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INEX and Enzon Complete the Filing of a New Drug Application for Onco TCS.


Business Editors/Health/Medical Writers

BRIDGEWATER, N.J. & VANCOUVER, Canada--(BUSINESS WIRE)--March 15, 2004

INEX INEX Integrated Numerical Experiment
INEX Internet Neutral Exchange
 Pharmaceuticals Corporation ("INEX"; TSX TSX Toronto Stock Exchange (TSE before April, 2002)
TSX Transfer from Stack Pointer to Index
TSX True Space Extension
:IEX IEX Ion Exchange (chromatography)
IEX Inter-Exchange Carrier
) and Enzon Pharmaceuticals Inc. ("Enzon"; NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:ENZN) announced today that they have submitted the final section of a "rolling submission" of a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) to the United States Food and Drug Administration United States Food and Drug Administration (FDA),
n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
 (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
). The NDA is seeking marketing approval for Onco TCS (Transportation Control System) A widely used integrated information system for railroad transportation developed by the Missouri Pacific Railroad Company in the late 1960s and early 1970s. It was later implemented by Union Pacific when the companies merged.  as a single-agent treatment for patients with relapsed aggressive non-Hodgkin's lymphoma (NHL NHL Non-Hodgkin's lymphoma, see there ) 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  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 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 vincristine /vin·cris·tine/ (vin-kris´ten) an antineoplastic vinca alkaloid; used as the sulfate salt in the treatment of various neoplasms, including Hodgkin's disease, acute lymphocytic leukemia, non-Hodgkin's lymphoma, Kaposi's  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 Lung Cancer, Small Cell Definition

Small cell lung cancer is a disease in which the cells of the lung tissues grow uncontrollably and form tumors.
Description

Lung cancer is divided into two main types: small cell and non-small cell.
, relapsed Hodgkin's disease, relapsed acute lymphoblastic leukemia acute lymphoblastic leukemia
n. Abbr. ALL
Lymphoblastic leukemia occurring mainly in older adults, characterized by rapid onset and progression of symptoms. Also called acute lymphocytic leukemia.
, relapsed pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
 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 pre·de·ter·mine  
v. pre·de·ter·mined, pre·de·ter·min·ing, pre·de·ter·mines

v.tr.
1. To determine, decide, or establish in advance:
 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 American Cancer Society,
n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research,
 and the Canadian Cancer Society The Canadian Cancer Society is a volunteer-based organization which seeks to eradicate cancer and to enhance the quality of life of those suffering from it.

The 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
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Mar 15, 2004
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