Auxilium Pharmaceuticals, Inc. To Ring the NASDAQ Stock Market Opening Bell On February 26, 2014
-Company Marks Milestone of Two New Product Launches-
CHESTERBROOK, Pa., Feb. 19, 2014 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a fully integrated specialty biopharmaceutical company, will ring the Opening Bell at the NASDAQ MarketSite in Times Square, New York at 9:30 a.m. ET on February 26, 2014 to celebrate Auxilium's transformation into a leading men's healthcare company, including two recent launches of new products in men's healthcare, XIAFLEX® (collagenase clostridium histolyticum, or CCH) for the treatment of Peyronie's disease and STENDRA™ (avanafil) for the treatment of erectile dysfunction, and to recognize all Auxilium employees who have contributed to the Company's success.
Chief Executive Officer and President, Adrian Adams, will perform the honorary bell ringing ceremony that will be held from 9:15 to 9:30 a.m. ET. A live webcast will be available at https://new.livestream.com/nasdaq/live. Company employees and certain members of Auxilium's Board of Directors and executive leadership team will join in the ceremony.
"We are looking forward to ringing The NASDAQ Opening Bell to celebrate two exciting product launches and the significant progress we've made transforming Auxilium," said Adrian Adams, CEO and President of Auxilium. "We have grown from a two-product company to a leading men's healthcare company with a broadened portfolio of 12 approved products. Across this expanded portfolio, we now have five products that we believe are growth assets, including two new products in men's healthcare that were recently launched in the beginning of 2014. We launched an additional indication for XIAFLEX - the first and only proven safe and effective FDA-approved treatment for Peyronie's disease in men with a curvature deformity of ≥30° at the start of therapy. We also launched STENDRA, a next generation, differentiated PDE5 inhibitor and the first new drug entry into the $3 billion erectile dysfunction market in nearly a decade. This is an exciting time for Auxilium and we believe that we are well positioned to deliver growth and to build long-term shareholder value."
STENDRA (avanafil) is approved by the FDA in the U.S. for the treatment of erectile dysfunction. STENDRA is rapidly absorbed and should be taken 30 minutes before sexual activity on an as-needed basis. STENDRA should not be taken more than once per day and may be taken without regard to food and with modest alcohol consumption. Auxilium Pharmaceuticals, Inc. has exclusive marketing rights to STENDRA in the U.S. and Canada and is in the early stages of commercializing STENDRA in the U.S.
STENDRA is currently available through retail and mail order pharmacies. Auxilium offers programs that will help patients with out-of-pocket costs.
SPEDRA™, the trade name for avanafil in the European Union (EU), is approved by the European Medicines Agency (EMA) for the treatment of erectile dysfunction in the EU. VIVUS has granted an exclusive license to the Menarini Group through its subsidiary Berlin-Chemie AG to commercialize and promote SPEDRA for the treatment of erectile dysfunction in over 40 European countries plus Australia and New Zealand.
Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation (MTPC). VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian-Pacific Rim countries. VIVUS is in discussions with other parties for the commercialization rights to its remaining territories.
For more information about STENDRA, please visit www.STENDRA.com.
XIAFLEX (collagenase clostridium histolyticum, or CCH) is a biologic approved in the U.S., EU, Canada and Australia for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord and for the treatment of adult men with Peyronie's disease (PD) with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy in the U.S. XIAFLEX consists of a combination of two subtypes of collagenase, derived from clostridium histolyticum. Together, the collagenase sub-types are thought to work synergistically to break the bonds of the triple helix collagen structure. XIAFLEX has been granted Orphan status in the U.S. by the FDA for DC and PD.
Auxilium Pharmaceuticals, Inc. is a fully integrated specialty biopharmaceutical company with a focus on developing and commercializing innovative products for specialist audiences. With a broad range of first- and second-line products across multiple indications, Auxilium is an emerging leader in the men's healthcare area and has strategically expanded its product portfolio and pipeline in orthopedics, dermatology and other therapeutic areas. The Company now has a broad portfolio of 12 approved products. Among other products in the U.S., Auxilium markets Edex® (alprostadil for injection), an injectable treatment for erectile dysfunction, Osbon ErecAid®, the leading device for aiding erectile dysfunction, STENDRA™ (avanafil), an oral erectile dysfunction therapy, Testim® (testosterone gel) for the topical treatment of hypogonadism, TESTOPEL® (testosterone pellets) a long-acting implantable testosterone replacement therapy, XIAFLEX® (collagenase clostridium histolyticum or CCH) for the treatment of Peyronie's disease and XIAFLEX for the treatment of Dupuytren's contracture. The Company also has programs in Phase 2 clinical development for the treatment of Frozen Shoulder syndrome and cellulite. Auxilium's mission is to improve the lives of patients throughout the world by successfully identifying, developing and commercializing innovative specialty biopharmaceutical products. To learn more, please visit www.Auxilium.com.
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, including statements made with respect to: the Company's successful transformation into a leading men's healthcare company; the growth of the Company's products; the success of the Company's recently launched products; the ability of the Company to grow and to deliver value to stockholders; and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Although forward-looking statements are based on Auxilium's current plans or assessments that are believed to be reasonable as of the date of this press release, they inherently involve certain risks and uncertainties. These forward-looking statements are subject to a number of risks and uncertainties, including those discussed under ''Risk Factors'' in Auxilium's Annual Report on Form 10-K for the year ended December 31, 2012 and in other public filings with the SEC, including, without limitation, as such Form 10-K was updated in Item 8.01 of the Current Report on Form 8-K filed on April 29, 2013 and Auxilium's Quarterly Reports for 2013. 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. Auxilium's SEC filings may be accessed electronically by means of the SEC's home page on the Internet at http://www.sec.gov. There may be additional risks that 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.
SOURCE Auxilium Pharmaceuticals, Inc.
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