SynriboTreatment for Chronic Myelogenous Leukemia
Update: Synribo (omacetaxine) Now FDA Approved - October 26, 2012
Submission of Non-Clinical Section of Rolling NDA for Omacetaxine
ChemGenex Announces Submission of Non-Clinical Section of Rolling NDA for Omacetaxine
MELBOURNE, Australia & MENLO PARK, Calif.-- ChemGenex Pharmaceuticals announced today that it has submitted the non-clinical section of the rolling submission of a New Drug Application (NDA) for omacetaxine mepesuccinate (formerly known as Ceflatonin to the U.S. Food and Drug Administration (FDA).
"The non-clinical section of the NDA is the first of three parts necessary to complete the NDA submission of omacetaxine and brings us one step closer to commercialization," said Dr. Greg Collier, ChemGenex’s Managing Director and Chief Executive Officer. The next submission will be the CMC (Chemistry and Manufacturing Controls) section due in the first half of 2009, followed by the clinical section, which we plan to submit to complete our filing in mid 2009.
This is a significant milestone for the company, and it follows the presentation of positive clinical data for omacetaxine at international conferences and the acquisition of global IP and European commercialization rights from Stragen Pharma over the past month, said Dr. Collier. We are delighted with the progress we have made, and believe that we are very well positioned for an exciting year ahead.
The FDA granted "fast track" designation for omacetaxine treatment for patients with CML who have failed prior treatment with imatinib mesylate (Gleevec) and have the T315I Bcr-Abl point mutation. Currently no approved therapy has been shown to be efficacious for this subset of CML patients. The FDA's fast track program is intended to expedite the review of drugs that treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
The rolling submission process enables companies that have been granted fast track designation to submit sections of the NDA to the agency as they become available, allowing the review process to begin before the complete dossier has been submitted.
Ceflatonin® is a registered trademark of ChemGenex Pharmaceuticals Limited.
Gleevec/Glivec is a registered trademark of Novartis AG.
About ChemGenex Pharmaceuticals Limited
ChemGenex Pharmaceuticals is a pharmaceutical development company dedicated to improving the lives of patients by developing personalized oncology medicines. ChemGenex harnesses the power of genomics both to discover novel targets and drug compounds, and in clinical trials to develop more individualized treatment outcomes. ChemGenex’s lead compound, omacetaxine mepesuccinate (formerly known as Ceflatonin), is currently in phase 2/3 clinical trials for chronic myeloid leukemia (CML). ChemGenex has a second anticancer compound, amonafide dihydrochloride (formerly known as Quinamed) which is in phase 2 clinical development for various solid cancers, and a portfolio of assets in pre-clinical development. ChemGenex currently trades on the Australian Stock Exchange under the symbol "CXS" and on NASDAQ under the symbol "CXSP".
Details on the clinical trials can be accessed from www.clinicaltrials.gov
Safe Harbor Statement
Certain statements made herein that use the words "estimate", "project", "intend", "expect", "believe" and similar expressions are intended to identify forward-looking statements within the meaning of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known and unknown risks and uncertainties which could cause the actual results, performance or achievements of the company to be materially different from those which may be expressed or implied by such statements, including, among others, risks or uncertainties associated with the development of the company's technology, the ability to successfully market products in the clinical pipeline, the ability to advance promising therapeutics through clinical trials, the ability to establish our fully integrated technologies, the ability to enter into additional collaborations and strategic alliances and expand current collaborations and obtain milestone payments, the suitability of internally discovered genes for drug development, the ability of the company to meet its financial requirements, the ability of the company to protect its proprietary technology, potential limitations on the company's technology, the market for the company's products, government regulation in Australia and the United States, changes in tax and other laws, changes in competition and the loss of key personnel. These statements are based on our management's current expectations and are subject to a number of uncertainties that could change the results described in the forward-looking statements. Investors should be aware that there are no assurances that results will not differ from those projected.Contacts ChemGenex Pharmaceuticals
Dr. Greg Collier
Cell (Australia): +61 419 897 501
Cell (USA): +1-650-200-8145
CEO and Managing Director
Rebecca Wilson, +61 2 9237 2800
Media Relations - Australia
Cell: + 61 (0) 417 382 391
Joan Kureczka, +1-415-821-2413
Media Relations - USA
Posted: July 2008
- FDA Approves Synribo for Chronic Myelogenous Leukemia - October 26, 2012
- ChemGenex Announces alignment of European and US regulatory strategies for omacetaxine - January 6, 2011
- ChemGenex Completes pre-NDA Meeting with U.S. FDA and Clarifies Timing for Second New Drug Application for Omapro - October 5, 2010
- ChemGenex and U.S. FDA Agree on Potential Regulatory Pathway for Omapro - July 16, 2010
- ChemGenex Receives a Complete Response Letter from the FDA for Omapro - April 12, 2010
- U.S. Food and Drug Administration's Oncologic Drug Advisory Committee Recommends ChemGenex Validate a Diagnostic Prior to Approval of Omapro in Chronic Myeloid Leukemia Patients with T315I Mutation - March 24, 2010
- U.S. Food and Drug Administration (FDA) Sets 22 March for Oncologic Drugs Advisory Committee (ODAC) Meeting to Review Omapro - March 2, 2010
- Extreme Weather in Washington D.C. has Postponed the FDA's Oncologic Drugs Advisory Committee Meeting Scheduled for 10 February 2010 - February 9, 2010
- ChemGenex Pharmaceuticals Announces Omapro to be Reviewed by the FDA's Oncologic Drugs Advisory Committee for the Treatment of Adults with Chronic Myeloid Leukemia who have Failed Prior Therapy with Imatinib and have the Bcr-Abl T315I Mutation - December 17, 2009
- ChemGenex Announces FDA Accepts NDA for Omapro (Omacetaxine Mepesuccinate) and Grants the Filing Priority Review Status - November 10, 2009
- ChemGenex Submits New Drug Application for Omapro (omacetaxine Mepesuccinate) to U.S. FDA - September 9, 2009
- ChemGenex appoints VP Regulatory Affairs - Confirms Planned NDA Rolling Submission for Omacetaxine Following Meeting with U.S. FDA - April 14, 2008