2012-12-11 00:01:19 -
NEW YORK, NY - December 10, 2012 -- Delcath Systems, Inc. (NASDAQ: DCTH)
announced today that executive management will present at the Oppenheimer
Healthcare Conference on Thursday, December 13, 2012 at 3:55 P.M. ET in New York
City. The presentation will include an overview of the Company's business
strategy and recent corporate developments.
A live webcast and subsequent archived replay of the presentation will be
available at www.delcath.com/investors/events/. The presentation
archived replay will be available approximately one hour after conclusion of the
live event for a period of 90 days.
About Delcath
Systems
Delcath Systems, Inc. is a 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
3 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 2 trial
to treat other liver cancers. The Company obtained authorization to affix a CE
Mark for the Generation Two CHEMOSAT® delivery system for melphalan
hydrochloride in April 2012. The right to affix the CE mark allows the Company
to market and sell the CHEMOSAT system for melphalan hydrochloride in Europe. In
October 2012, the Company satisfied all of the requirements to affix the CE Mark
to the Hepatic CHEMOSAT Delivery System device for intra-hepatic arterial
delivery and extracorporeal filtration of doxorubicin hydrochloride injection,
providing a regulatory pathway for the CHEMOSAT Delivery System to deliver and
filter doxorubicin for countries in Asia that accept the CE Marking as part of
their national regulatory requirements. The Company has not yet received FDA
approval for commercial sale of its system in the United States. The Company's
NDA has been accepted for filing and substantive review by the FDA. For more
information, please visit the Company's website at www.delcath.com.
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 impact, if any, of the change in the
indication in our NDA and approval of the same, timing of completion of the
FDA's review of our NDA, the extent to which the FDA may request additional
information or data and our ability to provide the same in a timely manner,
acceptability of the Phase 1, 2 and 3 clinical trial data by the FDA, FDA
approval of the Company's NDA for the treatment of ocular metastatic melanoma to
the liver, adoption, use and resulting sales, if any, in the United States,
adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver
and filter melphalan in the EEA, our ability to successfully commercialize the
chemosaturation system and the potential of the chemosaturation system as a
treatment for patients with primary and metastatic disease in the liver, market
acceptance of the Gen Two CHEMOSAT system and patient outcomes using the same,
approval of the current or future chemosaturation system for delivery and
filtration of melphalan, doxorubicin or other chemotherapeutic agents for
various indications in the US and/or in foreign markets, actions by the FDA or
other foreign regulatory agencies, our ability to successfully enter into
strategic partnership and distribution arrangements in foreign markets including
Australia and key Asian markets and timing and revenue, if any, of the same, the
approval of the Hepatic CHEMOSAT Delivery System device to deliver and filter
doxorubicin in key Asian markets and patient outcomes using the same, our
ability to obtain reimbursement for the CHEMOSAT system, uncertainties relating
to the timing and results of research and development projects, uncertainties
relating to the timing and results of 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.
Contact Information:
Investor Contact: Media Contact:
Gregory Gin/Patty Eisenhaur Janine McCargo
EVC Group EVC Group
646-445-4801/951-316-0577 646-688-0425
###
DELCATH TO PRESENT AT OPPENHEIMER HEALTHCARE CONFERENCE ON DECEMBER 13:
hugin.info/143764/R/1663888/539673.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Delcath Systems, Inc via Thomson Reuters ONE
[HUG#1663888]
