Bristol-Myers Squibb Company (BMS), incorporated on August 11, 1933, is engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of biopharmaceutical products on a global basis. It operates in BioPharmaceuticals. Its products are sold worldwide, primarily to wholesalers, retail pharmacies, hospitals, government entities and the medical profession. It manufactures products in the United States (U.S.), Puerto Rico and in 6 foreign countries. In February 2012, it acquired Inhibitex, Inc. (Inhibitex). In August 2012, the Company announced the acquisition of Amylin Pharmaceuticals, Inc. In August 2012, Synergy Pharmaceuticals Inc announced that it signed an Asset Purchase Agreement with the Company and acquired the assets related to FV-100, an orally available nucleoside analogue, being developed for the treatment of shingles.
The Company’s pharmaceutical products include chemically-synthesized drugs, or small molecules, and an increasing portion of products produced from biological processes (typically involving recombinant DNA technology), called biologics. Small molecule drugs are typically administered orally, e.g., in the form of a pill or tablet, although other drug delivery mechanisms are used as well. Biologics are typically administered to patients through injections or by infusion. Its revenues come from products in therapeutic classes: cardiovascular; virology, including human immunodeficiency virus (HIV) infection; oncology; neuroscience; immunoscience, and metabolics.
Plavix (clopidogrel bisulfate) is a platelet aggregation inhibitor, which is approved for protection against fatal or non-fatal heart attack or stroke in patients with a history of heart attack, stroke, peripheral arterial disease or acute coronary syndrome. Clopidogrel bisulfate was codeveloped and is jointly marketed with Sanofi. In October 2012, BMS and Sanofi announced a restructuring of their alliance. It obtains its requirements for clopidogrel bisulfate from Sanofi. Prior to January 1, 2013, both the Company and Sanofi finished the product in its own respective facilities.
Avapro/Avalide (irbesartan/irbesartan-hydrochlorothiazide) is an angiotensin II receptor antagonist indicated for the treatment of hypertension and diabetic nephropathy. Irbesartan was codeveloped and jointly marketed with Sanofi until the end of 2012. In October 2012, BMS and Sanofi announced a restructuring of their alliance following the loss of exclusivity of Plavix and Avapro/Avalide in many markets. It purchases Irbesartan was codeveloped and jointly marketed with Sanofi until the end of 2012. In October 2012, BMS and Sanofi announced a restructuring of their alliance following the loss of exclusivity of Plavix and Avapro/Avalide in many markets.
Eliquis (apixaban) is an oral Factor Xa inhibitor targeted at stroke prevention in atrial fibrillation and the prevention and treatment of venous thromboembolic (VTE) disorders. It is approved in the EU, Canada and Japan for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors and for use in VTE prevention in adult patients who have undergone elective hip or knee surgery. In December 2012, the U.S. Food and Drug Administration (FDA) approved Eliquis to reduce the risk of stroke and systemic embolism in patients with NVAF. Apixaban was discovered internally and is part of its alliance with Pfizer, Inc. (Pfizer). Apixaban is manufactured by both the Company and a third-party.
Abilify (aripiprazole) is an atypical antipsychotic agent for adult patients with schizophrenia, bipolar mania disorder and depressive disorder. Abilify also has pediatric uses in schizophrenia and bipolar disorder, among others. It has a global commercialization agreement with Otsuka Pharmaceutical Co., Ltd. (Otsuka), except in Japan, China, Taiwan, North Korea, South Korea, the Philippines, Thailand, Indonesia, Pakistan and Egypt. It obtains its bulk requirements for aripiprazole from Otsuka. Both the Company and Otsuka finish the product in its own respective facilities.
Reyataz (atazanavir sulfate) is a protease inhibitor for the treatment of human immunodeficiency virus (HIV). It has developed atazanavir under a worldwide license from Novartis Pharmaceutical Corporation (Novartis) for which a royalty is paid based on a percentage of net sales. It is entitled to promote Reyataz for use in combination with Norvir* (ritonavir) under a non-exclusive license agreement with Abbott Laboratories, as amended, for which a royalty is paid based on a percentage of net sales. It has a licensing agreement with Gilead Sciences, Inc. (Gilead) to develop and commercialize a fixed-dose combination containing Reyataz and one of Gilead’s compounds in development. It manufactures its bulk requirements for atazanavir and finishes the product in its facilities.
Sustiva (efavirenz) is a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV. The Sustiva Franchise includes Sustiva, an antiretroviral drug used in the treatment of HIV, and as well as bulk efavirenz which is included in the combination therapy Atripla (efavirenz 600 milligram/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), a once-daily single tablet three-drug regimen combining its Sustiva and Gilead’s Truvada (emtricitabine and tenofovir disoproxil fumarate). Atripla is the complete Active Antiretroviral Therapy treatment product for HIV available in the U.S. in a fixed-dose combination taken once daily. Fixed-dose combinations contain multiple medicines formulated together and help simplify HIV therapy for patients and providers.
Baraclude (entecavir) is a potent and selective inhibitor of hepatitis B virus that was approved by the FDA for the treatment of chronic hepatitis B infection. Baraclude was discovered and developed internally. It has also been approved and is marketed in over 50 countries outside of the U.S., including China, Japan and the EU. Entecavir is manufactured by both the Company and a third-party. The product is then finished in its facilities.
Erbitux (cetuximab) is an IgG1 monoclonal antibody designed to exclusively target and block the Epidermal Growth Factor Receptor (EGFR), which is expressed on the surface of certain cancer cells in multiple tumor types as well as some normal cells. Erbitux, a biological product, is approved for the treatment in combination with irinotecan for the treatment of patients with EGFR-expressing metastatic colorectal cancer (mCRC) who have failed an irinotecan-based regimen and as monotherapy for patients who are intolerant of irinotecan. The FDA also approved Erbitux for use in the treatment of squamous cell carcinoma of the head and neck. Erbitux is marketed in North America by them under an agreement with ImClone Systems Incorporated (ImClone), the predecessor company of ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company (Lilly).It obtains its finished goods requirements for cetuximab for use in North America from Lilly. Lilly manufactures bulk requirements for cetuximab in its own facilities and filling and finishing is performed by a third-party for which BMS has oversight responsibility.
Sprycel (dasatinib) is a multi-targeted tyrosine kinase inhibitor approved for treatment of adults with all phases of chronic myeloid leukemia with resistance or intolerance to prior therapy, including Gleevec* (imatinib mesylate), and for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy. Sprycel was internally discovered and is part of its strategic alliance with Otsuka. It manufactures its bulk requirements for dasatinib and finishes the product in its facilities.
Yervoy (ipilimumab), a biological product, is a monoclonal antibody for the treatment of patients with unresectable (inoperable) or metastatic melanoma. It is also being studied for other indications including lung cancer as well as adjuvant melanoma and hormone-refractory prostate cancer. Yervoy was discovered by Medarex and codeveloped by the Company and Medarex, which is its subsidiary.
Orencia (abatacept), a biological product, is a fusion protein with immunosuppressive activity targeted initially at adult patients with moderate to severe rheumatoid arthritis, who have had an inadequate response to certain available treatments. It obtain bulk abatacept from a third-party manufacturer and also manufacture bulk at own facility. It finishes the product in its facilities for both formulations.
Nulojix (belatacept), a biological product, is a fusion protein with immunosuppressive activity for the prevention of kidney transplant rejection. It manufactures bulk requirements for belatacept and finishes the products in its facilities.
Onglyza / Kombiglyze
Onglyza (saxagliptin), a dipeptidyl peptidase-4 inhibitor, is an oral compound indicated for the treatment of type 2 diabetes as an adjunct to diet and exercise. Kombiglyze (saxagliptin and metformin hydrochloride extended-release) is approved in the U.S. as a combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate. Onglyza was internally discovered by the Company and Kombiglyze was codeveloped by the Company and AstraZeneca PLC (AstraZeneca). It has a worldwide (except Japan) co-development and co-commercialization agreement with AstraZeneca for saxagliptin. It manufactures its bulk requirements for saxagliptin in its facilities. It obtains the bulk metformin for Kombiglyze from a third party. Both the Company and AstraZeneca finish Onglyza in their own facilities. The Company finishes Kombiglyze in its own facility.
Byetta (exenatide) is a twice daily glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of type 2 diabetes. Byetta was acquired from its Amylin acquisition in August 2012. Byetta was internally discovered by Amylin, a wholly-owned subsidiary of the Company. It has a worldwide development and commercialization agreement with AstraZeneca for Byetta. It also have an agreement with Lilly regarding the termination of their collaboration for the global development and commercialization of Byetta and Bydureon. The Company and Lilly are in the process of transferring the rights to the Company and AstraZeneca. The Company and Lilly are in the process of transferring the rights to the Company and AstraZeneca. It obtains the bulk requirements for exenatide from third parties. Manufacturing and finishing also takes place in third party facilities.
Bydureon (exenatide extended-release for injectable suspension) is a once-weekly GLP-1 receptor agonist for the treatment of type 2 diabetes. It has a worldwide development and commercialization agreement with AstraZeneca for Bydureon. The bulk requirements for exenatide are obtained from third parties and the microspheres manufacturing process required for the extended release formulation is performed by the Company. It finishes the product in its facilities
Forxiga (dapagliflozin) is an oral sodium-glucose cotransporter 2 (SGLT2) for the treatment of diabetes. It manufactures the bulk requirements for dapagliflozin and finishes the product in its own facilities.
Bristol-Myers Squibb Co
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