VANCOUVER, Nov. 22 /PRNewswire-FirstCall/ - Inex Pharmaceuticals Corporation announced today that it has received a Notice of Non-Compliance from the Therapeutics Products Directorate of Health Canada. The decision from Health Canada is consistent with the feedback from the United Stated Food and Drug Administration (FDA) requiring data from randomized phase 3 clinical trials be generated before Marqibo(TM) could be considered for marketing approval. In January 2005, the FDA provided a “not approvable” letter detailing that Marqibo would not be approved under the FDA’s accelerated approval regulations.
INEX has reached agreement in principle with the FDA on a path to commercial approval for Marqibo based on phase 3 clinical trial designs using complete response rate as the primary endpoint. The phase 3 trials would evaluate Marqibo as a treatment for both first-line non-Hodgkin’s lymphoma (NHL) and first-line acute lymphoblastic leukemia (ALL). Marqibo has shown promising anti-tumor activity in clinical trials in both of these cancers. Large cooperative medical groups have expressed an interest in participating in these phase 3 trials.
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 can be found at www.inexpharm.com.
Forward-Looking Statements
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.
Contact Information Investors Ian Mortimer Vice President, Finance and Chief Financial Officer Phone: 604-419-3200 Email: info@inexpharm.com Website: www.inexpharm.com Media Karen Cook Boas James Hoggan & Associates Inc. Phone: 604-739-7500 Email: kcook@hoggan.com
Inex Pharmaceuticals Corporation
CONTACT: Investors: Ian Mortimer, Vice President, Finance and ChiefFinancial Officer, Phone: (604) 419-3200, Email: info@inexpharm.com,Website: www.inexpharm.com; Media: Karen Cook Boas, James Hoggan &Associates Inc., Phone: (604) 739-7500, Email: kcook@hoggan.com
