NEW YORK, May 26, 2015 /PRNewswire/ -- Delcath
Systems, Inc. (NASDAQ: DCTH) announces that Jennifer Simpson, Ph.D., M.S.N., C.R.N.P. has
been named President and Chief Executive Officer by the Company's
Board of Directors, effective immediately. Dr. Simpson has
served as Interim President and Chief Executive Officer of Delcath
since September 2014 and as Interim
Co-President and Co-Chief Executive Officer from September 2013 to September 2014. She
joined Delcath in 2012 as Executive Vice President, Global
Marketing.
"Jennifer possesses a well-rounded skillset in all aspects of
oncology drug development and commercialization," said Roger G. Stoll, Ph.D., Executive Chairman of
Delcath's Board of Directors. "Under her leadership, Delcath has
successfully established a commercial beachhead in Europe while initiating our global clinical
development programs in metastatic ocular melanoma, intrahepatic
cholangiocarcinoma, and primary liver cancer. This appointment
demonstrates the Board's continuing confidence in Jennifer's
ability to drive our commercial and clinical strategies forward and
to ultimately realize the potential of our technology for patients
with cancers in the liver."
"I look forward to continuing the work we have begun in
expanding the adoption of CHEMOSAT® in Europe and in advancing our clinical
development programs to bring our CHEMOSAT and Melphalan/HDS
therapy to market to benefit patients with cancers of the liver
worldwide," stated Dr. Simpson.
Prior to joining Delcath Dr. Simpson was Vice President, Global
Marketing, Oncology Brand Lead at ImClone Systems, Inc. (now a
wholly-owned subsidiary of Eli Lilly and Company), where she was
responsible for all product commercialization activities and launch
preparation for one of its late-stage assets. From 2009 to 2011 Dr.
Simpson served as Vice President, Product Champion and from 2008 to
2009 as Associate Vice President, Product Champion for a late-stage
asset at ImClone. From 2006 to 2008 Dr. Simpson served as Product
Director, Oncology Therapeutics Marketing at Ortho Biotech (now
Janssen Biotech), a biotechnology company focused on innovative
solutions in immunology, oncology and nephrology. Earlier in her
career Dr. Simpson spent more than a decade as a
hematology/oncology nurse practitioner and educator.
Dr. Simpson received 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.
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical
device company focused on oncology with a principal focus on the
treatment of primary and metastatic liver cancers. Our proprietary
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. In April 2012 we obtained
authorization to affix a CE Mark to our second-generation system,
which is currently marketed in Europe as a device under the trade name
Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT).
In the U.S. Melphalan/HDS is considered a combination drug and
device product, and is regulated as a drug by the U.S. Food and
Drug Administration (FDA). Melphalan/HDS has not been approved
for sale in the U.S. We have commenced a global Phase 2 clinical
trial in Europe and the U.S. to
investigate Melphalan/HDS for the treatment of primary liver cancer
(hepatocellular carcinoma or HCC), and we are initiating a cohort
within the global phase 2 clinical trial to evaluate patients with
intrahepatic cholangiocarcinoma (ICC). We are also advancing
plans to conduct a global Phase 3 trial in ocular melanoma that has
metastasized to the liver.
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 timing and results
of the Company's clinical trials including without limitation
the HCC, ICC and OM clinical trial programs timely
enrollment and treatment of patients in the global Phase 2 HCC and
ICC clinical trial, FDA and European Health Authority approval of
the global Phase 3 OM clinical trial protocol, IRB or ethics
committee clearance of the Phase 2 HCC/ICC and/or Phase 3
OM protocols from participating sites and the timing of
site activation and subject enrollment in each trial, acceptance of
the Phase 3 manuscript at a leading peer reviewed medical journal
and the impact of publication to support the Company's business,
the impact of the presentations at ESSO and SSO and
future clinical results consistent with the data presented,
approval of Individual Funding Requests for reimbursement of the
CHEMOSAT procedure, the impact, if any of Value 4 status on
potential CHEMOSAT product use and sales in Germany, clinical adoption, use and resulting
sales, if any, for the CHEMOSAT system to deliver and filter
melphalan in Europe including the
key markets of Germany and the UK,
the Company's ability to successfully commercialize the Melphalan
HDS/CHEMOSAT system and the potential of the Melphalan HDS/CHEMOSAT
system as a treatment for patients with primary and metastatic
disease in the liver, our ability to obtain reimbursement for the
CHEMOSAT system in various markets, the Company's ability to
satisfy the requirements of the FDA's Complete Response Letter and
provide the same in a timely manner, approval of the current or
future Melphalan HDS/CHEMOSAT system for delivery and filtration of
melphalan or other chemotherapeutic agents for various indications
in the U.S. and/or in foreign markets, actions by the FDA or other
foreign regulatory agencies, the Company's ability to successfully
enter into strategic partnership and distribution arrangements in
foreign markets and the timing and revenue, if any, of the same,
uncertainties relating to the timing and results of research and
development projects, our ability to maintain NASDAQ listing, and
uncertainties regarding the Company's ability to obtain financial
and other resources for any research, development, clinical trials
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.
Contact Information:
Anne Marie Fields
LHA
212-838-3777
afields@lhai.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/delcath-names-dr-jennifer-simpson-president-and-ceo-300088520.html
SOURCE Delcath Systems, Inc.