Delcath Systems, Inc. Selects Quintiles to Support EU Launch of CHEMOSAT
Published: Mar 09, 2012
NEW YORK, March 9, 2012 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH) announced today that Quintiles will provide a specialized team of Medical Science Liaisons (MSLs) to support the launch of the Hepatic CHEMOSAT® Delivery system for the treatment of cancers in the liver in France, Germany, Italy, Netherlands, Spain, Ireland and the United Kingdom. In addition, it will provide medical communication to support patient advocacy, key opinion leader development, and field force materials.
Comprised of medical doctors, nurses, pharmacologists, and Ph.D. cancer specialists, the MSL team will draw on their understanding of the local healthcare environment and solid key opinion leader relationships to educate medical oncologists and hepatology specialists on the clinical benefits of CHEMOSAT.
"This agreement gives us a highly professional medical science team in Europe with which we can begin communicating to and educating medical oncologists and liver specialists on the benefits of chemosaturation therapy," said Eamonn P. Hobbs, President and CEO of Delcath Systems. "Quintiles brings a compelling combination of scientific and medical knowledge, as well as broad experience in the European oncology marketplace that will help to support our own sales and marketing efforts. This agreement also represents yet another important milestone in our preparations for the commercial launch of CHEMOSAT in Europe, and we look forward to working with such a reputable partner to begin realizing the potential of CHEMOSAT."
Chris Pepler, Quintiles' Head of Commercial Services in Europe, Middle East and Africa, said, "The complexities in the European health care market can pose significant operational and market-place risk for companies based internationally and looking to launch here. Successfully navigating local health care systems requires deep local knowledge and expertise. We're drawing on this local experience, alongside our consistent global standards of quality and delivery to provide comprehensive commercial solutions as Delcath launches their product in multiple markets across Europe."
Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of more than 20,000 engaged professionals in 60 countries works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit www.quintiles.com.
About Delcath Systems
Delcath Systems, Inc. is a development stage specialty pharmaceutical and medical device company focused on oncology. Delcath's proprietary system for chemosaturation is designed to administer high dose chemotherapy and other therapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents. The Company's initial focus is on the treatment of primary and metastatic liver cancers. In 2010, Delcath announced that its randomized Phase III clinical trial for patients with metastatic melanoma in the liver had successfully achieved the study's primary endpoint of extended hepatic progression-free survival. The Company also completed a multi-arm Phase II trial to treat other liver cancers. The Company obtained authorization to affix a CE Mark for the Hepatic CHEMOSAT delivery system in April 2011. The right to affix the CE mark allows the Company to market and sell the CHEMOSAT system in Europe. The Company has not yet received FDA approval for commercial sale of its system in the United States. The Company continues with the preparation of its NDA submission and intends to seek FDA approval for commercial sale of its chemosaturation system with melphalan. For more information, please visit the Company's website at www.delcath.com
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the results achieved by Quintiles in support of our commercial efforts in Europe, patient outcome from use of the CHEMOSAT system, future initial launch and training agreements and sales of the CHEMOSAT system to these centers, the future use and adoption of the CHEMOSAT system by the J.W. Goethe University Hospital, patient outcome resulting from treatment with the CHEMOSAT system, future initial launch and training agreements with other cancer centers in Europe, CE Marking for the Generation Two system and the timing of our commercial launch in Europe, the time required to build inventory and establish commercial operations in Europe, adoption, use and resulting sales, if any, for the Hepatic CHEMOSAT delivery system in the EEA, our ability to successfully commercialize the chemosaturation system and the potential of the chemosaturation system as a treatment for patients with terminal metastatic disease in the liver, acceptability of the Phase III clinical trial data by the FDA, our ability to address the issues raised in the Refusal to File letter received from the FDA and the timing of our re-submission of our NDA, re-submission and acceptance of the Company's NDA by the FDA, approval of the Company's NDA for the treatment of metastatic melanoma to the liver, adoption, use and resulting sales, if any, in the United States, approval of the current or future chemosaturation system for other indications, actions by the FDA or other foreign regulatory agencies, our ability to obtain reimbursement for the CHEMOSAT system, our ability to successfully enter into distribution and strategic partnership agreements in foreign markets and the corresponding revenue associated with such foreign markets, uncertainties relating to the results of research and development projects and future clinical trials, and uncertainties regarding our ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.
Doug Sherk/Gregory Gin
SOURCE Delcath Systems, Inc.