0001571049-17-003137.txt : 20170404 0001571049-17-003137.hdr.sgml : 20170404 20170404060051 ACCESSION NUMBER: 0001571049-17-003137 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20170403 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20170404 DATE AS OF CHANGE: 20170404 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CELGENE CORP /DE/ CENTRAL INDEX KEY: 0000816284 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 222711928 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-34912 FILM NUMBER: 17736129 BUSINESS ADDRESS: STREET 1: 86 MORRIS AVENUE CITY: SUMMIT STATE: NJ ZIP: 07901 BUSINESS PHONE: (908)673-9000 MAIL ADDRESS: STREET 1: 86 MORRIS AVENUE CITY: SUMMIT STATE: NJ ZIP: 07901 8-K 1 t1700965_8k.htm 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): April 3, 2017

 

CELGENE CORPORATION
(Exact name of registrant as specified in its charter)

 

Delaware   001-34912   22-2711928
(State or other Jurisdiction of
Incorporation)
  (Commission File Number)   (IRS Employer Identification No.)

 

86 Morris Avenue, Summit, New Jersey   07901
(Address of Principal Executive Offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (908) 673-9000

 

 

  (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:

 

¨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 8.01OTHER EVENTS

 

On April 3, 2017, Celgene Corporation announced it has received a Paragraph IV Notice Letter advising that Teva Pharmaceuticals USA, Inc. submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) seeking authorization from the FDA to manufacture and market a generic version of POMALYST® (pomalidomide) 1 mg, 2 mg, 3 mg and 4 mg in the United States.

 

The Notice Letter contains Paragraph IV certifications against certain of Celgene’s patents related to POMALYST®. Celgene intends to vigorously defend its extensive intellectual property rights related to POMALYST®.

 

Attached hereto and incorporated herein by reference as Exhibit 99.1 is the Press Release announcement.

 

ITEM 9.01FINANCIAL STATEMENTS AND EXHIBITS.

 

Exhibit 99.1 — Press Release dated April 3, 2017

 

 

 

 

EXHIBIT INDEX

 

Exhibit No.   Description
     
99.1   Press Release dated April 3, 2017.
 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  CELGENE CORPORATION
     
Date: April 3, 2017    
     
  By: Peter N. Kellogg
  Name: Peter N. Kellogg
  Title: Executive Vice President and Chief
Financial Officer

 

 

 

EX-99.1 2 t1700965_ex99-1.htm EXHIBIT 99.1

 

EXHIBIT 99.1

 

 

Contact:   Patrick E. Flanigan III Brian Gill
  Corporate VP, Investor Relations VP, Corporate Communications
  Celgene Corporation Celgene Corporation
  (908) 673-9969 (908) 673-9530

 

CELGENE NOTIFIED OF ANDA FILING FOR POMALYST®

 

SUMMIT, NJ – (April 3, 2017) – Celgene Corporation (NASDAQ: CELG) has received a Paragraph IV Notice Letter advising that Teva Pharmaceuticals USA, Inc. submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) seeking authorization from the FDA to manufacture and market a generic version of POMALYST® (pomalidomide) 1 mg, 2 mg, 3 mg and 4 mg in the United States.

 

The Notice Letter contains Paragraph IV certifications against certain patents related to POMALYST®. Celgene is assessing the notice. Celgene intends to vigorously defend its extensive intellectual property rights related to POMALYST®.

 

About Celgene

 

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.

 

About POMALYST®

 

In the U.S., POMALYST® (pomalidomide) is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

 

Forward-Looking Statements

 

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual

 

 

 

  

results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission. 

 

 
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