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): March 14, 2011
POZEN INC.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 000-31719 | 62-1657552 |
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
1414 Raleigh Road, Suite 400 Chapel Hill, North Carolina | 27517 |
| (Address of Principal Executive Offices) | (Zip Code) |
| (919) 913-1030 |
| (Registrant's telephone number, including area code) |
| | Not applicable | |
| | (Former Name or Former Address, if Changed Since Last Report) | |
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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)). |
On March 14, 2011, POZEN Inc., a Delaware corporation (“POZEN” or “the Company”), AstraZeneca AB (“AstraZeneca”), and AstraZeneca’s United States affiliate, AstraZeneca Pharmaceuticals, LP, received notice from Dr. Reddy’s Laboratories, Inc. (“DRL”) pursuant to 21 U.S.C. 355(j)(2)(A)(vii)(IV) (the “Paragraph IV Notice Letter”), that DRL had filed an Abbreviated New Drug Application (“ANDA”) with the United States Food and Drug Administration (“FDA”) seeking regulatory approval to market a generic version of VIMOVO™ (naproxen and esomeparazole magnesium) delayed release tablets before the expiration of U.S. Patent No. 6,926,907 in 2023. The patent is assigned to Pozen and listed with respect to VIMOVO™ in the FDA’s Approved Drug Products with Therapeutic Equivalents Evaluation publication (commonly referred to as the “Orange Book”). DRL’s Paragraph IV Notice Letter asserts that its generic product will not infringe the listed patent or that the listed patent is invalid or unenforceable. The Company and AstraZeneca are evaluating DRL’s Paragraph IV Notice Letter.
The Company has full confidence in its intellectual property portfolio related to VIMOVO™ and will vigorously defend its patent from any infringement. The Company may receive additional Paragraph IV Notice Letters from other companies seeking to market generic versions of VIMOVO™ in the future and, after evaluation, may commence patent infringement lawsuits against such companies.
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.
| | POZEN Inc. |
| | | |
| | By: | /s/ William L. Hodges |
| | Name: | William L. Hodges |
| | Title: | Chief Financial Officer |
Date: March 15, 2011
