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UNITED STATES 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) November 27, 2006
QUESTCOR PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| California | 001-14758 | 33-0476164 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS 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
(Former name or former address, if changed since last report.)
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 | ||||||||
| SIGNATURES | ||||||||
| EXHIBIT INDEX | ||||||||
| EXHIBIT 99.1 | ||||||||
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Item 7.01 Regulation FD Disclosure.
On November 27, 2006, the Company issued a press release announcing the initiation of
patient dosing under its investigational new drug (IND) application with the U.S. Food & Drug
Administration for QSC-001, a unique orally disintegrating tablet (ODT) formulation of hydrocodone
bitartrate and acetaminophen (HB/APAP) for the treatment of moderate to moderately severe
pain. A copy of the press release is attached as Exhibit 99.1 to this Current Report on
Form 8-K and is incorporated herein by reference.
In accordance with General Instruction B.2. of Form 8-K, the information furnished pursuant to
this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18
of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to
the liability of that section, nor shall it be deemed incorporated by reference in any filing under
the Securities Act of 1933, as amended, or the Exchange Act except as expressly set forth by
specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits.
| Exhibit | ||||
| Exhibit Description | Number | |||
Press Release, dated November 27, 2006.
|
99.1 | |||
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SIGNATURES
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.
| Questcor Pharmaceuticals, Inc. | ||||||
Date: November 28, 2006
|
By: | /s/ James L. Fares | ||||
| James L. Fares | ||||||
| President and Chief Executive Officer | ||||||
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Exhibit 99.1
FOR IMMEDIATE RELEASE
QUESTCOR ANNOUNCES INITIATION OF CLINICAL PROGRAM FOR QSC-001
Union City, CA – November 27, 2006 — Questcor Pharmaceuticals, Inc. (AMEX:QSC) announced today the
initiation of patient dosing under its investigational new drug (IND) application with the U.S.
Food & Drug Administration (FDA) for QSC-001, a unique orally disintegrating tablet (ODT)
formulation of hydrocodone bitartrate and acetaminophen (HB/APAP) for the treatment of moderate to
moderately severe pain. QSC-001 was formulated for Questcor by Eurand and will utilize Eurand’s
proprietary Microcaps® taste-masking and AdvaTab™ ODT technologies. Questcor
owns the world-wide rights to commercialize QSC-001 and Eurand will exclusively supply the product
and receive a royalty on product sales.
HB/APAP, in its variety of strengths, is one of the most frequently prescribed products in the
United States with over 100 million prescriptions written in the past year according to Wolters
Kluwer. HB/APAP is one of the five most frequently prescribed products by Neurologists, who
accounted for over one million prescriptions. There are currently no ODT formulations of HB/APAP
available in the United States.
“The successful initiation of our first clinical development program represents an important
milestone in Questcor’s evolution into a leading CNS-focused specialty pharmaceutical company. We
believe that QSC-001 could fill a critical gap in the treatment of pain and represents a tremendous
opportunity for Questcor,” commented James Fares, Questcor’s President and CEO. “Neurologists
prescribe pain medication for a large number of their patients, particularly those with Multiple
Sclerosis, Headache, Chronic Pain, and Spinal lesions. For the many individuals who experience
significant difficulty swallowing pills, we believe QSC-001 represents a valuable option for the
treatment of their pain.”
Questcor expects to file the QSC-001 New Drug Application with the FDA in the second half of 2007.
Eurand will receive milestone payments upon the achievement of certain development milestones.
About Eurand’s ODT Technology: AdvaTab™ can be combined with Eurand’s
Microcaps® taste-masking technology to provide an ODT with a pleasant taste. In
addition, AdvaTab™ tablets dissolve rapidly in the mouth within 15 to 30 seconds, and
the smooth mixture of carrier excipients and taste-masked drug granules is suitable for delivering
high drug doses. Modified-release drug granules can also be incorporated into the
AdvaTab™ dosage form to provide a fast-dissolve tablet with sustained-release
properties. AdvaTab™ tablets can be packaged in either bottles or blisters.
About Eurand: Eurand is a specialty pharmaceutical company that develops, manufactures and
commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug
formulation technologies. The company has had three products approved by the FDA since 2001 and
has a pipeline of products in development both for its co-development partners and its proprietary
portfolio. The company’s lead product candidate, a treatment for exocrine pancreatic insufficiency
associated with cystic fibrosis and other diseases, is currently
undergoing Phase III clinical trials in the United States. Eurand’s technology platforms include:
bioavailability enhancement of poorly soluble drugs, customized release, taste
masking/fast-dissolving formulations, and drug conjugation. Eurand is an established business with
manufacturing and research facilities in the United States, Italy and France. For more information,
visit Eurand’s website at www.eurand.com.
About Questcor - Questcor Pharmaceuticals, Inc.® (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® Gel (repository
corticotropin injection), an injectable drug indicated for the treatment of exacerbations
associated with multiple sclerosis and Doral® (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 INFORMATION:
Eric Liebler
510-400-0700
IR@Questcor.com
510-400-0700
IR@Questcor.com
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