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Applied Molecular Evolution (AMEV) Files Investigational New Drug Application For AME-527, Next-Generation Remicade(R), In Rheumatoid Arthritis


10/19/2005 5:10:47 PM

SAN DIEGO, Nov. 18 /PRNewswire-FirstCall/ -- Applied Molecular Evolution, Inc. (AME) today announced that it has submitted an investigational new drug (IND) application to the U.S. Food & Drug Administration (FDA) to evaluate AME-527 as a potential new therapy for rheumatoid arthritis. Under this IND, AME plans to assess the safety and effectiveness of AME-527 in subjects with active rheumatoid arthritis. AME-527 is a humanized monoclonal antibody with fully human frameworks that recognizes human tumor necrosis factor-alpha (TNF-alpha) with high affinity and specificity. In preclinical models conducted by AME, AME-527 is ten-fold more potent than Remicade(R) (infliximab) and 6 to 8-fold more potent than Humira(TM) (adalimumab).

"The filing of AME's first IND for a next-generation therapeutic antibody candidate was our most significant corporate goal for 2003, and was completed in a timeframe that we believe sets a new standard in the protein therapeutics industry," commented William D. Huse, M.D., Ph.D., President, CEO and Chairman of AME. "AME has a robust pipeline of internally developed, optimized next-generation biotherapeutics that address large markets, and we are committed to move them forward quickly and effectively. For AME-527, our Development team designed and built a Phase II GMP bioprocessing facility, recruited an experienced bioproduct team, manufactured the antibody and brought it to the IND stage in less than two years under the leadership of Jim Breitmeyer, M.D., Ph.D., Vice President of Pharmaceutical Operations and Chief Medical Officer."

"The preclinical profile of AME-527 is very exciting," said Dr. Breitmeyer. "Currently approved biologic therapies for rheumatoid arthritis have limitations, and AME-527 shows features in animal models that are quite encouraging and may address those limitations. We have successfully implemented the AME model of accelerated product development through the manufacturing and pre-clinical stage, and believe that our interactions with the FDA have been positive and productive. The AME clinical team is now poised to enter Phase I/II human clinical trials with this optimized and humanized anti-TNF-alpha antibody, immediately upon activation of the IND."

The principal investigator in the AME-527 Phase I/II trial is Arthur Kavanaugh, M.D. of the Center for Innovative Therapy at the University of California, San Diego. The study is designed to enroll 24-30 patients with active rheumatoid arthritis and test the safety, biologic effects and pharmacokinetics of AME-527.

About AME-527

Rheumatoid arthritis is a chronic disease characterized by pain, stiffness, swelling, joint damage, and loss of function of the joints often accompanied by non-synovial complications. Tumor necrosis factor-alpha (TNF-alpha) has a key role in rheumatoid synovitis, as an inflammatory cytokine at the top of the inflammatory cascade. Blocking TNF-alpha with antibodies or fusion proteins is an important and established disease intervention, validating the role of the cytokine in disease activity and progression. AME-527 is a humanized monoclonal antibody that recognizes human TNF-alpha (hTNF-alpha) with high affinity and specificity. AME-527 was generated by protein engineering and identified from a library of antibody variants based on its improved binding properties. The variable regions are comprised of engineered complementarity determining regions (CDRs) supported by fully human frameworks derived from germline genes. In pre-clinical studies, AME-527 is approximately ten-fold more potent than Remicade(R) in binding to and neutralizing the hTNF-alpha molecule, and 6 to 8-fold more potent than Humira(TM). Any comparisons between AME-527 and other products were made to assist in clinical trial design only, and should not be construed as a claim of clinical superiority. The clinical effects of AME-527 are unknown, and its efficacy and safety over various doses will be determined in human clinical trials.

Remicade(R) is a registered trademark of Centocor. Humira(TM) is a registered trademark of Abbott Laboratories. About Applied Molecular Evolution

Applied Molecular Evolution, Inc., (AME) is a leader in applying directed molecular evolution to improve healthcare by optimizing and developing human biotherapeutics. Directed molecular evolution is a process for optimizing genes and proteins for specific commercial purposes. Since its inception, AME's principal focus has been on applying its proprietary AMEsystem(TM) technology platform to human biotherapeutics, the largest market for directed molecular evolution. Biotherapeutics, or biopharmaceuticals, are protein pharmaceuticals such as antibodies, cytokines, hormones and enzymes. AME uses its proprietary technology to develop improved versions of currently marketed, FDA-approved biopharmaceuticals as well as novel human biotherapeutics. For more information, please visit http://www.ame.biz/ .

This press release contains forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements, including uncertainties related to AME-527 clinical trials, uncertainties related to product development, uncertainties related to the need for regulatory or other government approvals, dependence on proprietary technology, uncertainty of market acceptance of the Company's products, uncertainties related to business opportunities, the receipt of future payments, including royalties, the continuation of customer relationships and other risks cited in the Company's Annual Report on Form 10-K for the year ended December 31, 2002, and other SEC Filings. These forward-looking statements speak only as of the date hereof. The Company disclaims any intent or obligation to update these forward-looking statements.

For further information, please contact: Christopher Erdman of Applied Molecular Evolution, Inc., +1-858-597-4990.

Applied Molecular Evolution, Inc.

CONTACT: Christopher Erdman of Applied Molecular Evolution, Inc.,+1-858-597-4990



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