Teva Achieves Positive Conclusion for the European Decentralised Procedure (DCP) for BRALTUS® (tiotropium bromide)

AMSTERDAM, May 30, 2016

Positive conclusion of a European DCP for approval of a tiotropium bromide-based maintenance treatment for those people living with COPD in a new inhaler (Zonda®)

Teva Pharmaceutical Industries Ltd., announced today that it has received a positive conclusion of a DCP for BRALTUS^® (tiotropium bromide) as once-daily tiotropium bromide maintenance bronchodilator treatment for adult patients with chronic obstructive pulmonary disease (COPD). Tiotropium bromide is the most widely prescribed maintenance treatment for people with COPD. BRALTUS^® contains a new dry-powder formulation of tiotropium bromide, delivered through a new capsule based inhaler, the Zonda^® inhaler.

"We are all excited at the news of the positive conclusion for the DCP in Europe, and our local companies are looking forward to the opportunity of bringing BRALTUS^® to their local COPD communities," said Luca Frangoni, Head of Respiratory Europe. "It is an important goal of our growing respiratory franchise to bring new treatment options to healthcare professionals who support people living with long-term chronic conditions including COPD. We want to give patients an effective role in their own treatment while at the same time aiming to reduce costs for healthcare systems."

COPD is a progressive disease that affects up to 10% of adults in Europe; it is currently ranked sixth on the World Health Organization's mortality list, and is projected to be the third leading cause of death by 2020.^[1] There are high numbers of people with poorly controlled COPD who consequently require treatment escalation or acute care, resulting in up to 1.1 million hospital admissions each year.^[2] Almost half of the total annual financial burden of lung disease in Europe is due to COPD, and it accounts for more time off work than any other illness.^[1]

About BRALTUS^® 

BRALTUS^® is indicated as a once-daily bronchodilator treatment to relieve chronic obstructive pulmonary disease (COPD) in adults. The BRALTUS^® European DCP has been positively concluded. National Marketing Authorisations and launches will take place in selected markets over the coming months as assessed by national Teva companies.