Synribo
Generic name: omacetaxine mepesuccinate
Treatment for: Chronic Myelogenous Leukemia
ChemGenex and U.S. FDA Agree on Potential Regulatory Pathway for Omapro
MELBOURNE, Australia & MENLO PARK, Calif.--(BUSINESS WIRE)--Jul 13, 2010 - ChemGenex Pharmaceuticals Limited announced today it has agreed with the U.S. Food and Drug Administration (FDA) on a potential regulatory path to progress Omapro (omacetaxine mepesuccinate) for the treatment of patients with Chronic Myeloid Leukemia (CML).
The recent Type A Meeting, which included discussion of a regulatory path forward, addressed outstanding issues regarding the previously received Complete Response letter dated 8 April 2010.
Based on the discussion with the FDA, ChemGenex intends to combine data from its two pivotal studies, Study 202 and Study 203, and submit a New Drug Application (NDA) for Omapro for those patients with CML who have failed prior treatment with two or more currently approved tyrosine kinase inhibitors (TKIs). The proposed indication of this new NDA will be for the treatment of CML patients who have failed two or more TKIs, regardless of their mutation status.
"The FDA's agreement that a combined data set could serve as the basis of an NDA in a third-line setting provides us with a pathway to an expanded indication for Omapro to treat CML patients who are resistant to at least two TKIs," said Adam Craig, MD, Chief Medical Officer of ChemGenex.
"We also appreciate FDA's invitation to discuss this approach further in a pre-NDA meeting," he added. "We welcome the opportunity granted by the agency to submit combined data from our two completed pivotal studies and to potentially provide a new therapeutic choice for this significant group of patients who currently have very limited treatment options."
Greg Collier Ph.D., Managing Director and Chief Executive Officer of ChemGenex added: "We are pleased with the outcome of this Type A meeting as it provides another option for advancing the development timeline for Omapro. By pursuing this new indication for multi TKI-resistant patients, Omapro can potentially treat a significantly larger patient population in the United States, and we plan to submit our new NDA to the FDA by the end of the year."
ChemGenex is continuing its discussions with the FDA's Center for Devices and Radiological Health towards approval of a diagnostic test for the T315I mutation, and the existing NDA for T315I positive CML patients who have failed imatinib remains open.
The Company also has a Marketing Authorisation Application under review with the European Medicines Agency for CML patients who have failed imatinib and have the T315I mutation. This review is on track, with a potential approval in Europe in the first quarter of 2011.
The updated corporate overview for ChemGenex is available on the company's website.
About Omapro (omacetaxine mepesuccinate)
Omacetaxine is a first-in-class cetaxine with demonstrated clinical activity as a single agent in a range of hematological malignancies. Omacetaxine has a novel mechanism of action, specifically binding to the ribosomal A-site cleft and inhibiting protein translation of short-lived oncoproteins that are up-regulated in leukemic cells (particularly Cyclin-D1, Mcl-1 and c-Myc).
Omacetaxine mepesuccinate is administered subcutaneously and acts differently from TKIs. It may have a therapeutic advantage for patients who have failed TKIs. Omacetaxine has been granted Orphan Drug designations by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) as well as Fast Track status by the FDA.
About Chronic Myeloid Leukemia (CML)
Chronic myeloid leukemia (CML) is a cancer of the bone marrow with a worldwide prevalence of greater than 100,000 patients. The bone marrow is responsible for the production of specialized cells that constitute blood; these cells include red blood cells (to carry oxygen around the body), thrombocytes (to help stop bleeding) and certain white cells (part of the body's defense system against infection). In patients with CML the cell production system is diseased and defective. Cells multiply uncontrollably and do not fully develop (differentiate) into functional blood cells.
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. 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 (Aust): +61 419 897501
Cell (USA): +1-650-200-8145
CEO and Managing Director
gcollier@chemgenex.com
or
Buchan Consulting
Investor Relations – Australia
Kyahn Williamson, +61 (0)3 9866 4722
Cell: + 61 (0)401 018 828
kwilliamson@bcg.com.au
or
Blueprint Life Science Group
Investor Relations – USA
Remy Bernarda, +1-415-375-3340 x 2022
Cell: +1-415-203-6386
rbernarda@bplifescience.com
Posted: July 2010
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- 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 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
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- 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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