- Encore data highlighted from trials evaluating Xiaflex/Xiapex, the first and only FDA approved treatment for Peyronie's Disease.
Auxilium Pharmaceuticals, Inc. AUXL and Swedish Orphan Biovitrum AB (publ) (Sobi) today announced that encore data were presented from multiple clinical trials evaluating the use of Xiapex/Xiaflex® (collagenase clostridium histolyticum or CCH) in adult patients with Peyronie's disease (PD). These data were presented at the 29th Annual European Association of Urology (EAU) Congress being held 11-15 April, 2014 in Stockholm, Sweden.
Poster presentations on Xiapex/Xiaflex included analysis from the pivotal Phase 3 IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials which evaluated Xiapex/Xiaflex for the treatment of PD. Xiaflex is the first and only FDA-approved treatment proven effective for PD in men with a palpable plaque and a curvature deformity of 30 degrees or greater at the start of therapy. Work is on-going by Sobi to potentially file for approval of Xiapex in the EU for the treatment of PD. Xiapex is approved by the EMA for the treatment of Dupuytren's contracture, and as the Market Authorization Holder in Europe, Sobi intends to submit a Variation to the EMA to extend the Xiapex label to include Peyronie's disease.
Highlights of the data related to the use of Xiapex/Xiaflex in PD include:
- A post-hoc analysis of the pooled data from the IMPRESS I and II Phase 3 trials showed improved clinical outcomes following CCH-treatment regardless of subjects' baseline PD treatment history, erectile function scores, and/or prostatectomy history. These data were also presented at the Sexual Medicine Society of North America (SMSNA) 19th Annual Fall Scientific Meeting held 21-24 November, 2013 in New Orleans.
- The global safety analysis of seven clinical trials of CCH for the treatment of PD shows that the adverse events were mostly localized to the penis, non-serious and resolved without intervention before the next injection. Serious adverse events (SAEs) related to treatment were also all localised to the penis in these clinical studies. A total of 60 (5.7%) of CCH-treated subjects experienced at least one treatment-emergent SAE, 0.9% experienced treatment-related SAEs (five penile hematoma and four corporal rupture). These data were also presented at the American Urological Association (AUA) Meeting held 4-8 May, 2013 in San Diego.
Additional details about the presentations and the meeting can be found at: http://www.eaustockholm2014.org/the-congress/.
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About Peyronie's disease
PD is a condition that involves the development of collagen plaque, or scar tissue, on the shaft of the penis. The scar tissue, known as a Peyronie's plaque, may harden and reduce flexibility, which may cause bending or arching of the penis during erection. PD can result in varying degrees of penile curvature deformity and disease "bother" (encompassing concern about erection appearance, erection pain and the impact of PD on intercourse and on frequency of intercourse). PD is a disease with an initial inflammatory component. This inflammatory phase is poorly understood with a somewhat variable disease course and spontaneous resolution occurring in less than 13 percent of cases[i]. After approximately 12 months of disease, the disease is reported to often develop into a more chronic, stable phasei. The incidence of PD is estimated between 3 and 9 percentii; however the disease is thought to be underdiagnosed and undertreatedi.
About Xiapex
Xiapex (collagenase clostridium histolyticum), is a pharmacological treatment for Dupuytren's contracture and may be an alternative to invasive and often complicated surgery for patients. Xiapex is a combination of two purified clostridial collagenases for injection that enzymatically disrupts the contracting cord and reduces the contraction. It is administered by local injection directly into the Dupuytren's cord - a procedure which can be carried out in an outpatient setting. Twenty-four hours after the injection, a finger extension procedure can be carried out as necessary to break the cord and allow extension of the finger.
In addition, work is on-going to potentially file for approval of Xiapex in the EU for the treatment of Peyronie's disease, the development of collagen plaque, or scar tissue, on the shaft of the penis.
About Sobi
Sobi is an international specialty healthcare company dedicated to rare diseases. Our mission is to develop and deliver innovative therapies and services to improve the lives of patients. The product portfolio is primarily focused on Inflammation and Genetic diseases, with three late stage biological development projects within Haemophilia and Neonatology. We also market a portfolio of specialty and rare disease products for partner companies. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2013, Sobi had total revenues of SEK 2.2 billion (€253 M) and about 550 employees. The share SOBI is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com.
About Sobi Partner Products
Sobi Partner Products (SPP) is a business unit within Sobi which offers a unique commercial platform for partners with niche and specialty products. SPP provides extensive knowledge and local experience through our direct presence across EU, Eastern Europe, Russia, Middle East and North Africa. We apply an integrated commercial, medical, and market access approach to products which address important unmet needs, spanning from named patient use (NPU) programs, through to reimbursement and full commercialisation, primarily in the Centre of Expertise setting.
About Auxilium
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. Auxilium 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(TM) (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.
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, including statements made with respect to: Sobi's plans to submit a request to potentially expand the label of Xiapex to include Peyronie's disease;; 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, 2013 on file with the United States Securities and Exchange Commission ("SEC"). 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.
Sobi Contacts:
Media relations Investor relations
Charlotte af Klercker Jörgen Winroth
T: +46 707 297 327 T: +1 347-224-0819, +1 212-579-0506,
charlotte.afklercker@sobi.com jorgen.winroth@sobi.com
Auxilium Contacts:
Keri P. Mattox Nichol L. Ochsner
(484) 321-5900 (484) 321-5900
kmattox@auxilium.com nochsner@auxilium.com
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Swedish Orphan Biovitrum AB (publ) via Globenewswire
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