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| XTLS > SEC Filings for XTLS > Form 8-K on 3-Jan-2013 | All Recent SEC Filings |
3-Jan-2013
Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
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.
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.
(d) Exhibits.
99.1 Joint Press Release, dated January 3, 2013, issued by Xstelos Holdings, Inc. and Auxilium Pharmaceuticals, Inc.
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