Implicit licenses clinical stage antibody program from Lilly

Implicit Bioscience Ltd has announced the acquisition of the clinical-stage monoclonal antibody IC14 from Eli Lilly and Company. Implicit has paid an undisclosed consideration combining cash and stock to Lilly. Lilly will also receive a royalty on future IC14 sales.

"Implicit Bioscience brings substantial expertise and passion to the treatment of patients with immune-mediated disease," commented Professor Ian Frazer FAA, Implicit's Chief Scientific Officer. "We intend to develop this promising drug to treat acute lung injury (ALI) caused by a dysregulated immune response amongst intensive care patients who are on mechanical ventilation. These patients have a significant mortality risk with limited treatment options."

"An effective treatment for ALI has the potential to reduce overall health care costs by allowing the earlier discharge of patients from high-cost intensive care units," Professor Frazer added.

Garry Redlich, Implicit CEO, added, "The transaction to acquire IC14 is a logical and exciting next step in Implicit's business model. We seek to mitigate product risk through acquiring clinical stage programs with proven safety and defined opportunities in immunological indications. We further mitigate risk by seeking non-dilutive third party funding to support a portion of our development expense. We are optimistic that IC14 is an excellent opportunity, and a good fit to our capabilities and business model."

IC14 had earlier been in development for severe sepsis at Icos Corporation which was acquired by Lilly in 2007. It has been used in the treatment of more than 150 patients, and has well characterized safety and pharmacology profiles. Implicit intends to initiate Phase 2 clinical development in ALI during 2009, and recently completed a capital round in which its shareholders added AU$6m to its cash balance.

Johnson and Johnson, The Scripps Research Institute, The Rockefeller University, and Lilly are parties to a separate agreement with Implicit which will see the payment to them by Implicit of milestones and royalties on IC14 development and commercialisation.

Acute lung injury (ALI) is a severe inflammatory disease which can rapidly progress to acute respiratory distress syndrome, multi-organ dysfunction and death. The incidence of this disorder is estimated at around 200,000 cases per annum in the US and is responsible for over 75,000 deaths -- more than breast cancer and HIV AIDS combined. It is diffuse heterogeneous lung injury characterized by hypoxemia, non-cardiogenic pulmonary edema, low lung compliance and widespread capillary leakage. ALI is caused by any stimulus of local or systemic inflammation and commonly occurs after acute insults to the body, such as trauma, severe pneumonia and sepsis.

IC14 is a clinical stage recombinant chimeric monoclonal antibody which recognizes and blocks the function of human CD14, an essential component of the innate inflammatory response to bacterial infection. CD14 triggers activation of the innate immune response to bacterial components including lipopolysaccharide via the Toll-like receptor (TLR) pathway. Lung inflammation in response to innate immune activation through the TLR pathway is a primary factor in the early pathogenesis of ALI.