AVAX Technologies Announces Completion of Contract Manufacturing Alliance and Funding Agreement with OPi
2004年2月24日 - 10:33PM
PRニュース・ワイアー (英語)
AVAX Technologies Announces Completion of Contract Manufacturing
Alliance and Funding Agreement with OPi - $1.5 Million Per Year
Funding Commitment From OPi for Each of the Next 2 Years - 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 alreadyreceived
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 additionto 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. About OPi 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. DATASOURCE: AVAX Technologies, Inc. CONTACT:
Richard P. Rainey, President of AVAX Technologies, Inc.,
+1-913-693-8491 Web site: http://www.avax-tech.com/
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