UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 11, 2010
QUESTCOR PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
| California (State or Other Jurisdiction of Incorporation) |
001-14758 (Commission File Number) |
33-0476164 (I.R.S. Employer Identification No.) |
| 3260 Whipple Road, Union City, California (Address of Principal Executive Offices) |
94587 (Zip Code) |
Registrant’s telephone number, including area code: (510) 400-0700
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events.
On June 11, 2010, Questcor Pharmaceuticals, Inc. (the “Company”) was informed by the U.S. Food
& Drug Administration (“FDA”) that the PDUFA date for Questcor’s supplemental new drug application
(sNDA) to approve Acthar for the treatment of infantile spasms (IS) has been extended to September
11, 2010. The FDA extended the PDUFA date in order to review information regarding labeling and
potential post-approval commitments that they solicited from Questcor. This follows the May 6, 2010
votes by the Advisory Committee to the Division of Peripheral and Central Nervous System Drugs of
the FDA which indicated support for approval of this new Acthar indication.
Investors should note that there can be no assurance that the FDA will approve this sNDA by
September 11, 2010, or thereafter.
A copy of the press release announcing the FDA’s extension of the PDUFA date is filed as
Exhibit 99.1 hereto and incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(c) Exhibits.
| Exhibit No. | Description | |
99.1
|
Questcor Pharmaceuticals, Inc. press release dated June 11, 2010. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: June 14, 2010 | QUESTCOR PHARMACEUTICALS, INC. |
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| By: | /s/ Gary M. Sawka | |||
| Gary M. Sawka | ||||
| Senior Vice-President, Finance and Chief Financial Officer |
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EXHIBIT INDEX
| Exhibit No. | Description | |
99.1
|
Questcor Pharmaceuticals, Inc. press release dated June 11, 2010. |
Exhibit 99.1
QUESTCOR RECEIVES NOTIFICATION OF PDUFA DATE EXTENSION TO
SEPTEMBER 11, 2010
SEPTEMBER 11, 2010
Union City, CA — June 11, 2010 — Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR) today announced
that it has received notification from the U.S. Food & Drug Administration (FDA) that the PDUFA
date for Questcor’s supplemental new drug application (sNDA) to approve Acthar for the treatment of
infantile spasms (IS) has been extended to September 11, 2010. The FDA extended the PDUFA date in
order to review information regarding labeling and potential post-approval commitments that they
solicited from Questcor. This follows the May 6, 2010 votes by the Advisory Committee to the
Division of Peripheral and Central Nervous System Drugs of the FDA which indicated support for
approval of this new Acthar indication.
“We look forward to working with the FDA over the next few months in order to finalize these
critical elements,” said Don M. Bailey, President and CEO of Questcor.
Investors should note that there can be no assurance that the FDA will approve this sNDA by
September 11, 2010, or thereafter.
About Questcor
Questcor Pharmaceuticals, Inc. is a pharmaceutical company that markets H.P. Acthar® Gel
(repository corticotropin injection). H.P. Acthar Gel (“Acthar”) is an injectable drug that is
approved for the treatment of certain disorders with an inflammatory component, including the
treatment of exacerbations associated with multiple sclerosis (“MS”) and to induce a diuresis or a
remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that is
due to lupus erythamatosus. In addition, Acthar is not indicated for, but is used in treating
patients with infantile spasms (“IS”), a rare form of refractory childhood epilepsy, and opsoclonus
myoclonus syndrome, a rare autoimmune-related childhood neurological disorder. The Company also
markets Doral® (quazepam), which 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.
CONTACT INFORMATION:
Questcor Pharmaceuticals, Inc.
Don Bailey
510-400-0776
dbailey@Questcor.com
Questcor Pharmaceuticals, Inc.
Don Bailey
510-400-0776
dbailey@Questcor.com
EVC Group, Inc. |
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Investors
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Media | |
Doug Sherk
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Christopher Gale | |
415-896-6820
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646-201-5431 |