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: September 28, 2011
Date of earliest event reported: September 28, 2011
Warner Chilcott Public Limited Company
(Exact name of registrant as specified in its charter)
| Ireland | 0-53772 | 98-0626948 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
1 Grand Canal Square
Docklands
Dublin 2, Ireland
(Address of principal executive offices, including zip code)
+353 1 897 2000
(Registrant’s telephone number, including area code)
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. |
Warner Chilcott plc (together with its subsidiaries, the “Company”) today announced that it received a Notice of Paragraph IV certification from Zydus Pharmaceuticals USA, Inc. (“Zydus”) indicating that Zydus had submitted to the U.S. Food and Drug Administration (“FDA”) an Abbreviated New Drug Application seeking approval to manufacture and sell a generic version of ASACOL® HD (mesalamine) 800 mg delayed-release tablets, one of the Company’s products for the treatment of moderately active ulcerative colitis. The notice letter contends that the Company’s U.S. Patent No. 6,893,662, expiring in November 2021 (the “‘662 Patent”), is not infringed.
The Company is currently reviewing the details of the Paragraph IV certification notice letter from Zydus. In addition, Zydus indicated that it has submitted a Paragraph III certification with respect to U.S. Patent Nos. 5,541,170 and 5,541,171, formulation and method patents exclusively licensed by the Company that cover ASACOL® HD and expire in July 2013. The Company intends to vigorously defend the ‘662 Patent and protect its legal rights and continues to have full confidence in the intellectual property protecting ASACOL® HD.
Caution Concerning Forward-Looking Statements
This Current Report on Form 8-K includes certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on the current expectations and beliefs of the management of the Company and are subject to uncertainty and changes in circumstances. Actual results may vary materially from those expressed or implied by the statements herein due to changes in economic, business, competitive, technological and/or regulatory factors, as well as other factors affecting the operation of the business of the Company. More detailed information about these factors may be found in the filings by the Company with the Securities and Exchange Commission, including its most recent annual report on Form 10-K for the year ended December 31, 2010. The Company is under no obligation, and expressly disclaims any obligation, to update or alter the forward-looking statements, whether as a result of new information, future events or otherwise.
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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.
| WARNER CHILCOTT PUBLIC LIMITED COMPANY | ||
| By: | /s/ Paul Herendeen | |
| Name: | Paul Herendeen | |
| Title: | Executive Vice President and Chief Financial Officer | |
Date: September 28, 2011
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