07.20.18
Headquarters: Canonsburg, PA
twitter.com/MylanNews
www.mylan.com
Headcount: 35,000
Year Established: 1970
Revenues: $11,908 (+8%)
Net Income: $696 (+45%)
R&D: $783 (-5%)
It was prosperous 2017 for Mylan in the way of drug approvals. The FDA approved Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, a substitutable generic version of Teva’s Copaxone 40 mg/mL, and Glatiramer Acetate Injection 20 mg/mL for once-daily injection a substitutable generic version of Teva’s Copaxone 20 mg/mL. Both are indicated for the treatment of patients with relapsing forms of multiple sclerosis. In another approval, both the FDA and Brazil’s ANVISA green-lighted Mylan’s Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab), co-developed with Biocon, for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer. Mylan and Biocon received another approval from their collaboration, with the FDA also approving Fulphila (pegfilgrastim-jmdb), a biosimilar to Neulasta (pegfilgrastim). Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells, in patients treated with chemotherapy in certain types of cancer.
Mylan collaborated with numerous companies over the course of the year. A license agreement with Otsuka Pharmaceutical was initiated to commercialize delamanid for the treatment of adults with pulmonary multidrug-resistant tuberculosis (MDR-TB) in low- and middle-income countries. Delamanid was discovered, developed, and is currently marketed by Otsuka under the brand name Deltyba. Under the terms of the agreement, Mylan has been granted an exclusive license by Otsuka to prioritize access to Deltyba in South Africa and India. In a collaboration with Theravance Biopharma a New Drug Application for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA), was approved by the FDA. It is currently pending. If approved, revefenacin would be the first once-daily, nebulized bronchodilator for the treatment of chronic obstructive pulmonary disease (COPD). Additionally, in a major partnership with Fujifilm Kyowa Kirin Biologics, the companies are working together to commercialize a biosimilar to Humira (adalimumab). Through the agreement, Mylan will leverage its regulatory platform to seek approval and commercialize the product in Europe. Humira is a TNF-inhibitor1 aimed at treating multiple chronic inflammatory conditions. The product is indicated in Europe for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.
Mylan had numerous drug launches during the year, including Imatinib Mesylate Tablets, 100 mg and 400 mg, a generic version of Novartis’s Gleevec Tablets, and Caspofungin Acetate for Injection, one of the first generic versions of Merck’s Cancidas. Also launched was Bivalirudin for Injection, 250 mg single-dose vial, a generic version of Angiomax from The Medicines Company. That product is a direct thrombin inhibitor indicated for use as an anticoagulant in patients.
Within acquisitions, Mylan acquired the global marking rights to GA Depot, a once monthly Glatiramer Acetate Product, through a partnership with Mapi Pharma. GA Depot is a proposed once-monthly injection for the treatment of patients with relapsing-remitting multiple sclerosis, or RRMS. Recently there were reports that Mylan was in advanced talks to acquire Merck KGaA’s consumer health products business, but that report was immediately denied by Mylan.
twitter.com/MylanNews
www.mylan.com
Headcount: 35,000
Year Established: 1970
Revenues: $11,908 (+8%)
Net Income: $696 (+45%)
R&D: $783 (-5%)
It was prosperous 2017 for Mylan in the way of drug approvals. The FDA approved Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, a substitutable generic version of Teva’s Copaxone 40 mg/mL, and Glatiramer Acetate Injection 20 mg/mL for once-daily injection a substitutable generic version of Teva’s Copaxone 20 mg/mL. Both are indicated for the treatment of patients with relapsing forms of multiple sclerosis. In another approval, both the FDA and Brazil’s ANVISA green-lighted Mylan’s Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab), co-developed with Biocon, for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer. Mylan and Biocon received another approval from their collaboration, with the FDA also approving Fulphila (pegfilgrastim-jmdb), a biosimilar to Neulasta (pegfilgrastim). Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells, in patients treated with chemotherapy in certain types of cancer.
Mylan collaborated with numerous companies over the course of the year. A license agreement with Otsuka Pharmaceutical was initiated to commercialize delamanid for the treatment of adults with pulmonary multidrug-resistant tuberculosis (MDR-TB) in low- and middle-income countries. Delamanid was discovered, developed, and is currently marketed by Otsuka under the brand name Deltyba. Under the terms of the agreement, Mylan has been granted an exclusive license by Otsuka to prioritize access to Deltyba in South Africa and India. In a collaboration with Theravance Biopharma a New Drug Application for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA), was approved by the FDA. It is currently pending. If approved, revefenacin would be the first once-daily, nebulized bronchodilator for the treatment of chronic obstructive pulmonary disease (COPD). Additionally, in a major partnership with Fujifilm Kyowa Kirin Biologics, the companies are working together to commercialize a biosimilar to Humira (adalimumab). Through the agreement, Mylan will leverage its regulatory platform to seek approval and commercialize the product in Europe. Humira is a TNF-inhibitor1 aimed at treating multiple chronic inflammatory conditions. The product is indicated in Europe for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.
Mylan had numerous drug launches during the year, including Imatinib Mesylate Tablets, 100 mg and 400 mg, a generic version of Novartis’s Gleevec Tablets, and Caspofungin Acetate for Injection, one of the first generic versions of Merck’s Cancidas. Also launched was Bivalirudin for Injection, 250 mg single-dose vial, a generic version of Angiomax from The Medicines Company. That product is a direct thrombin inhibitor indicated for use as an anticoagulant in patients.
Within acquisitions, Mylan acquired the global marking rights to GA Depot, a once monthly Glatiramer Acetate Product, through a partnership with Mapi Pharma. GA Depot is a proposed once-monthly injection for the treatment of patients with relapsing-remitting multiple sclerosis, or RRMS. Recently there were reports that Mylan was in advanced talks to acquire Merck KGaA’s consumer health products business, but that report was immediately denied by Mylan.