Synribo

Treatment 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: chemgenex@chemgenex.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 Contacts:
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
Email:
gcollier@chemgenex.com
Kyahn Williamson
Buchan Consulting
Tel: +61 (0)3 9866 4722
Cell: + 61 (0)401 018 828
Email:
kwilliamson@bcg.com.au
Dr. Andrew McDonald
LifeSci Advisors, LLC
Cell: +1.415.205.0591
Email:
andrew@lifesciadvisors.com

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 forwardlooking statements. Investors should be aware that there are no assurances that results will not differ from those projected.


Posted: October 2010

Related Articles

Synribo (omacetaxine mepesuccinate) FDA Approval History

View comments

Hide
(web5)