Celgene Corporation, a multinational integrated biopharmaceutical company, engages in the discovery, development and commercialization of therapies designed to treat cancer and immune-inflammatory-related diseases.
The company’s primary products include: REVLIMID (lenalidomide) and THALOMID (thalidomide). Its portfolio of drug candidates in its product pipeline includes IMiDs compounds, which are proprietary to the company and have demonstrated certain immunomodulatory and other biologically important properties.
The company is involved in research in various scientific areas that may deliver proprietary next-generation therapies, such as intracellular signaling, immunomodulation and placental stem cell research. The therapies (drugs and cell therapies) that the company develops are designed to treat life-threatening diseases or chronic debilitating conditions.
Commercial Stage Programs
The company’s commercial programs include pharmaceutical product sales of REVLIMID, THALOMID, ALKERAN and sales of FOCALIN to Novartis Pharma AG (Novartis); a licensing agreement with Novartis which entitles the company to royalties on FOCALIN XR and the RITALIN family of drugs; a licensing and product supply agreement with Pharmion Corporation for its sales of thalidomide; and sales of bio-therapeutic products and services through its Cellular Therapeutics subsidiary. In addition, the company has contracted with Ivers Lee Corporation, doing business as Sharp, a specialty distributor, to distribute THALOMID and REVLIMID in the United States.
REVLIMID (LENALIDOMIDE): REVLIMID is an oral immunomodulatory drug approved for treatment in combination with dexamethasone for multiple myeloma patients who have received at least one prior therapy. REVLIMID is also approved for treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS, associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID is distributed primarily through contracted pharmacies under the RevAssist program. The company's collaborators include Southwest Oncology Group and Eastern Cooperative Oncology Group.
The company is evaluating REVLIMID in approximately 75 clinical trials either alone or in combination with one or more other therapies in the treatment of a range of debilitating diseases, including multiple myeloma, MDS, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), other hematological and solid tumor cancers and other inflammatory and immunological diseases. The advanced of these studies include Phase III and Phase II trials evaluating REVLIMID across a range of hematological cancers, including multiple myeloma, MDS, CLL and NHL. REVLIMID has been designated as an Orphan Medicinal Product in the European Union (EU) for the treatment of multiple myeloma and MDS. Also, REVLIMID received orphan drug designation for the treatment of CLL. REVLIMID is being made offered to patients in the EU under a Named Patient Program (NPP).
THALOMID (THALIDOMIDE): THALOMID was approved in May 2006 in combination with dexamethasone for the treatment of newly diagnosed multiple myeloma. THALOMID has also approved for the acute treatment of cutaneous manifestations of moderate to severe ENL and as maintenance therapy for prevention and suppression of the cutaneous manifestation of ENL recurrence. The company has a strategic alliance with Pharmion Corporation to expand the THALOMID franchise in countries other than the United States, Canada, Mexico, Japan and provinces of China other than Hong Kong.
The company developed S.T.E.P.S. (SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY) which is a proprietary strategic education and risk-management distribution program with the target of providing for the safe and appropriate distribution and use of THALOMID.
ALKERAN: The company has a supply and distribution agreement with GlaxoSmithKline (GSK) to distribute, promote and sell ALKERAN (melphalan) in all dosage forms in the United States under the Celgene label. ALKERAN is approved for the palliative treatment of multiple myeloma and of carcinoma of the ovary. Under the terms of the agreement, the company purchases ALKERAN tablets and ALKERAN for injection from GSK and distributes the products in the United States under the Celgene label.
RITALIN FAMILY OF DRUGS: The company has licensed to Novartis the worldwide rights (excluding Canada) to FOCALIN and FOCALIN XR, the extended release version, in exchange for milestone payments, a product supply agreement under which the company sells FOCALIN to Novartis and royalties on FOCALIN XR and the entire RITALIN family of drugs. The company has retained the commercial rights to FOCALIN and FOCALIN XR for oncology-related disorders. FOCALIN is approved for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents and FOCALIN XR is approved for the treatment of ADHD in adults, adolescents and children.
Preclinical and Clinical-Stage Pipeline
IMIDS: IMiDs compounds are proprietary small molecule, orally available compounds that modulate the immune system and other biologically important targets through multiple mechanisms of action. The company has marketed REVLIMID (CC-5013) and has advanced two other IMiDs compounds into clinical development, CC-4047 and CC-11006. Additional compounds, including CC-10015, are in preclinical development.
CC-4047: The company is evaluating Phase II trials to determine CC-4047's potential efficacy as an oral therapy for a range of oncology and potentially non-oncology uses, including myelofibrosis, multiple myeloma and solid tumor cancers.
CC-11006: Following the completion of Phase I human clinical trials, the company is evaluating conditions where this profile would have therapeutic application including MDS.
ORAL ANTI-INFLAMMATORY AGENTS: The company’s anti-inflammatory program is focused on providing an oral approach for treating chronic inflammatory diseases. CC-10004, the company’s primary investigational drug in this class, is an orally available small molecule that inhibits PDE-4, resulting in the inhibition of multiple pro-inflammatory mediators, including TNF-(alpha). CC-10004 is under evaluation in Phase II clinical trials for psoriasis and psoriatic arthritis to position this candidate for subsequent trials in various chronic inflammatory diseases.
ANTI-PROLIFERATIVES: CC-8490 has completed Phase I clinical trials in glioblastoma, an aggressive form of brain cancer. A follow-on compound in the same class, CC-0227113, which has anti-tumor activity, is at the preclinical stage of development.
KINASE INHIBITORS: The Celgene kinase inhibitor platform includes inhibitors of the c-Jun N-terminal kinase (JNK) pathway, and inhibitors of the NFkB pathway. The JNK inhibitor, CC-401, has completed a Phase I trial in healthy volunteers and in acute myelogenous leukemia (AML) patients to determine safety and tolerability. The company’s next JNK inhibitor, CC-930, is in pre-clinical development, advancing toward clinical testing.
LIGASE INHIBITORS: The ligases regulate the degradation of intracellular proteins. These ligases, as a class of targets, have potential for drug discovery in oncology. By identifying drug targets and compounds that regulate ligase pathways, the company is addressing the potential to develop a new class of anti-cancer and anti-inflammatory therapeutics.
PLEIOTROPIC PATHWAY MODIFIERS: The company has identified a new class of molecules that impact activity of various key pathways of therapeutic relevance. The first of these, CC-16057, has moved into preclinical development for inflammatory conditions.
STEM CELLS: At Celgene Cellular Therapeutics, the company is researching stem cells derived from the human placenta as well as from the umbilical cord. CCT is the company’s research and development division. It intends to develop proprietary cell therapy products for the treatment of autoimmune diseases and cancer. The company has developed proprietary technology for collecting, processing, and storing placental stem cells with potential therapeutic applications in cancer, autoimmune, cardiovascular, neurological and other diseases. The company's first placental derived adherent cell product include PDA-001.
Suppliers
The company has contracted with third-party manufacturers to supply the raw materials and finished products. The active pharmaceutical ingredient (API) for THALOMID is obtained from Aptuit, Inc., which acquired Eagle Picher Pharmaceutical Services, a Division of Eagle-Picher Incorporated.
The company relies on two drug product manufacturers, Penn Pharmaceuticals Services Limited and Institute of Drug Technology Australia Limited for the formulation and encapsulation of the finished dosage form of THALOMID capsules, and on one contract packager, Sharp Corporation, for the packaging of the final product.
The API for REVLIMID is manufactured by the company’s Zofingen, Switzerland, manufacturing facility purchased in December 2006 and by Evotec OAI, Ltd. It has also contracted and registered two manufacturing service providers, OSG Norwich Pharmaceuticals and Penn Pharmaceuticals Services Limited, for the formulation and encapsulation of the finished dosage form of REVLIMID capsules, and one contract packager, Sharp Corporation, for the packaging of the final product.
The API for FOCALIN is obtained from two suppliers, Johnson Matthey, Inc. and Siegfried USA, Inc., and it relies on a single manufacturer, Mikart, Inc., for the tableting and packaging of FOCALIN finished product. It obtains the API for FOCALIN XR from Johnson Matthey Inc., on behalf of Novartis for the manufacture of FOCALIN XR finished product.
Competition
The company's competitors include Bristol-Myers Squibb Co., Amgen Inc., Genentech, Inc., Sanofi-Aventis SA., Novartis AG, AstraZeneca PLC., Eli Lilly and Company, F. Hoffmann-LaRoche, Ltd, Millennium Pharmaceuticals, Inc., MGI Pharma, Inc., Biogen Idec Inc., Merck and Co., Inc., Johnson and Johnson, Pfizer, Inc., and Centocor, Inc.
History
Celgene Corporation was founded in 1980.
