Kansas City, MO, April 13, 2000 -- AVAX Technologies, Inc. (NASDAQ: AVXT) today announced that its Australian subsidiary, AVAX Australia Pty. Ltd., has signed a contract manufacturing agreement with Bio Enterprises Pty. Ltd., Sydney, for the manufacture of AVAX's AC Vaccine (autologous cell vaccine) M-Vax for the Australian market. In 1999, AVAX announced that it had received notice from Australia's Therapeutic Goods Administration (TGA) that M-Vax, for the treatment of Stage III melanoma, may be made available for commercial sale, subject only to licensure of a manufacturing facility. AVAX Australia is a joint venture with Neptunus International Holdings Limited (NIHL), which was recently renamed Australian Vaccine Technologies Ltd. (AVT). M-Vax is AVAX Technologies' lead cancer vaccine and is currently being evaluated in the U.S. in a multicenter pivotal registration trial in Stage III melanoma and in a Phase 2 trial in Stage IV melanoma.
Jeffrey M. Jonas, M.D., President and CEO of AVAX Technologies, Inc., stated, "With this contract manufacturing agreement in place, we now have the appropriate space and qualified personnel to meet our production needs in Australia. We look forward to working aggressively to implement the systems and processes necessary to manufacture our vaccine, while meeting the TGA's requirements, marking another important step leading to our product's commercialization."
As previously announced, AVT has made a $7.0 million (AUD) investment in AVAX Australia for the purchase of a 35% interest in the joint venture. AVT also has the option to purchase an additional 15% interest for $3.0 million (AUD). Under the terms of the agreement, AVAX Technologies has been granted an option to purchase common stock equivalent to 5% of AVT's fully diluted shares, which trade on the Australian Stock Exchange (ASX) under the symbol "AVT."
M-Vax, a therapeutic cancer vaccine, is an essentially non-toxic, post-surgical experimental treatment for Stage III and Stage IV melanoma. To date, over 350 patients have been treated with M-Vax on an outpatient basis in the U.S. In Phase 2 studies, patients with Stage III melanoma demonstrated a five-year survival rate of 55%.
AVAX Technologies, Inc. specializes in the development and commercialization of novel biotechnologies, immunotherapies and pharmaceuticals for cancer and other life-threatening diseases using three core technologies: the AC Vaccine technology, topoisomerase inhibitors and anti-estrogens.
Except for statements that are historical, the statements in this release are "forward-looking"statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements involve significant risks and uncertainties, and in light of the significant uncertainties inherent in such statements, the inclusion of such information should not be regarded as a representation by AVAX that the objectives and plans of the company will be achieved; in fact, actual results could differ materially from those contemplated by such forward-looking statements. Many important factors affect the company's ability to achieve the stated outcomes and to successfully develop and commercialize its product candidates, including, among other things, the ability to obtain substantial additional funds, obtain and maintain all necessary patents or licenses, to demonstrate the safety and efficacy of product candidates at each stage of development, to meet applicable regulatory standards and receive required regulatory approvals, to meet obligations and required milestones under its license agreements, to be capable of producing drug candidates in commercial quantities at reasonable costs, to compete successfully against other products, and to market products in a profitable manner, as well as other risks detailed from time to time in AVAX's public disclosure filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-KSB for the fiscal year ended December 31,1999. AVAX does not undertake any obligation to publicly release any revisions to these forward-looking statements or to reflect the occurrence of unanticipated events.