2012-11-01 11:30:34 -
NEW YORK, November 1, 2012 - Delcath Systems, Inc. (NASDAQ: DCTH) announced
today that the U.S. Food and Drug Administration (FDA) assigned a Prescription
Drug User Fee Act (PDUFA) goal date of June 15, 2013, for substantive review of
the Company's New Drug Application (NDA) of its proprietary chemosaturation
system with melphalan hydrochloride for injection.
The FDA accepted Delcath's NDA submission for filing on October 14, 2012, and
designated the NDA for standard review.
The Company seeks approval to market and sell its proprietary chemosaturation
system with melphalan hydrochloride in the United States as a treatment for
patients with unresectable metastatic melanoma in the liver.
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 Delcath Hepatic CHEMOSAT® Delivery System with melphalan
hydrochloride for injection in April 2011 and for the second generation
hemofiltration cartridge for CHEMOSAT with melphalan hydrochloride for injection
in April 2012. 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's
NDA has been accepted for filing and substantive review by the FDA. The Company
is seeking approval for its proprietary chemosaturation system with melphalan
hydrochloride as a treatment for patients with unresectable metastatic melanoma
in the liver.
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 contents of the 74 Day letter and our ability
to address 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 metastatic melanoma to the liver, adoption, use and resulting
sales, if any, in the United States, patient outcomes using the Generation 2
system, 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, 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
strategic partnerships in foreign markets including in key Asian markets and
timing of the same, the initiation of clinical trials in key Asian markets with
the CHEMOSAT system for doxorubicin and timing and results of the same, approval
of the CHEMOSAT system with doxorubicin in key Asian markets, patient outcomes
using the CHEMOSAT system with doxorubicin, 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.
Contact Information:
Investor Contact: Media Contact:
Doug Sherk/Gregory Gin Janine McCargo
EVC Group EVC Group
415-568-4887/646-445-4801 646-688-0425
This announcement is distributed by Thomson Reuters on behalf of
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(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
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