BioCentury
ARTICLE | Company News

Teva provides details of NTEs in program update

December 5, 2013 1:55 AM UTC

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) said it has approved 15 new therapeutic entity (NTE) programs for development, including four abuse-deterrent opioids, four fixed-dose combinations of antiretrovirals for HIV, a once-daily fixed combination of a prostaglandin agonist and beta blocker for glaucoma and a once-monthly subcutaneous formulation of schizophrenia drug risperidone. The details came in a Wednesday update on Teva's NTE program, which is focused on developing reformulations and novel combinations of approved drugs. Over the next three years, Teva plans to submit applications to FDA for eight of the products under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products.

The NTE program is part of a strategy developed and introduced by former President and CEO Jeremy Levin to put the ailing generics and specialty pharmaceuticals company back on a growth trajectory. Levin abruptly departed from the company in October due to disagreement over an unspecified aspect of implementing the strategy (see BioCentury, Nov. 4). ...