Tibotec Submits Application to U.S. Food and Drug Administration Seeking Traditional Approval for INTELENCE(TM) (etravirine)
8:45 a.m. EST Feb. 5, 2009
[Yardley, PA, February 5, 2009]-- Tibotec, Inc. today announced it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking traditional approval for INTELENCE(TM) (etravirine) tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI). The application for traditional approval includes 48-week data from two Phase 3 studies known as DUET-1 and DUET-2. INTELENCE is currently marketed in the U.S. by Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P.
INTELENCE received accelerated approval in January 2008. As part of the post-marketing commitment, Tibotec is required to submit 48-week data from the DUET studies to the FDA in order for it to consider traditional approval for INTELENCE.
INTELENCE, in combination with other antiretroviral agents, is currently 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 antiretroviral (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.
The following points should be considered when initiating therapy with INTELENCE:
-- Treatment history and, when available, resistance testing, should guide
the use of INTELENCE.
-- The use of other active antiretroviral agents with INTELENCE is
associated with an increased likelihood of treatment response.
-- In patients who have experienced virologic failure on a NNRTI-containing
regimen, do not use INTELENCE in combination with only N[t]RTIs.
-- The risks and benefits of INTELENCE have not been established in
pediatric patients or in treatment-naive adult patients.
DUET-1 AND DUET-2
The traditional approval filing includes the 48-week efficacy and safety results of DUET-1 and DUET-2, two Phase 3 randomized, placebo-controlled studies that examined the use of INTELENCE in combination with other antiretroviral agents in adult treatment-experienced HIV-1 patients with documented resistance to NNRTIs and protease inhibitors. Participants in the DUET studies were randomized to receive INTELENCE 200 mg twice daily or placebo, each given in addition to a background regimen. For all patients, the BR included darunavir/ritonavir, plus at least two investigator-selected antiretroviral drugs (N(t)RTIs with or without enfuvirtide). Forty-eight-week data from this study were presented at the 15th Conference on Retroviruses and Opportunistic Infections in Boston on February 7, 2008.
Important Safety Information
INTELENCE does not cure HIV infection or AIDS, and does not prevent passing HIV to others.
-- Severe and potentially life-threatening skin reactions, including
Stevens-Johnson Syndrome, hypersensitivity reaction, and erythema
multiforme, have occurred (<0.1 percent) in patients taking
INTELENCE. Treatment with INTELENCE should be discontinued and
appropriate therapy initiated if severe rash develops.
-- In general, in clinical trials, rash was mild to moderate, occurred
primarily in the second week of therapy, and was infrequent after Week
4. Rash generally resolved within 1-2 weeks on continued therapy.
Discontinuation rate due to rash was two percent.
-- Redistribution and/or accumulation of body fat have been observed in
patients receiving antiretroviral (ARV) therapy. The causal
relationship, mechanism, and long-term consequences of these events have
not been established.
-- Immune reconstitution syndrome has been reported in patients treated
with ARV therapy, including INTELENCE.
-- INTELENCE should be used with caution in patients with severe hepatic
impairment (Child-Pugh class C) as pharmacokinetics of INTELENCE have
not been evaluated in these patients.
-- The most common adverse events (>10 percent) of any intensity that
occurred at a higher rate than placebo at 24-weeks were rash (16.9
percent vs. 9.3 percent) and nausea (13.9 percent vs. 11.1 percent).
-- The most common treatment-emergent adverse reactions (Grade 2-4) that
occurred in patients receiving an INTELENCE-containing regimen vs.
placebo at 24-weeks were rash (9.0 percent vs. 3.1 percent), diarrhea
(5.2 percent vs. 9.6 percent), nausea (4.7 percent vs. 3.5 percent),
fatigue (3.3 percent vs. 4.0 percent), abdominal pain (3.0 percent vs.
2.5 percent), peripheral neuropathy (2.8 percent vs. 1.8 percent),
hypertension (2.8 percent vs. 2.2 percent), headache (2.7 percent vs.
4.1 percent), and vomiting (2.3 percent vs. 2.0 percent).
-- INTELENCE should not be co-administered with the following ARVs:
tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/ritonavir,
full-dose ritonavir (600 mg bid), protease inhibitors administered
without ritonavir, and other NNRTIs.
-- INTELENCE should not be co-administered with carbamazepine,
phenobarbital, phenytoin, rifampin, rifapentine, rifabutin (when part of
a regimen containing protease inhibitor/ritonavir) or products
containing St. John's wort (Hypericum perforatum).
-- INTELENCE and lopinavir/ritonavir should be co-administered with
-- Co-administration of INTELENCE with other agents such as substrates,
inhibitors, or inducers of CYP3A4, CYP2C9, and/or CYP2C19 may alter the
therapeutic effect or adverse events profile of INTELENCE or the
co-administered drug(s). This is not a complete list of potential drug
Please see full Prescribing Information for more details. Full prescribing information is also available at www.INTELENCE-info.com.
About Tibotec, Inc.
Tibotec, Inc., 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.
About Tibotec Therapeutics
Tibotec Therapeutics, a division of Centocor Ortho Biotech Products, L.P., 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.
Centocor Ortho Biotech Products, L.P. and Tibotec Pharmaceuticals are subsidiaries of Johnson & Johnson.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
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SOURCE Tibotec, Inc.