1 clinical development and initiation of pivotal clinical studies to demonstrate therapeutic equivalency to Advair is planned in 2016. Oncology The company’s oncology portfolio includes Treanda, Granix,Trisenox and Synribo in the United States; and Lonquex, Myocet, Eporatio, Tevagrastim/Ratiograstim and Trisenox outside the United States. Treanda (bendamustine hydrochloride injection) is approved in the United States for the treatment of patients with chronic lymphocytic leukemia (CLL) and patients with indolent B-cell non-Hodgkin’s lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. The company markets the product only in the United States, and also holds rights to Treanda in certain other countries, including Canada. Bendeka (bendamustine hydrochloride) injection was approved by the FDA in 2015. Bendeka is a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride that the company has licensed from Eagle to complement its Treanda franchise. Bendeka is approved for the treatment of patients with CLL and patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Bendeka became commercially available to prescribers in January 2016. Filgrastim (branded as Tevagrastim (in the EU) and Granix (in the U.S.)) and Lonquex (lipegfilgrastim) are Granulocyte Colony Stimulating Factor (G-CSF) medicines that stimulate the production of white blood cells and are primarily used to reduce the risk of infections in oncology patients receiving chemotherapy. Tevagrastim (short-acting G-CSF) is approved in the EU for multiple indications and is available in most European countries. Tevagrastim is also marketed as Ratiograstim and Biograstim in the EU. Granix (short-acting G-CSF) is approved in the United States. The product is approved and available in Japan and certain other ROW markets. In 2014, the FDA also approved Granix injection for self-administration by patients and caregivers. Lonquex (long-acting G-CSF) is a G-CSF with the active ingredient lipegfilgrastim, a glycoPEGylated (PEG; polyethylene glycol) filgrastim molecule. Lonquex is protected by patents expiring in 2024 in Europe, with extension to 2028 in various countries. Women’s Health The company’s women’s health portfolio includes ParaGard, Plan B One-Step OTC/Rx (levonorgestrel), Zoely, Seasonique and Ovaleap, along with a number of other products marketed in various countries. Plan B One-Step OTC/Rx (levonorgestrel) is an emergency oral contraceptive, which consists of a single tablet dose of levonorgestrel for emergency contraception. Plan B One-Step is intended to prevent pregnancy when taken within 72 hours after unprotected intercourse or contraceptive failure. Plan B One-Step has various generic competitors on the market. ParaGard T380 A (intrauterine copper contraceptive) is a non-hormonal intrauterine contraceptive marketed in the United States. ParaGard provides women with a reversible, non-hormonal contraceptive option. Competition: ParaGard faces competition from oral contraceptives, as well as intrauterine devices like Mirena, Jaydess in Europe and Skyla in the United States by Bayer and patches and vaginal hormonal contraceptive rings like NuvaRing by Merck. Other Specialty Products—Pipeline CEP-41750 (Mesenchymal Precursor Cell, Revascor) consists of human stem cells, the immature cells that give rise to different types of mature cells that make up the organs and tissues of the human body. Other Activities Consumer Healthcare Joint Venture PGT Healthcare (PGT) is the company’s consumer healthcare joint venture with The Procter & Gamble Company (P&G). PGT manufactures and markets approximately 200 consumer healthcare brands, including OTC medicines and vitamins, minerals and food supplements (VMS), in approximately 70 countries around the world. Its portfolio includes cough and cold brand Vicks, Germany’s OTC brand, ratiopharm, and other brands. The company owns 49% and P&G owns 51% of the joint venture,
teva pharmaceutical-sp adr
5 Basel Street
PO Box 3190
Petach Tikva, 49131
Phone: 972 3 926 7267
Fax: 972 3 923 4050www.tevapharm.com
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