release are legally protected
For more information please contact
Lucy Heaton Maria Vigneau
Ketchum, London Roche, Basel
Mobile: + 44 7939 037 108 Mobile: + 41 79 506 9941
Telephone: + 44 20 7611 3859 Telephone: + 41 61 688 9291
E-Mail: lucy.heaton@ketchum.com E-Mail: maria.vigneau@roche.com
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