|By PR Newswire||
|August 28, 2014 06:00 AM EDT||
CHESTERBROOK, Pa., Aug. 28, 2014 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that data from trials evaluating the use of collagenase clostridium histolyticum (CCH) for treating two Dupuytren's contracture (DC) cords concurrently in adult patients with a palpable cord will be presented at the upcoming 69th Annual Meeting of the American Society for Surgery of the Hand (ASSH) being held in Boston on September 18-20, 2014. XIAFLEX® (CCH) is a biologic approved in the U.S., EU, Canada and Australia for the treatment of adult DC patients with a palpable cord.
DC is a progressive hand disease that can present with multiple collagen "cords" that limit finger movement and hand function. It is estimated that 35 to 40 percent of annual surgical procedures in the U.S. are performed to treat more than one DC cord at a time1.
The AUX-CC-867 MULTICORD (MULtiple Treatment Investigation of Collagenase Optimizing the Resolution of Dupuytrens) study data examining the effect of delayed finger extension on patients who received two concurrent injections of CCH to treat two affected joints in the same hand were selected for the meeting's Best Paper Session. Additional findings from the MULTICORD study featured in meeting presentations include the safety and efficacy of CCH as a treatment for two affected joints in the same hand concurrently and an analysis of efficacy based upon baseline joint severity. Additionally, a podcast has been selected for presentation that describes an analysis of the MULTICORD study treating two affected joints in the same hand concurrently using local anesthesia prior to finger extension. Finally, data will also be presented from the AUX-CC-862 retreatment study examining the retreatment of recurrent contractures in DC joints that were previously treated with CCH.
"The data presented at this year's Annual ASSH Meeting help support the efficacy and safety profile of CCH as a non-surgical treatment option for treating two cords concurrently during one office procedure, expanded flexibility with timing of the finger extension procedure and the retreatment of recurrent joints in those who were previously treated with CCH," said Adrian Adams, Chief Executive Officer and President of Auxilium Pharmaceuticals.
Data to be presented on CCH include:
- Effect of Delayed Finger Extension on the Efficacy and Safety of Collagenase Clostridium Histolyticum Treatment for Dupuytren's Contracture (Clinical Paper 01, Selected for the Best Paper Session, Podium Presentation, Thursday, September 18, 2:00 p.m. ET)
- Prospective Multicenter, Multinational Study to Evaluate the Safety and Efficacy of Concurrent Collagenase Clostridium Histolyticum Injections to Concurrently Treat Two Dupuytren's Contractures in the Same Hand (Clinical Paper 47, Podium Presentation, Friday, September 19, 2:00 p.m. ET)
- Treatment of Recurrent Dupuytren's Contractures in Joints Previously Effectively Treated With Collagenase Clostridium Histolyticum: Final Results (Clinical Paper 48, Podium Presentation, Friday, September 19, 2:00 p.m. ET)
- Effect of Baseline Severity on the Safety and Efficacy of Concurrent Collagenase Clostridium Histolyticum Injections to Treat Two Dupuytren's Contractures (Clinical Paper 44, Podium Presentation, Friday, September 19, 2:00 p.m. ET)
- Use of Local Anesthesia During Finger Extension: Effects on Efficacy and Safety of Collagenase Clostridium Histolyticum for Concurrent Treatment of Two Dupuytren's Contractures ( Podcast 1384)
The U.S. Food and Drug Administration is reviewing the Company's submission of a supplemental Biologics License Application (sBLA) requesting approval of XIAFLEX for the treatment of two Dupuytren's cords concurrently. The PDUFA date for the sBLA is October 20, 2014.
About Dupuytren's Contracture (DC)
DC is a progressive condition affecting the hand, specifically the layer of tissue just under the skin of the palm and fingers. While this layer of tissue normally contains collagen, in patients with DC there is an increase in the amount of collagen produced. Abnormal collagen build-up results in nodule and cord formation that worsens over time. Eventually, rope-like collagen cords may form, thicken and shorten, causing the fingers to be drawn in toward the palm. This thickening and shortening of the Dupuytren's cord can reduce the finger's range of motion (how much a person can move or straighten them). Once the Dupuytren's collagen cord can be felt, it is referred to as a "palpable cord." 1,2
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 in the U.S. for the treatment of adult men with PD with a palpable plaque and penile curvature deformity of at least 30 degrees at the start of therapy. 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, an Authorized Generic version of Testim (testosterone gel) with its partner Prasco, LLC, 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. 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, which discuss matters that are not facts, and may include words to indicate their uncertain nature such as "believe," "expect," anticipate," "intend," "plan," "could," "estimate," "project," "will," and "target." Our forward-looking statements convey management's expectations, beliefs, plans and objectives regarding future performance of the Company and are based upon preliminary information and management assumptions, and include statements about the Company's plans to present XIAFLEX data at the ASSH annual meeting, the efficacy and safety profiles of XIAFLEX, continued evaluation of XIAFLEX, whether and when the FDA might approve the Company's sBLA for treating two Dupuytren's cords concurrently; and the Company's product candidates in development. While the Company may elect to update the forward-looking statements made in this news release in the future, the Company specifically disclaims any obligation to do so. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ in material respects, including those relating to product development, revenue, expense and earnings expectations, intellectual property rights, results and timing of clinical trials, success of marketing efforts, the need for additional research and testing, and the timing and content of decisions made by regulatory authorities, including the U.S. Food and Drug Administration, and those risks discussed in our reports on file with the Securities and Exchange Commission (the "SEC"). Our 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 the Company's home page on the Internet at http://www.auxilium.com under the heading " Investors - SEC Filings." There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements.
Keri P. Mattox / SVP, IR &
Nichol L. Ochsner / Senior Director, IR &
Auxilium Pharmaceuticals, Inc.
Auxilium Pharmaceuticals, Inc.
1 Luck JV. Dupuytren's contracture: a new concept of the pathogenesis correlated with surgical management. J Bone Joint Surg Am. 1959;41(4):635-664.
2 Desai SS, Hentz VR. Collagenase clostridium histolyticum for Dupuytren's contracture. Expert Opin Biol Ther. 2010;10(9):1395-1404.
SOURCE Auxilium Pharmaceuticals, Inc.
With billions of sensors deployed worldwide, the amount of machine-generated data will soon exceed what our networks can handle. But consumers and businesses will expect seamless experiences and real-time responsiveness. What does this mean for IoT devices and the infrastructure that supports them? More of the data will need to be handled at - or closer to - the devices themselves.
Apr. 25, 2017 02:45 PM EDT Reads: 430
Bert Loomis was a visionary. This general session will highlight how Bert Loomis and people like him inspire us to build great things with small inventions. In their general session at 19th Cloud Expo, Harold Hannon, Architect at IBM Bluemix, and Michael O'Neill, Strategic Business Development at Nvidia, discussed the accelerating pace of AI development and how IBM Cloud and NVIDIA are partnering to bring AI capabilities to "every day," on-demand. They also reviewed two "free infrastructure" pr...
Apr. 25, 2017 02:45 PM EDT Reads: 1,218
Blockchain is a shared, secure record of exchange that establishes trust, accountability and transparency across supply chain networks. Supported by the Linux Foundation's open source, open-standards based Hyperledger Project, Blockchain has the potential to improve regulatory compliance, reduce cost and time for product recall as well as advance trade. Are you curious about Blockchain and how it can provide you with new opportunities for innovation and growth? In her session at 20th Cloud Exp...
Apr. 25, 2017 02:30 PM EDT Reads: 1,733
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
Apr. 25, 2017 02:30 PM EDT Reads: 442
Most technology leaders, contemporary and from the hardware era, are reshaping their businesses to do software in the hope of capturing value in IoT. Although IoT is relatively new in the market, it has already gone through many promotional terms such as IoE, IoX, SDX, Edge/Fog, Mist Compute, etc. Ultimately, irrespective of the name, it is about deriving value from independent software assets participating in an ecosystem as one comprehensive solution.
Apr. 25, 2017 01:45 PM EDT Reads: 289
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore t...
Apr. 25, 2017 01:45 PM EDT Reads: 366
SYS-CON Events announced today that CA Technologies has been named "Platinum Sponsor" of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, New York, and 21st International Cloud Expo, which will take place in November in Silicon Valley, California.
Apr. 25, 2017 01:30 PM EDT Reads: 2,242
While some vendors scramble to create and sell you a fancy solution for monitoring your spanking new Amazon Lambdas, hear how you can do it on the cheap using just built-in Java APIs yourself. By exploiting a little-known fact that Lambdas aren’t exactly single threaded, you can effectively identify hot spots in your serverless code. In his session at 20th Cloud Expo, David Martin, Principal Product Owner at CA Technologies, will give a live demonstration and code walkthrough, showing how to o...
Apr. 25, 2017 01:14 PM EDT Reads: 192
New competitors, disruptive technologies, and growing expectations are pushing every business to both adopt and deliver new digital services. This ‘Digital Transformation’ demands rapid delivery and continuous iteration of new competitive services via multiple channels, which in turn demands new service delivery techniques – including DevOps. In this power panel at @DevOpsSummit 20th Cloud Expo, moderated by DevOps Conference Co-Chair Andi Mann, panelists will examine how DevOps helps to meet th...
Apr. 25, 2017 12:30 PM EDT Reads: 1,164
SYS-CON Events announced today that Hitachi, the leading provider the Internet of Things and Digital Transformation, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help globa...
Apr. 25, 2017 12:15 PM EDT Reads: 928
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain.
Apr. 25, 2017 12:15 PM EDT Reads: 2,511
@DevOpsSummit has been named the ‘Top DevOps Influencer' by iTrend. iTred processes millions of conversations, tweets, interactions, news articles, press releases, blog posts - and extract meaning form them and analyzes mobile and desktop software platforms used to communicate, various metadata (such as geo location), and automation tools. In overall placement, @DevOpsSummit ranked as the number one ‘DevOps Influencer' followed by @CloudExpo at third, and @MicroservicesE at 24th.
Apr. 25, 2017 12:00 PM EDT Reads: 2,702
SYS-CON Events announced today that T-Mobile will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. As America's Un-carrier, T-Mobile US, Inc., is redefining the way consumers and businesses buy wireless services through leading product and service innovation. The Company's advanced nationwide 4G LTE network delivers outstanding wireless experiences to 67.4 million customers who are unwilling to compromise on ...
Apr. 25, 2017 12:00 PM EDT Reads: 884
The goal of Continuous Testing is to shift testing left to find defects earlier and release software faster. This can be achieved by integrating a set of open source functional and performance testing tools in the early stages of your software delivery lifecycle. There is one process that binds all application delivery stages together into one well-orchestrated machine: Continuous Testing. Continuous Testing is the conveyor belt between the Software Factory and production stages. Artifacts are ...
Apr. 25, 2017 11:30 AM EDT Reads: 1,054
SYS-CON Events announced today that Juniper Networks (NYSE: JNPR), an industry leader in automated, scalable and secure networks, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Juniper Networks challenges the status quo with products, solutions and services that transform the economics of networking. The company co-innovates with customers and partners to deliver automated, scalable and secure network...
Apr. 25, 2017 11:30 AM EDT Reads: 4,814