Biotech Values

[DewDiligence]

JNJ reports 48-week data on Intelence (TMC125).
24-week data from these phase-3 trials were reported
in July (#msg-20997326). Intelence is an NNRTI
for HIV that was approved by the FDA last month
(#msg-26126733); this is the same drug class as
Sustiva and IDIX’s IDX899.

http://biz.yahoo.com/prnews/080207/nyth009.html?.v=101

>>
48-Week Efficacy and Safety Data Presented for Intelence in HIV Combination Therapy

Thursday February 7, 8:00 am ET

BRIDGEWATER, N.J., Feb. 7 /PRNewswire/ -- New data showed that at 48 weeks, significantly more treatment-experienced adults with HIV-1 with documented resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs) had an undetectable viral load (defined as less than 50 HIV-1 RNA copies/mL) with INTELENCE (etravirine) tablets plus a background regimen (BR) compared with placebo plus a BR. These findings from two ongoing double-blind, placebo-controlled, randomized Phase 3 studies (DUET-1 and DUET-2) were presented at the 15th Conference on Retroviruses and Opportunistic Infections in Boston.

In the DUET-1 and -2 studies, 60 percent and 61 percent of patients in the INTELENCE arms had a confirmed undetectable viral load at 48 weeks compared with 39 percent and 41 percent of those in the placebo arms, respectively. In each study, this difference was significant [p<0.0001].

INTELENCE, a new NNRTI from Tibotec, received accelerated approval from the U.S. Food and Drug Administration (FDA) on January 18, 2008. It is the first NNRTI to receive approval in almost ten years. INTELENCE received approval based on the 24-week analysis of HIV viral load and CD4+ cell counts from the pooled DUET-1 and -2 studies. The 48-week results will be filed with the FDA for consideration of traditional approval of INTELENCE.

"Etravirine is an important new option for treatment-experienced patients with NNRTI resistance and these data build upon the 24-week data that had previously been available," said Richard Haubrich, M.D., Professor of Medicine, Division of Infectious Diseases, University of California, San Diego, and investigator in the INTELENCE Phase 3 DUET studies.

INTELENCE, in combination with other antiretroviral (ARV) agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a NNRTI and other ARV agents.

This indication is based on Week 24 analyses from two randomized, double- blind, placebo-controlled trials of INTELENCE. Both studies were conducted in clinically advanced, three-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults.

DUET-1 and -2 Study Design

The DUET-1 and -2 studies, identical in design but conducted in different regions, assessed the 24- and 48-week efficacy and safety of INTELENCE in combination with a BR in treatment-experienced adult HIV-1 patients with documented evidence of NNRTI and PI resistance. The primary endpoint was the proportion of patients who achieved a confirmed undetectable viral load (less than 50 copies/mL)

Patients with HIV-1 who were eligible for the DUET studies had a viral load of greater than 5,000 copies/mL while on a stable antiretroviral therapy regimen for at least eight weeks and had evidence of at least one NNRTI- resistance-associated mutation, either at screening or from prior resistance tests, as well as evidence of three or more primary PI mutations (D30N, V32I, L33F, M46I/L, I47A/V, G48V, I50L/V, V82A/F/L/S/T, I84V, N88S, or L90M) at screening.

Participants in the DUET studies were randomized to receive INTELENCE 200 mg twice daily (599 patients) or placebo (604 patients), each given in addition to a BR. For all patients, the BR included darunavir/ritonavir, plus at least two investigator-selected antiretroviral drugs (N(t)RTIs with or without enfuvirtide). The study remained double-blinded through 48-weeks.

48-Week Efficacy Findings

-- In DUET-1, 60 percent of patients in the INTELENCE arm had a confirmed undetectable viral load at 48 weeks compared with 39 percent of those in the placebo arm [p<0.0001].

-- In DUET-2, 61 percent of patients in the INTELENCE arm had a confirmed undetectable viral load at 48 weeks compared with 41 percent of those in the placebo arm [p<0.0001].

-- In DUET-1, the mean increase in CD4+ cell count from baseline was 103 cells/mm3 in the INTELENCE arm compared with 74 cells/mm3 in the placebo arm [p=0.0025].

-- In DUET-2, the mean increase in CD4+ cell count from baseline was 94 cells/mm3 in the INTELENCE arm compared with 72 cells/mm3 in the placebo arm [p=0.0160].

48-Week Safety Findings

In DUET-1, the most commonly reported adverse events among patients in the INTELENCE arm vs. placebo arm were rash of any type (22 percent vs. 11 percent), diarrhea (14 percent vs. 24 percent), and nausea (15 percent vs. 15 percent).

In DUET-2, the most commonly reported adverse events among patients in the INTELENCE arm vs. placebo arm were diarrhea (22.0 percent vs. 22.6 percent), rash of any type (16.6 percent vs. 11.1 percent) and nausea (14.6 percent vs. 10.8 percent).

…About INTELENCE

INTELENCE was developed by Tibotec Pharmaceuticals Ltd. and is marketed in the U.S. by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P. Applications for approval of INTELENCE have been submitted to the European Agency for the Evaluation of Medicinal Products (EMEA) and to regulatory authorities in other countries, including Canada, Switzerland, Russia, Australia, and South Korea.

Tibotec Therapeutics

Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., a subsidiary of Johnson & Johnson, headquartered in Bridgewater, N.J., is dedicated to delivering innovative virology therapeutics that help healthcare professionals address serious unmet needs in people living with HIV.

Tibotec Pharmaceuticals Ltd.

Tibotec Pharmaceuticals Ltd., a subsidiary of Johnson & Johnson, based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
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