CMC Biopharmaceuticals A/S, a Copenhagen based contract manufacturing organization, and Ambrx, Inc. a drug development company based in San Diego, CA announced today that they have entered into a development and manufacturing agreement for the cGMP production of a PEGylated recombinant growth hormone using Ambrx’s ReCODE™ technology. The product will be manufactured at CMC’s facility in Copenhagen, Denmark, for use in human clinical studies.

CMC’s facility is state-of-the-art and has been designed and constructed specifically for contract manufacturing services in full GMP compliance. It has been purpose-built to operate with a high degree of flexibility and to provide full segregation of products. It is capable of handling simultaneous multi-product manufacturing. The facility has approval from the Danish Medicines Agency on behalf of EMEA for manufacture of Active Pharmaceutical Ingredients from both microbial and mammalian production systems.

Mr. Mads Laustsen, CMC’s CEO, remarked on the agreement: “CMC is delighted to have formed this relationship with Ambrx. This contract continues to validate CMC’s expertise in cGMP manufacturing and re-enforces CMC’s position as an important manufacturing partner for companies that are based in the United States.”

Dr. Tom Daniel, Ambrx’s Chief Scientific Officer, stated that ”CMC offers a highly capable contract manufacturing organization that is deeply committed to flexibility and quality. We look forward to working with them to advance this program."

About CMC Biopharmaceuticals A/S
Based in Copenhagen, Denmark, CMC is a contract development and manufacturing organization with Sales offices located in the UK and the U.S.

CMC specializes in process and analytical development as well as the scale-up and cGMP manufacture of Active Pharmaceutical Ingredients for pre-clinical, clinical trials and in-market supply. CMC’s competitive strength is centered around flexibility combined with unique and extensive experience of its management and key personnel in the field of biopharmaceutical manufacture and development. The appointment of CMC’s Chief Quality Officer, Dr. Anders Vinther, to the board of the Parenteral Drug Association strongly positions the company with respect to future trends and implementations of regulatory and cGMP standards.

About Ambrx, Inc.
Ambrx is a biopharmaceutical company committed to transforming the science and performance of protein-based medicines. Building on a fundamental advance in protein biosynthesis, Ambrx genetically engineers proteins with novel amino acid building blocks beyond the common twenty. This approach represents a new paradigm in protein engineering and permits the pharmaceutical optimization of proteins in a manner analogous to that used to improve the properties of small molecule-based drugs and peptides. The company’s most advanced product candidate, a human growth hormone with superior performance, is currently in preclinical development with an IND anticipated in 2006. In addition, Ambrx is optimizing several other protein therapeutics representing large markets and significant unmet medical need.