Industry Veterans Add Clinical Trial, Financial, and Drug
Development Expertise
New York, NY -
December 15, 2014 - Delcath Systems, Inc. (NASDAQ: DCTH) today
announced the appointment of Dr. Dennis H. Langer, William D.
Rueckert and Dr. Marco Taglietti to the Company's Board of
Directors. Dr. Langer will serve as a Class III director with his
term expiring at the 2015 annual meeting; and Mr. Rueckert and Dr.
Taglietti will both serve as Class I directors with terms expiring
at the 2016 annual meeting. Concurrent with these additions, the
Company also announced the resignations from the Board of Laura A.
Brege, Tasos G. Konidaris, and Gabriel Leung. All changes
were effective as of December 11, 2014.
The new directors are all
distinguished business professionals who bring a wealth of
experience in clinical trials, finance, and drug development to the
Delcath Board. Dr. Langer possesses extensive operating experience
in pharmaceutical and biotechnology companies, and has been the CEO
or co-founder of several healthcare companies. Mr. Rueckert has
served on public or private corporate boards for several companies
in the life science and banking industries, and has extensive
expertise in investment banking and corporate finance. Dr.
Taglietti has more than 20 years of experience in senior leadership
positions in pharmaceutical research and development, and over the
course of his career has successfully brought 35 different
healthcare products to market in the U.S. and internationally.
Commenting on the announcements,
Dr. Roger G. Stoll, Executive Chairman and Director of Delcath,
said, "I am pleased to welcome Dennis, William and Marco to the
Delcath Board. Their operational, financial and drug development
expertise will provide invaluable insights and strategic guidance
through the next phases of our clinical development program. I also
want to thank Laura, Tasos and Gabe for their many contributions,
guidance and leadership over the years. On behalf of the
Board, we wish them well in their future endeavors."
Dr. Dennis H.
Langer
Dennis H. Langer, M.D., J.D. has
served as a Director of several specialty pharmaceutical,
biotechnology and diagnostic companies, and has been CEO and/or
co-founder of several health care companies. From 2005 to 2010, Dr.
Langer served as a Managing Partner of Phoenix IP Ventures, a
private equity/venture capital firm specializing in life sciences.
Previously, he was President, North America, of Dr. Reddy's
Laboratories, Limited. From September 1994 until January 2004, Dr.
Langer held several high-level positions at GlaxoSmithKline plc,
and its predecessor, SmithKline Beecham, including most recently as
a Senior Vice President of Research and Development. Prior to
SmithKline Beecham, Dr. Langer was President and CEO of Neose
Technologies, Inc., and before that held R&D and marketing
positions at Eli Lilly, Abbott and Searle. At the beginning
of his career, he was a Chief Resident at Yale University School of
Medicine, and held clinical fellowships at Harvard Medical School
and the National Institutes of Health. Dr. Langer serves as a
Director of Myriad Genetics, Inc. and Dicerna Pharmaceuticals, Inc.
Previously, Dr. Langer served as a Director of Ception
Therapeutics, Inc. (acquired by Cephalon, Inc.), Cytogen
Corporation (acquired by EUSA Pharma Inc.), Pharmacopeia, Inc.
(acquired by Ligand Pharmaceuticals, Inc.), Sirna
Therapeutics, Inc. (acquired by Merck and Co., Inc.), and
Transkaryotic Therapies, Inc. (acquired by Shire plc). Dr.
Langer is a Clinical Professor in the Department of Psychiatry,
Georgetown University School of Medicine. Dr. Langer received
a J.D. from Harvard Law School, an MD from Georgetown University
School of Medicine, and a B.A. in Biology from Columbia
University.
William D.
Rueckert
Mr. Rueckert has served on many
public and private corporate boards in both the life science and
banking industries. He is currently President of Oyster Management
Group, LLC, an investment partnership specializing in community
banking. From 2007 until 2012 he served on the board of Novogen
Ltd. (ASX, NASDAQ) a biotechnology company based in Sydney,
Australia. He acted as Chairman from 2010 until 2012, and as
acting CEO led the restructuring of the company, spinning off its
major subsidiary, Marshall Edwards, Inc. (now MEI Pharma, Inc.
NASDAQ.) He is currently a director of MEI Pharma, Inc.
(NASDAQ), a San Diego based company that is developing novel
oncology therapies. Until its sale to H. Lundbeck A/S, he was
a director of Chelsea Therapeutics International, Ltd. (NASDAQ)
whose drug candidate, Northera, was approved by the FDA in
2014. He has also served on the boards of several banks
including Westport Bank and Trust, Lafayette American Bank and
Hudson United Bank (all NASDAQ.) He currently serves on the
board of Fairfield County Bank, a mutually owned, community bank
based in Ridgefield, Connecticut. Among his civic
associations, Mr. Rueckert is a Director and President of the
Cleveland H. Dodge Foundation, Co-Chairman of the Board of Trustees
of Teachers College, Columbia University, a Director of the Y
Retirement Fund, a Trustee of International House, an Emeritus
Director of the YMCA of Greater New York and a Director of Wave
Hill, Inc. He earned a BA in Spanish in 1977 from the University of
New Hampshire.
Dr. Marco
Taglietti
Dr. Taglietti serves on the Board
of Directors of NASDAQ-listed SCYNEXIS, Inc., a pharmaceutical
company committed to the discovery, development and
commercialization of novel anti-infectives; and NephroGenex, Inc.,
a pharmaceutical company focused on the development of therapeutics
to treat kidney disease. Prior to its recent acquisition, Dr.
Taglietti served as Executive Vice President, Research and
Development, and Chief Medical Officer of Forest Laboratories. He
also served as President of the Forest Research Institute. Prior to
joining Forest Labs in 2007, Dr. Taglietti held the position of
Senior Vice President, Head of Global Research and Development, at
Stiefel Laboratories, Inc. for three years. He joined Stiefel after
12 years at Schering-Plough Corporation where he last held the
position of Vice President, Worldwide Clinical Research for
Anti-Infectives, Oncology, CNS, Endocrinology and Dermatology. Dr.
Taglietti began his career at Marion Merrell Dow Research
Institute. He received his medical degree and board certifications
from the University of Pavia in Italy.
About Delcath
Systems
Delcath Systems, Inc. is a
specialty pharmaceutical and medical device company focused on
oncology. Our 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 the systemic exposure to those agents.
The Company's principal focus is on the treatment of primary
and metastatic liver cancers. In the United States, the
Melphalan/HDS system is considered a combination drug and device
product, and is regulated as a drug by the United States Food and
Drug Administration (FDA). The Melphalan/HDS system has not
been approved for sale in the United States. In Europe, our
proprietary system to deliver and filter melphalan hydrochloride is
marketed as a device under the trade name Delcath Hepatic CHEMOSAT®
Delivery System for Melphalan (CHEMOSAT). In April 2012, we
obtained authorization to affix a CE Mark for the Generation Two
CHEMOSAT system. The right to affix the CE mark
allows the Company to market and sell the CHEMOSAT system in
Europe. The Company has commenced a Global Phase 2 clinical trial
in Europe and the United States to investigate Melphalan/HDS system
for primary liver cancer and is initiating plans to evaluate
intrahepatic cholangiocarcinoma, and is initiating a Phase 3 trial
in ocular melanoma liver metastases in 2015.
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 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, the impact of
the presentations at ESSO 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 US 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: |
Investor Contact: |
Media Contact: |
Michael Polyviou/Doug Sherk |
John Carter |
EVC Group |
EVC Group |
212-850-6020 |
212-850-6021 |
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responsible for the content, accuracy and originality of the
information contained therein.
Source: Delcath Systems, Inc via Globenewswire
HUG#1879972