BioCentury
ARTICLE | Company News

Teva neurology, infectious and ophthalmic news

December 9, 2013 8:00 AM UTC

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 an 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. Teva expects the program to generate peak risk-adjusted sales of $1-$1.5 billion by 2018 and $3 billion by 2020. The company estimates that each NTE will take three to six years and $10-$50 million to develop, as compared to 10-15 years and $1-$2 billion for new chemical entities. ...