Synribo
Generic name: omacetaxine mepesuccinate
Treatment for: Chronic Myelogenous Leukemia
Complete Response Letter for Omapro
ChemGenex Receives a Complete Response Letter from the FDA for Omapro
MELBOURNE, Australia & MENLO PARK, Calif.--(BUSINESS WIRE)--Apr 11, 2010 - ChemGenex Pharmaceuticals announces that the U.S. Food and Drug Administration's (FDA) Office of Oncology Drug Products has issued a complete response letter regarding the new drug application (NDA) for Omapro (omacetaxine mepesuccinate) for the treatment of adults with chronic myeloid leukemia (CML) who have failed prior therapy with imatinib and have the Bcr-Abl T315I mutation.
The complete response letter does not contain a request for a new study, nor is there a request for enrollment of additional patients into the pivotal study on Omapro.
Commenting on the correspondence from the FDA, Greg Collier, PhD, CEO for ChemGenex said, "The complete response letter from the FDA provides the initial guidance towards our endeavor to bring a new therapy to CML patients who harbour the T315I mutation and currently have very limited or unsatisfactory treatment options. Because the principal issues raised by the FDA were similar to those discussed during the 22 March meeting of the Oncology Drug Advisory Committee (ODAC), and based upon our interpretation of the scientific requirements underpinning the complete response letter, we are confident that we can work in a positive manner with the FDA to address the outstanding matters. We appreciate the constructive comments made by the agency in the response letter and ChemGenex will seek a meeting with the FDA to discuss and find agreeable solutions for each of the FDA's requests."
ChemGenex also met on April 9th with the US FDA's Center for Devices and Radiological Health (CDRH) to discuss a path forward for the development of a well defined diagnostic test for the T315I mutation. Both parties agreed to work together toward the validation of the T315I assay that meets the FDA's requirements.
About ChemGenex Pharmaceuticals Limited
ChemGenex is an oncology focused biopharmaceutical company developing small molecules with new mechanisms of action to treat malignancies with significant unmet medical needs. A New Drug Application has been accepted by the U.S. Food and Drug Administration and a Marketing Authorisation Application has been validated by the European Medicines Agency for CML patients who have failed imatinib therapy and have the Bcr-Abl T315I mutation. ChemGenex has established a corporate alliance with Hospira to develop and commercialize omacetaxine in Europe, the Middle East and parts of Africa, and is seeking to establish commercial partnerships in the rest of the world. ChemGenex plans to commercialize omacetaxine itself in North America. ChemGenex trades on the Australian Stock Exchange under the symbol "CXS" For additional information on ChemGenex Pharmaceuticals, please visit the company's website at http://www.chemgenex.com.
Omapro is a trademark of ChemGenex Pharmaceuticals Limited.
Safe Harbor Statement
Certain statements made herein (including for this purpose sites to which a hyperlink has been provided) 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.
Contact: ChemGenex
Dr. Greg Collier
Cell (Australia): +61 419 897501
Cell (USA): +1-650-200-8145
CEO and Managing Director
gcollier@chemgenex.com
or
Buchan Consulting
Kyahn Williamson, +61 (0)3 9866 4722
Cell: + 61 (0)401 018 828
Investor Relations – Australia
kwilliamson@bcg.com.au
or
Blueprint Life Science Group
Remy Bernarda, +1-415-375-3340 x 2022
Cell: +1-415-203-6386
Investor Relations – USA
rbernarda@bplifescience.com
Posted: April 2010
Related articles
- 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
- 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 Announces Submission of Non-Clinical Section of Rolling NDA for Omacetaxine - July 1, 2008
- ChemGenex appoints VP Regulatory Affairs - Confirms Planned NDA Rolling Submission for Omacetaxine Following Meeting with U.S. FDA - April 14, 2008
Synribo (omacetaxine mepesuccinate) FDA Approval History
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