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XTLS > SEC Filings for XTLS > Form 8-K on 3-Jan-2013All Recent SEC Filings

Show all filings for XSTELOS HOLDINGS, INC. | Request a Trial to NEW EDGAR Online Pro

Form 8-K for XSTELOS HOLDINGS, INC.


3-Jan-2013

Regulation FD Disclosure, Other Events, Financial Statements and Exhibits


Item 7.01 Regulation FD Disclosure.

Xstelos Holdings, Inc. (OTCQB: XTLS) ("Xstelos") and Auxilium Pharmaceuticals, Inc. ("Auxilium") issued a joint press release announcing that they have received a notice from Upsher-Smith Laboratories, Inc. ("USL") that advises them of USL's filing of a 505(b)(2) New Drug Application (NDA) containing a Paragraph IV certification under 21 U.S.C. Section 314.52(c) for testosterone gel. This Paragraph IV certification notice refers to the ten U.S. patents, covering Testim®, 1% testosterone gel, that are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration. These ten patents are owned by FCB I LLC, an indirect majority owned subsidiary of Xstelos ("FCB"). Xstelos holds the assets of CPEX Pharmaceuticals, Inc., the predecessor owner of the patents. The referenced Testim patents will expire between 2023 and 2025.

The foregoing is qualified in its entirety by the text of the joint press release attached as Exhibit 99.1 hereto and incorporated herein by reference. All readers are encouraged to read the entire text of the joint press release attached hereto.



Item 8.01 Other Events.

On or about December 28, 2012, FCB and Auxilium became aware of a notice from Upsher-Smith Laboratories, Inc. ("USL") that advises them of USL's filing of a
505(b)(2) New Drug Application (NDA) containing a Paragraph IV certification under 21 U.S.C. Section 314.52(c) for testosterone gel. This Paragraph IV certification notice refers to the ten U.S. patents, covering Testim®, 1% testosterone gel, that are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration. These ten patents are owned by FCB, an indirect majority owned subsidiary of Xstelos. Xstelos holds the assets of CPEX Pharmaceuticals, Inc., the predecessor owner of the patents. The referenced Testim patents will expire between 2023 and 2025.



Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

99.1 Joint Press Release, dated January 3, 2013, issued by Xstelos Holdings, Inc. and Auxilium Pharmaceuticals, Inc.


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