Teva Announces Launch of Generic Epzicom® Tablets in the United States

Teva Pharmaceutical Industries Ltd announced the launch of a generic equivalent of Epzicom®1 (abacavir and lamivudine) tablets, 600 mg/300 mg, in the United States (U.S.). Abacavir and lamivudine tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

When used in combination with other antiretroviral medicines used to treat HIV-1 infection, abacavir and lamivudine tablets may help to:Reduce the amount of HIV-1 in affected patients’ blood (viral load), and Increase the number of CD4+ (T) cells in affected patients’ blood to help fight off other infections.

Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in the blood may help improve affected patients’ immune systems, and may reduce the risk of death or getting infections that can happen when a patient’s immune system is weak (opportunistic infections). Abacavir and lamivudine tablets are not a cure for HIV or AIDS.

Teva continues its commitment to strengthening its generics business with continued investment in newer, higher-quality generic products. With nearly 600 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market. The addition of this product to Teva’s HIV antiretroviral portfolio allows Teva to continue to grow in this therapeutic area.

To date, Teva has over 300 product registrations pending FDA approval and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, 1-in-6 generic prescriptions dispensed in the U.S. is filled with a Teva generic product.

Epzicom® (abacavir and lamivudine) tablets had annual sales of approximately $449 million in the U.S. according to IMS data as of July 2016.

About Abacavir and Lamivudine Tablets
Abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Abacavir and lamivudine tablets are contraindicated in patients who have the HLA-B*5701 allele; patients with prior hypersensitivity reaction to abacavir or lamivudine; and patients with moderate or severe hepatic impairment.

Hepatic decompensation, some fatal, has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon alfa with or without ribavirin. Discontinue abacavir and lamivudine tablets as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both. Immune reconstitution syndrome and redistribution/accumulation of body fat have been reported in patients treated with combination antiretroviral therapy.

Abacavir and lamivudine tablets are not recommended with other products containing abacavir or lamivudine or emtricitabine-containing products. The underlying risk of coronary heart disease should be considered when prescribing antiretroviral therapies, including abacavir, and action taken to minimize all modifiable risk factors. The most commonly reported adverse reactions of at least moderate intensity (incidence greater than 5%) in an adult HIV-1 clinical trial were drug hypersensitivity, insomnia, depression/depressed mood, headache/migraine, fatigue/malaise, dizziness/vertigo, nausea, and diarrhea.

About Teva
Teva Pharmaceutical Industries Ltd is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva’s net revenues in 2015 amounted to $19.7 billion. For more information, visit www.tevapharm.com.

Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.

IR Contacts:

Kevin C. Mannix, United States, 215-591-8912
Ran Meir, United States, 215-591-3033
Tomer Amitai, Israel, 972 (3) 926-7656

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PR Contacts:

Iris Beck Codner, Israel, 972 (3) 926-7687
Denise Bradley, United States, 215-591-897
Nancy Leone, United States, 215-284-0213