SynriboTreatment for Chronic Myelogenous Leukemia
Update: Synribo (omacetaxine) Now FDA Approved - October 26, 2012
Extreme Weather in Washington D.C. has Postponed the FDA's Oncologic Drugs Advisory Committee Meeting Scheduled for 10 February 2010
MELBOURNE, Australia & MENLO PARK, Calif.--(BUSINESS WIRE)--Feb 9, 2010 - ChemGenex Pharmaceuticals Limited announced today that the U.S. Food and Drug Administration (FDA) has notified the company that the Oncologic Drugs Advisory Committee (ODAC) public advisory meeting scheduled for 10 February 2010 has been suspended due to extreme weather conditions in Washington D.C.
The ODAC meeting was scheduled to review two New Drug Applications, one of which was the application submitted by ChemGenex for Omapro (omacetaxine mepesuccinate) for the treatment of adults with chronic myeloid leukemia (CML) who have failed prior therapy with imatinib and who have developed the Bcr-Abl T315I mutation. ChemGenex submitted the NDA on 9 September 2009. The NDA was accepted by the FDA on 10 November 2009 and granted Priority Review.
The FDA will notify the company of a new date for the meeting as soon as possible.
ChemGenex believes in the safety and efficacy of Omapro for the treatment of patients with chronic myeloid leukemia (CML) who are resistant to imatinib and have the Bcr-Abl T315I mutation. The company is aware of the questions posed by the FDA and we are confident in our ability to answer these questions during the ODAC meeting. Omapro addresses a significant unmet need for patients with the T315I mutation, a marker for resistance to tyrosine kinase inhibitors, who currently have no effective treatment option and often have a poor prognosis.
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 Information
Dr. Greg Collier, Cell (Australia): +61 419 897501
Cell (USA): +1-650-200-8145
CEO and Managing Director
Investor Relations – Australia
Kyahn Williamson, +61 (0)3 9866 4722
Cell: + 61 (0)401 018 828
Investor Relations – USA
Blueprint Life Science Group
Remy Bernarda, +1-415-375-3340 ext. 2022
Posted: February 2010
- 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
- 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