Press Release: Alteon and OXIS International Expand Licensing Deal
Alteon and OXIS International Expand Licensing Deal to Include Exclusive Rights of Organoselenium Compounds for All Indications MONTVALE, N.J., April 9 -- Alteon Inc. and OXIS International announced that they have amended and restated an existing licensing agreement. Under the new terms of the agreement, Alteon obtains exclusive worldwide rights to develop, manufacture and market ALT-2074 and related organoselenium compounds in the OXIS library in all indications. Alteon will be responsible for the worldwide product development programs and will pay OXIS an upfront license fee and make an equity investment, as well as pay additional fees for the achievement of certain development and regulatory approval milestones, and royalties. ALT-2074 (formerly BXT-51072), Alteon's lead compound under this license, is currently in a Phase 2 clinical study for cardiovascular indications. 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. Diabetes is a large and growing healthcare problem worldwide. It has been suggested that 10% of all healthcare spending in the United States is diabetes related. As many as 250 million people worldwide may have diabetes or a predisposition for the disease. That number may grow by 50% over the next 20 years. "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, particularly among diabetic patients. ALT-2074 is currently in an exploratory Phase 2 trial seeking to reduce myocardial injury in diabetic patients undergoing angioplasty or similar interventions. Our plans are to launch another 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." "We are excited that Alteon has elected to expand its license with OXIS," said Marvin S. Hausman M.D., OXIS International's President and CEO. "As a result of this license, OXIS has the opportunity to benefit from the developments 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 Alteon to bring ALT-2074 and other products through the clinic." Under the license agreement, Alteon will pay OXIS an up-front payment of $500,000, as well as milestone fees, and royalties on product sales. Alteon will also make an equity investment in OXIS. About OXIS OXIS International, Inc. develops technologies and products to research, diagnose, 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, and has focused commercialization programs in clinical cardiovascular markers, 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. For 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.