Delcath Systems, Inc. (NASDAQ- DCTH) is a specialty pharmaceutical and medical device company focused on the treatment of primary and metastatic liver cancers. The Company’s proprietary product---Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS)---is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure.
Delcath is in late-stage clinical development in the United States with initial commercial activities in Europe, where the Melphalan/HDS is marketed as a CE Marked device under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT). The Company’s commercial strategy for CHEMOSAT is to steadily grow clinical adoption in major European markets and utilize physician experience to support appeals for reimbursement. Since launch over 250 CHEMOSAT treatments have been performed at over 20 leading European cancer centers, and investigators have begun to produce a steady flow of published and presented clinical data. In 2015, the Company received its first national reimbursement coverage when German authorities granted a dedicated procedure code for CHEMOSAT scheduled to take effect in 2016.
Delcath’s clinical development pipeline is focused on development of the orphan indications metastatic ocular melanoma, hepatocellular carcinoma and intrahepatic cholangiocarcinoma. The Company’s development program is designed to validate the safety and efficacy profile for Melphalan/HDS observed in Europe, support clinical adoption and the expansion of reimbursement for CHEMOSAT in Europe, and to support regulatory submissions and approvals in various jurisdictions including the U.S. The orphan designations Delcath has for melphalan in these tumor-types create barriers to entry as well as the potential for high gross margins and the basis of profitable long-term business model.
Cancers in the liver represent an unmet medical need and a multibillion-dollar market opportunity. Approximately 1.2 million patients are diagnosed annually with primary or metastatic liver cancer. Prognosis after liver involvement is poor, with overall survival generally less than 12 months. Delcath believes that the Melphalan/HDS is uniquely positioned to meet the needs of these patients as a stand-alone or complementary therapy.
The therapeutic concept behind Melphalan/HDS originated with isolated hepatic perfusion (IHP), an open surgical procedure that permits the administration of high dose chemotherapy directly to the liver. Though the use of melphalan in IHP has shown efficacy, it is a demanding 6-8 hour surgery that can be performed only once, and is associated with significant co-morbidities.
Treatment with Melphalan/HDS is performed in a minimally invasive procedure known as percutaneous hepatic perfusion (PHP). Catheters placed percutaneously temporarily isolate the liver from the body’s circulatory system, administer a high dose of melphalan hydrochloride directly to the liver, and route blood exiting the liver to our proprietary filters. The filters absorb the majority of the chemotherapeutic agent in the blood, reducing systemic exposure and related toxic side effects before returning the filtered blood the patient’s circulatory system. PHP is a 2-3 hour procedure and is repeatable. Patients treated in both clinical trial and commercial settings have received as many as six treatments.
Delcath’s Melphalan/HDS product and the PHP procedure have been improved through early clinical development and initial commercialization of CHEMOSAT in Europe. Results observed in Europe provide the Company with confidence that the efficacy and safety can be validated in the studies that comprise its Clinical Development Program and will ultimately allow for more widespread adoption.
Delcath’s clinical development program for the Melphalan/HDS includes a Global Phase 3 overall survival trial in ocular melanoma metastatic to the liver and a Global Phase 2 trial in hepatocellular carcinoma and intrahepatic cholangiocarcinoma. The Company has also initiated a prospective registry of commercial treatments in Europe and is supporting Investigator Initiated Trials in select tumor types.
Ocular melanoma originates in the eye and has a high likelihood of metastasizing to the liver. Once ocular melanoma has spread to the liver, current evidence suggests median overall survival is generally 6-8 months. The American Cancer Society and other international health agencies estimate that approximately 8,600 cases of ocular melanoma are diagnosed annually in the U.S. and Europe, with over half of these patients developing metastatic disease and approximately 90% will have liver involvement. There currently is no standard of care for the treatment of ocular melanoma metastatic to the liver. Delcath believes that ocular melanoma liver metastases represent a high unmet medical need.
Delcath expects to initiate its pivotal Phase 3 ocular melanoma trial near the end of 2015. This trial builds on learnings from a prior Phase 3 study completed in 2010 that demonstrated statistically significant hepatic progression free survival (primary endpoint) in ocular melanoma, the results of which were published in the Annals of Surgical Oncology in 2015. Delcath believes that pursuit of an indication in this disease state may be the fastest path to potential approval of the Melphalan/HDS in the U.S.
Hepatobiliary cancers such as HCC and ICC are among the most prevalent and lethal forms of cancer. According to GLOBOCAN, an estimated 76,000 new cases of primary liver cancers are diagnosed in the U.S. and Europe annually. Excluding patients who are eligible for surgical resection or certain focal treatments, approximately 15,000 patients with HCC and 6,500 patients with ICC may candidates for treatment with Melphalan/HDS in the U.S. and Europe. Delcath has commenced patient enrollment in its global Phase 2 HCC/ICC trial and expects interim data in early 2016.
Experienced Pharmaceutical Management Team Executing Data-Driven Plan
Jennifer K. Simpson, President & Chief Executive Officer – Dr. Simpson is a distinguished pharmaceutical industry executive, oncology nurse practitioner and educator. Dr. Simpson was named President and CEO of Delcath in May of 2015 and to the Company’s Board of Directors in October 2015. Previously Dr. Simpson has served as Delcath’s Interim President and CEO, and as Interim Co-President and Co-CEO. She first joined Delcath in 2012 as Executive Vice President of Global Marketing. Prior to joining Delcath Dr. Simpson held several leadership positions in product commercialization and late-stage asset management at ImClone Systems, Inc., and Ortho Biotech (now Jansen Biotech). Dr. Simpson earned a Ph.D. in Epidemiology from the University of Pittsburgh, an M.S. in Nursing from the University of Rochester, and a B.S. in Nursing from the State University of New York at Buffalo.
John Purpura, Executive Vice President Regulatory Affairs, Quality Assurance – Mr. Purpura has been Delcath's Executive Vice President for Regulatory Affairs and Quality Assurance since November 2009. Prior to Delcath, Mr. Purpura was Executive Director of International Regulatory Affairs at Bracco Diagnostics, Inc. Earlier in his career Mr. Purpura held senior leadership positions at Sanofi-Aventis, Eon Labs Manufacturing, Luitpold Pharmaceuticals, and Bolar Pharmaceuticals. He earned a MS in Management & Policy and BS degrees in Chemistry and Biology at the State University of New York at Stony Brook.
Barbra C. Keck Senior Vice President, Finance – Ms. Keck is an experienced manager and financial executive that has served Delcath in positions of increasing responsibility since 2009. She first joined Delcath as Controller in January 2009, was promoted to Vice President in October 2009 and to Senior Vice President in 2015. Prior to joining Delcath, she was an auditor with Deloitte & Touche, LLP. Earlier in her career, Ms. Keck served in management and executive positions with several non-profit organizations. She earned her M.B.A. in Accountancy from Baruch College and Bachelor of Music in Music Education from the University of Dayton.
The Future – Compelling Data & Near-Term Valuation Drivers
Delcath anticipates a number of value-creating milestones in 2016 and beyond. Initiation of the pivotal Phase 3 trial in ocular melanoma is expected near the beginning of the New Year. Interim data from the Global Phase 2 HCC/ICC trial is also expected in early 2016, as well as from an initial cohort of patients enrolled in the European prospective registry. Reimbursement coverage in Germany is expected to support continued increases in European sales and procedure volumes, and the steady flow of published and presented data will support appeals for reimbursement in additional European markets.
Delcath is building on an exceptionally productive period and looking toward an exciting future. The Company’s dedicated team is executing a data driven plan with clear milestones, combining a growing revenue base with disciplined financial management. Delcath is committed to establishing Melphalan/HDS therapy as the standard of care for certain cancers in the liver, and to providing access to this to this important treatment to patients worldwide.
For more information about Delcath Systems, Inc., please visit: www.Delcath.com
The company paid consideration to SNN or its affiliates for this article.
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