UNION CITY, Calif.--(BUSINESS WIRE)--Aug. 23, 2006--Questcor
Pharmaceuticals, Inc. (AMEX:QSC) announced today that the U.S. Food
and Drug Administration (FDA) has accepted for review its supplemental
new drug application (sNDA) seeking approval for H.P. Acthar(R) Gel
(repository corticotropin injection) for the treatment of infantile
spasms. Questcor anticipates that the FDA will take action on the sNDA
during the second quarter of 2007. No drug is currently approved in
the United States for the treatment of infantile spasms.
"Today's announcement demonstrates our continued commitment to the
treatment of central nervous system diseases and disorders," said
James Fares, Questcor's president and chief executive officer. "Acthar
Gel is an important drug today in the treatment of infantile spasms.
However, we believe this filing supports an even greater role for
Acthar Gel in managing this life-threatening form of childhood
epilepsy. We look forward to working closely with the FDA throughout
this review process."
The sNDA provides clinical data to support the addition of the
infantile spasms indication to the current Acthar Gel label.
Supportive information includes historical data on the use of Acthar
Gel in the treatment of infantile spasms, including the results from
randomized clinical trials involving greater than 250 patients, which
were published in peer-reviewed medical literature.
About Infantile Spasms -- Infantile spasms (IS) is a seizure
disorder of early childhood also known as West Syndrome. The onset is
predominantly in the first year of life, typically between 3 to 6
months. The typical pattern of IS is a sudden bending forward and
stiffening of the body, arms, and legs; although there can also be
arching of the torso. Spasms tend to begin soon after arousal from
sleep. Individual spasms typically last for 1 to 5 seconds and occur
in clusters, ranging from 2 to 100 spasms at a time. Infants may have
dozens of clusters and several hundred spasms per day. Infantile
spasms usually stop by age 5, but are often replaced by other seizure
types. IS is characterized by seizures, hypsarrhythmia (abnormal,
chaotic brain wave patterns), and mental retardation. Other
neurological disorders, such as cerebral palsy, may be seen in 30-50%
of those with IS. The incidence of IS is estimated to be about 1 per
2,000 to 4,000 live births. It is the most frequent type of epileptic
encephalopathy, the group of conditions in which epilepsy determines
cognitive deterioration. No drug is currently approved in the United
States for the treatment of IS. Patients diagnosed with this disorder
are typically treated with a variety of agents, including Acthar Gel.
About Acthar Gel - H.P. Acthar Gel(R) is a natural
adrenocorticotropic hormone (ACTH) designed to provide a prolonged
release after intramuscular or subcutaneous injection. Acthar Gel is
currently indicated for the treatment of acute exacerbations of
multiple sclerosis, and for several other diseases and disorders.
For full prescribing information and safety information on Acthar
Gel, please visit http://www.acthar.com.
About Questcor - Questcor Pharmaceuticals, Inc.(R) (AMEX:QSC) is a
specialty pharmaceutical company that develops and commercializes
novel therapeutics for the treatment of neurological disorders.
Questcor currently markets H.P. Acthar(R) Gel (repository
corticotropin injection), an injectable drug indicated for the
treatment of exacerbations associated with multiple sclerosis and
Doral(R) (quazepam) that is indicated for the treatment of insomnia
characterized by difficulty in falling asleep, frequent nocturnal
awakenings, and/or early morning awakenings. For more information,
please visit www.questcor.com.
Note: Except for the historical information contained herein, this
press release contains forward-looking statements that involve risks
and uncertainties. Such statements are subject to certain factors,
which may cause Questcor's results to differ from those reported
herein. Factors that may cause such differences include, but are not
limited to, Questcor's ability to accurately forecast and create the
demand for its products, the gross margin achieved from the sale of
its products, Questcor's ability to enforce its product returns
policy, the accuracy of the prescription data purchased from
independent third parties by Questcor, the sell-through by Questcor's
distributors, the inventories carried by Questcor's distributors, and
the expenses and other cash needs for the upcoming periods, Questcor's
ability to obtain finished goods from its sole source contract
manufacturers on a timely basis if at all, Questcor's potential future
need for additional funding, Questcor's ability to utilize its net
operating loss carry forwards to reduce income taxes on the sale of
its non-core products, research and development risks, uncertainties
regarding Questcor's intellectual property and the uncertainty of
receiving required regulatory approvals in a timely way, or at all,
and the ability of Questcor to implement its strategy and acquire
products and, if acquired, to market them successfully, as well as the
risks discussed in Questcor's annual report on Form 10-K for the year
ended December 31, 2005 and other documents filed with the Securities
and Exchange Commission. The risk factors and other information
contained in these documents should be considered in evaluating
Questcor's prospects and future financial performance.
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 hereof or to
reflect the occurrence of unanticipated events.
CONTACT: Questcor Pharmaceuticals, Inc.
Eric Liebler, 510-400-0740
SOURCE: Questcor Pharmaceuticals, Inc.