onco diagnostic systems inc

VANCOUVER, March 15, 2004 -– Inex Pharmaceuticals Corporation (“INEX”;TSX: IEX) and Enzon Pharmaceuticals Inc onco diagnostic systems inc. (“Enzon”; NASDAQ: ENZN) announcedtoday 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) onco diagnostic systems inc. The NDA is seeking marketing approval for Onco TCS as a single-agenttreatment for patients with relapsed aggressive non-Hodgkin’s lymphoma(NHL) previously treated with at least two combination chemotherapy regimens onco diagnostic systems inc. The final section contained data gathered from clinical trials conducted withOnco TCS.

INEX has requested that the Onco TCS NDA be granted a Priority Review as itis a product intended to address an unmet medical need onco diagnostic systems inc. Applications that aregranted Priority Review status are targeted for action by the FDA within sixmonths from the date that the submission is complete.

David Main, President and CEO of INEX said, “The completion of the filingof the NDA is a significant achievement and signals the start of the six-monthregulatory review phase to seek approval for Onco TCS as a treatment for relapsedaggressive NHL onco diagnostic systems inc. This is an important step forward for these patients who havevery few treatment options.”

Arthur Higgins, Enzon’s chairman and chief executive officer, said, “Thesubmission of the third and final piece of this NDA supports our commitmentto advance this important therapy to the market place onco diagnostic systems inc. We are eager to continueto investigate this exciting product’s potential in indications beyondrelapsed aggressive NHL.”

INEX and Enzon will hear from the FDA within 60 days as to whether or not thesubmission 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 patientswith aggressive NHL were treated who had not responded to their previous therapyor had responded and subsequently relapsed onco diagnostic systems inc. After treatment, an overall responserate of 25% was attained onco diagnostic systems inc. Currently, there is no effective treatment for patientswith aggressive NHL that have relapsed following at least two prior treatmentregimens.
The results of this pivotal trial were released in June 2003 and presented inDecember 2003 at the American Society of Hematology annual conference alongwith interim results from two ongoing phase II trials in relapsed Hodgkin’sdisease and relapsed B-cell lymphoma.

Onco TCS is a proprietary drug comprised of the widely used off-patent anticancerdrug vincristine encapsulated in INEX’s TCS (liposomal) drug delivery technology onco diagnostic systems inc. The TCS technology provides prolonged blood circulation, tumor accumulationand extended drug release at the cancer site onco diagnostic systems inc. These characteristics are designedto increase the effectiveness and reduce the side effects of the encapsulateddrug.

In addition to the lead indication, relapsed aggressive NHL, Enzon and INEXintend to develop Onco TCS for use as a single-agent therapy or in combinationtherapy for several cancers in which vincristine is now used.

Onco TCS is being evaluated in several phase II clinical trials as a treatmentfor first-line NHL, relapsed small cell lung cancer, relapsed Hodgkin’sdisease, relapsed acute lymphoblastic leukemia, relapsed pediatric malignancies,relapsed NHL in combination with the approved cancer drug Rituxan® (rituximab),and relapsed NHL in combination with the approved cancer drug etoposide.

In January 2004, Enzon and INEX announced a strategic partnership to developand commercialize Onco TCS onco diagnostic systems inc. Under the terms of the agreement, Enzon has theexclusive North American commercialization rights for Onco TCS for all indications,subject to certain co-promotion rights of INEX onco diagnostic systems inc. INEX retains commercializationrights outside North America.

INEX received a US$12 million up-front payment and will receive up to a US$20million payment upon Onco TCS receiving approval from the FDA onco diagnostic systems inc. Additional developmentmilestones and sales-based bonus payments could total US$43.75 million onco diagnostic systems inc. INEXwill also receive a percentage of sales of Onco TCS and this percentage willincrease 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 (23,400estimated in 2003) and the sixth-leading cause of cancer deaths in Canada (2,800estimated in 2003), according to estimates of the American Cancer Society andthe Canadian Cancer Society onco diagnostic systems inc. Approximately 53,400 and 6,400 new cases were diagnosedin the U.S onco diagnostic systems inc. and Canada respectively in 2003.

About INEX
INEX is a Canadian biopharmaceutical company developing and commercializingproprietary 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-threateningdiseases.

Source: Inex Pharmaceuticals Corporation
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