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OXIS International, Inc. (OTCBB: OXIS) announced today that Alteon, Inc.
(AMEX: ALT) has entered into a worldwide exclusive license under which
OXIS has granted Alteon exclusive rights to a family of orally
bioavailable organoselenium compounds that have demonstrated potent
anti-oxidant and anti-inflammatory properties in clinical and
preclinical studies. The new agreement expands the scope of a previous
license to Alteon (formerly HaptoGuard) to include non-cardiovascular
indications. Under the license agreement, Alteon will pay OXIS $500,000
payable over a six month period and upon closing of an Alteon financing
approved by Alteon’s shareholders. OXIS is
also entitled to receive development milestone payments as well as
royalties from the sales of products developed from the license. In
addition, Alteon has agreed to invest $500,000 in OXIS common stock, at
a per-share price equal to 125% of the quoted price of OXIS common stock
immediately prior to the date of the investment, and no less than $0.24
per share.
ALT-2074 (formerly BXT-51072), Alteon’s lead
compound under this license, is currently in a Phase 2 clinical study
for cardiovascular indications. By mimicking glutathione peroxidase
(GPx), ALT-2074 may protect against excessive oxidation of lipids and
thereby limit inflammation. Alteon believes that the compound may be
useful in patients with diabetes, whose cardiovascular disease may be
caused by high levels of circulating oxidized lipids and associated
inflammation. OXIS previously reported that BXT-51072 demonstrated
anti-inflammatory activity in preclinical studies as well as in a
clinical study in Ulcerative Colitis.
“We are excited that Alteon has elected to
expand its license with OXIS,” said Marvin S.
Hausman M.D., OXIS International’s President
and Chief Executive Officer. “As a result of
this license, OXIS has the opportunity to benefit from the development
of its technology by Alteon’s world-class
scientific team, while sharing in product sales that could generate
millions of dollars in licensing income. We look forward to working
closely with Dr. Berkowitz, Alteon’s CEO, to
bring ALT-2074 and other products through the clinic. Successful
clinical application of this potent antioxidant will pave the way for
increased therapeutic use of these classes of compounds in other disease
states and further increase the value of OXIS’
broad antioxidant and anti-inflammatory portfolio.”
Under terms of the agreement, Alteon obtains exclusive worldwide rights
to develop, manufacture and market ALT-2074 and related
organoselenium-related compounds in the OXIS library in all indications.
Alteon will be responsible for worldwide product development programs
and will pay OXIS an upfront license fee and make an equity investment,
as well as royalties and milestone payments upon the achievement of
certain development and regulatory approval milestones.
“We are pleased to expand our agreement with
OXIS for this novel group of potent, anti-inflammatory compounds,”
said Noah Berkowitz, M.D., Ph.D., President and Chief Executive Officer
of Alteon. “Oxidized lipids, or lipid
peroxides, have been increasingly recognized as pathological and are
associated with an increased risk for larger heart attacks and more
severe heart failure. ALT-2074 is currently in an exploratory Phase 2
trial seeking to reduce myocardial injury in diabetic patients
undergoing angioplasty or similar interventions. We have plans for
launching a study looking at the impact of ALT-2074 on inflammatory
biomarkers and we may investigate the potential benefits of this new
class of compounds in the treatment of other diseases.”
About OXIS
OXIS International, Inc. develops technologies and products to research,
treat and prevent diseases of oxidative stress associated with damage
from free radical and reactive oxygen species and the related increased
inflammation that accompanies oxidative stress. OXIS presently holds the
rights to three therapeutic classes of compounds in the treatment of
oxidative stress/inflammation, and has also developed novel agents
and/or markers to identify inflammatory diseases including MPO
(myeloperoxidase) and GPx (glutathione peroxidase), as well as the super
potent antioxidant, Ergothioneine, that is planned to be introduced as
an over-the-counter nutraceutical supplement. OXIS’s
customers include leading pharmaceutical companies such as Pfizer, Glaxo
SmithKline and Genzyme and universities such as Baylor College of
Medicine, University of Minnesota, Virginia School of Technology,
distributors and government laboratories. OXIS holds a controlling
interest in BioCheck, Inc., a provider of high quality enzyme
immunoassay research services and products, and a leading provider of
immunoassay kits for cardiac and tumor biomarkers, infectious diseases,
thyroid function, steroids, and fertility hormones. BioCheck operates a
15,000 square-foot, U.S. Food and Drug Administration (FDA) certified
cGMP, and ISO device-manufacturing facility in Foster City, California.
More information about OXIS, BioCheck and their products and services
visit www.oxisresearch.com and www.biocheckinc.com.
About Alteon
Alteon is a product-based biopharmaceutical company engaged in the
development of small molecule drugs to treat and prevent the
inflammatory aspects of cardiovascular disease and diabetes. The Company
has identified several promising product candidates that it believes
represent novel approaches to some of the largest pharmaceutical markets.
Alagebrium, a product of Alteon’s drug
discovery and development program, is being developed for the treatment
of diastolic heart failure. This disease represents a rapidly growing
market of unmet medical need, particularly common among diabetic
patients. Alagebrium has demonstrated relevant clinical activity in two
Phase 2 clinical trials in heart failure, as well as in animal models of
heart failure and nephropathy, among others. Alagebrium has been tested
in approximately 1,000 patients in multiple Phase 1 and Phase 2 clinical
trials, which represents a sizeable human safety database.
The Company’s portfolio also includes orally
bioavailable, organoselenium mimics of glutathione peroxidase that
metabolize lipid peroxides and have the potential to limit myocardial
damage subsequent to a myocardial infarction. Alteon’s
lead compound for that program, ALT-2074, is in Phase 2 clinical trials.
The Company also has rights to a diagnostic assay that identifies a
large subset of diabetic patients at highest risk for cardiovascular
complications, because of a defect in oxidized lipid metabolism that
results in increased cardiovascular inflammation. For more detailed
information about Alteon’s research and
development, please visit Alteon’s website at www.alteon.com.
Any statements contained in this press release that relate to future
plans, events or performance are forward-looking statements that involve
risks and uncertainties including, but not limited to the risks
associated with the transaction described in this press release, and
other risks identified in the respective filings by Alteon and
OXIS with the Securities and Exchange Commission. Further information on
risks faced by Alteon are detailed under the caption “Risk
Factors” in Alteon’s
Annual Report on Form 10-K for the year ended December 31, 2006 and in
its subsequent Quarterly Reports on Form 10-Q. Further information on
risks faced by OXIS are detailed under the caption “Risk
Factors” in the Annual Report on Form 10-KSB
for the year ended December 31, 2006 and in its subsequent Quarterly
Reports on Form 10-QSB. These filings are or will become available on a
website maintained by the Securities and Exchange Commission at http://www.sec.gov.
The information contained in this press release is accurate as of the
date indicated. Actual results, events or performance may differ
materially. Neither Alteon or OXIS undertake any obligation to
publicly release the result of any revision to these forward- looking
statements that may be made to reflect events or circumstances after the
date hereof or to reflect the occurrence of unanticipated events.