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): November 5, 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 8.01 Other Events
Inex Pharmaceuticals Corporation ("INEX"; TSX: IEX) and Enzon Pharmaceuticals
Inc. ("Enzon"; NASDAQ: ENZN) announced today that they have filed a New Drug
Submission (NDS) with the Therapeutics Products Directorate (TPD) of Health
Canada for Marqibo(TM) (formerly referred to as Onco TCS).
The NDS is seeking marketing approval in Canada for Marqibo(TM) as a
single-agent treatment for patients with relapsed aggressive non-Hodgkin's
lymphoma (NHL) previously treated with at least two combination chemotherapy
regimens.
INEX and Enzon will hear from the TPD within 45 days of filing as to whether or
not the submission has been accepted for review. Subject to acceptance of the
NDS for review, a response is anticipated from Health Canada in 12 to 18 months.
The NDS follows a New Drug Application that was submitted to the US Food and
Drug Administration (FDA) seeking marketing approval for the same indication.
The NDA was completed in March of this year, and the FDA will include in its
review an evaluation by the Oncologic Drugs Advisory Committee (ODAC) on
December 1, 2004. INEX and Enzon expect the FDA's response on the NDA by January
15, 2005.
About Marqibo(TM) (vincristine sulfate liposomes injection)
Marqibo(TM) is a proprietary drug comprised of the widely used off-patent
anticancer drug vincristine encapsulated in INEX's sphingosomal 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 the completed multi center pivotal phase 2/3 clinical trial, 119 patients
with aggressive NHL who had not responded to their previous therapy or had
responded and subsequently relapsed were treated with Marqibo(TM). Prior to
enrolment in this study, patients had received on average four other therapies.
After treatment with Marqibo(TM) as a single-agent, an overall response rate of
25% was attained. Currently, there is no standard treatment for patients with
aggressive NHL who have not responded to or 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 2 trials in relapsed Hodgkin's disease
and relapsed B-cell lymphoma.
In addition to the lead indication, Enzon and INEX are also exploring the
development of Marqibo(TM) for use as a single-agent therapy or in combination
therapy for several cancers in which vincristine is now used.
About Non-Hodgkin's Lymphoma (NHL)
NHL is the fifth-leading cause of cancer deaths in the Canada (2,900 estimated
in 2004) and the fifth-leading cause of cancer deaths in United States (19,400
estimated in 2004), according to estimates of the Canadian Cancer Society and
the American Cancer Society. Approximately 6,400 and 53,400 new cases were
diagnosed in Canada and the U.S. and 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.
Further information about INEX and this news release can be found at
www.inexpharm.com.
About Enzon
Enzon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery,
development and commercialization of therapeutics to treat life-threatening
diseases. Further information about Enzon and this news release can be found at
www.enzon.com.
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. Examples of such statements above
include the statements regarding expectations of the time frames within which
Health Canada will act. 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 Health Canada's acceptance of the New Drug Submission and its
ultimate decision regarding approval may be delayed and, the risk that Marqibo
may not receive regulatory approval from the Therapeutics Products Directorate
of Health Canada or the U.S. FDA under Subpart H of the Food and Drug Act for
the lead indication and the fact that any such approval, if granted, will
include post approval commitments, as well as those risks described in Enzon's
Form 10-K and Forms 10-Q on file with the SEC and INEX's publicly filed periodic
reports. 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 November 5, 2004, and Enzon and INEX undertake no
duty to update this information.
Item 9.01 Financial Statements and Exhibits
Exhibit 99.1 Press Release dated November 5, 2004
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: November 5, 2004
By: /s/ Kenneth J. Zuerblis
----------------------------
Kenneth J. Zuerblis
Vice President, Finance and
Chief Financial Officer
Exhibit 99.1
ENZON
PHARMACEUTICALS For Immediate Release
PRESS RELEASE
Contacts: Susan M. Mesco
Director, Investor Relations
908-541-8777
Euro RSCG Life NRP
Mark R. Vincent, Media Relations
212-845-4239
ENZON AND INEX ANNOUNCE FILING OF NEW DRUG SUBMISSION TO HEALTH CANADA
BRIDGEWATER, NEW JERSEY - November 5, 2004 - Enzon Pharmaceuticals Inc.
("Enzon"; NASDAQ: ENZN) and Inex Pharmaceuticals Corporation ("INEX"; TSX: IEX)
announced today that they have filed a New Drug Submission (NDS) with the
Therapeutics Products Directorate (TPD) of Health Canada for Marqibo(R)
(formerly referred to as Onco TCS).
The NDS is seeking marketing approval in Canada for Marqibo(R) as a single-agent
treatment for patients with relapsed aggressive non-Hodgkin's lymphoma (NHL)
previously treated with at least two combination chemotherapy regimens.
INEX and Enzon will hear from the TPD within 45 days of filing as to whether or
not the submission has been accepted for review. Subject to acceptance of the
NDS for review, a response is anticipated from Health Canada in 12 to 18 months.
The NDS follows a New Drug Application that was submitted to the US Food and
Drug Administration (FDA) seeking marketing approval for the same indication.
The NDA was completed in March of this year, and the FDA will include in its
review an evaluation by the Oncologic Drugs Advisory Committee (ODAC) on
December 1, 2004. INEX and Enzon expect the FDA's response on the NDA by January
15, 2005.
David Main, President and CEO of INEX said, "The New Drug Submission for
Marqibo(R) is a significant milestone as we work towards providing a promising
treatment option for patients with relapsed non-Hodgkin's lymphoma in Canada."
Kenneth J. Zuerblis, Executive Vice President and CFO of Enzon said, "The NDS
reaffirms our commitment to bring this product to the North American market and
builds on the potential near term approval in the U.S. Our commercial team
eagerly awaits the opportunity to offer a new single-agent treatment option to
patients with relapsed aggressive non-Hodgkin's lymphoma."
About Marqibo(R) (vincristine sulfate liposomes injection)
Marqibo(R) is a proprietary drug comprised of the widely used off-patent
anticancer drug vincristine encapsulated in INEX's sphingosomal 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.
-more-
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685 Route 202/206 Bridgewater, NJ 08807
Phone: (908) 541-8600 Fax: (908) 575-9457
http://www.enzon.com
NDS Submission/ Page 2
In the completed multi center pivotal Phase 2/3 clinical trial, 119 patients
with aggressive NHL who had not responded to their previous therapy or had
responded and subsequently relapsed were treated with Marqibo(R). Prior to
enrolment in this study, patients had received on average four other therapies.
After treatment with Marqibo(R) as a single-agent, an overall response rate of
25% was attained. Currently, there is no standard treatment for patients with
aggressive NHL who have not responded to or 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 2 trials in relapsed Hodgkin's disease
and relapsed B-cell lymphoma.
In addition to the lead indication, Enzon and INEX are also exploring the
development of Marqibo(R) for use as a single-agent therapy or in combination
therapy for several cancers in which vincristine is now used.
About Non-Hodgkin's Lymphoma (NHL)
NHL is the fifth-leading cause of cancer deaths in the Canada (2,900 estimated
in 2004) and the fifth-leading cause of cancer deaths in United States (19,400
estimated in 2004), according to estimates of the Canadian Cancer Society and
the American Cancer Society. Approximately 6,400 and 53,400 new cases were
diagnosed in Canada and the U.S. and 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.
Further information about INEX and this news release can be found at
www.inexpharm.com.
About Enzon
Enzon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery,
development and commercialization of therapeutics to treat life-threatening
diseases. Further information about Enzon and this news release can be found at
www.enzon.com.
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. Examples of such statements above
include the statements regarding expectations of the time frames within which
Health Canada will act. 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 Health Canada's acceptance of the New Drug Submission and its
ultimate decision regarding approval may be delayed and, the risk that
Marqibo(R) may not receive regulatory approval from the Therapeutics Products
Directorate of Health Canada or the U.S. FDA under Subpart H of the Food and
Drug Act for the lead indication and the fact that any such approval, if
granted, will include post approval commitments, as well as those risks
described in Enzon's Form 10-K and Forms 10-Q on file with the SEC and INEX's
publicly filed periodic reports. 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 November 5, 2004, and
Enzon and INEX undertake no duty to update this information.
###
================================================================================
685 Route 202/206 Bridgewater, NJ 08807
Phone: (908) 541-8600 Fax: (908) 575-9457
http://www.enzon.com