0001193125-15-253755.txt : 20150715 0001193125-15-253755.hdr.sgml : 20150715 20150715172257 ACCESSION NUMBER: 0001193125-15-253755 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20150715 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150715 DATE AS OF CHANGE: 20150715 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Allergan plc CENTRAL INDEX KEY: 0001578845 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: L2 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36867 FILM NUMBER: 15989951 BUSINESS ADDRESS: STREET 1: 70 SIR JOHN ROGERSON'S QUAY CITY: DUBLIN 2 STATE: L2 ZIP: 2 BUSINESS PHONE: (216) 523-5000 MAIL ADDRESS: STREET 1: 70 SIR JOHN ROGERSON'S QUAY CITY: DUBLIN 2 STATE: L2 ZIP: 2 FORMER COMPANY: FORMER CONFORMED NAME: Actavis plc DATE OF NAME CHANGE: 20130930 FORMER COMPANY: FORMER CONFORMED NAME: Actavis Ltd DATE OF NAME CHANGE: 20130607 8-K 1 d87991d8k.htm FORM 8-K Form 8-K

 

 

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): July 15, 2015

 

 

 

Commission

File Number

 

Exact name of registrant as
specified in its charter,

principal office and address
and telephone number

 

State of incorporation

or organization

  

I.R.S. Employer

Identification No.

001-36867  

Allergan plc

1 Grand Canal Square,

Docklands Dublin 2, Ireland

(862) 261-7000

  Ireland    98-1114402

 

 

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):

 

¨ 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 7.01 Regulation FD Disclosure.

On July 15, 2015, Allergan plc (the “Company”) issued a press release announcing that the Company received a notice letter dated July 10, 2015 from Akorn Pharmaceuticals (“Akorn”) stating that the U.S. Food and Drug Administration (FDA) has received Akorn’s Abbreviated New Drug Application (ANDA) containing “Paragraph IV” patent certification seeking approval to market a generic version of the Company’s Restasis® (cyclosporine ophthalmic emulsion) 0.05% product. In addition, the Company has received communication suggesting that additional ANDAs for generic versions of Restasis® may have been received by the FDA.

A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.

The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act of 1934, as amended (the “Exchange Act”), or as otherwise subject to liability of that section, nor shall such information be deemed to be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended or the Exchange Act.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit

  

Description of Exhibit

Exhibit 99.1    Press Release dated July 15, 2015.


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: July 15, 2015

ALLERGAN PLC
By:

/s/ A. Robert D. Bailey

Name: A. Robert D. Bailey
Title: Chief Legal Officer and Corporate Secretary


Exhibit Index

 

Exhibit

  

Description of Exhibit

Exhibit 99.1*    Press Release dated July 15, 2015.

 

* Exhibits filed herewith
EX-99.1 2 d87991dex991.htm EX-99.1 EX-99.1

LOGO

Exhibit 99.1

NEWS RELEASE

CONTACTS:

Investors:

Lisa DeFrancesco

(862) 261-7152

Media:

David Belian

(862) 261-8141

Mark Marmur

(862) 261-7558

Allergan Notes Receipt of Paragraph IV Notification on Restasis

DUBLIN, IRELAND – July 15, 2015 – Allergan plc (NYSE: AGN) today confirmed that the Company has received a notice letter dated July 10, 2015 (the “Notice Letter”) from Akorn Pharmaceuticals stating that the U.S. Food and Drug Administration (FDA) has received Akorn’s Abbreviated New Drug Application (ANDA) containing a “Paragraph IV” patent certification seeking approval to market a generic version of Allergan’s Restasis® (cyclosporine ophthalmic emulsion) 0.05% product. In addition, Allergan has received communication suggesting that additional ANDAs for generic versions of Restasis® may have been received by the FDA.

The Notice Letter received from Akorn states that the “Paragraph IV” patent certification was made with respect to certain U.S. patents covering the formulation and method of use of the Restasis® product, which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Allergan has five Orange Book-listed patents covering Restasis® that are scheduled to expire in August 2024.

Allergan is highly confident in its intellectual property rights relating to Restasis® and intends to vigorously enforce such rights in all applicable venues.

About Allergan

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.


Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women’s health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world’s third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

For more information, visit Allergan’s website at www.allergan.com.

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan’s current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan’s current expectations depending upon a number of factors affecting Allergan’s business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan’s products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan’s periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2015 (such periodic public filings having been filed under the “Actavis plc” name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

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