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New Patent for Recombinant TNF Receptor Releasing Enzyme Issued to Meyer Pharmaceuticals

July 15, 2003
Business Editors/Health/Medical Writers
Business Wire
Irvine, Calif

Meyer Pharmaceuticals LLC announces that the U.S. Patent & Trademark Office is today issuing U.S. Patent Nos. 6,593,456. This is the first U.S. patent covering recombinant forms of TNF Receptor Releasing Enzyme, a family of new biological agents for treating inflammatory disease. Rights to this technology has been licensed exclusively to Meyer Pharmaceuticals from the University of California at Irvine.

Rheumatoid arthritis is triggered by excessive signaling between cells in the body, causing white cells to damage the tissue in joints. Two of the signaling molecules involved in this process are TNF and IL-6. Normally there is a feedback mechanism that causes the receptors from these molecules to be shed from inflammatory cells, preventing the signal from getting through. TNF Receptor Releasing Enzyme is a naturally occurring human enzyme that promotes the shedding process. Meyer Pharmaceuticals is working on the idea that administering TRRE will supplement the feedback process, and help resolve the symptoms and joint damage that occurs in arthritis.

"This patent for recombinant TRRE is very satisfying," says Michael O'Neill, president and chief executive officer. "It is Meyer's corporate mission to take promising new leads in the biotechnology field forwards to help improve clinical medicine. This new patent provides the protection we need to take the project forward for commercial development. It protects six proteins in the TRRE family, including our lead candidate, MP8. We are now in the process of scaling up our production process for human therapy, and expect to apply for clinical trials within the year. We are also talking with large pharmaceutical companies to see if they would like to help us with the testing and marketing of this important family of biological agents."

MP8 is believed to have several important advantages over current treatments for arthritis. For example, it can be produced much more cheaply and in larger quantities than antibody compositions. The patient can also be given a much smaller dose, because MP8 works as a catalyst, and simply boosts a natural anti-inflammatory pathway.

Tetsuya Gatanaga, Ph.D., executive vice president and chief operating officer of Meyer Pharmaceuticals, brought the TRRE project to Meyer Pharmaceuticals from UC Irvine, where it was first discovered. "The cloning of the gene was the result of a very long and difficult project," says Dr. Gatanaga. "Other groups in Israel and around the world also tried, but we were the first to be successful. We developed a functional cloning process, in which a DNA library was screened using a special cell that was engineered to detect shedding activity." The human genome has now been completely sequenced, but this project was the first to express this gene family and describe its function.

The availability of the recombinant form of the protein has allowed Meyer Pharmaceuticals to put MP8 through extensive preclinical evaluation. Over the last year, the enzyme has been tested in models for arthritis, septic shock, edema, multiple sclerosis, and asthma. In animals that had established arthritis, MP8 significantly reduced joint swelling, and pathology associated with the disease. MP8 was found to prevent arthritis at a dose level that is less than one tenth of what is typically used for other anti-inflammatory biological agents currently on the market.

Members of the Scientific Advisory Board at Meyer Pharmaceuticals include Gary S. Firestein, M.D. at the University of California at San Diego, and Carl F. Ware, Ph.D. at the La Jolla Institute for Allergy and Immunology.

Meyer Pharmaceuticals LLC is a privately-held pharmaceutical company. It engages in discovery research, provides pharmaceutical research services under the service mark Meyer Pharmaceuticals(SM), and develops biological agents into compositions suitable for human clinical therapy. Its two core technologies are cellular cancer vaccines, and protein products that control inflammation by modulating cytokine signaling.

This news release contains forward-looking statements involving risks and uncertainties inherent in pharmaceutical research, clinical development, and intellectual property protection.

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