SAN DIEGO, Aug. 15 /PRNewswire/ -- Avanir Pharmaceuticals, today announced the formation of Xenerex Biosciences, a wholly owned subsidiary, to commercialize a platform technology to generate completely human antibodies for therapeutic and diagnostic applications. Xenerex plans to partner with companies to generate completely human antibodies to their proprietary disease targets, as well as to produce monoclonal antibodies to its own targets. Avanir's vice president of commercial development, J. David Hansen, has been named president and chief operating officer of the new subsidiary.
``The creation of Xenerex allows us to focus on the development and commercialization of our antibody technology with the objective of increasing shareholder value,'' said Gerald J. Yakatan, Ph.D., president and chief executive officer of Avanir Pharmaceuticals. ``We expect Xenerex to play an important role in the future growth of Avanir.''
The Xenerex technology produces human monoclonal antibodies indistinguishable from antibodies isolated directly from humans. What differentiates the Xenerex technology from other methods used to generate human antibodies is its ability to utilize human immune system cells to generate human antibodies in a mouse deficient in its own immune system. The platform technology makes use of many unique in-vivo cellular interactions in the human immune system that result in antibodies of high specificity and affinity.
``We believe our technology may have inherent advantages that could allow us to compete effectively with other human antibody generation technologies that have already shown significant commercial potential,'' said J. David Hansen. ``Using human cells to produce human antibodies may have advantages over other mouse antibody generation technologies, because our technology makes available all the genetic information for the entire library of antibodies. The Xenerex model is also unique in that it allows for the inclusion of genetic information from multiple individuals, thus, maximizing genetic diversity in the antibody generation effort. This is in contrast to the transgenic mouse model currently used by two other companies, that has used only a subset of genetic information from a single genetic configuration.
``Collaborating with companies to generate human antibodies to their proprietary disease targets is one of Xenerex's highest priorities,'' Mr. Hansen continued. ``We also intend to establish partnerships with companies in both the genomics and proteomics areas. There are literally thousands of new targets being identified by companies involved in this effort and many of these targets will use monoclonal antibodies as the first approach to developing diagnostic or therapeutic applications.''
Xenerex Biosciences's intellectual property platform resides in a series of patents to generate completely human antibodies of high affinity and specificity to a wide array of antigenic disease targets or human proteins. The two original patents (U.S. patent 5,698,767 and U.S. patent 5,476,996) are based on the pioneering work of Donald Mosier, M.D., Ph.D. and current Member of the Department of Immunology at The Scripps Research Institute in La Jolla, California. These patents claim the grafting of human lymphoid cells into Severe Combined Immmunodeficient (SCID) mice, for the purpose of studying various aspects of the human immune system outside the human body as well as the generation of completely human antibodies. These patents were extended by U.S. Patent 5,958,765, based on the work of Dr. Phillip Morrow, a founding scientist at Xenerex, and co-workers, that claim methods for generating human monoclonal antibodies using improved human cell sources and immunization procedures.
``This is an optimal time for exploiting this particular platform technology,'' noted Mr. Hansen. ``The number and pace of therapeutic antibodies receiving FDA approval has rapidly grown in the last three years, accounting for substantial worldwide sales. The market expects that companies with these types of technologies will make significant contributions to the flow of new products from the biopharmaceutical industry over the next decade.''
To accelerate the start-up of the new company, Avanir has allocated facilities including laboratory and office space, scientists, management, infrastructure, and financial support to Xenerex. On September 1, 2000, Avanir and Xenerex will move into new facilities that will allow Xenerex to begin operations.
Avanir Pharmaceuticals, a specialty pharmaceutical company, develops and commercializes novel therapeutic products for the treatment of chronic diseases. Avanir's lead product, docosanol 10% cream, was recently approved for marketing by the FDA. The company's product development pipeline includes a recently in-licensed drug product for the treatment of multiple central nervous system disorders, including emotional lability, neuropathic pain and chronic cough. Also, the company has a drug discovery program in the advanced pre-clinical stage of development for the treatment of the underlying biological causes of allergy and asthma.
The information contained in this press release, including any forward-looking statements contained herein, should be reviewed in conjunction with the company's Annual Report on Form 10-K and other publicly available information regarding the company, copies of which are available from the company upon request. Such publicly available information sets forth many risks and uncertainties related to the company's business and technology. Forward-looking statements often contain such words like ``estimate,'' ``anticipate,'' ``believe,'' ``plan'' or ``expect.'' Preliminary research findings are not always supportable by the scale-up of commercial operations, and many known and unknown risks and uncertainties could cause our actual results to differ materially from those indicated in these forward-looking statements. For example, final review decisions made by the FDA and other regulatory agencies concerning any antibody product candidate are unpredictable and outside of the influence and/or control of the company. Further, at this time, the company can provide no assurance that Xenerex will be able to successfully compete in the marketplace to commercialize its technology or that Xenerex will be profitable in the foreseeable future. |
