SynriboTreatment for Chronic Myelogenous Leukemia
Update: Synribo (omacetaxine) Now FDA Approved - October 26, 2012
ChemGenex Completes pre-NDA Meeting with U.S. FDA and Clarifies Timing for Second New Drug Application for Omapro
MELBOURNE, Australia, and MENLO PARK, California U.S.A. (5 October 2010) – ChemGenex Pharmaceuticals Limited (ASX: CXS) announced today it has completed a pre- NDA meeting with the U.S. Food and Drug Administration (FDA) concerning the potential regulatory path to progress Omapro (omacetaxine mepesuccinate) for the treatment of patients with Chronic Myeloid Leukemia (CML) who have failed two or more tyrosine kinase inhibitors (TKIs).
At the meeting the FDA agreed that the proposed New Drug Application (NDA) for Omapro for CML patients who have failed prior treatment with two or more currently approved tyrosine kinase inhibitors (TKIs) could be submitted based on combined data from ChemGenex’s two pivotal studies, Study 202 and Study 203.
It was agreed that no further clinical trials are required to complete this NDA submission, however further data will need to be collected from participating clinical centres. ChemGenex believes that based on the timing required for collection of this additional data, the NDA for Omapro for the treatment of CML patients who have failed two or more TKIs regardless of their mutation status, will be submitted in H2 2011.
Greg Collier Ph.D., Managing Director and Chief Executive Officer of ChemGenex said: "We appreciate the guidance that the FDA has given the company as it prepares this new NDA, and look forward to working with the FDA to seek approval for the use of Omapro to potentially treat a significantly larger patient population in the United States." 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 is under review by the U.S. Food and Drug Administration and a Marketing Authorisation Application is under review by the European Medicines Agency for CML patients who have failed imatinib therapy and have the Bcr-Abl T315I mutation. An additional New Drug Application is in preparation for CML patients who have failed two or more currently approved tyrosine kinase inhibitors. 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 ChemGenex Completes pre-NDA Meeting with U.S. FDA and Clarifies Timing for Second New Drug Application for Omapro Page 2 of 2 Level 4, 199 Moorabool St, Geelong, Victoria 3220, Australia Telephone: +61 3 5223 9900 Facsimile: +61 3 5229 0100 Email: email@example.com ABN 79 000 248 304 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.
ChemGenex Information Investor Relations – Australia Investor Relations – USA
Dr. Greg Collier
CEO and Managing Director
Cell (Aust): +61 419 897501
Cell (USA): +1 650 200 8145
Tel: +61 (0)3 9866 4722
Cell: + 61 (0)401 018 828
Dr. Andrew McDonald
LifeSci Advisors, LLC
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Posted: October 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 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 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