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InterMune Pharmaceuticals, Inc. develops and
commercializes innovative products for the treatment of
serious pulmonary and infectious diseases and congenital
disorders. The Company currently markets ACTIMMUNE©
(Interferon gamma-1b) Injection in the U.S. for the treatment
of Chronic Granulomatous Disease (CGD) and osteopetrosis.
Our Business
InterMune Pharmaceuticals develops and
commercializes innovative products for the
treatment of serious pulmonary and infectious
diseases and congenital disorders. We have the
exclusive license rights in the United States to
ACTIMMUNE© (interferon gamma-1b injection)
for a range of indications, including chronic
granulomatous disease, osteopetrosis, idiopathic
pulmonary fibrosis, mycobacterial infections,
systemic fungal infections and cystic fibrosis.
We currently market ACTIMMUNE for chronic
granulomatous disease. We have active
development programs underway for the other
indications, several of which are in mid- or
advanced-stage human testing, known as clinical
trials. Idiopathic pulmonary fibrosis,
mycobacterial infections and systemic fungal
infections are serious and difficult to treat
diseases that we believe represent a combined
potential market opportunity for ACTIMMUNE
of approximately $3.5 billion annually in the
United States.
Interferon gamma-1b, the active ingredient in
ACTIMMUNE, is a human protein which plays a
key role in preventing the formation of excessive
scar, or fibrotic, tissue and is a potent stimulator
of the immune system. Interferon gamma is
biologically distinct from interferon alpha and
interferon beta, two related proteins that are
currently marketed for the treatment of diseases
such as hepatitis B infection and multiple
sclerosis. Interferon gamma has a superior safety
profile as compared to interferon alpha and
interferon beta because it results in fewer and less
severe adverse side effects.
ACTIMMUNE
Marketed Indication
Chronic Granulomatous Disease. The U.S.
Food and Drug Administration has approved
ACTIMMUNE for the treatment of chronic
granulomatous disease, and we currently market
and sell ACTIMMUNE in the United States for
this disease. Chronic granulomatous disease is a
life-threatening congenital disorder of the immune
system that causes patients to be vulnerable to
severe recurrent infections. This disease affects
children, and no other FDA-approved treatment
currently exists. ACTIMMUNE was approved by
the FDA based on its ability to reduce the
frequency and severity of infections in these
patients.
Indications in Development
Osteopetrosis. In August 1999, upon the
completion of a Phase III clinical trial, we
submitted a supplement to our biologics license
application, or BLA, to the FDA for this
indication. The FDA has designated
osteopetrosis as eligible for both an accelerated
review, known as fast track review, and orphan
drug status. Osteopetrosis is a life-threatening,
congenital disorder in which an overgrowth of
bony structures leads to blindness, deafness and
increased susceptibility to infection. This disorder
primarily affects children, and no effective
treatment is currently available.
Idiopathic Pulmonary Fibrosis. We believe the
most significant near-term use of ACTIMMUNE
is for the treatment of idiopathic pulmonary
fibrosis, a life-threatening lung condition that
afflicts approximately 50,000 persons in the
United States. Idiopathic pulmonary fibrosis is
characterized by progressive scarring of the
lungs, which leads to their deterioration and
destruction. The prognosis of patients with
idiopathic pulmonary fibrosis is poor and most
patients die from progressive loss of lung
function, which leads to suffocation. Therapeutic
options for idiopathic pulmonary fibrosis are
limited and only minimally effective.
The results of a Phase II clinical trial published in
October 1999 in The New England Journal of
Medicine showed statistically significant
evidence that interferon gamma-1b halts and
reverses the progression of idiopathic pulmonary
fibrosis. We are continuing the clinical
development of ACTIMMUNE for idiopathic
pulmonary fibrosis by initiating a Phase II/III
pivotal clinical trial during the first half of 2000.
Other indications. We are also developing
ACTIMMUNE to treat a variety of other diseases,
including infectious diseases and cystic fibrosis.
Preclinical studies and clinical trials have
demonstrated the therapeutic potential of
ACTIMMUNE against a broad range of infectious
diseases, notably mycobacterial and systemic
fungal infections. A study published in May 1997
in The Lancet showed that ACTIMMUNE was
effective in the treatment of multidrug-resistant
tuberculosis, a type of mycobacterial infection. As
a result of these studies, we are initiating a Phase
III pivotal clinical trial for ACTIMMUNE in the
treatment of multidrug-resistant tuberculosis and
have commenced a Phase II clinical trial in
cryptococcal meningitis, a type of systemic fungal
infection. We intend to initiate Phase II clinical
trials in cystic fibrosis and in atypical
mycobacterial infections in the second half of
2000.
We believe that the risks and time required to
obtain FDA approval for new indications of
ACTIMMUNE may be reduced because
ACTIMMUNE has proven to be safe for patients
since its approval in 1990 for the treatment of
chronic granulomatous disease.
Other Products In Development
We also have two preclinical development
programs that address infections caused by two
types of bacteria, pseudomonas aeruginosa and
staphylococcus aureus. We believe that these
indications present combined market
opportunities of approximately $2 billion annually
in the United States.
Strategy
We plan to pursue a growth strategy through:
growing product revenue;
expanding the number of FDA-approved
indications for ACTIMMUNE;
enhancing physician awareness and
education;
developing a sales and marketing
organization to serve pulmonologists and
infectious disease specialists; and
continuing to in-license preclinical and
development-stage programs.
Background
InterMune was formed in 1998 and began
operations as a wholly-owned subsidiary of
Connetics Corporation. In 1998, Connetics
acquired from Genentech Inc., and subsequently
sublicensed to us, rights to develop and
commercialize ACTIMMUNE for a broad range
of indications. We initially focused on marketing
ACTIMMUNE for chronic granulomatous disease
and developing it for serious infectious diseases
and congenital disorders.
In October 1999, a study published in the The
New England Journal of Medicine showed
significant evidence that interferon gamma-1b
halts and reverses the progression of idiopathic
pulmonary fibrosis. As a result, we expanded our
development and commercialization plans to
include idiopathic pulmonary fibrosis as well as
other life-threatening pulmonary diseases.
intermune.com
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