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): March 15, 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 they have submitted the final
section of a "rolling submission" of a New Drug Application (NDA) to the United
States Food and Drug Administration (FDA). 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. The final section contained data gathered from clinical
trials conducted with Onco TCS.
INEX has requested that the Onco TCS NDA be granted a Priority Review as it is a
product intended to address an unmet medical need. Applications that are granted
Priority Review status are targeted for action by the FDA within six months from
the date that the submission is complete.
INEX and Enzon will hear from the FDA within 60 days as to whether or not the
submission has been accepted for review and given Priority Review status.
About Onco TCS
In the completed multi center pivotal phase II/III 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 effective
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 TCS (liposomal) drug delivery
technology. The TCS technology provides prolonged blood circulation, tumor
accumulation and extended drug release at the cancer site. These characteristics
are designed 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 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.
INEX received a US$12 million up-front payment and will receive up to a US$20
million payment upon Onco TCS receiving approval from the FDA. Additional
development milestones and sales-based bonus payments could total US$43.75
million. INEX will also receive a percentage of sales of Onco TCS and this
percentage will increase as sales reach certain predetermined thresholds.
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 Priority Review
status or regulatory approval from the FDA, 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 March
15, 2004, and Enzon and INEX undertake no duty to update this information.
This release is also available at http://www.enzon.com and
http://www.inexpharm.com
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: March 17, 2004
By: /s/ Kenneth J. Zuerblis
-------------------------------
Kenneth J. Zuerblis
Vice President, Finance and
Chief Financial Officer
Exhibit 99.1
[LOGO] ENZON PHARMACEUTICALS For Immediate Release
================================================================================
PRESS RELEASE
Contact: Susan Mesco
Director, Investor Relations
908-541-8678
Euro RSCG Life NRP
Mark R. Vincent, Media Relations
212-845-4239
INEX and Enzon Complete the Filing of a New Drug Application for Onco TCS
Bridgewater, NJ, and Vancouver, Canada - March 15, 2004 - INEX
Pharmaceuticals Corporation ("INEX"; TSX: IEX) and Enzon Pharmaceuticals Inc.
("Enzon"; NASDAQ: ENZN) announced today that they have submitted the final
section of a "rolling submission" of a New Drug Application (NDA) to the United
States Food and Drug Administration (FDA). 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. The final section contained data gathered from clinical
trials conducted with Onco TCS.
INEX has requested that the Onco TCS NDA be granted a Priority Review as
it is a product intended to address an unmet medical need. Applications that are
granted Priority Review status are targeted for action by the FDA within six
months from the date that the submission is complete.
David Main, President and CEO of INEX said, "The completion of the filing
of the NDA is a significant achievement and signals the start of the six-month
regulatory review phase to seek approval for Onco TCS as a treatment for
relapsed aggressive NHL. This is an important step forward for these patients
who have very few treatment options."
Arthur Higgins, Enzon's chairman and chief executive officer, said, "The
submission of the third and final piece of this NDA supports our commitment to
advance this important therapy to the market place. We are eager to continue to
investigate this exciting product's potential in indications beyond relapsed
aggressive NHL."
INEX and Enzon will hear from the FDA within 60 days as to whether or not
the
-more-
================================================================================
685 Route 202/206 Bridgewater, NJ 08807
Phone: (908) 541-8600 Fax: (908) 575-9457
http://www.enzon.com
NDA Completion/ page 2
submission has been accepted for review and given Priority Review status.
About Onco TCS
In the completed multi center pivotal phase II/III 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 effective
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 TCS (liposomal) drug delivery
technology. The TCS technology provides prolonged blood circulation, tumor
accumulation and extended drug release at the cancer site. These characteristics
are designed 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 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.
INEX received a US$12 million up-front payment and will receive up to a
US$20 million payment upon Onco TCS receiving approval from the FDA. Additional
development milestones and sales-based bonus payments could total US$43.75
million. INEX will also receive a
-more-
================================================================================
685 Route 202/206 Bridgewater, NJ 08807
Phone: (908) 541-8600 Fax: (908) 575-9457
http://www.enzon.com
NDA Completion/page 3
percentage of sales of Onco TCS and this percentage will increase as sales reach
certain predetermined thresholds.
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 Priority Review
status or regulatory approval from the FDA, 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
-more-
================================================================================
685 Route 202/206 Bridgewater, NJ 08807
Phone: (908) 541-8600 Fax: (908) 575-9457
http://www.enzon.com
NDA Completion/page 4
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 March 15, 2004, and Enzon and INEX undertake no duty to update
this information.
This release is also available at http://www.enzon.com and
http://www.inexpharm.com
###
================================================================================
685 Route 202/206 Bridgewater, NJ 08807
Phone: (908) 541-8600 Fax: (908) 575-9457
http://www.enzon.com