InterMune, Inc. (NASDAQ:ITMN), Brisbane, Calif. has completed a
review of its research and development programs and infrastructure
requirements. InterMune will implement a number of operational and
infrastructure changes that, when fully implemented by 2008, are
expected to reduce annual operating expenses by approximately $40 to $50
million. The expense savings result from: 1) a reduction in staffing
levels by 50%, or 116 full-time and contract positions affecting all
departments; 2) a reduction of development, clinical and regulatory
costs due to the termination of the INSPIRE trial; and 3) a reduction of
SG&A expenses related to Actimmune(R).
Regarding its development programs, the company reconfirmed its
focus on its Phase 3 CAPACITY program studying pirfenidone in idiopathic
pulmonary fibrosis (IPF) and on its HCV protease inhibitor, ITMN-191
currently in Phase 1a development with its partner Roche. InterMune
currently projects that enrollment of the CAPACITY trials will be
completed several months sooner than previous guidance due to stronger
than expected patient enrollment, and that the company will refine and
expand the CAPACITY program to further enhance its ability to
demonstrate clinically and statistically significant benefits for IPF
patients.
The company also announced its current intention to retain all its
territorial rights to pirfenidone to maintain maximum strategic
flexibility.
"We have quickly and aggressively moved to reduce our
operating expenses in light of the termination of the INSPIRE trial of
Actimmune in IPF," said Dan Welch, president and CEO of InterMune.
Welch added, "We remain very excited about the progress and
potential of both ITMN-191 in hepatitis C and our CAPACITY program
studying pirfenidone in IPF. With CAPACITY enrollment significantly
exceeding our expectations, we are in a position to expand the program
and still complete it ahead of our previously announced timeline. We now
expect patient enrollment to be completed in July of 2007 and the
results of CAPACITY available in Q1 2009, several months ahead of our
previous guidance."
Update on Clinical Development Programs
In updating the status and timelines for its clinical development
programs, InterMune announced that the Phase 1a program for its HCV
protease inhibitor, ITMN-191, remains on schedule. The company continues
to expect to complete the currently running Phase 1a study of ITMN-191
in healthy subjects in the first half of 2007. InterMune plans to
evaluate ITMN-191 in a Phase 1b randomized, double-blind, placebo
controlled, multiple ascending dose study in patients infected with
chronic hepatitis C virus. In this study ITMN-191 will be administered
to treatment-naive patients for 14 days; the study will also include a
cohort of non-responder patients. InterMune and its partner Roche expect
to announce initial viral kinetic results from the Phase 1b trial in the
second half of 2007.
The refinements to the two Phase 3 trials in the CAPACITY program
follow InterMune's review of two new and unique data sets related
to: 1) changes in forced vital capacity (FVC) and other important
measures of lung function over time in the placebo group of the recently
un-blinded INSPIRE trial and 2) the effect of pirfenidone on vital
capacity (VC) and other lung function parameters in the Phase 3 study of
pirfenidone in IPF recently concluded by Shionogi & Co. in Japan.
The planned changes to the CAPACITY program will increase the power of
the studies to demonstrate statistically significant effects on the
primary and secondary endpoint analyses. A total of 135 patients will be
added to the previously planned 580 patients and the treatment duration
will be increased by 12 weeks, from 60 to 72 weeks. The primary efficacy
endpoint remains change in forced vital capacity (FVC). The increased
sample size and treatment duration will provide in excess of 90% power
to detect a 50% reduction in the rate of FVC progression after 72 weeks
of treatment with pirfenidone compared to placebo and will also increase
the power on the various secondary endpoints. Taking into account these
changes, InterMune projects that the two trials will be fully enrolled
with a total of 715 patients in July of 2007 and completed in the first
quarter of 2009, several months ahead of previous guidance.
Steve Porter, M.D., Ph.D. and Chief Medical Officer of InterMune,
said, "We have recently had the unique opportunity to review two
new data sets from clinical studies in IPF that directly inform the
design of our CAPACITY program: the INSPIRE study and the Phase 3 study
of pirfenidone conducted by Shionogi in Japan. Based on our review of
these data, we have refined the CAPACITY program to further enhance the
probability of meeting its objectives. We are also pleased that as a
result of very strong enrollment trends, we expect that we will complete
the refined CAPACITY program well ahead of our previous projection. The
study conduct in the CAPACITY program, which has experienced a low
patient drop-out rate to date, is proceeding according to our plans. We
are also making excellent progress on our ITMN-191 Phase 1a program
which is proceeding as we expected."
Updated 2007 Financial Guidance and 2008 Expense Outlook
InterMune's revenues are comprised of revenues from our HCV
collaboration with Roche and sales of Actimmune(R), which is approved
for two indications, chronic granulomatous disease (CGD) and severe,
malignant osteopetrosis. In the United States, the company estimates
that there are approximately 1,200 patients with CGD and less than 500
patients with severe, malignant osteopetrosis. InterMune believes that
substantially all Actimmune(R) revenues are and have been historically
derived from physicians' prescriptions for the off-label use of
Actimmune(R) in the treatment of IPF.
In light of the INSPIRE study results, InterMune expects revenues
from physician prescriptions of Actimmune(R) for the treatment of IPF to
significantly decline. Since InterMune does not promote Actimmune(R) for
IPF and has no visibility on revenues in that setting, the company has
no basis on which to forecast revenues for the 2007 fiscal year
following the INSPIRE results announced on March 5, 2007. Therefore,
InterMune has withdrawn its previous guidance for revenues and Cost of
Goods Sold as a percentage of revenues for the year ending December 31,
2007. However, InterMune currently expects that Actimmune(R) revenues
for the first quarter of 2007 will be in a range of approximately $19 to
$21 million, assuming that product returns in this quarter are no higher
than those observed in previous periods. Revenues recognized during the
fiscal year ending December 31, 2007 from the Roche collaboration are
expected to be approximately $13 million, based on amortization of
previous collaboration payments already received and anticipated
collaboration payments during 2007.
InterMune will take a number of steps to reduce operating expenses,
which will have the effect, once fully implemented by 2008, of reducing
the company's total annual operating expense levels by $40 to $50
million, compared to the company's original 2007 financial
guidance. The company will reduce staffing levels by 50%, or 116
full-time and contract positions, primarily in the Clinical, Regulatory,
Medical Affairs and Commercial areas. The majority of staffing
reductions will occur in April and the remaining reductions will be
implemented over the coming months as the INSPIRE trial is closed. The
company will also take additional steps intended to significantly reduce
non-personnel related expenses.
For the year ending December 31, 2007, R&D expenses are
anticipated to be in a range of approximately $100 to $110 million, and
SG&A expenses in a range of approximately $25 to $35 million. These
ranges represent reductions in R&D and SG&A of $10 to $15
million and $10 million, respectively, from the original 2007 financial
guidance provided on February 8, 2007. InterMune will record charges for
restructuring related expenses associated with these operational changes
of approximately $3.5 million, which are expected to be recorded during
the year. In addition, InterMune may incur charges related to various
Actimmune(R) assets. The company has recorded a $4.5 million
Actimmune(R)-related impairment as of December 31, 2006.
InterMune currently expects to have between $205 and $210 million
in cash, cash equivalents and available-for-sale securities at March 31,
2007.
About InterMune
InterMune is a biotechnology company focused on the research,
development and commercialization of innovative therapies in pulmonology
and hepatology. InterMune has a pipeline portfolio addressing idiopathic
pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The
pulmonology portfolio includes the Phase 3 program, CAPACITY, which is
evaluating pirfenidone as a possible therapeutic candidate for the
treatment of patients with IPF and a research program focused on small
molecules for pulmonary and fibrotic disease. The hepatology portfolio
includes the HCV protease inhibitor compound ITMN-191 in Phase 1a, a
second-generation HCV protease inhibitor program, and a research program
evaluating a new target in hepatology.
For more information, visit http://www.intermune.com or call
415/466-2228.
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