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

AMSTERDAM, May 30, 2016 /PRNewswire/ --

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(R))

Teva Pharmaceutical Industries Ltd., announced today that it has received a positive conclusion of a DCP for BRALTUS(R) (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(R) contains a new dry-powder formulation of tiotropium bromide, delivered through a new capsule based inhaler, the Zonda(R) 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(R) 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]


BRALTUS(R) is indicated as a once-daily bronchodilator treatment to relieve chronic obstructive pulmonary disease (COPD) in adults. The BRALTUS(R) 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.

About Teva Respiratory 

Teva Respiratory develops and delivers high-quality treatment options for respiratory conditions, including asthma, COPD and allergic rhinitis. The Teva Respiratory portfolio is centered on optimizing respiratory treatment for patients and healthcare providers through the development of novel delivery systems and therapies that help address unmet needs. Teva's respiratory pipeline and clinical trial program are based on drug molecules delivered in proprietary dry powder formulations and breath-actuated device technologies, as well as a targeted biologic treatment for severe asthma. Through research and clinical development, Teva Respiratory continually works to expand, strengthen and build upon its treatment portfolio to positively impact the lives of the millions of patients living with respiratory disease.

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 1,000 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


1. European Federation of Allergy and Airways Diseases Patients' Association, COPD Explained [accessed April 2016].

2. European Respiratory Society, European Lung White Book [accessed May 2016].


CONTACT: Fiona Cohen +31-6-2008-2545

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