Questcor To Commence Phase 2 Study of Acthar for Acute Respiratory Distress
ANAHEIM, Calif., Oct. 22, 2013
ANAHEIM, Calif., Oct. 22, 2013 /PRNewswire/ --QuestcorPharmaceuticals, Inc.
(NASDAQ: QCOR) announced today that it will commence a Phase 2 study to
explore the efficacy and safety of H.P.Acthar®
Gel(repositorycorticotropininjection) for Acute Respiratory Distress
Syndrome (ARDS). The Company's Investigational New Drug (IND) application for
the study has been reviewed by the U.S. Food and Drug Administration (FDA) and
is now active. ARDS is an acute life-threatening lung condition that can
result from pulmonary and non-pulmonary infections or a multitude of other
serious conditions. Based on our understanding of its potential mechanism of
action, Questcor believes that Acthar could have both steroid-independent and
steroid-dependent protective effects in this condition.
The study will seek to enroll up to 210 patients in a 4-week randomized,
placebo controlled trial designed to explore the efficacy and safety of
several dosing regimens of Acthar in patients with moderate to severe ARDS.
The primary objective of the study will be to determine if Acthar increases
the number of ventilator-free days during the 28-day treatment period.
Secondary endpoints include whether Acthar therapy diminishes mortality, organ
failure and the length of hospital or ICU stay.
"Despite advances in supportive care, there are no pharmacologic therapies
that address acute respiratory distress syndrome, an urgent medical condition
that results in mortality rates from 25 percent to over 40 percent of
patients," said Dr. David Young, Questcor's Chief Scientific Officer. "While
Acthar's exact mechanism of action is unknown, based on our understanding from
scientific literature and nonclinical data, we believe Acthar may be
beneficial in ARDS patients via its potential anti-inflammatory and
immune-modulatory properties that could reduce lung inflammation and injury,
making ARDS a compelling area to investigate further."
The ARDS study will be the second company-sponsored IND study Questcor has
initiated in 2013. Questcor has company-sponsored clinical studies underway to
investigate the safety and efficacy of Acthar in the treatment of amyotrophic
lateral sclerosis (ALS), diabetic nephropathy, idiopathic membranous
nephropathy and lupus. For more information on studies related to Acthar,
please visit http://www.clinicaltrials.gov.
Acute respiratory distress syndrome (ARDS) is the sudden failure of the
respiratory system, and can result from exposure to diverse direct and
indirect insults, including respiratory and non-pulmonary infections,
aspiration of gastric contents, trauma and transfusion reactions. A person
with ARDS has rapid breathing, difficulty getting enough air into the lungs,
low blood oxygen levels and often requires mechanical ventilatory support.
Multi-organ failure often develops as a consequence of or in association with
this condition. It is estimated there are approximately 141,500 incident cases
of ARDS in the U.S. each year.
Questcor Pharmaceuticals, Inc. is a biopharmaceutical company focused on the
treatment of patients with serious, difficult-to-treat autoimmune and
inflammatory disorders. Questcor also provides specialty contract
manufacturing services to the global pharmaceutical industry through its
wholly-owned subsidiary BioVectra Inc. Questcor's primary product is H.P.
Acthar® Gel (repository corticotropin injection), an injectable drug that is
approved by the FDA for the treatment of 19 indications. Of these 19
indications, Questcor currently generates substantially all of its net sales
from the following approved indications: the treatment of proteinuria in the
nephrotic syndrome (NS) of the idiopathic type, the treatment of acute
exacerbations of multiple sclerosis (MS) in adults, the treatment of infantile
spasms (IS) in infants and children under two years of age, and the treatment
of certain rheumatology related conditions. With respect to NS, the FDA has
approved Acthar to "induce a diuresis or a remission of proteinuria in the
nephrotic syndrome without uremia of the idiopathic type or that due to lupus
erythematosus." Questcor has announced its intention to initiate a pilot
commercialization effort for Acthar for the treatment of respiratory
manifestations of symptomatic sarcoidosis. The FDA-approved package insert
for Acthar includes "symptomatic sarcoidosis" under the heading "Respiratory
Diseases". Questcor is also exploring the possibility of developing markets
for other FDA-approved indications and the possibility of pursuing FDA
approval of additional indications not currently on the Acthar label where
there is high unmet medical need. Questcor also has agreed to acquire certain
international rights for Synacthen® (tetracosactide) and Synacthen Depot®, and
has licensed the right to develop and seek FDA approval for these products in
the United States. For more information about Questcor, please visit
Note: Except for the historical information contained herein, this press
release contains forward-looking statements that have been made pursuant to
the Private Securities Litigation Reform Act of 1995. These statements relate
to future events or our future financial performance. In some cases, you can
identify forward-looking statements by terminology such as "believes,"
"continue," "could," "ensuring," "estimates," "expects," "growth," "may,"
"momentum," "plans," "potential," "remain," "should," "start," "substantial,"
"sustainable" or "will" or the negative of such terms and other comparable
terminology. These statements are only predictions. Actual events or results
may differ materially. Factors that could cause or contribute to such
differences include, but are not limited to, the following:
oResearch and development risks, including risks associated with our work
in the area of ARDS, our reliance on third-parties to conduct research and
development, and the ability of research and development to generate
oOur reliance on Acthar for substantially all of our net sales and profits
and the possible FDA approval and market introduction of competitive
oThe lack of patent protection for Acthar;
oOur ability to effectively manage our growth, including the expansion of
our sales forces, planned international expansion, recent acquisitions,
and our reliance on key personnel;
oThe risk of product liability lawsuits;
oOther risks discussed in Questcor's annual report on Form 10-K for the
year ended December 31, 2012 as filed with the Securities and Exchange
Commission, or SEC, on February 27, 2013, and other documents filed with
The risk factors and other information contained in these documents should be
considered in evaluating Questcor's prospects and future financial
Questcor undertakes no obligation to publicly release the result of any
revisions to these forward-looking statements, which may be made to reflect
events or circumstances after the date of this release.
SOURCE Questcor Pharmaceuticals, Inc.
Contact: EVC Group, Gregory Gin/Patty Eisenhaur, 646-445-4801/951-316-0577, or
Janine McCargo, 646-688-0425
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