OVERLAND PARK, Kan., Feb. 24 /PRNewswire-FirstCall/ -- AVAX Technologies, Inc. (BULLETIN BOARD: AVXT) announces the completion of a contract manufacturing funding and alliance agreement between its operating subsidiary Genopoeitic and OPISODIA, SAS a division of OPi, SAS.
The alliance will utilize the biological manufacturing facilities of Genopoeitic and OPi, and will be managed by Dr. Andres Crespo, General Manager of Genopoeitic. The alliance will produce biological products on behalf of AVAX and OPi for clinical and commercial purposes and will also offer expanded contract manufacturing services for the production and processing of biological products, for clinical and commercial uses, to biotechnology and pharmaceutical companies. Specifically the alliance will combine Genopoeitic's facilities, personnel and expertise in the cell and gene therapy area with OPISODIA's facilities and personnel that have capabilities for fermentation, purification and know how to produce purified solutions of monoclonal antibodies. Genopoeitic's facility has already received the designation of "Etablissement Pharmacuetique" from the French Regulatory Authorities (AFSSaPS), permitting the Company to manufacture biologicals commercially.
Dr. Andres Crespo, General Manager of Genopoeitic, stated, "We are very pleased to combine these resources with OPISODIA in order to expand the product services available to third parties, while also increasing our capacity to manufacture monoclonal antibodies and purified protein products on a larger scale. This expanded capacity will allow us to pursue a greater array of potential contracts with outside third parties."
"We are excited to complete this agreement with OPi," stated Richard Rainey, President of AVAX. "With the funding of $1.5M for each of the next two years it will allow us to direct our current funds towards advancing our clinical development and commercial operations in Europe, including the work preparing and filing a BLA for the Autologous Cell (AC) vaccine for the treatment of Stage III Melanoma in France." Mr. Rainey stated further "With the expertise that OPi's staff and facilities brings to the alliance we are very excited about the expanded manufacturing capabilities of the alliance and the opportunity to market these capabilities."
In addition to offering contract manufacturing services, the alliance will produce OPi's inolimomab (Leukotac(TM)) anti-IL2 receptor antibody currently in phase II trials for the treatment of acute GvHD and AVAX's Autologous Cell Vaccines for clinical and commercial purposes in Europe and the United States.
Dr. Gilles Alberici, CEO President and founder of OPi, stated "We have been impressed by the know-how and skills developed at AVAX/Genopoeitic. We expect that this combined manufacturing platform, which will be used for our development programs, will allow OPi to reduce the time to market for our monoclonal antibodies, most notably Leukotac(TM)".
AVAX Technologies, Inc. is a biotechnology company with operations in the United States and Europe. The Company is engaged in the research, clinical and commercial development of biological products and cancer therapeutics. In addition the Company offers contract-manufacturing services of biological products to other pharmaceutical and biotechnology companies.
Founded in 1999, OPi is a European biopharmaceutical company whose mission is to develop and market pharmaceuticals aimed at treating patients suffering from rare and severe diseases. Innovation and medical needs are the mainstays of OPi's approach. The Company has already one product approved in Europe and several projects in clinical development.
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 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 prospects, including (1) the Company's ability to obtain substantial additional funds, beyond the announced bridge loans, (2) the Company's ability to enter into and to maintain contract manufacturing agreements that are adequate to sustain its operations, (3) the Company's ability to identify a merger or acquisition partner, (4) the results of laboratory testing of our vaccine technologies and the small molecule compounds, (5) possible future FDA or AFSSAPS questions regarding the Company's products and manufacturing processes, (6) the Company's ability to maintain its rights under license and research funding agreements and to meeting funding requirements under its license and research funding agreements, (7) the Company's ability to demonstrate the safety and efficacy of product candidates at each stage of development and to meet applicable regulatory standards and receive required regulatory approvals, as well as other risks detailed from time to time in AVAX's public disclosure filings with the Securities and Exchange Commission, including its Annual Report on Form 10-KSB for the year ended December 31, 2002. AVAX does not undertake any obligation to release publicly any revisions to these forward-looking statements or to reflect the occurrence of unanticipated events.
AVAX Technologies, Inc.