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XTLS > SEC Filings for XTLS > Form 8-K on 29-Jan-2013All Recent SEC Filings

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Form 8-K for XSTELOS HOLDINGS, INC.


29-Jan-2013

Regulation FD Disclosure, Other Events, Financial Statements and Exhibits


Item 7.01 Regulation FD Disclosure.

On January 28, 2013, Xstelos Holdings, Inc. (OTCQB: XTLS) ("Xstelos") and Auxilium Pharmaceuticals, Inc. ("Auxilium") announced that they filed a lawsuit against Upsher-Smith Laboratories, Inc. ("USL") for infringement of 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 ("FDA"). These ten patents are owned by FCB I LLC, an indirect majority owned subsidiary of Xstelos, and are exclusively licensed to Auxilium. Xstelos holds the assets of CPEX Pharmaceuticals, Inc. ("CPEX"), the predecessor owner of the patents. The lawsuit was filed in the United States District Court for the District of Delaware on January 28, 2013.

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 January 28, 2013, Xstelos and Auxilium filed a lawsuit against USL for infringement of 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 FDA. These ten patents are owned by FCB I LLC, an indirect majority owned subsidiary of Xstelos, and are exclusively licensed to Auxilium. Xstelos holds the assets of CPEX, the predecessor owner of the patents. The lawsuit was filed in the United States District Court for the District of Delaware.

Xstelos and Auxilium filed this lawsuit in response to a notice letter sent by USL regarding its filing with the FDA of New Drug Application ("NDA") No. 204399 for a 1% testosterone gel product. This letter also stated that NDA No. 204399 contained Paragraph IV certifications, under 21 U.S.C. Section 314.52(c) of the Federal Food, Drug, and Cosmetic Act, with respect to the ten patents listed in the Orange Book as covering Testim: U.S. Patent Nos. 7,320,968; 7,608,605; 7,608,606; 7,608,607; 7,608,608; 7,608,609; 7,608,610; 7,935,690; 8,063,029; and 8,178,518. These ten patents are expected to expire on various dates ranging from April 21, 2023 through January 18, 2025. Auxilium and Xstelos remain committed to protecting their intellectual property rights, including their patent protection for Testim.

Under the Hatch-Waxman Act, as a result of the patent infringement lawsuit filed against USL, final FDA approval of USL's NDA for its proposed generic version of Testim will be stayed until at least the earlier of 30 months from the date USL's notice letter was received (i.e., June 24, 2015) or final resolution of the pending patent infringement lawsuit. While USL may receive tentative approval from the FDA for its version of Testim before one of those events occurs, it would not be permitted to launch its generic product in the U.S. until it receives the necessary final approval of its NDA from the FDA.




Item 9.01 Financial Statements and Exhibits.

(d)      Exhibits.

99.1  Joint Press Release, dated January 28, 2013,
      issued by Xstelos Holdings, Inc. and Auxilium
      Pharmaceuticals, Inc.


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