MedImmune and Critical Therapeutics Enter Alliance to Co-Develop Treatments for Severe Inflammatory Diseases

04-Aug-2003

MedImmune, Inc. and Critical Therapeutics, Inc., a private biopharmaceutical company, announced the signing of an agreement to co-develop biologic products targeting a novel pro-inflammatory cytokine to treat severe inflammatory diseases.

MedImmune and CTI will collaborate on the research and development of antibodies and other drug products targeting the High Mobility Group Box Chromosomal Protein 1 (HMGB-1), which is believed to be involved in the tissue damage associated with a range of inflammatory illnesses, such as rheumatoid arthritis and sepsis. The companies plan to focus on developing drug products with the potential to block HMGB-1, which if successful, could help reduce the injury and death associated with severe inflammatory diseases and infections.

"CTI's proprietary anti-HMGB-1 technology is a great fit with our core expertise in antibody technology and anti-arthritic/anti-inflammatory disease research," commented James F. Young, Ph.D., MedImmune's president of research and development. "Elevated levels of HMGB-1 are found in many acute and chronic diseases, including rheumatoid arthritis, inflammatory bowel disease, hemorrhagic shock, sepsis, endotoxemia, and acute lung injuries. We believe that treatment with anti-HMGB-1 antibodies or antagonists may help alleviate or prevent the severe tissue damage that often results from such afflictions."

HMGB-1 is a cytokine, which means it is one of the many hormone-like proteins secreted by different cell types that regulate the intensity and duration of an immune response. HMGB-1 is expressed at high levels beginning approximately 12 to 72 hours after an inflammatory reaction of the immune system has been initiated and at about the time tissue damage is believed to occur.

Because of the timing and the duration of its expression, HMGB-1 could potentially be a more important factor than other cytokines, including TNF- alpha, in the sequence of events that result in severe tissue damage following an injury or inflammatory disease. Preclinical studies to date have suggested that blocking HMGB-1 may help protect animals from injury associated with many chronic and acute inflammatory diseases, and may reduce sepsis-related deaths.

Under the terms of the agreement, CTI will receive $12.5 million in upfront payments from MedImmune plus future undisclosed milestone payments and royalties on sales of any approved products resulting from the research. MedImmune will develop the commercial production process for any and all potential drug products. MedImmune will also fund a majority of the research and development activities, the level to which is subject to CTI's exercise of a co-promotion option for the lead anti-HMGB-1 candidate.

"MedImmune has made a strong commitment in the area of anti-inflammatory medicine, and we are extremely pleased to collaborate with the company in the emerging area of biologics," said Walter Newman, CTI's chief scientific officer. "Our alliance combines MedImmune's expertise in commercializing drug products with CTI's strong intellectual property in the area of HMGB-1, where we hold recently issued patents in the U.S. and Europe. In addition, this agreement provides CTI with the opportunity for U.S. co-promotion of the products emanating from our collaboration. This is an important component in our plans to create a fully integrated biopharmaceutical company."

In addition to today's agreement, MedImmune has also committed to participating in the next round of Critical Therapeutics' financing via its subsidiary, MedImmune Ventures, Inc.

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Topic world Antibodies

Topic world Antibodies

Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous