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
Date of Report (Date of earliest event reported): May 21, 2004
ENZON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware 0-12957 22-2372868
(State or other jurisdiction of (Commission (IRS Employer
incorporation) File Number) Identification)
685 Route 202/206, Bridgewater, New Jersey 08807
(Address of principal executive offices) (Zip Code)
(Registrant's telephone number, including area code: (908) 541-8600
----------------------------------------------------------------------
(Former name or former address, if changed since last report)
Item 5. Other Events
Inex Pharmaceuticals Corporation ("INEX"; TSX: IEX) and Enzon Pharmaceuticals
Inc. ("Enzon"; NASDAQ: ENZN) announced today that the New Drug Application (NDA)
for Onco TCS (vincristine sulfate liposomes injection) has been accepted by the
United States Food and Drug Administration (FDA) and has been granted a Standard
Review designation. Based on this designation, the FDA has established a target
date of January 15, 2005 for completion of review of the Onco TCS NDA.
The NDA is seeking marketing approval for Onco TCS as a single-agent treatment
for patients with relapsed aggressive non-Hodgkin's lymphoma (NHL) previously
treated with at least two combination chemotherapy regimens.
About Onco TCS
In the completed multi-center pivotal phase II/III clinical trial for Onco TCS,
119 patients with aggressive NHL were treated who had not responded to their
previous therapy or had responded and subsequently relapsed. After treatment, an
overall response rate of 25% was attained. Currently, there is no standard
treatment for patients with aggressive NHL that have relapsed following at least
two prior treatment regimens.
The results of this pivotal trial were released in June 2003 and presented in
December 2003 at the American Society of Hematology annual conference along with
interim results from two ongoing phase II trials in relapsed Hodgkin's disease
and relapsed B-cell lymphoma.
Onco TCS is a proprietary drug comprised of the widely used off-patent
anticancer drug vincristine encapsulated in INEX's liposomal drug delivery
technology. INEX's technology is designed to provide prolonged blood
circulation, tumor accumulation and extended drug release at the cancer site.
These characteristics are intended to increase the effectiveness and reduce the
side effects of the encapsulated drug.
In addition to the lead indication, relapsed aggressive NHL, Enzon and INEX
intend to develop Onco TCS for use as a single-agent therapy or in combination
therapy for several cancers in which vincristine is now used.
Onco TCS is currently being evaluated in several phase II clinical trials as a
treatment for first-line NHL, relapsed small cell lung cancer, relapsed
Hodgkin's disease, relapsed acute lymphoblastic leukemia, relapsed pediatric
malignancies, relapsed NHL in combination with the approved cancer drug
Rituxan(R) (rituximab), and relapsed NHL in combination with the approved cancer
drug etoposide.
In January 2004, Enzon and INEX announced a strategic partnership to develop and
commercialize Onco TCS. Under the terms of the agreement, Enzon has the
exclusive North American commercialization rights for Onco TCS for all
indications, subject to certain co-promotion rights of INEX. INEX retains
commercialization rights outside North America.
About Non-Hodgkin's Lymphoma (NHL)
NHL is the fifth-leading cause of cancer deaths in the United States (23,400
estimated in 2003) and the sixth-leading cause of cancer deaths in Canada (2,800
estimated in 2003), according to estimates of the American Cancer Society and
the Canadian Cancer Society. Approximately 53,400 and 6,400 new cases were
diagnosed in the U.S. and Canada respectively in 2003.
About INEX
INEX is a Canadian biopharmaceutical company developing and commercializing
proprietary drugs and drug delivery systems to improve the treatment of cancer.
About Enzon
Enzon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery,
development and commercialization of therapeutics to treat life-threatening
diseases.
There are forward-looking statements contained herein that are not based on
historical fact, including without limitation statements containing the words
"believes," "may," "plans," "will," "estimate," "continue," "anticipates,"
"intends," "expects," and similar expressions. Such forward looking statements
involve known and unknown risks, uncertainties and other factors that may cause
actual results, events or developments to be materially different from future
results, events or developments described in the forward looking statements.
Such factors include the risk that Onco TCS may not receive regulatory approval
from the FDA under Subpart H of the Food and Drug Act and the fact that any such
approval, if granted, will include post approval commitments, as well as those
described in Enzon's Form 10-K and Forms 10-Q on file with the SEC and INEX's
publicly filed periodic reports and others, such as, (i) as to Enzon, Enzon's
ability to successfully launch and market Onco TCS, Enzon's ability to sustain
profitability, and positive cash flow; risks in obtaining and maintaining
regulatory approval for indications and expanded indications for Enzon's
products; market acceptance of and continuing demand for Enzon's products;
timing and results of clinical trials and the impact of competitive products and
pricing and (ii) as to INEX, INEX's stage of development, lack of product
revenues, additional capital requirements, risks associated with the completion
of clinical trials and obtaining regulatory approval to market INEX's products,
risks associated with the failure to secure all necessary intellectual property
from third parties, the ability to protect its intellectual property and
dependence on collaborative partners. These factors should be considered
carefully and readers are cautioned not to place undue reliance on such
forward-looking statements. All information in this press release is as of May
21, 2004, and Enzon and INEX undertake no duty to update this information.
Contacts for Inex Pharmaceuticals Corporation
Investors
Ian Mortimer
Senior Director, Investor Relations
Phone: 604-419-3200
Media
Miriam Zitner
James Hoggan & Associates Inc.
Phone: 604-739-7500
Contacts for Enzon Pharmaceuticals, Inc.
Investors
Susan M. Mesco
Director, Investor Relations
Phone: 908-541-8678
Media
Mark Vincent
Euro RSCG Life NRP
Phone: 212-845-4239
INEX's common shares are traded on the Toronto Stock Exchange under the trading
symbol "IEX".
Enzon's common shares are traded on NASDAQ under the trading symbol "ENZN".
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Dated: May 21, 2004
By: /s/ Kenneth J. Zuerblis
---------------------------
Kenneth J. Zuerblis
Vice President, Finance and
Chief Financial Officer
Exhibit 99.1
INEX and Enzon Announce FDA Acceptance of
Onco TCS New Drug Application
For Immediate Release May 21, 2004
VANCOUVER - Inex Pharmaceuticals Corporation ("INEX"; TSX: IEX) and Enzon
Pharmaceuticals Inc. ("Enzon"; NASDAQ: ENZN) announced today that the New Drug
Application (NDA) for Onco TCS (vincristine sulfate liposomes injection) has
been accepted by the United States Food and Drug Administration (FDA) and has
been granted a Standard Review designation. Based on this designation, the FDA
has established a target date of January 15, 2005 for completion of review of
the Onco TCS NDA.
The NDA is seeking marketing approval for Onco TCS as a single-agent treatment
for patients with relapsed aggressive non-Hodgkin's lymphoma (NHL) previously
treated with at least two combination chemotherapy regimens.
David Main, President and CEO of INEX said, "The acceptance of the NDA is the
next step towards approval for Onco TCS and providing a new treatment option for
lymphoma patients. We will continue to work closely with the FDA to address any
questions during the review process."
Arthur Higgins, Enzon's chairman, said, "As Onco TCS progresses through the
approval process, we are aggressively preparing for its commercial launch. Our
marketing programs are being defined and Enzon's sales organization is eagerly
awaiting the launch of this important treatment for relapsed aggressive
non-Hodgkin's lymphoma. In addition to relapsed aggressive NHL, Onco TCS is also
being evaluated in several phase II oncology clinical trials, including
first-line non-Hodgkin's lymphoma. Based upon its successes to date, we believe
that Onco TCS has significant revenue potential."
About Onco TCS
In the completed multi-center pivotal phase II/III clinical trial for Onco TCS,
119 patients with aggressive NHL were treated who had not responded to their
previous therapy or had responded and subsequently relapsed. After treatment, an
overall response rate of 25% was attained. Currently, there is no standard
treatment for patients with aggressive NHL that have relapsed following at least
two prior treatment regimens.
The results of this pivotal trial were released in June 2003 and presented in
December 2003 at the American Society of Hematology annual conference along with
interim results from two ongoing phase II trials in relapsed Hodgkin's disease
and relapsed B-cell lymphoma.
Onco TCS is a proprietary drug comprised of the widely used off-patent
anticancer drug vincristine encapsulated in INEX's liposomal drug delivery
technology. INEX's technology is designed to provide prolonged blood
circulation, tumor accumulation and extended drug release at the cancer site.
These characteristics are intended to increase the effectiveness and reduce the
side effects of the encapsulated drug.
In addition to the lead indication, relapsed aggressive NHL, Enzon and INEX
intend to develop Onco TCS for use as a single-agent therapy or in combination
therapy for several cancers in which vincristine is now used.
Onco TCS is currently being evaluated in several phase II clinical trials as a
treatment for first-line NHL, relapsed small cell lung cancer, relapsed
Hodgkin's disease, relapsed acute lymphoblastic leukemia, relapsed pediatric
malignancies, relapsed NHL in combination with the approved cancer drug
Rituxan(R) (rituximab), and relapsed NHL in combination with the approved cancer
drug etoposide.
In January 2004, Enzon and INEX announced a strategic partnership to develop and
commercialize Onco TCS. Under the terms of the agreement, Enzon has the
exclusive North American commercialization rights for Onco TCS for all
indications, subject to certain co-promotion rights of INEX. INEX retains
commercialization rights outside North America.
About Non-Hodgkin's Lymphoma (NHL)
NHL is the fifth-leading cause of cancer deaths in the United States (23,400
estimated in 2003) and the sixth-leading cause of cancer deaths in Canada (2,800
estimated in 2003), according to estimates of the American Cancer Society and
the Canadian Cancer Society. Approximately 53,400 and 6,400 new cases were
diagnosed in the U.S. and Canada respectively in 2003.
About INEX
INEX is a Canadian biopharmaceutical company developing and commercializing
proprietary drugs and drug delivery systems to improve the treatment of cancer.
About Enzon
Enzon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery,
development and commercialization of therapeutics to treat life-threatening
diseases.
There are forward-looking statements contained herein that are not based on
historical fact, including without limitation statements containing the words
"believes," "may," "plans," "will," "estimate," "continue," "anticipates,"
"intends," "expects," and similar expressions. Such forward looking statements
involve known and unknown risks, uncertainties and other factors that may cause
actual results, events or developments to be materially different from future
results, events or developments described in the forward looking statements.
Such factors include the risk that Onco TCS may not receive regulatory approval
from the FDA under Subpart H of the Food and Drug Act and the fact that any such
approval, if granted, will include post approval commitments, as well as those
described in Enzon's Form 10-K and Forms 10-Q on file with the SEC and INEX's
publicly filed periodic reports and others, such as, (i) as to Enzon, Enzon's
ability to successfully launch and market Onco TCS, Enzon's ability to sustain
profitability, and positive cash flow; risks in obtaining and maintaining
regulatory approval for indications and expanded indications for Enzon's
products; market acceptance of and continuing demand for Enzon's products;
timing and results of clinical trials and the impact of competitive products and
pricing and (ii) as to INEX, INEX's stage of development, lack of product
revenues, additional capital requirements, risks associated with the completion
of clinical trials and obtaining regulatory approval to market INEX's products,
risks associated with the failure to secure all necessary intellectual property
from third parties, the ability to protect its intellectual property and
dependence on collaborative partners. These factors should be considered
carefully and readers are cautioned not to place undue reliance on such
forward-looking statements. All information in this press release is as of May
21, 2004, and Enzon and INEX undertake no duty to update this information.
Contacts for Inex Pharmaceuticals Corporation
Investors
Ian Mortimer
Senior Director, Investor Relations
Phone: 604-419-3200
Media
Miriam Zitner
James Hoggan & Associates Inc.
Phone: 604-739-7500
Contacts for Enzon Pharmaceuticals, Inc.
Investors
Susan M. Mesco
Director, Investor Relations
Phone: 908-541-8678
Media
Mark Vincent
Euro RSCG Life NRP
Phone: 212-845-4239
INEX's common shares are traded on the Toronto Stock Exchange under the trading
symbol "IEX".
Enzon's common shares are traded on NASDAQ under the trading symbol "ENZN".