Navigation Links
Auxilium Pharmaceuticals, Inc. and FCB I LLC Receive Paragraph IV Certification Notice from Watson Laboratories, Inc. for Testim®
Date:4/16/2012

MALVERN, Pa. and MAHWAH, N.J., April 16, 2012 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. and FCB I LLC ("FCB") today announced that they have received a notice from Watson Laboratories, Inc. ("Watson") that advises them of Watson's filing of an Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification under 21 U.S.C. Section 355(j) for testosterone gel. This Paragraph IV certification notice refers to FCB's nine U.S. patents, covering Testim®, 1% testosterone gel, that are listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration.  The referenced patents will expire between 2023 and 2025. 

(Logo:   http://photos.prnewswire.com/prnh/20101202/MM10881LOGO )

Auxilium and FCB are currently reviewing the details of this notice from Watson. Auxilium and FCB intend to pursue all available legal and regulatory options in defense of Testim, including enforcement of their intellectual property rights and approved labeling.

About Auxilium
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences. Auxilium markets XIAFLEX® (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture patients with a palpable cord and Testim® 1%, a testosterone gel, for the topical treatment of hypogonadism in the U.S. Pfizer has marketing rights for XIAPEX® (the EU tradename for collagenase clostridium histolyticum) in Europe; Asahi Kasei Pharma Corporation has development and commercial rights for XIAFLEX in Japan; and Actelion Pharmaceuticals Ltd has development and commercial rights for XIAFLEX in Canada, Australia, Brazil and Mexico. Ferring International Center S.A. markets Testim in the EU and Paladin Labs Inc. markets Testim in Canada. Auxilium has three projects in clinical development. XIAFLEX is in phase III of development for the treatment of Peyronie's disease, in phase IIa of development for the treatment of Frozen Shoulder syndrome (Adhesive Capsulitis) and is in phase Ib of development for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Auxilium also has rights to pursue additional indications for XIAFLEX. For additional information, visit http://www.auxilium.com.

About FCB I LLC
FCB is an indirect, majority-owned subsidiary of Xstelos Holdings, Inc. ("Xstelos"), which is a wholly-owned subsidiary of Footstar, Inc. ("Footstar"). Footstar (OTC BB: FTAR.OB) is a holding company that is winding down pursuant to an Amended Plan of Complete Dissolution and Liquidation ("Plan of Dissolution"). On January 19, 2012, the board of directors of Footstar approved a Plan of Reorganization pursuant to which Footstar contributed all of its assets to Xstelos. In exchange for the contribution of all of its assets, including its interest in FCB, Xstelos assumed all of Footstar's liabilities and issued all of its shares of common stock to Footstar.  On January 25, 2012, Xstelos filed a registration statement on Form S-1, File No. 333-179148 with the SEC in order to register the distribution of all of the common stock of Xstelos to stockholders of Footstar.  This registration statement, as amended, was declared effective on April 12, 2012. Footstar anticipates distributing all of the Xstelos common stock to holders of Footstar's common stock pro rata on a one-for-one basis shortly on a distribution date to be announced. Immediately after the distribution is completed, Footstar's stockholders will own all of the outstanding shares of common stock of Xstelos, and Xstelos stockholders' holdings will be proportionate to their percentage ownership of Footstar shares as of the record date for the distribution.  This press release does not constitute an offer of any securities for sale.

AUXILIUM SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, which discuss matters that are not facts, and may include words to indicate their uncertain nature such as "believe," "expect," anticipate," "intend," "plan," "should," "could," "estimate," "project," "will," and "target." Auxilium's forward-looking statements convey management's expectations, beliefs, plans and objectives regarding future performance of Auxilium and are based upon preliminary information and management assumptions. No specific assurances can be given with respect to whether Auxilium will pursue any of the legal or regulatory options available to it in defense of the nine patents covering Testim, including enforcement of their intellectual property rights and approved labeling, or whether Auxilium will be successful in any of those efforts that it does choose to pursue. While Auxilium may elect to update the forward-looking statements made in this news release in the future, Auxilium specifically disclaims any obligation to do so. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause Auxilium's results to differ in material respects, including those relating to product development, revenue, expense and earnings expectations, intellectual property rights, litigation strategies, and the timing and content of decisions made by regulatory authorities, including the U.S. Food and Drug Administration, and those risks discussed in Auxilium's reports on file with the Securities and Exchange Commission (the "SEC"). Auxilium's SEC filings may be accessed electronically by means of the SEC's home page on the Internet at http://www.sec.gov or by means of Auxilium's home page on the Internet at http://www.auxilium.com under the heading "For Investors - SEC Filings." There may be additional risks that the Auxilium does not presently know or that Auxilium currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements.                 

FCB I LLC SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on FCB's parent companies' current estimates and assumptions and, as such, involve uncertainty and risk.  Forward-looking statements include the information concerning FCB and its parent companies' possible or assumed future results of operations and also include those preceded or followed by the words "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "should," "plans," "targets" and/or similar expressions. These statements relate to future events or future financial performance and involve known and unknown risks, uncertainties and other factors that could cause FCB or its parent companies' actual results, levels of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements. These risks and uncertainties include, among others, competition from existing products or new products that may emerge, regulatory difficulties relating to products that have already received regulatory approval, potential product liability claims, dependency on third-party manufacturers to supply or manufacture products, ability to establish or maintain collaborations, licensing or other arrangements, Xstelos' ability and third parties' abilities to protect intellectual property rights, limitation on the ability to utilize net operating losses, compliance with obligations under intellectual property licenses with third parties, ability to successfully invest for future growth, and those risks discussed in Footstar's and Xstelos' reports on file with the SEC. The forward-looking statements are not guarantees of future performance, events or circumstances, and actual results may differ materially from those contemplated by these forward-looking statements. For these reasons, one should not place undue reliance on any forward-looking statements. Xstelos' and Footstar's SEC filings may be accessed electronically by means of the SEC's home page on the Internet at http://www.sec.gov

Auxilium Contacts:
James E. Fickenscher/CFO
Auxilium Pharmaceuticals, Inc.
(484) 321-5900
jfickenscher@auxilium.com

William Q. Sargent Jr./ VP IR
Auxilium Pharmaceuticals, Inc.
(484) 321-5900
wsargent@auxilium.com

FCB I LLC Contacts:

Jonathan M. Couchman, President
FCB I LLC
(201) 934-2000


'/>"/>
SOURCE Auxilium Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Auxilium Pharmaceuticals to Present at the 2012 Barclays Capital Global Healthcare Conference
2. Auxilium Pharmaceuticals to Present at the 2012 Cowen Healthcare Conference
3. BioSpecifics Announces Partnership Between Auxilium and Actelion for XIAFLEX® in Canada, Australia, Brazil and Mexico
4. Auxilium Pharmaceuticals, Inc. and Actelion Pharmaceuticals Ltd. Enter a Collaboration Agreement for XIAFLEX® in Canada, Australia, Brazil and Mexico
5. Auxilium Pharmaceuticals to Present at the Leerink Swann 2012 Global Healthcare Conference
6. Auxilium Pharmaceuticals, Inc. Announces First Patients Dosed in XIAFLEX® Phase Ib Cellulite Study
7. Auxilium Pharmaceuticals to Present at the 30th Annual J.P. Morgan Healthcare Conference
8. Auxilium Pharmaceuticals, Inc. Announces First Patient Dosed in XIAFLEX® Study for Frozen Shoulder Syndrome
9. Auxilium Pharmaceuticals to Present at the Oppenheimer 22nd Annual Healthcare Conference
10. Auxilium Pharmaceuticals, Inc. Announces Publication of U.S. CPT® Codes and Related Reimbursement Rates for XIAFLEX®
11. Auxilium Pharmaceuticals to Announce Third Quarter 2011 Results and Conduct Conference Call on Monday, October 31, 2011
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... 2016 Amgen (NASDAQ: AMGN ) will present ... Conference at 9:15 a.m. ET on Wednesday, Feb. 10, 2016, ... W. Meline , executive vice president and chief financial officer ... the presentation can be accessed from the Events Calendar on ... the webcast will also be available on Amgen,s website for ...
(Date:2/5/2016)... 2016  Patients in Alabama seeking ... therapy no longer have to travel out of state. ... Urology Centers of Alabama to provide a total ... qualifying patients. Alabama is ... of prostate cancer using many different modalities. They are the ...
(Date:2/5/2016)... York , February 5, 2016 ... Transparency Market Research report states that the global active ... 2014 and is predicted to reach US$185.9 bn by ... of 6.50% from 2014 to 2020. The title of ... Chemical/Biological, Captive/Contract Manufactured, by Geography, and by Therapeutic Area) ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... February 05, 2016 , ... Pivot Point Consulting, a leading ... Software & Services for HIT Implementation Support & Staffing report with an outstanding ... performance by healthcare executives, managers and clinicians representing over 4,500 hospitals and 2,500 ...
(Date:2/5/2016)... ... ... Dr. Justin Scott and Dr. Lydia Muccioli of Pure Dental Health ... need. The event is scheduled to take place on February 27, 2016 from 9am ... care to community members in need. Each patient will be given the opportunity to ...
(Date:2/5/2016)... Francisco, CA (PRWEB) , ... February 05, 2016 ... ... and founder of CitiDent, announces that it is now welcoming orthodontist, ... Dr. Cheng, CitiDent offers a complete range of oral health care, including general ...
(Date:2/5/2016)... ... February 05, 2016 , ... In sleep, when the defenses of ... A hallmark feature of patients with eating disorders is significant self-criticism, and consequently these ... and obsessions are regarded as maladaptive means for coping with this unease, but also ...
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... ... manufactures practical mobile kitchens, recently announced the debut of their latest mobile kitchen ... Mobile Kitchens provides organizations with modern, high-volume commercial kitchens for use anywhere in ...
Breaking Medicine News(10 mins):