Elusys Therapeutics and Lonza today announced an agreement for the scale-up and commercial production of Anthim, a therapeutic monoclonal antibody in late-stage development for the treatment of inhaled anthrax. Under the new contract, Lonza will provide process scale-up, technology transfer, validation, and commercial manufacturing at one of its facilities in the USA. The manufacturing process for Anthim was optimized for full scale production by Lonza under a separate agreement announced in 2009. The Anthim manufacturing process uses Lonza's GS Gene Expression System.

"Elusys is pleased to extend its relationship with Lonza for the commercial production of Anthim, an anti-toxin that has been highly effective in treating anthrax infected animals," said James Porter, Vice President of Development and Manufacturing at Elusys. "Anthim has the potential to deliver significant therapeutic benefit to Americans infected with anthrax in a bioterrorism emergency and therefore, we believe that partnering with Lonza provides Elusys the manufacturing experience and large-scale capacity needed to ensure commercial quantities of Anthim long-term. As the world's leading contract manufacturer of monoclonal antibodies and recombinant proteins, Lonza has considerable experience in large-scale manufacturing and a well-established reputation with regulatory agencies for the production of licensed products."

In 2009, Elusys was awarded a contract totaling up to $143 million from the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services to complete the final development, commercial manufacturing and licensure of Anthim. This contract represented one of the largest awarded by BARDA for advanced product development.

"Working with the team at Elusys on such a novel new antibody therapy has been very rewarding," said Dr. Stephan Kutzer, Head of Lonza Custom Manufacturing. "We are excited about continuing our successful relationship and look forward to supporting Elusys in the launch and long-term commercial supply of Anthim."

Anthim Background

Based on extensive testing, which included multiple models of anthrax infection, Anthim has demonstrated excellent potential as an effective, single dose therapeutic for the treatment of people infected by or exposed to anthrax spores. These study results showed Anthim prevented death in 70 – 100% of animals treated with a single dose of drug.

Anthim is a high-affinity, humanized and deimmunized monoclonal antibody that targets the protective antigen of B. anthracis and neutralizes the lethal effects of anthrax toxins. It is being developed for prevention and treatment of inhaled anthrax following a biowarfare attack.

This project is supported with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201000026C, and the National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health (NIH), the Department of Health and Human Services (HHS) and BARDA under Contract No. HHSN272200700035C.

About Elusys Therapeutics

Elusys Therapeutics, a private company based in Pine Brook, NJ, is focused on the development of antibody therapeutics for the treatment of life-threatening disease. Elusys has been engaged in development of biodefense countermeasures since 2000. The company has established experience in government contract management and to date has received multiple grants and contracts totally up to $177 million in government funding. Anthim, a highly effective anthrax anti-toxin, is in late-stage development and is a strong candidate for future procurement into the Strategic National Stockpile.

About Lonza

Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers' needs from research to final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Lonza is also a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets. Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange. In 2009, Lonza had sales of CHF 2.690 billion.

Source: Elusys Therapeutics

Pharmaceutical News

Elusys Therapeutics and Lonza Extend Manufacturing Agreement for Anthim, a New Anthrax Treatment in Late-Stage Development

Basel, Switzerland Jul 15, 2010

Basel, Switzerland
Jul 15, 2010