Agreement VANCOUVER, Aug. 4 /CNW/ - Inex Pharmaceuticals Corporation (INEX; TSX:IEX) announced today that it has received notice that GlaxoSmithKline (GSK; LSE and NYSE:GSK) will terminate the agreement to develop liposomal topotecan (INX-0076) effective September 1, 2004. As part of the agreement, GSK can terminate with 30 days written notice. INEX and GSK entered into an agreement in November 2001 to develop GSK's anticancer drug, topotecan hydrochloride, with INEX's proprietary liposomal drug delivery technology. Since 2001, all of the preclinical studies including toxicology have been completed in anticipation of clinical development. However, GSK has experienced a number of technical problems in manufacturing the necessary supply of materials needed for clinical trials, and these problems have delayed the commencement of clinical development. To date, GSK has paid INEX US$5.25 million in upfront and milestone payments. David Main, President and CEO of INEX, said that it is disappointing that this program did not advance as quickly as both GSK and INEX had envisioned. "The research results for INX-0076 have been impressive and have shown that topotecan hydrochloride encapsulated in our proprietary liposomal technology is more effective when compared to the unencapsulated drug in preclinical models. We are now evaluating our options regarding the future of INX-0076 including the opportunity of developing INX-0076 or other camptothecin compounds by ourselves," said Main. About INEX INEX is a Canadian biopharmaceutical company developing and commercializing proprietary drugs and drug delivery systems to improve the treatment of cancer. INEX's lead product is Onco TCS, a proprietary drug comprised of the widely used off-patent anticancer drug vincristine encapsulated in INEX's liposomal drug delivery technology. INEX is commercializing Onco TCS with partner Enzon Pharmaceuticals Inc. A New Drug Application (NDA) for Onco TCS has been accepted by the FDA with a target date of January 15, 2005 for completion of review. 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. 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 the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others, 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, 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. The Company disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments. INEX's common shares are traded on the Toronto Stock Exchange under the trading symbol "IEX". -0- 08/04/2004 /For further information: INEX investor contact: Ian Mortimer, Senior Director, Investor Relations Inex Pharmaceuticals Corporation, Tel: (604) 419-3200, Email: info(at)inexpharm.com, Website: www.inexpharm.com; INEX media contact: Miriam Zitner, James Hoggan & Associates Inc., Tel: (604) 739-7500, Email: mzitner(at)hoggan.com/ (IEX.) CO: Inex Pharmaceuticals Corporation ST: British Columbia IN: MTC SU: -30- -0- Aug/04/2004 12:30 GMT
GlaxoSmithKline Provides Notice to Terminate Topotecan
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