UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of
1934
July
23, 2008 (July 17, 2008)
Date
of
Report (Date of earliest event reported)
DELCATH
SYSTEMS, INC.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
001-16133
|
06-1245881
|
|
(State
or other jurisdiction
of
incorporation)
|
(Commission
File No.)
|
(IRS
Employer
Identification
No.)
|
600
Fifth Avenue, 23rd
Floor
New
York, NY 10020
(Address
of principal executive offices, including zip code)
Registrant's
telephone number, including area code: (212)
489-2100
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligations of the registrant under any of the following
provisions (see General Instruction A.2. below):
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
| ITEM 5.02. |
DEPARTURE
OF DIRECTORS OR CERTAIN OFFICERS; ELECTION OF DIRECTORS; APPOINTMENT
OF
CERTAIN OFFICERS; COMPENSATORY ARRANGEMENTS OF CERTAIN
OFFICERS.
|
On
July
17, 2008, Dr. Seymour Fein resigned as the Chief Medical Officer of Delcath
Systems, Inc. (“Delcath” or the “Company”), effective as of that date.
| ITEM 8.01 |
OTHER
EVENTS.
|
On
July
17, 2008, Delcath announced the addition of two senior executives, Mark
Morrison, M.D., Ph.D., as Chief Medical Officer to oversee the expansion of
clinical activity of the Company's first Phase III clinical trial, and Mr.
John
Talarico as Senior Vice President Regulatory Affairs and Quality
Systems.
CHIEF
MEDICAL OFFICER -- MARK MORRISON, M.D., PH.D.
Board
Certified in Medical Oncology and Internal Medicine, Dr. Morrison brings broad
experience in clinical research of both drugs and devices. Dr. Morrison earned
his M.D. and Ph.D. from the Mt. Sinai School of Medicine in New York City,
where
his thesis explored the potential targeted therapy of melanoma. Following his
internship and residency at Beth Israel Medical Center and Fellowship in Medical
Oncology at Memorial Sloan-Kettering Cancer Center (MSKCC), Dr. Morrison
remained as an instructor in the Clinical Immunology Service, Melanoma Group
at
MSKCC. Dr. Morrison began his career in the pharmaceutical industry with
American Cyanamid, where he served as Clinical Team Leader, with a primary
focus
on the development of therapies with monoclonal antibody conjugates. He
subsequently spent twelve years at Pfizer, beginning in New Product Development,
where his role encompassed both clinical trial conduct and market analysis,
leading to the development of comprehensive product life cycle plans for
Pfizer's Oncology pipeline. Dr. Morrison then moved to the Medical Affairs
division where he led the post-marketing clinical development of the
chemotherapy Camptosar(TM) (irinotecan). Most recently at Pfizer, Dr. Morrison
created and headed a team focused specifically on optimizing the clinical
development of new drug and device products. Dr. Morrison's career also has
included the position of Senior Director, Medical Affairs and Oncology Medical
Section Director, overseeing strategic planning and the conduct of Oncology
clinical trials to lead to regulatory approvals at i3 Research, a global
Clinical Research Organization.
SENIOR
VICE PRESIDENT REGULATORY AFFAIRS AND QUALITY SYSTEMS -- MR. JOHN TALARICO
Mr.
Talarico recently held a similar title at Excelsior Medical and ProRhythm,
Inc.,
manufacturers of Class II and III combination products involving a drug and
device. He has held senior engineering, quality and regulatory roles at a series
of medical device companies, during which time he was responsible for PMA,
IDE
and 510(k) submissions. Besides numerous FDA approvals, Mr. Talarico has also
been successful in gaining international device approvals including the European
CE Mark. He has managed worldwide clinical trials for numerous products and
directed the QA, regulatory and compliance activities through approval and
commercialization.
A
copy of
the press release announcing their appointments is attached as Exhibit
99.1.
| ITEM 9.01 |
FINANCIAL
STATEMENTS AND EXHIBITS.
|
| (a) |
Not
applicable.
|
| (b) |
Not
applicable.
|
| (c) |
Not
applicable.
|
| (d) |
Exhibits
|
|
No.
|
Description
|
|
99.1
|
Press
release of the Company dated July 17,
2008
|
2
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the
registrant has duly caused this Current Report on Form 8-K to be signed on
its
behalf by the undersigned thereunto duly authorized.
|
Dated:
July 23, 2008
|
DELCATH
SYSTEMS, INC.
|
|
| |
|
|
| By: | /s/ Richard L. Taney | |
|
Name:
Richard L. Taney
Title:
Chief Executive Officer
|
||
3
EXHIBIT
INDEX
|
No.
|
Description
|
|
99.1
|
Press
release of the Company dated July 17,
2008
|
4
Delcath
Systems Announces Clinical and Regulatory Appointments
New
Executives Add Experience With FDA Approvals
NEW
YORK, NY--(MARKET WIRE)--Jul 17, 2008
--
Delcath Systems, Inc. (NasdaqCM:DCTH) announced today the addition of two senior
executives as the Company accelerates its Phase III clinical trial towards
completion. Mark Morrison, M.D., Ph.D. joins Delcath as Chief Medical Officer
to
oversee the expansion of clinical activity of the Company's first Phase III
clinical trial. He replaces Dr. Seymour Fein in this position. Mr. John Talarico
joins Delcath in the newly created position of Senior Vice President Regulatory
Affairs and Quality Systems.
Commenting
on the new additions, Richard L. Taney, President and Chief Executive Officer
of
Delcath, said, "As we move towards US FDA approval, we continue building a
senior team capable of addressing all phases of product development and
commercialization. Both of these individuals are veterans in their fields and
bring extensive and impressive experience in oncology drugs and devices. The
additions of Dr. Morrison and Mr. Talarico will greatly help Delcath advance
the
Percutaneous Hepatic Perfusion (PHP) System from the clinic to expanded
commercial use. The team at Delcath is excited to be working with Mark and
John.
We look forward to continuing to build the Company, reach our milestones and
propel Delcath forward."
CHIEF
MEDICAL OFFICER -- MARK MORRISON, M.D., PH.D.
Board
Certified in Medical Oncology and Internal Medicine, Dr. Morrison brings broad
experience in clinical research of both drugs and devices. Dr. Morrison earned
his M.D. and Ph.D. from the Mt. Sinai School of Medicine in New York City,
where
his thesis explored the potential targeted therapy of melanoma. Following his
internship and residency at Beth Israel Medical Center and Fellowship in Medical
Oncology at Memorial Sloan-Kettering Cancer Center (MSKCC), Dr. Morrison
remained as an instructor in the Clinical Immunology Service, Melanoma Group
at
MSKCC. Dr. Morrison began his career in the pharmaceutical industry with
American Cyanamid, where he served as Clinical Team Leader, with a primary
focus
on the development of therapies with monoclonal antibody conjugates. He
subsequently spent twelve years at Pfizer, beginning in New Product Development,
where his role encompassed both clinical trial conduct and market analysis,
leading to the development of comprehensive product life cycle plans for
Pfizer's Oncology pipeline. Dr. Morrison then moved to the Medical Affairs
division where he led the post-marketing clinical development of the
chemotherapy Camptosar(TM) (irinotecan). Most recently at Pfizer, Dr. Morrison
created and headed a team focused specifically on optimizing the clinical
development of new drug and device products. Dr. Morrison's career also has
included the position of Senior Director, Medical Affairs and Oncology Medical
Section Director, overseeing strategic planning and the conduct of Oncology
clinical trials to lead to regulatory approvals at i3 Research, a global
Clinical Research Organization.
SENIOR
VICE PRESIDENT REGULATORY AFFAIRS AND QUALITY SYSTEMS -- MR. JOHN
TALARICO
Mr.
Talarico recently held a similar title at Excelsior Medical and ProRhythm,
Inc.,
manufacturers of Class II and III combination products involving a drug and
device. He has held senior engineering, quality and regulatory roles at a series
of medical device companies, during which time he was responsible for PMA,
IDE
and 510(k) submissions. Besides numerous FDA approvals, Mr. Talarico has also
been successful in gaining international device approvals including the European
CE Mark. He has managed worldwide clinical trials for numerous products and
directed the QA, regulatory and compliance activities through approval and
commercialization.
ABOUT
DELCATH SYSTEMS, INC.
Delcath
Systems is a developmental stage company testing its percutaneous perfusion
technology for the isolated delivery of high doses of therapeutic and
chemotherapeutic agents. The Delcath System is currently being tested in Phase
III and Phase II clinical trials for the treatment of hepatocellular carcinoma
and metastatic tumors in the liver, including melanomas, neuroendocrine tumors
and adenocarcinomas. The Company's intellectual property portfolio currently
consists of twenty-eight patents on a worldwide basis including the U.S.,
Europe, Asia and Canada. For more information, please visit the Company's
website at www.delcath.com.
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 successfully complete Phase III
clinical trials and secure regulatory approval of our current or future
drug-delivery 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. 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.