0001157523-12-001743.txt : 20120410 0001157523-12-001743.hdr.sgml : 20120410 20120410130533 ACCESSION NUMBER: 0001157523-12-001743 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20120410 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120410 DATE AS OF CHANGE: 20120410 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AKORN INC CENTRAL INDEX KEY: 0000003116 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 720717400 STATE OF INCORPORATION: LA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32360 FILM NUMBER: 12751454 BUSINESS ADDRESS: STREET 1: 1925 W. FIELD COURT, SUITE 300 CITY: LAKE FOREST STATE: IL ZIP: 60045 BUSINESS PHONE: 8472796100 MAIL ADDRESS: STREET 1: 1925 W. FIELD COURT, SUITE 300 CITY: LAKE FOREST STATE: IL ZIP: 60045 8-K 1 a50232933.htm AKORN, INC. 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 10, 2012

Akorn, Inc.
(Exact Name of Registrant as Specified in Charter)

Louisiana

 

001-32360

 

72-0717400

(State or Other
Jurisdiction of
Incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification Number)

1925 West Field Court, Suite 300
Lake Forest, IL

 

60045

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including area code:

(847) 279-6100

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 8.01  Other Events.

On April 10, 2012, Akorn, Inc. (the “Company”) issued a press release announcing that it received approval from the U.S. Food and Drug Administration (“FDA”) of its Abbreviated New Drug Application (“ANDA”) application for Vancomycin Hydrochloride USP 125mg and 250mg capsules, the generic version of ViroPharma’s Vancocin®.  The Company further announced that it has begun shipping its FDA-approved generic version in both strengths in a 20 capsule pack size.

Item 9.01  Financial Statements and Exhibits.

  (d) Exhibits.
 
99.1 Press release issued by Akorn, Inc., dated April 10, 2012, announcing FDA approval of its ANDA application for Vancomycin Hydrochloride USP 125mg and 250mg capsules, and commencement of shipping of both strengths of this product to customers.


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.

AKORN, INC.

 
 

Date:

April 10, 2012

By:

/s/ Timothy A. Dick

Timothy A. Dick

Sr. Vice President, Chief Financial Officer

EX-99.1 2 a50232933_ex991.htm EXHIBIT 99.1

Exhibit 99.1

Akorn Announces the Approval and Launch of Generic Vancocin®

LAKE FOREST, Ill.--(BUSINESS WIRE)--April 10, 2012--Akorn, Inc. (NASDAQ: AKRX), a niche specialty pharmaceutical company, today announced that it has launched Vancomycin Hydrochloride USP 125mg and 250mg capsules, the generic version of ViroPharma’s Vancocin®, which is indicated for the treatment of Clostridium difficile-associated diarrhea (CDAD). Vancocin® is also used for the treatment of enterocolitis caused by Staphylococcus aureus including methicillin-resistant strains.

According to IMS Health, Vancocin® 125mg and 250mg had combined sales of approximately $328 million in the U.S. for the twelve months ended December 31, 2011. Akorn has begun shipping its U.S. Food and Drug Administration (FDA) approved generic version in both strengths in a 20 capsule pack size.

About Akorn, Inc.

Akorn, Inc. is a niche specialty pharmaceutical company engaged in the development, manufacture and marketing of multisource and branded pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois, Somerset, New Jersey, and Paonta Sahib, India where the Company manufactures ophthalmic and injectable pharmaceuticals. Additional information is available on the Company’s website at www.akorn.com.

Forward Looking Statement

This press release includes statements that may constitute "forward-looking statements", including projections of certain measures of Akorn's results of operations, projections of certain charges and expenses, and other statements regarding Akorn's goals, regulatory approvals and strategy. Akorn cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," and other words and terms of similar meaning in connection with a discussion of future operating or financial performance. Factors that could cause or contribute to such differences include, but are not limited to: statements relating to future steps we may take, prospective products, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results. These cautionary statements should be considered in connection with any subsequent written or oral forward-looking statements that may be made by the company or by persons acting on its behalf and in conjunction with its periodic SEC filings. You are advised, however, to consult any further disclosures we make on related subjects in our reports filed with the SEC. In particular, you should read the discussion in the section entitled "Cautionary Statement Regarding Forward-Looking Statements" in our most recent Annual Report on Form 10-K, as it may be updated in subsequent reports filed with the SEC. That discussion covers certain risks, uncertainties and possibly inaccurate assumptions that could cause our actual results to differ materially from expected and historical results. Other factors besides those listed there could also adversely affect our results.

CONTACT:
At the Company:
Akorn, Inc.
Tim Dick, Chief Financial Officer
(847) 279-6150