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Title: FDA Issues Approvable Letter in Response to Application for Use of Fuzeon® with Needle-Free Injection Device

"FDA Issues Approvable Letter in Response to Application for Use of Fuzeon® with Needle-Free Injection Device"

NUTLEY, NJ and MORRISVILLE, NC -- November 24, 2005 -- Roche and Trimeris announced that the companies have received an approvable letter from the U.S. Food and Drug Administration (FDA), in response to their request for inclusion of information about the Biojector® 2000 (B2000) needle-free injection device in the Fuzeon® (enfuvirtide) labeling. In the approvable letter, FDA has requested additional information from the ongoing ENF-404 or WAND (With A Needle-Free Device) study, a randomized, open-label, two-way, cross-over study assessing the tolerability of the B2000 device for administration of Fuzeon. The B2000, made by Bioject Medical Technologies Inc., is a needle-free, CO2-powered injector that disperses liquid medication beneath the skin. Fuzeon is the first and only entry inhibitor available for the treatment of HIV and is currently approved for administration with a needle and syringe. Roche and Trimeris filed a supplemental New Drug Application (sNDA) in May 2005 based on data from the T20-405 study, a single-dose pharmacokinetic study of Fuzeon administered by a nurse via the B2000 needle-free device, compared to standard needle-syringe administration. In August 2005, Roche and Trimeris announced the initiation of the Fuzeon WAND (With A Needle- Free Device, or ENF-404) study, an eight-week trial designed to assess patient acceptance and experience of Fuzeon administration via the B2000 needle-free device compared to the standard needle and syringe. The primary endpoints of this study are tolerability and injection site reactions. This trial is currently enrolling and final data are expected in the second half of 2006. Healthcare providers and patients can call Roche/Trimeris at 877-4Fuzeon (877-438-9366) or visit www.clinicaltrials.gov for details regarding participation in the Fuzeon WAND study. Facts About Fuzeon Fuzeon is the first and only fusion inhibitor for the treatment of HIV. Unlike other HIV drugs that work after HIV has entered the human immune cell, Fuzeon works outside the CD4 cell, blocking HIV from entering the cell. For this reason, Fuzeon is effective in treatment-experienced patients who have developed resistance to other anti-HIV drugs, though patients may still develop resistance to Fuzeon. Fuzeon was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in March 2003 on the basis of 24-week data, and was granted traditional (full) approval on Oct. 15, 2004 on the basis of long-term 48-week data. Injection Site Reactions (ISRs): ISRs are the most common adverse events associated with Fuzeon. ISRs occurred in 98% of patients studied and 4% discontinued Fuzeon due to ISRs. Signs/symptoms may include pain and discomfort, hardened skin, redness, bumps, itching and swelling. Eleven percent of patients had local reactions that required analgesics or limited usual activities. Pneumonia: An increased rate of bacterial pneumonia was observed in subjects treated with Fuzeon in the Phase III clinical trials compared to the control arm. It is unclear if the increased incidence of pneumonia is related to Fuzeon use. Patients with HIV infection should be carefully monitored for signs and symptoms of pneumonia. Risk factors for pneumonia included low initial CD4 cell count, high initial viral load, intravenous drug use, smoking and a prior history of lung disease. Hypersensitivity Reactions: Systemic hypersensitivity reactions have been associated with Fuzeon therapy and may recur on rechallenge. Hypersensitivity reactions have included individually and in combination: rash, fever, nausea and vomiting, chills, rigors, hypotension and elevated serum liver transaminases. Other adverse events that may be immune mediated and have been reported in subjects receiving Fuzeon include primary immune complex reaction, respiratory distress, glomerulonephritis and Guillain-Barre syndrome. Other Adverse Events: The events most frequently reported in patients receiving Fuzeon plus an optimized background regimen were diarrhea (32%), nausea (23%) and fatigue (20%). These events were seen at a lower incidence in patients taking a Fuzeon-based regimen compared to those receiving an optimized background regimen without Fuzeon when taking into account the uneven number of patients in each arm and the length of time they are in that arm. As measured in number per 100 patient years, the incidence was: diarrhea (38 per 100 patient-years in subjects receiving Fuzeon-based regimens vs. 73 per 100 patient-years in patients who did not receive Fuzeon), nausea (27 vs. 50, respectively) and fatigue (24 vs. 38, respectively). SOURCE: Roche

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