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. Three IMiDs compounds are currently approved or in development. Lenalidomide and pomalidomide have gained regulatory approvals in certain settings and are being evaluated in clinical trials for additional indications.
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 IMiDs 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.
Our IMiDs compounds use multiple mechanisms of action that target the sources rather than the symptoms of disease.
In addition, lenalidomide is also approved in the U.S., Canada, Japan and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. It has also been approved in the U.S. for the treatment of relapsed or refractory mantle cell lymphoma after treatment with two prior medicines, one of which included bortezomib. Marketing Authorization Applications are currently being evaluated in a number of other countries.
Celgene continues to pursue a broad clinical development program for our IMiDs compounds. Currently, more than 300 clinical trials worldwide are evaluating the promise of our IMiDs compounds across a broad range of cancer-related and other debilitating diseases.
The products represented as in development and found in the product pipeline are intended for investors and members of the media to provide general information on Celgene. This information is not represented to be a complete description and is subject to change without notice. Celgene Corporation may from time to time update this information but does not warrant that will take place at any particular time nor assume any obligation to update this information.