Deal Valued in Excess of $33 Million Plus Royalties
NEW YORK, Jan. 10 /PRNewswire/ -- ACCESS Oncology, Inc., of New York, New
York, announced at the 20th Annual JP Morgan H&Q Healthcare Conference, that
it's wholly-owned pharmaceutical subsidiary entered into a definitive license
agreement with Gem Pharmaceuticals, Inc. of Birmingham, Alabama for GPX-100
and GPX-150, two novel, non-cardiotoxic analogs of doxorubicin. The agreement
calls for ACCESS Oncology to fund all future development plus pay upfront
payments and development milestones of up to $33 million followed by royalties
on sales of approved products. ACCESS Oncology will have exclusive licensing
rights in all markets of the world with exception of Asia, which has been
retained by Gem. GPX-100, the lead compound, completed Phase I/II testing in
the U.S. in 2001.
"In choosing a Corporate Partner, many factors need to be considered,"
said Gordon Ramseier, Chairman & CEO of Gem, who continued "ACCESS Oncology
demonstrated very early on that they had all the expertise of the larger
companies but in a smaller, more entrepreneurial organization. Their
oncology-focused clinical research and sales and marketing expertise,
professionals with a track-record for developing successful cancer drugs and
unparalleled access to the world's experts were all integral to our decision
to select ACCESS Oncology as our Corporate Partner."
GPX-100 is a novel non-cardiotoxic analog of doxorubicin, a chemotherapy
generally recognized as one of the most potent agents in treating breast
cancer. However, doxorubicin's clinical utility is limited because it causes
cardiac damage that can progress to potentially fatal congestive heart
failure. Following more than a decade of research into the mechanism of this
cardiotoxicity, Gem scientists identified GPX-100, which has been shown in
preclinical studies to maintain the anti-cancer effects of its parent
compound, doxorubicin, while virtually eliminating chronic cardiotoxicity.
Based on its mechanism of action and impressive pre-clinical data, GPX-100 may
have significant utility in the treatment of breast cancer, sarcoma and
certain hematological cancers. It is widely held that the development of a
"non-cardiotoxic doxorubicin" would satisfy a major unmet medical need,
representing a market opportunity in excess of $500 million.
"We believe that Gem's discoveries and pioneering work in identifying the
mechanism of anthracycline cardiotoxicity and, through proprietary
modifications to the molecules, eliminating this key limitation in their
effective use, heralds a new era in the importance of these drugs in the
treatment of many cancers." stated Michael S. Weiss, Chairman & CEO of ACCESS
Oncology. "Through our clinical development program, we intend to show the
oncology community that these potent compounds can be used at higher doses and
for longer periods than previously imagined for this class of drugs and that
no longer will patients have to be denied their anti-cancer value due to the
potential for serious damage to the heart."
About ACCESS Oncology
ACCESS Oncology, Inc. is a biopharmaceutical company focused on the
acquisition, development and commercialization of novel therapeutics for
cancer and related conditions. The Company's current product pipeline
includes three drug candidates in late-stage clinical development, including
two products scheduled to enter Pivotal studies in 2002.
The Company is building its product pipeline by in-licensing from and
partnering with small to mid-sized biotechnology companies who are developing
such products and are seeking a clinical development and commercialization
partner (commonly referred to as a "corporate partner"). Through the creation
of several oncology-focused service businesses (a CRO and a medical
communications company), the Company has built an expertise in cancer drug
development and oncology sales and marketing, which make it an attractive
corporate partner to these companies.
About Gem Pharmaceuticals, Inc.
Gem Pharmaceuticals, a privately held company focused on the discovery of
novel, improved anthracyclines for use in oncology, autoimmune disease and
anti-infective therapy. Gem Pharmaceuticals, Inc., is focusing on the
continued discovery and development of anthracycline analogs with reduced
toxicity, in order to expand the use of this important class of drugs, not
only in oncology, but in other areas of medicine where their potent cytotoxic
effects may be of benefit. According to Gordon Ramseier, Chairman & CEO of
Gem, "Researchers have for years been intrigued by the potential use of
anthracyclines in autoimmune and infectious diseases. It has been known for
some time that these compounds can have dramatic effects on overproliferating
immune cells, such as those responsible for the debilitating effects of
diseases such as multiple sclerosis and psoriasis. In addition and, possibly
more importantly, the ability of these compounds to play a key role in
antibiotic therapy has been demonstrated, but never pursued. Due to the
severe toxic effects to the heart and important blood cells, these compounds
have been passed over in favor of less toxic alternatives. Our research at
Gem is designed to yield new, chemically modified, analogs within this class
of drugs, which will allow their broad promise to be realized. The
anti-cancer program with ACCESS Oncology is the key first step in our campaign
to revitalize the role of anthracyclines in major disease therapy."
SOURCE ACCESS Oncology, Inc.
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CONTACT: Lauren Fischer of ACCESS Oncology, Inc., +1-212-531-5969; or Gordon Ramseier, Chairman & CEO of Gem Pharmaceuticals, Inc., +1-205-621-9911
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