Questcor to Initiate Pilot Commercialization Effort In Pulmonology for
ANAHEIM, Calif., July 11, 2013
ANAHEIM, Calif., July11, 2013 /PRNewswire/ --QuestcorPharmaceuticals, Inc.
(NASDAQ: QCOR) today announcedits intentto initiate a pilot
commercialization effort for H.P.Acthar®
Gel(repositorycorticotropininjection) for the treatment of respiratory
manifestations of symptomatic sarcoidosis, a potentially serious,
difficult-to-treat disorder already included on the FDA-approved package
insert forActhar. The pilot effort will focus on pulmonologists, who are the
respiratory specialists treating this rare autoimmune disorder.
The company anticipates hiring and training a small, pilot sales force of five
to ten sales representatives during the current quarter, with introductory
sales calls expected to begin in the fourth quarter of this year. While this
approach mirrors the pilot commercial efforts by Questcor in neurology,
nephrology and rheumatology, there can be no assurance that this initiative
will lead to a fully-sized pulmonology sales force or that the company's
efforts with respect to this disorder will otherwise be successful.
Questcoris also evaluating several potential clinical studies that have been
recently proposed by key opinion leaders in the sarcoidosis field.
"This commercial expansion, together with our increasing R&D investment,
continues our efforts to expand patient access tothe FDA-approved, on-label
indications of Acthar," said Don M. Bailey,Questcor'sPresident and Chief
Executive Officer. "Already, patients suffering fromnephroticsyndrome (NS),
multiple sclerosis(MS) exacerbations, infantile
spasms,andcertainrheumatology-related conditions have benefitted
fromActhar. Our plansto increase awareness among pulmonologists treating
patients suffering from respiratory manifestations of symptomatic
sarcoidosiswill followthe model we have used successfully for these other
markets as wecontinueto explorethe full therapeutic potential of Acthar."
"We areexperiencing soliduptake ofActharin rheumatology including, most
recently, alargerthan expectednumber of prescriptions for rheumatoid
arthritis, an additional on-label indication, and are receiving positive
feedback from physicians in the rheumatology community," commented
SteveCartt, Chief Operating Officer ofQuestcor. "Based on this early
success, and our track record of successful entry into multiple new Acthar
markets, we are accelerating our plans to begin a pilot effortforActharwith
pulmonologists to help patients suffering fromsymptomaticsarcoidosis. We
will hire a small group of new Acthar Specialists to begin calling onand
educating pulmonologists about Acthar and its potential role in the treatment
of this difficult-to-treat autoimmune disorder. As we have successfully done
in the past with ourMS,NS and rheumatology commercial efforts, weexpectto
gain valuable information from this initial pilot effort,which
willinformour potential next steps in the commercialization process."
More commonly affecting young adults, sarcoidosis is a systemic inflammatory
disease where cell nodules or granulomas can manifest in multiple organs, most
often in the lungs. There are about 150,000 diagnosed sarcoidosis patients in
the U.S., of which approximately 90% have some degree of pulmonary
Sarcoidosis can be difficult to treat, and if not treated successfully,
serious health issues can develop, including lung scarring, fibrosis and
infections, which may lead to respiratory deterioration and eventual failure.
Between 30,000 and 45,000 diagnosed U.S. patients are considered to have
moderate to severe chronic or relapsing disease. Only Acthar and steroids are
approved for the treatment of respiratory symptomatic sarcoidosis.
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 on-label indications: the treatment of proteinuria in the
nephrotic syndrome of the idiopathic type, or NS, the treatment of acute
exacerbations of multiple sclerosis, or MS, in adults, the treatment of
infantile spasms, or IS, in infants and children under two years of age, and
the treatment of certain rheumatology related conditions, including the
treatment of the rare and closely related neuromuscular disorders
dermatomyositis and polymyositis. With respect to nephrotic syndrome, 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." 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 on-label
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 www.questcor.com.
For more information about Acthar, including important safety information,
please visit www.acthar.com.
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," "estimates," "expects," "growth," "intent," "may,"
"plans," "potential," "should," "substantial," "will," or "would" 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,
oOur reliance on Acthar for substantially all of our net sales and profits;
oOur ability to receive high reimbursement levels from third party payers;
oThe lack of patent protection for Acthar; and the possible FDA approval
and market introduction of competitive products;
oOur ability to continue to generate revenue from sales of Acthar to treat
on-label indications associated with NS, MS, IS or rheumatology-related
conditions, and our ability to develop other therapeutic uses for Acthar,
including symptomatic sarcoidosis;
oResearch and development risks, including risks associated with Questcor's
work in the area of NS and Lupus, and potential work in the area of
oThe results of any pending or future litigation, investigations or claims,
including with respect to the investigation by the United States
Attorney's Office for the Eastern District of Pennsylvania regarding the
Company's promotional practices and litigation brought by certain
shareholders arising from the federal securities laws, currently pending
in the United States District Court for the Central District of
oOur ability to comply with federal and state regulations, including
regulations relating to pharmaceutical sales and marketing practices;
oAn increase in the proportion of our Acthar unit sales comprised of
Medicaid-eligible patients and government entities;
oOur ability to estimate reserves required for Acthar used by government
entities and Medicaid-eligible patients and the impact that unforeseen
invoicing of historical Medicaid prescriptions may have upon our results;
oOur ability to effectively manage our growth, including the expansion of
our sales forces, and our reliance on key personnel; and
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.
For more information, please visit www.questcor.com or www.acthar.com.
SOURCE Questcor Pharmaceuticals, Inc.
Contact: EVC Group, Patty Eisenhaur/Gregory Gin, 951-316-0577/646-445-4801,
Doug Sherk, 415-652-9100; Janine McCargo, 646-688-0425
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