IMiDs® compounds are proprietary small molecule, orally available compounds that modulate the immune system and other biological targets through multiple mechanisms of action, not all of which have been fully characterized. We have advanced four IMiDs compounds into development: (lenalidomide), CC-4047 (pomalidomide), CC-11006are being evaluated in human clinical trials. CC-10015 is advancing toward potential clinical testing. Our IMiDs compounds are covered by a comprehensive intellectual property estate of issued and pending patent applications in the U.S., EU, and other regions, including composition-of-matter and use patents.
Our leading IMiD compound, lenalidomide, has been granted approval in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.
In addition, our leading IMiD compound is also approved in the United States, Canada, Japan and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Marketing Authorization Applications are currently being evaluated in a number of other countries.
Celgene continues to pursue a broad clinical development program for our IMiD compounds. Currently, there are more than 300 clinical trials worldwide evaluating the promise of our IMiD compounds across a broad range of cancer-related and other debilitating diseases. CC-4047: Our next-generation IMiD is currently being evaluated as a potential oral treatment regimen in multiple studies. The first Phase III clinical trial is for patients with myelofibrosis – a rare blood cancer that affects the blood-forming tissues of the body. A second Phase III clinical trial is underway for patients with relapsed/refractory multiple myeloma.
CC-11006: Represents one of the newer members to the IMiDs family of compounds.CC-11006 is now in early stage trials to evaluate its clinical potential in myelodysplastic disorders.
CC-4047 and CC-11006 are investigational compounds not approved by the FDA in any indication and are currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.