For immediate release: November 30, 2004
Vancouver, BC and Bridgewater, NJ – Inex Pharmaceuticals Corporation (“INEX”; TSX: IEX) and Enzon Pharmaceuticals Inc. (“ENZON”; NASDAQ: ENZN) announced today that the United States Food and Drug Administration (FDA) has posted on its website briefing documents for the Oncologic Drugs Advisory Committee (ODAC) meeting on Wednesday, December 1, 2004.
It is INEX and ENZON policy not to comment on the contents of the briefing documents prior to the Advisory Committee meeting.
This meeting is an open public forum for the presentation and discussion of safety and efficacy information contained in the MARQIBO New Drug Application (NDA) for marketing approval 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 briefing information can be accessed on the FDA website at: http://www.fda.gov/ohrms/dockets/ac/cder04.html#Oncologic
Conference Call
A conference call will be held on December 1, 2004 at 6:00 pm EST (3:00 pm PST) to discuss the outcome of the ODAC meeting on MARQIBO.
To participate in the conference call, please dial 1-877-211-7911. The call will be available for replay until December 8, 2004 by calling 1-800-408-3053 and entering the pass code 3115637#.
The live or archived webcast can be accessed through the companies’ websites at www.inexpharm.com or www.enzon.com.
About MARQIBO™ (vincristine sulfate liposomes injection)
MARQIBO 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 May 2004, the FDA accepted a New Drug Application (NDA) seeking marketing approval of MARQIBO as a single-agent treatment for patients with relapsed aggressive non-Hodgkin’s lymphoma previously treated with at least two combination chemotherapy regimens. 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 FDA will include the evaluation by ODAC on December 1, 2004 in its review. The FDA has established a target to complete its review of the NDA by January 15, 2005.
In addition to the lead indication, INEX and ENZON are also exploring the development of MARQIBO 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 sixth-leading cause of cancer deaths in the United States (19,400 estimated in 2004) and the fifth-leading cause of cancer deaths in Canada (2,900 estimated in 2004), according to estimates of the American Cancer Society and the Canadian Cancer Society. An estimated 54,370 and 6,200 new cases will be diagnosed in the US and Canada respectively in 2004.
About ODAC
The Oncologic Drugs Advisory Committee (ODAC) is a committee formed by the FDA of external experts to advise the FDA in the evaluation of marketed and investigational drugs for use in the treatment of cancer. The Committee is comprised of a core of thirteen voting members from the fields of general oncology, pediatric oncology, hematologic oncology, immunologic oncology, biostatistics and other related professions.
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 Inc. 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.
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”.
