Biotech Values

[drbio45]

ChemGenex and U.S. FDA Agree on Potential Regulatory Pathway for
OMAPROTM
• Company will submit new NDA in CML patients who have failed multiple TKIs
• Investor Teleconference to be held today - Wednesday 14th July 10.30am AEST /
Tuesday 13th July 5.30pm PDT
MELBOURNE, Australia, and MENLO PARK, California U.S.A. (14 July 2010) –
ChemGenex Pharmaceuticals Limited (ASX: CXS) announced today it has agreed with the
U.S. Food and Drug Administration (FDA) 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 and U.S. FDA Agree on Potential Regulatory Pathway for OMAPROTM
Page 2 of 4
Level 4, 199 Moorabool St, Geelong, Victoria 3220, Australia Telephone: [phone] Facsimile: [phone]
Email: [e-mail] ABN 79 000 248 304
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.
Investor teleconference
ChemGenex will host an investor teleconference today: Wednesday 14th July 10.30am
Australian Eastern Standard Time / Tuesday 13th July 5.30pm Pacific Daylight Time
To join the call please dial the access number below for your location. A participant pin
number is not required.
Dial-In numbers: 1800 131 617 Australia Free Call
866 746 2596 USA/Canada Free Call
[phone] International / Metered Number
0800 446 958 New Zealand Free Call
800 120 4406 Singapore Free Call
800 962 283 Hong Kong Free Call
001 803 011 4106 Indonesia Free Call
0044 22 132 558 Japan Free Call
0800 376 8339 UK Free Call
0800 330 2094 Germany Free Call
0805 111 476 France Free Call
0800 001 230 Switzerland Free Call
A recording of the call will be made available on the ChemGenex 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.
ChemGenex and U.S. FDA Agree on Potential Regulatory Pathway for OMAPROTM
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Level 4, 199 Moorabool St, Geelong, Victoria 3220, Australia Telephone: [phone] Facsimile: [phone]
Email: [e-mail] ABN 79 000 248 304
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.
ChemGenex Contacts:
ChemGenex Information Investor Relations – Australia Investor Relations – USA
Dr. Greg Collier
CEO and Managing Director
Cell (Aust): [phone]
Cell (USA): [phone]
Email:
[e-mail]
Kyahn Williamson
Buchan Consulting
Tel: [phone]
Cell: + 61 (0)401 018 828
Email:
[e-mail]
Remy Bernarda
Blueprint Life Science Group
Tel: [phone] x 2022
Cell: +1.415.203.6386
Email:
[e-mail]
ChemGenex and U.S. FDA Agree on Potential Regulatory Pathway for OMAPROTM
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Level 4, 199 Moorabool St, Geelong, Victoria 3220, Australia Telephone: [phone] Facsimile: [phone]
Email: [e-mail] ABN 79 000 248 304
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