Biopharmaceutical Company With Supportive Care, Oncology and Infectious Disease
Focus Streamlines Study Implementation and Data Collection with Medidata Rave
NEW YORK, N.Y. - October 19, 2010 - Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that Progenics Pharmaceuticals, Inc. has selected the Medidata Rave® electronic data capture (EDC) and clinical data management (CDM) platform. Progenics has decided to implement Rave integrated with United BioSource Corp's (UBC) interactive voice response system (IVRS) to manage a Phase III study evaluating methylnaltrexone, an opioid-induced constipation treatment, throughout investigative sites in Europe, Canada and the U.S.
Based in Tarrytown, NY, Progenics focuses on innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases, with principal programs directed toward supportive care, oncology and infectious diseases.
To implement the integration process, UBC also provided a unified project management system for multi-technology implementation and integration. UBC has strategically partnered with Medidata for a number of years, joining the Medidata ASPire to Win® partner program for contract research organizations in 2007 and becoming a Medidata Technology Partner for its IVRS integration with Rave in 2009.
"We are pleased that Progenics' clinical development team selected an integrated EDC and IVRS solution-one that will enable seamless sharing of key clinical data for streamlined data management, subject screening, randomization, drug supply management and site management processes," said Glen de Vries, President, Medidata Solutions. "We're continuing to see sponsors make significant investments in best-of-breed, easily interoperable solutions that will meet their specific requirements across all areas of the clinical research process."
Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. Principal programs are directed toward supportive care, oncology and infectious diseases. Progenics is developing RELISTOR® (methylnaltrexone bromide) for the treatment of opioid-induced constipation. RELISTOR is now approved in over 50 countries, including the U.S., E.U., Canada, Australia and Brazil. Progenics is pursuing strategic alternatives for RELISTOR, including licensing, collaboration, strategic alliances and U.S. commercialization or co-promotion, following termination of its 2005 collaboration with Wyeth Pharmaceuticals, now part of Pfizer Inc., which is continuing manufacturing, sales, marketing, clinical, and certain development and regulatory activities for RELISTOR during the transition. Ono Pharmaceutical Co., Ltd. has an exclusive license from Progenics for development and commercialization of subcutaneous RELISTOR in Japan. In oncology, the Company is conducting a phase 1 clinical trial of PSMA ADC, a human monoclonal antibody-drug conjugate for the treatment of prostate cancer. PSMA is a protein found on the surface of prostate cancer cells as well as in blood vessels supplying other solid tumors. In virology, Progenics is also developing the viral-entry inhibitor PRO 140, a humanized monoclonal antibody which binds to co-receptor CCR5 to inhibit human immunodeficiency virus (HIV) infection. PRO 140 is currently in phase 2 clinical testing. In early development, Progenics is evaluating novel antibodies to toxins produced by the bacteria C. difficile, as well as single-agent multiplex PI3-Kinase inhibitors as a potential strategy to combat some of the most aggressive forms of cancer, and is also seeking to identify novel entry-inhibitors of HCV infection.
United BioSource Corporation (UBC) is a global scientific and medical affairs organization that partners with life science companies to develop and commercialize biopharmaceuticals, medical devices, and other health care products. We help deliver authoritative, real-world evidence to characterize product effectiveness, address safety risk, and demonstrate value. UBC brings together recognized scientific and industry experts, research operations professionals, and new technologies to provide innovative solutions across the product lifecycle. The company is headquartered in Bethesda, Maryland, with offices in North and South America, Europe and Asia. For more information about UBC, visit www.unitedbiosource.com.
About Medidata Solutions Worldwide
Medidata Solutions (www.mdsol.com) is a leading global provider of SaaS-based clinical development solutions that enhance the efficiency of customers' clinical trials. For over 10 years, Medidata has consistently brought next-generation innovation to the life science industry to lower the total cost of clinical development through informed trial planning and management, optimized clinical processes and platform interoperability. Medidata's advanced solutions address key functions throughout the clinical development process including protocol development (Medidata Designer®), trial planning and management (Medidata Grants Manager®, Medidata CRO Contractor®), user and learning management (iMedidataTM), randomization and trial supply management (Medidata BalanceTM), monitoring (Medidata Rave Monitor, Medidata Rave Targeted SDV), Serious Adverse Events capture (Medidata Rave Safety Gateway) and clinical data capture, management and reporting (Medidata Rave®). Our diverse customer base spans biopharmaceutical companies, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies as well as organizations of all sizes developing life-enhancing medical treatments and diagnostics.