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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): December 2, 2008
QUESTCOR PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
| California | 001-14758 | 33-0476164 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) | (I.R.S. Employer Identification No.) |
| 3260 Whipple Road, Union City, California | 94587 | |
| (Address of Principal Executive Offices) | (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)) |
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| Item 7.01 Regulation FD Disclosure | ||||||||
| Item 9.01. Financial Statements and Exhibits | ||||||||
| SIGNATURE | ||||||||
| EXHIBIT INDEX | ||||||||
| EX-99.1 | ||||||||
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Item 7.01 Regulation FD Disclosure.
On December 2, 2008, Questcor Pharmaceuticals, Inc. (the “Company”) announced via press
release that the Company has resubmitted to the U.S. Food & Drug Administration (FDA) its
supplemental New Drug Application (sNDA) seeking approval to market H.P. Acthar® Gel (repository
corticotropin injection) for the treatment of infantile spasms. A copy of the Company’s press
release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(c) Exhibits.
| Exhibit No. | Description | |
99.1
|
Questcor Pharmaceuticals, Inc. press release dated December 2, 2008. |
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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: December 5, 2008 | QUESTCOR PHARMACEUTICALS, INC. |
|||
| By: | /s/ Gary Sawka | |||
| Gary 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 December 2, 2008. |
Exhibit 99.1
Questcor Resubmits Supplemental New Drug Application to FDA for H.P. Acthar® Gel for Treatment of Infantile Spasms
UNION CITY, Calif., December 2, 2008 -— Questcor Pharmaceuticals, Inc. (Nasdaq: QCOR) announced
that it has resubmitted to the US Food & Drug Administration (FDA) its supplemental New Drug
Application (sNDA) seeking approval to market H.P. Acthar ® Gel (repository corticotrophin
injection) for the treatment of infantile spasms.
In June 2006 Questcor submitted a sNDA to the FDA and in May 2007 the FDA determined the sNDA was
not approvable in the form submitted in 2006. Subsequently, Questcor met with the FDA to review
the company’s plans for resubmission.
“We have worked closely with the FDA for the past 18 months to gather and present necessary data to
support the sNDA and we look forward to working with the FDA during the review process of our
resubmission,” said Don M. Bailey, President and CEO of Questcor.
About Questcor
Questcor Pharmaceuticals, Inc. is a pharmaceutical company that markets two commercial products,
H.P. Acthar(r) Gel (“Acthar”) and Doral(r). Acthar (repository corticotropin injection) 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 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. Doral is indicated for the treatment of insomnia characterized by difficulty in falling
asleep, frequent nocturnal awakenings, and/or early morning awakenings. The Company is also
developing QSC-001, a unique orally disintegrating tablet formulation of hydrocodone bitartrate and
acetaminophen for the treatment of moderate to moderately severe pain. For more information, please
visit www.questcor.com.
Note: Except for the historical information contained herein, this press release contains
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
1995. Such statements involve risks and uncertainties and 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 continue to successfully implement its Acthar-centric business strategy; | |
| -- | the introduction of competitive products, | |
| -- | regulatory changes including possible outcomes relating to a July 2008 Congressional hearing regarding orphan drug pricing; | |
| -- | Questcor’s ability to accurately forecast the demand for its products; | |
| -- | the gross margin achieved from the sale of its products; | |
| -- | Questcor’s ability to estimate the quantity of Acthar used by government entities and Medicaid-eligible patients; | |
| -- | that the actual amount of rebates and discounts related to the use of Acthar by government entities and Medicaid-eligible patients may differ materially from Questcor’s estimates; | |
| -- | the expenses and other cash needs for upcoming periods; | |
| -- | the inventories carried by Questcor’s distributors, specialty pharmacies and hospitals, | |
| -- | volatility in Questcor’s monthly and quarterly Acthar shipments and end-user demand; | |
| -- | Questcor’s ability to obtain finished goods from its sole source contract manufacturers on a timely basis if at all; | |
| -- | Questcor’s ability to attract and retain key management personnel; | |
| -- | Questcor’s ability to utilize its net operating loss carry forwards to reduce income taxes on taxable income; | |
| -- | research and development risks, including risks associated with Questcor’s sNDA for IS, its preliminary work in the area of nephrotic syndrome and QSC-001; | |
| -- | uncertainties regarding Questcor’s intellectual property; | |
| -- | the uncertainty of receiving required regulatory approvals in a timely way, or at all; | |
| -- | uncertainties in the credit and capital markets and the impact a further deterioration of these markets could have on Questcor’s investment portfolio; | |
| -- | as well as the risks discussed in Questcor’s annual report on Form 10-K for the year ended December 31, 2007 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 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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