Monday December 17, 5:10 pm Eastern Time
Press Release
SOURCE: InterMune, Inc.
InterMune Announces Positive Phase III Clinical Trial Results for Oritavancin In Bacterial Skin Infections
Oritavancin Cut Treatment Time in Half Versus Standard Care
CHICAGO and BRISBANE, Calif., Dec. 17 /PRNewswire/ -- InterMune, Inc. (Nasdaq: ITMN - news) today announced results of a Phase III clinical trial demonstrating that oritavancin, its glycopeptide antibiotic to treat Gram-positive bacterial infections, cut the treatment time in half for complicated skin and skin-structure infections (CSSIs) versus current standard therapy of vancomycin plus cephalexin. The results of the study are being presented tomorrow as a late-breaker poster session at the 41st Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).
Due to the favorable pharmacokinetics of oritavancin, the Phase III study tested the hypothesis that a shorter duration of intravenous therapy alone would be as efficacious as the traditional approach of intravenous followed by oral therapy administered for a longer period. Oritavancin was shown to be safe, well tolerated and as effective as vancomycin/cephalexin, defined by either a cure or improvement in their condition, after an average of 5.5 days of intravenous treatment, as compared to an average of 11.9 days of therapy for patients who received intravenous vancomycin followed by oral cephalexin.
``Oritavancin significantly reduced treatment time, eliminating the need for follow-up oral antibiotics,'' said James Pennington, M.D., Executive Vice President of Medical and Scientific Affairs at InterMune. ``This could translate into reduced rates of non-compliance with oral therapy and subsequent relapse, thereby reducing health care costs associated with CSSIs. These advantages, combined with oritavancin's favorable resistance profile and other attributes, make it a strong candidate to become a new standard of care for serious Gram-positive infections, including strains resistant to many antibiotics.''
In the double-blind, positive-control study, 517 patients with CSSIs caused by Gram-positive pathogens received treatment with either 1.5 mg/kg or 3.0 mg/kg of oritavancin for 3-7 days followed by oral placebo, or 15 mg/kg of vancomycin for 3-7 days followed by oral cephalexin, for a total therapy course of 10-14 days. As the study was designed to demonstrate, in all dosed patients (as assessed by 95 percent confidence intervals), oritavancin was clinically equivalent to vancomycin/cephalexin with 63% of patients treated with 3.0 mg/kg of oritavancin having a successful clinical outcome versus 65% of the vancomycin/cephalexin patients.
In addition, 80% of the patients treated with the 3.0 mg/kg dose of oritavancin who had clinically evaluable methicillin-resistant staphylococcus aureus (MRSA) infection had a successful outcome, an identical percentage to that observed in the vancomycin/cephalexin group. Oritavancin was well tolerated and demonstrated an adverse event profile similar to vancomycin/cephalexin.
``Oritavancin could be the first antibiotic ever to treat serious infections in seven or less days, significantly improving the treatment of Gram-positive bacterial infections,'' said W. Scott Harkonen, M.D., President and CEO of InterMune. ``Oritavancin adds a third potential blockbuster program to InterMune's broad development pipeline, alongside Actimmune for idiopathic pulmonary fibrosis and PEG-Infergen for treatment of hepatitis C infections. In 2002, we plan to conduct three additional Phase III studies of oritavancin in Gram-positive infections and file an NDA with the FDA by the end of 2003.''
Oritavancin is in development for the treatment of a broad range of Gram-positive bacterial infections including those resistant to conventional antibiotics. Its novel mechanism of action kills harmful and resistant strains of bacteria, unlike many other agents that merely suppress them.
Conference Call Details
The Company will host a conference call to discuss the Phase III oritavancin and Phase II Actimmune results tomorrow, December 18, at 8:30 a.m. EST. Those interested can call 800-894-4892 (domestic) or 212-748-2746 (international) and reference call number 20083858. The call may also be accessed via webcast through InterMune's Web Site at www.intermune.com. Please log on 10 minutes prior to the start of the call. A replay will be available by dialing 800-633-8284 (domestic) or 858-812-6440 (international) and reference call number 20083858.
About InterMune
InterMune is a commercial-stage biotechnology company dedicated to developing innovative products for the treatment of serious pulmonary and infectious diseases and cancer. InterMune has three marketed products, growing product revenues and advanced-stage clinical programs addressing a range of diseases with attractive commercial markets. For additional information about InterMune, please visit www.intermune.com. |
