The Company Presents Positive Phase III Clinical Trial Results for Bacterial Skin Infections
Nine Additional Oritavancin Abstracts Presented
BRISBANE, Calif. and CHICAGO, Sep 15, 2003 /PRNewswire-FirstCall via COMTEX/ -- InterMune, Inc. (Nasdaq: ITMN) announced that positive results of its
confirmatory pivotal Phase III clinical trial of oritavancin, the Company's
investigational intravenous antibiotic, for the treatment of complicated
skin/skin-structure infections (cSSSI) caused by gram-positive bacteria, were
presented today at the 43rd Interscience Conference on Antimicrobial Agents
and Chemotherapy (ICAAC). Nine additional abstracts concerning the
distribution, resistance profile and bactericidal properties of oritavancin
are being presented throughout the course of the conference.
The double blind phase III trial achieved its primary efficacy endpoint
and demonstrated that oritavancin was as effective as the comparator regimen
of vancomycin followed by cephalexin. Moreover, oritavancin achieved this
efficacy endpoint despite being administered for only half the number of days
and with a significantly lower frequency of adverse events than the comparator
regimen. The secondary endpoint of bacteriological eradication was also met.
"This Phase III trial is the second to demonstrate the safety and efficacy
of this agent, and further showed that oritavancin was as effective as
vancomycin/cephalexin despite requiring half the duration of therapy," said
James E. Pennington, M.D., Executive Vice President of Medical and Scientific
Affairs at InterMune. "Importantly, the results also show that oritavancin
was associated with fewer adverse events than the comparator regimen. This
study provides compelling evidence for the potential of oritavancin as an
effective treatment for patients with gram-positive cSSSI."
InterMune's phase III study enrolled 1,267 patients with cSSSI caused by
gram-positive pathogens at 103 sites in 22 countries. Patients were
randomized to receive oritavancin once daily for 3-7 days followed by oral
placebo, or vancomycin for 3-7 days followed by oral cephalexin, for a total
course of 10-14 days in both treatment arms. The primary efficacy endpoint of
clinical cure of infection, as well as the secondary endpoint of
bacteriological eradication, were met, with oritavancin requiring an average
of only 5.3 days of treatment compared to an average of 10.9 days for the
vancomycin/cephalexin group. The clinical cure rates associated with the
oritavancin and vancomycin/cephalexin arms were 78.6% and 76.2%, respectively.
Furthermore, oritavancin showed a significantly better safety profile with
11.1% fewer patients in the oritavancin treatment group experiencing an
adverse event compared with patients treated with vancomycin/cephalexin
(p<0.001). The most commonly observed side effects in this Phase III
clinical trial were headache, nausea, vomiting, constipation, and dizziness,
which occurred at similar rates in the two treatment arms.
A late-breaking poster presentation, entitled: "Phase III Trial Comparing
3-7 days of Oritavancin vs. 10-14 days of Vancomycin/Cephalexin in the
Treatment of Patients with Complicated Skin and Skin Structure Infections
(cSSSI)," was led by Professor H. Giamerellou, Sismanoglion General Hospital,
Athens, Greece.
In addition to the Phase III results summarized above, additional studies
to be presented at the conference further indicate the therapeutic potential
of oritavancin. Oritavancin was shown to readily distribute from the blood
into the skin, allowing effective concentrations to reach the site of
infection in cSSSI. At the cellular level, oritavancin showed good
intracellular penetration into macrophages, where in contrast to comparator
agents studied, it retained its high level of bactericidal activity.
Furthermore, oritavancin showed a favorable resistance profile with good
activity against pathogenic and drug resistant strains of enterococcal,
streptococcal and staphylococcal species. Finally, the potential for
resistance development to oritavancin in vancomycin susceptible or vancomycin
non-susceptible strains of S. aureus and enterococci appears low, based on the
results of in vitro resistance studies.
About cSSSI
Deep soft tissue abscesses, wound infections and cellulitis are serious
skin infections caused by a wide variety of bacterial pathogens. These
infections require rapid and intensive antimicrobial intervention to minimize
tissue damage and prevent further spread of infection. Each year, there are
approximately 400,000 patients with cSSSI who require hospitalization in the
United States. As drug resistance in hospitals and the community increases,
the frequency of cSSSI that require hospitalization is likely to increase.
About InterMune
InterMune is a biopharmaceutical company focused on the applied research,
development and marketing of life-saving therapies for pulmonary, hepatic and
infectious diseases. For additional information about InterMune, please visit
www.intermune.com.
Except for the historical information contained herein, this press release
contains certain forward-looking statements that involve risks and
uncertainties, including without limitation the statement that this study
provides compelling evidence for the potential of oritavancin as an effective
treatment for patients with gram-positive cSSSI. All forward-looking
statements and other information included in this press release are based on
information available to InterMune as of the date hereof, and InterMune
assumes no obligation to update any such forward-looking statements or
information. InterMune's actual results could differ materially from those
described in InterMune's forward-looking statements. Factors that could cause
or contribute to such differences include, but are not limited to those
discussed in detail under the heading "Risk Factors" and other risks and
factors discussed in InterMune's 10-Q report filed with the SEC on August 14,
2003 and InterMune's other periodic reports (i.e., 10-K and 8-K) filed with
the SEC, which are incorporated herein by reference. The risks and other
factors that follow, concerning the forward-looking statements in this press
release, should be considered only in connection with the fully discussed
risks and other factors discussed in detail in the 10-Q report and InterMune's
other periodic reports filed with the SEC. InterMune's forward-looking
statement stated above is subject to the risks and uncertainties that include
without limitation those associated with clinical product development,
including being able to have a third party manufacture oritavancin with a
comparable safety profile to the oritavancin that was manufactured by Eli
Lilly and Company; having no additional unexpected safety issues; obtaining
marketing approval; using third parties for clinical, regulatory and
manufacturing assistance; and significant regulatory, manufacturing, supply,
and competitive barriers to entry.
SOURCE InterMune, Inc.
Carolyn Tang of InterMune, Inc.
415-466-2242
or
ir@intermune.com
or Ian McConnell of WeissCom Partners, Inc.
415-362-5018, or ian@weisscom.net
http://www.intermune.com
