FDA accepted Teva’s Fluticasone Propionate and Fluticasone Propionate RespiClick Inhalers

Teva Pharmaceutical Industries Ltd. announced that the U.S. FDA has accepted for review the company’s new drug applications (NDAs) for two products for adolescent and adult patients with asthma.

The first, fluticasone propionate/salmeterol, is a fixed-dose combination inhaled corticosteroid (ICS) and long-acting beta agonist (LABA) delivered via Teva’s RespiClick® breath-actuated, multi-dose dry powder inhaler (MDPI). The second, fluticasone propionate, is an ICS monotherapy also delivered via the RespiClick® device.

“The FDA acceptance of these two filings represents an exciting time for Teva’s specialty respiratory medicines business as we integrate both fixed dose combination and monotherapy into our core, breath-actuated RespiClick device,” said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Researchand Development. “By utilizing our RespiClick inhaler platform, we will be able to deliver these established medications at a lower dosage while eliminating the need for hand-breath coordination during inhalation. We are pleased to proceed with the review of these applications, aiming to ultimately provide a complete breath-actuated asthma management system to help meet the needs of patients with asthma.”

The NDAs for fluticasone propionate/salmeterol RespiClick and fluticasone propionate RespiClick are supported by data from Teva’s clinical development program, including data from three Phase III trials which evaluated the efficacy and safety of the treatments in adolescent and adult patients with asthma. In the double-blind studies, both therapies showed clinically relevant and greater benefit compared with placebo in the improvement of lung function as measured by Forced Expiratory Volume in one second (FEV1).

Safety profiles for fluticasone propionate/salmeterol RespiClick and fluticasone propionate RespiClick were found to be generally comparable to placebo and the majority of adverse events were mild to moderate in severity. In clinical trials for fluticasone propionate/salmeterol RespiClick, the most common adverse reactions (incidence ≥3%) were nasopharyngitis, headache, cough, oral candidiasis and back pain. In fluticasone propionate RespiClick clinical trials, the most common adverse reactions (incidence ≥3%) were nasopharyngitis, headache, cough, oral candidiasis and upper respiratory tract infection.

The NDAs for fluticasone propionate/salmeterol RespiClick and fluticasone propionate RespiClick have been accepted by the FDA for standard review with FDA Regulatory Action expected during the first quarter of 2017.

About Asthma
Asthma is a chronic (long term) disease usually characterized by airway inflammation and narrowing of the airways, which can vary over time. Asthma may cause recurring periods of wheezing (a whistling sound when you breathe), chest tightness, shortness of breath and coughing that often occurs at night or early in the morning. Without appropriate treatment, asthma symptoms may become more severe and result in an asthma attack, which can lead to hospitalization and even death.

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. The company’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. (NYSE and TASE: TEVA) 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 www.tevapharm.com.

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