Teva Announces FDA Approval of QVAR® RediHaler™ (Beclomethasone Dipropionate HFA) Inhalation Aerosol

Maintenance Treatment Option Designed to Eliminate the Need for Hand-Breath Coordination During Inhalation

JERUSALEM, Israel I August 7, 2017 I Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved QVAR® RediHaler™ (beclomethasone dipropionate HFA) inhalation aerosol, a breath-actuated inhaler for the maintenance treatment of asthma as a prophylactic therapy in patients 4 years of age and older. QVAR® RediHaler™ is not indicated for the relief of acute bronchospasm. The product is expected to become commercially available in both 40mcg and 80mcg strengths to patients by prescription during the first quarter of 2018.

QVAR® RediHaler™ differs from conventional metered-dose inhalers (MDIs) as it delivers medication via a breath-actuated MDI, eliminating the need for hand-breath coordination during inhalation. QVAR® RediHaler™ administers the same active drug ingredient found in QVAR® (beclomethasone dipropionate HFA) Inhalation Aerosol, with a different mode of delivery. In addition, QVAR® RediHaler™ is designed to be used without shaking or priming. It should not be used with a spacer or volume holding chamber.

“When working to manage asthma on a daily basis, proper administration of medication is of paramount importance,” said Dr. Warner W. Carr, MD, Associate Medical Director of Southern California Research at Allergy and Asthma Associates of Southern California Medical Group in Mission Viejo, California. “However, research has indicated that approximately 76 percent of patients still struggle to use their MDI inhalers correctly1, thus placing them at increased risk for asthma exacerbations. From a clinical perspective, QVAR® RediHaler™ is a much-needed treatment option for these patients who may be experiencing continued difficulty with hand-breath coordination.”

“It’s important that we uncover new opportunities to take longstanding, clinically effective medications, such as QVAR®, and incorporate them into device technologies that may help address key ongoing issues for patients, including inhaler technique,” said Tushar Shah, MD, Head, Late Stage Development at Teva Pharmaceuticals. “The FDA approval of QVAR® RediHaler™ brings to market inhaler technology aimed at enabling patients to more accurately administer the medication and ensuring they are receiving a proper dose with each inhalation.”

QVAR® MDI with dose counter, the currently available form of QVAR®, was originally approved by the FDA in 2014. Teva plans to discontinue sales of this current QVAR® MDI formulation upon the launch of QVAR® RediHaler™ in the first quarter of 2018. Patients and caregivers are encouraged to speak with a healthcare professional about how this transition may impact their current treatment plan.

This approval is supported by Teva’s clinical development program for QVAR® RediHaler™, which includes data from one Phase I and four Phase III studies that evaluated the safety and efficacy of the product in asthma patients ages four years and older.

Indication
QVAR® RediHaler™ (beclomethasone dipropionate HFA) Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age or older.

Important Limitation of Use: QVAR RediHaler Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm.

About Teva Respiratory
Teva Respiratory develops and delivers 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 1,800 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.

1. American Thoracic Society, Rescue Inhaler Study: New Approach Increases Mastery of Life-Saving Technique, March 18, 2016. Available at: https://www.thoracic.org/about/newsroom/press-releases/journal/rescue-inhaler-study-new-approach-increases-mastery-of-life-saving-technique.php. Accessed on May 25, 2016.

SOURCE: Teva Pharmaceutical Industries

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