MALVERN, Pa., Oct. 8, 2012— Auxilium Pharmaceuticals, a leading company focused on products for urology and sexual health, has selected DSG’s eCaseLink™ as its provider for electronic data capture (EDC). Auxilium will also use DSG’s interactive web response system (IWRS) and clinical data management services for supporting the submission of a supplemental Biologics License Application (sBLA) to the FDA for their XIAFLEX® program in Peyronie’s Disease by end of 2012.
Auxilium deployed DSG technology and services in the global studies on the safety and efficacy of XIAFLEX®, a novel, in-office, first-in-class biologic therapy for the treatment of Peyronie's disease. “Working successfully with DSG in the past, we found that eCaseLink is a flexible and cost-effective solution for our studies,” said Dr. James Tursi, Chief Medical Officer at Auxilium Pharmaceuticals.
“DSG’s integrated IWRS and data management services allow us to work with one proven vendor ensuring rapid completion of this study, saving Auxilium both time and money safely, with absolute data integrity.”
DSG’s proprietary eCaseLink EDC system operates differently from all others, providing the friendliest and fastest data collection while dramatically reducing the volume of queries, simplifying the data management effort, reducing costs, and consistently leading to the most rapid Auxilium clinical data base locks.
“DSG is proud to partner with Auxilium on this program and looks forward to a successful sBLA submission,” said Tony Varano, CEO at DSG. “
Auxilium’s selection of DSG’s EDC, IWRS and data management software and services speaks volumes about the trust they placed with us. DSG is very confident in the successful outcome of the program and looks to continue our long term relationship with Auxilium.”
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences. Auxilium markets Testim® 1% (testosterone gel) for the topical treatment of hypogonadism in the U.S. and XIAFLEX® (collagenase clostridium histolyticum) for the treatment of adult Dupuytren’s contracture patients with a palpable cord. GlaxoSmithKline LLC co-promotes Testim with Auxilium in the U.S. Ferring International Center S.A. markets Testim in certain countries of the EU and Paladin Labs Inc. markets Testim in Canada. Pfizer has marketing rights for XIAPEX® (the EU tradename for collagenase clostridium histolyticum) in 46 countries in Eurasia; 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. Auxilium has three projects in clinical development. XIAFLEX is in phase III of development for the treatment of Peyronie’s Disease. Collagenase clostridium histolyticum (“CCH”) is in phase IIa of development for the treatment of Frozen Shoulder syndrome (adhesive capsulitis) and phase Ib of development for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Auxilium also has rights to pursue additional indications for CCH.
For additional information, visit http://www.auxilium.com
DSG, Inc. supports clinical trial data collection and management with innovative technology solutions, including Electronic Data Capture with specialized Clinical Data Management services, IWRS, Clinical Trial Management Systems and digital on-demand Case Report Form publishing management software. DSG’s products allow user-friendly, accurate and efficient data capture at any investigator site regardless of the technological infrastructure. DSG has successfully supported over 1,000 clinical trials for more than 400 companies at over 25,000 sites in more than 90 countries. Founded in 1992, DSG is a global company headquartered in Malvern, Pa., with additional offices in the U.S., Japan and India.
For more information, please visit www.dsg-us.com. All products and services mentioned in this announcement are the property of their respective owners.