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
Date of Report (Date of earliest event reported): November 20, 2013
Horizon Pharma, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-35238 | 27-2179987 | ||
| (State of incorporation) | (Commission File No.) | (IRS Employer Identification No.) | ||
| 520 Lake Cook Road, Suite 520, Deerfield, Illinois | 60015 | |||
| (Address of principal executive offices) | (Zip Code) | |||
Registrant’s telephone number, including area code: (224) 383-3000
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:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | 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 November 20, 2013, we were notified by counsel for Par Pharmaceutical Companies, Inc. and Par Pharmaceutical, Inc. (collectively, “Par”) that Par had elected to withdraw its Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) for a generic version of RAYOS® containing 2 mg and 5 mg of prednisone. On October 22, 2013, we, together with Jagotec AG, filed suit in the United States District Court for the District of New Jersey against Par in response to a Paragraph IV Patent Certification from Par advising that Par had filed an ANDA with the FDA for a generic version of RAYOS® containing 2 mg and 5 mg of prednisone. The lawsuit alleges that Par has infringed U.S. Patent Nos. 6,488,960, 6,677,326, 8,168,218, 8,309,124 and 8,394,407 by filing an ANDA seeking approval from the FDA to market generic versions of RAYOS® prior to the expiration of the patents. We will work with Par to provide a stipulation of dismissal of the case to the Court. The subject patents are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.
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.
| Date: November 22, 2013 | Horizon Pharma, Inc. | |||||
| By: | /s/ Robert J. De Vaere | |||||
| Robert J. De Vaere | ||||||
| Executive Vice President and Chief Financial Officer | ||||||