Delcath Signs First Partner Agreement in Asia
09 Februar 2010 - 1:15PM
PR Newswire (US)
Chi-Fu Trading Co., Ltd. Becomes Exclusive Distributor of The
Delcath PHP System In Taiwan Minimum Value To Delcath Expected To
Be Approximately $10 Million NEW YORK, Feb. 9
/PRNewswire-FirstCall/ -- Delcath Systems, Inc. (NASDAQ: DCTH), a
medical technology company testing its proprietary treatment system
for primary and metastatic cancers to the liver, announced today
the signing of its first research, distribution, sales and
marketing agreement for its Percutaneous Hepatic Perfusion (PHP)
System (the Delcath PHP System(TM)). The agreement grants Chi-Fu
Trading Co., Ltd. the exclusive right to market and sell the
Delcath PHP System in Taiwan for hepatic malignancies and
infectious disease upon Taiwan Food and Drug Administration (TFDA)
approval, and any other approved use, with a conditional option for
Singapore. Under terms of the agreement, Chi-Fu will fund and
manage clinical studies at up to four sites to gather data for
submission to Taiwan government regulatory agencies for approval.
Any regulatory filings will be in the name of Delcath Systems, Inc.
For the clinical studies, Chi-Fu will purchase, at a discount,
Delcath PHP Systems to treat up to 200 patients with hepatic
cancer. Any additional systems required will be sold at a
confidential distributor price. It is intended that at least two of
the clinical study sites will become reference sites when the
studies are completed. Under the terms of the agreement, Delcath is
to receive $1 million in milestone payments, comprised of $300,000
upon execution of the agreement and the balance upon receipt of the
CE Mark and upon receipt of FDA approval. In addition Chi-Fu will
be contractually committed to purchase a minimum number of systems
annually during the term of the agreement, commencing when
commercial sales begin in Taiwan. The term of the agreement extends
for five years from the month when TFDA approval is received. The
total value of the agreement to Delcath assuming receipt of the
necessary approvals is estimated to be at least $10 million. The
terms of the agreement do not include Delcath providing any drugs
used with the Delcath PHP System to Chi-Fu. If during the term of
this agreement, other indications for the Delcath PHP System are
approved by the TFDA, Chi-Fu will have the right to distribute the
Delcath PHP System in Taiwan for those indications as well.
According to Eamonn P. Hobbs, CEO of Delcath Systems, "This
agreement is an important first step in bringing our proprietary
technology to Asia, where the incidence of liver cancer and related
hepatic disease is a major health issue and a leading cause of
death. In Taiwan, malignant neoplasms represent 29% of all deaths
and as such, we view Taiwan as an excellent opportunity to seek
approval to demonstrate the ability of the Delcath PHP System to
help patients and improve outcomes. In addition, we look forward to
working with Chi-Fu to identify additional indications for our
targeted drug delivery platform technology. We believe the Chi-Fu
agreement is a significant validation for the Delcath PHP System
and we are continuing to pursue additional strategic partnerships
to address other key Asian markets," Mr. Hobbs concluded. According
to Wayne Hsu, Managing Director of Chi-Fu and board member of
Shing-Er Lii Hsu memorial foundation for the research of medical
treatments, "Becoming the exclusive distributor in Taiwan of the
Delcath PHP System is key in helping Chi-Fu and the foundation to
achieve a number of its goals. Among these goals is our desire to
bring innovative technology to the Taiwan medical community, to
expand our current product offerings in the oncology segment, and
lastly and most importantly, to support the government healthcare
system efforts to potentially reduce the death rate and improve the
quality of life for hepatic cancer patients. We further see this as
the first step in building a strong partnership with Delcath as
their platform technology is adapted to treat new cancers and other
disease indications in the future." About Delcath Systems, Inc.
Delcath Systems, Inc. is a medical device company specializing in
cancer treatment. The Company is testing a proprietary, patented
drug delivery system for the treatment of primary and metastatic
liver cancers. Delcath's novel drug delivery platform is testing
the delivery of ultra-high doses of anti-cancer drugs to the liver
while preventing these high doses of drug from entering the
patient's bloodstream. Delcath is currently conducting a Phase III
clinical trial and multi-arm Phase II clinical trial of the Delcath
PHP System with melphalan in patients with liver cancers. The
Company maintains a broad intellectual property portfolio on a
worldwide basis including the U.S., Europe, Asia and Canada. For
more information, please visit the Company's website at
http://www.delcath.com/. About Chi-Fu Trading Co., Ltd. Chi-Fu is a
private company that has been serving the medical community in
Taiwan since 1930. As an importer and distributor of medical
devices, medical equipment, pharmaceuticals, consumables and
biotechnology products, Chi-Fu focuses its sales activities on
hospitals and clinics, which represent 79% of their revenues. Other
segments include drug stores and wholesalers. Among the companies
that Chi-Fu represents are AstraZeneca, Sanofi-Aventis, and Bausch
& Lomb . In 2009 their revenues exceeded $60 million(USD).
Chi-Fu is headquartered in Taipei City, with sales representation
throughout Taiwan. The 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 our
ability to obtain TFDA approval and other necessary regulatory
approvals, including the approval of the U.S. Food and Drug
Administration of the Delcath PHP System 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, including our recently
filed prospectus supplement filed with the Securities and Exchange
Commission on November 13, 2009 and our most recently filed
Quarterly Report on Form 10-Q and our Annual Report on Form 10-K
for our fiscal year ended December 31, 2008. 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.
Delcath PHP System(TM) is a trademark of Delcath Systems, Inc. All
rights reserved. DATASOURCE: Delcath Systems, Inc. CONTACT:
Investors, Doug Sherk or Barbara Domingo, +1-415-896-6820, Media,
Steve DiMattia, +1-646-201-5445, all of EVC Group, for Delcath
Systems, Inc. Web Site: http://www.delcath.com/
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