Chemgenex (ASX:CXS)
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From Feb 2020 to Feb 2025
ChemGenex Pharmaceuticals (ASX:CXS)(NASDAQ:CXSP) announced today that
the company will gain full commercial control of omacetaxine
mepesuccinate (formerly known as Ceflatonin®)
through an arrangement with its European partner Stragen Pharma to
transfer the ownership of Intellectual Property (IP) and commercial
rights currently held by Stragen.
Omacetaxine is ChemGenex’s lead product in
clinical development and is in the final stages of a phase 2/3 clinical
trial in chronic myeloid leukemia (CML) patients with the T315I mutation
for whom there are currently no effective drug treatments.
The new agreement will result in the assignment of Stragen’s
omacetaxine IP suite to ChemGenex, removing the need for an IP royalty
on manufacturing and significantly reducing the cost of goods.
Similarly, the new agreement removes the need for a European joint
venture, allowing ChemGenex to control European development and access
all profits from sales of omacetaxine in Europe, including current
compassionate use sales of the drug. The new acquisition strengthens
ChemGenex’s ability to freely pursue multiple
commercialization opportunities for omacetaxine.
Subject to approval by ChemGenex shareholders at a General Meeting to be
held within the next two months, consideration for the acquisition of
global IP rights and European commercialization rights will be through
the issuance by the company of 37,235,343 new ordinary shares in
ChemGenex.
Reflecting Stragen’s manufacturing expertise
and understanding of omacetaxine, Stragen will remain ChemGenex’s
supplier of omacetaxine and will become a significant shareholder.
The new agreement concludes formal manufacturing and commercialization
agreements entered into by ChemGenex and Stragen three years ago. Under
the prior agreements ChemGenex provided expertise in drug development
and clinical trial management while Stragen provided a patented
manufacturing process, GMP manufacturing and product distribution
expertise. The prior agreements also entailed an IP royalty as a
component of the manufacturing cost, and mandated the establishment of a
European joint venture to control marketing in Europe. The profit split
of sales by the joint venture that had been agreed at ChemGenex 49%,
Stragen 51% will no longer be in effect.
“Stragen has been an excellent partner and has
worked with us to progress omacetaxine to an advanced state where we
have growing confidence in the ability of the drug to be an effective
therapy for the subset of CML patients who have developed the T315I
mutation and who have failed to respond to imatinib,”
said Dr. Greg Collier, ChemGenex’s Managing
Director and Chief Executive Officer.
“This is a logical progression of what has
been a very productive alliance to date,”
added Jean-Luc Tetard, President of Stragen Pharma. "We believe that the
consolidation of global IP and commercialization rights for omacetaxine
will open a range of new possibilities for ChemGenex to continue to
build upon the successes reported over the past year."
Ceflatonin® is a
registered trademark of ChemGenex Pharmaceuticals Limited.
About ChemGenex Pharmaceuticals Limited (http://www.chemgenex.com)
ChemGenex Pharmaceuticals is a pharmaceutical development company
dedicated to improving the lives of patients by developing personalized
oncology medicines. ChemGenex harnesses the power of genomics both to
discover novel targets and drug compounds, and in clinical trials to
develop more individualized treatment outcomes. ChemGenex’s
lead compound, omacetaxine mepesuccinate (formerly known as Ceflatonin®),
is currently in phase 2/3 clinical trials for chronic myeloid leukemia
(CML). ChemGenex has a second anticancer compound, amonafide
dihydrochloride (formerly known as Quinamed®),
which is in phase 2 clinical development for various solid cancers, and
a portfolio of assets in pre-clinical development. ChemGenex currently
trades on the Australian Stock Exchange under the symbol "CXS" and on
NASDAQ under the symbol "CXSP".
Details on the clinical trials can be accessed from the following
websites;
http://clinicaltrials.gov/ct2/show/
NCT00375219?term=homoharringtonine&rank=9 and http://www.tkiresistantcmltrials.com
(Due to its length, this URL may need to be copied/pasted into your
Internet browser's address field. Remove the extra space if one exists.)
Safe Harbor Statement
Certain statements made herein 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.