Aphton and VaxGen's Joint Venture Celltrion Announce Commercialization and Manufacturing Agreements for IGN311.PHILADELPHIA & BRISBANE, Calif. -- Celltrion to Have Manufacturing and Distribution Rights to IGN IGN Ignored (Status) IGN Institut Geographique National IGN Ignition IGN Instituto Geografico Nacional (Spain) IGN Imagine Games Network IGN In-Game Name (gaming) 311 in Certain Asian Markets in Exchange for Milestone Payments, Royalties, Manufacturing and Provision of Clinical and Commercial Product Aphton Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :APHT APHT Advance Physical Test ), and VaxGen's (Pink Sheets:VXGN) joint venture Celltrion, Inc. announced today that Aphton's wholly-owned subsidiary Igeneon signed a licensing and commercialization agreement and a product development and manufacturing agreement related to the manufacturing, marketing and distribution of Igeneon's clinical product candidate IGN311. IGN311 is a humanized monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing targeting the Lewis-Y antigen that is being developed as a potential new therapy for the treatment of certain epithelial tumors. Lewis-Y is a tumor-related antigen expressed in up to 90% of all epithelial cancers, which includes breast, colon, gastric and pancreatic cancers. Under the agreements, Igeneon granted Celltrion a license to commercialize IGN311 in certain Asian countries, including Japan. In return, Igeneon will receive from Celltrion milestone payments totalling $6 million. In addition, Celltrion will provide development and manufacturing services related to the optimization and upscaling of IGN311 and will produce material for further clinical development. As part of the market authorization process, Celltrion will manage clinical development activities in Asia. Upon market approval of IGN311, Igeneon will also be entitled to receive royalties from sales of IGN311 in Asia, and Celltrion will have the option to manufacture for global market supply. The transaction is expected to close on October 1, 2005. "We are very excited about this new relationship with Celltrion and believe that these agreements contribute to Aphton in a number of important ways. We expect that these agreements with Celltrion will strengthen the Company's balance sheet, allow us to further the development of IGN311, and, most importantly Adv. 1. most importantly - above and beyond all other consideration; "above all, you must be independent" above all, most especially , validate the interest in IGN311 and its target the Lewis Y antigen. We estimate that the manufacturing scale-up and clinical material production services being provided by Celltrion represent a savings of approximately $10 million to Aphton," commented Patrick Mooney, MD, Chairman and Chief Executive Officer of Aphton. "We are pleased to have Celltrion as a partner, a company which has an excellent reputation in the global life sciences industry, as noted by its recent agreement with Bristol Myers Squibb, and outstanding expertise in the large-scale manufacturing of antibodies and other biopharmaceutical products." "These agreements are another significant milestone for Celltrion's development as a global biopharmaceutical company," said James Panek, Celltrion's Co-Chief Executive Officer and VaxGen's Senior Vice President of Manufacturing Operations Manufacturing operations concern the operation of a facility, as opposed to maintenance, supply and distribution, health, and safety, emergency response, human resources, security, information technology and other infrastructural support organizations. . "We are pleased to work with Aphton on the further development of this important therapy. The development and potential licensure of IGN311 represent important steps in our efforts to establish Celltrion as a major player in the Asian biopharmaceutical market." About IGN311 IGN311 is a humanized monoclonal antibody against the Lewis-Y carbohydrate antigen, a blood group related oligosaccharide oligosaccharide: see carbohydrate. oligosaccharide Any carbohydrate with a few (between 3 and about 6 to 10) units of simple sugars (monosaccharides). A wide variety of oligosaccharides are made by partially breaking down polysaccharides. . Lewis-Y is over-expressed in up to 90% of all epithelial cancers and its expression on adult normal tissues is very restricted; hence IGN311 has the potential to target a broad range of carcinomas. IGN311 is designed to exert clinical effects by destruction of tumor cells by activation of effector effector /ef·fec·tor/ (e-fek´ter) 1. an agent that mediates a specific effect. 2. an organ that produces an effect in response to nerve stimulation. functions and by selective growth inhibition Growth inhibition (GI) is a medical term pertaining to cancer therapy and the specific reduction in growth of tumors and oncogene cells by a chemical compound, mechanical therapy (e.g. via functional receptors. About Aphton Aphton Corporation, headquartered in Philadelphia, PA, is a clinical stage biopharmaceutical company focused on developing targeted immunotherapies for cancer. Aphton's products seek to empower the body's own immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. to fight disease. Through the acquisition of Igeneon AG in March 2005, Aphton acquired late-stage products, IGN101, a cancer vaccine The term cancer vaccine is often used to describe a process whereby a person's immune system is coaxed into recognizing and destroying malignant cells without harming normal cells. designed to induce an immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. against EpCAM-positive tumor cells, as well as IGN311. Aphton has strategic alliances with sanofi-aventis for the development and commercialization of Insegia related to cancers of the gastrointestinal system gastrointestinal system: see digestive system. and other cancers in North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. and Europe; Daiichi Pure Chemicals for the development, manufacturing and commercialization of gastrin-related diagnostic kits; and Xoma for treating gastrointestinal and other gastrin-sensitive cancers using anti-gastrin monoclonal and other antibodies. For more information about Aphton or its programs please visit Aphton's website at: http://www.aphton.com. About Celltrion Established in 2002, Celltrion is one of the largest biopharmaceutical contract manufacturers of therapeutic monoclonal antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of monoclonal antibodies"). and recombinant proteins Since human recombinants have replaced the animal version in human therapeutics, the prefix of "rh" for "human recombinant" appears less and less in the literature Human recombinants that replaced animal or harvested from human types About VaxGen VaxGen, Inc. is a biopharmaceutical company engaged in the development, manufacture and commercialization of biologic products for the prevention and treatment of human infectious diseases infectious diseases: see communicable diseases. , including anthrax anthrax (ăn`thrăks), acute infectious disease of animals that can be secondarily transmitted to humans. It is caused by a bacterium (Bacillus anthracis , smallpox and Meningitis B. Based in Brisbane, CA, VaxGen operates a wholly-owned manufacturing facility in California. VaxGen is also the largest shareholder in Celltrion, Inc., a South Korean joint venture established to provide contract manufacturing to the global pharmaceutical industry. Celltrion recently completed construction of a 50,000-liter mammalian cell culture facility and initiated an expansion to build an additional 50,000 liters of capacity by 2010. For more information, please visit the company's web site at: http://www.vaxgen.com. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. This press release includes forward-looking statements within the meaning of the federal securities laws, including statements about Aphton's and Celltrion's expectations regarding: (1) the potential benefits to Aphton resulting from the licensing and commercialization agreements and (2) the potential of IGN311 to target a broad range of carcinomas, destroy tumor cells, and exert clinical effects by destruction of tumor cells. These forward-looking statements may be affected by risks and uncertainties that could cause the actual results to differ materially from those expressed in such forward-looking statements. These risk factors include, but are not limited to: (1) the risks and uncertainties inherent in the drug development process and in Aphton's and Igeneon's business; (2) the ability of Aphton and Celltrion to successfully collaborate in the development of IGN311; (3) Aphton's and/or Celltrion's ability to satisfy their respective closing conditions in the agreements; (4) the timing or results of ongoing and future clinical trials for IGN311; (5) the ability of Aphton and Celltrion to obtain regulatory approval for IGN311; (6) the ability of Celltrion and any approved third parties to manufacture and supply IGN311 in commercial quantities; (7) the ability of Aphton and Celltrion to gain commercial acceptance for IGN311; (8) the ability of Aphton and Celltrion to fund the development, manufacturing and commercialization of IGN311; (9) intellectual property risks; (10) the impact of competitive products and pricing; and (11) changing economic conditions. This information is qualified in its entirety by cautionary statements and risk factor disclosure contained in Aphton's Securities and Exchange Commission filings, including Aphton's report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. filed with the Commission on March 16, 2005. Aphton and Celltrion undertake no obligation to update forward-looking statements to reflect events or circumstances after the date hereof. The forward-looking statements in this press release also include, without limitation, the statements about the potential benefits to VaxGen's joint venture, Celltrion, resulting from the licensing and commercialization agreements between Igeneon and Celltrion. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Item 8.01 of VaxGen's Current Report on Form 8-K Form 8-K The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock. Form 8-K See 8-K. filed by VaxGen on March 31, 2005, under the heading "Risk Factors" for a more detailed description of such risks. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. VaxGen undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law. |
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