Late Stage Data from Multiple Studies Showcase Safety and Efficacy Profile
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced that four company-sponsored abstracts evaluating the safety and efficacy of albuterol multi-dose dry-powder inhaler (MDPI), an investigational breath-actuated, dry-powder, short-acting beta-agonist (SABA), will be presented at the 2014 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Atlanta, Georgia on November 6-10, 2014.
“We are extremely pleased by the albuterol MDPI data that is being presented at ACAAI this year,” said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. “It is our hope that, if approved, albuterol MDPI will fill an unmet need in the asthma and reversible bronchospasm marketspace by providing patients with an inhalation-driven, multi-dose dry-powder inhaler that helps eliminate the need to coordinate inhalation with actuation.”
The following albuterol MDPI data will be presented during poster sessions on Saturday, November 8 from 3:30-4:30 p.m. and Sunday, November 9 from 7:30-8:30 a.m. in Hall A-1 of the Georgia World Conference Center at the 2014 ACAAI Annual Scientific Meeting:
All abstracts will be published in a supplement to the November issue of Annals of Allergy, Asthma & Immunology, ACAAI’s scientific journal.
In July 2014, the U.S. Food and Drug Administration accepted for review the new drug application submitted by Teva for albuterol MDPI with FDA Regulatory Action expected in March 2015. The submission was based on data from eight clinical studies that evaluated the safety and efficacy of albuterol MDPI in adults and adolescents (12 years of age and older) with asthma and EIB. If approved, albuterol MDPI would become the first breath-actuated, dry-powder, symptomatic, and rescue inhaler available to asthma patients in the US.
The studies to be presented compare the safety and efficacy of albuterol MDPI to albuterol hydrofluoroalkane (HFA) metered-dose inhaler and to placebo. The safety profile of albuterol MDPI in these studies was comparable to both the placebo and albuterol HFA and consistent with that of the well-characterized profile of albuterol in subjects with asthma. Additional data regarding the use of albuterol MDPI for exercise-induced bronchoconstriction (EIB) in adolescents and adults with a history of the condition will also be presented.
Asthma is a chronic (long-term) disease of inflammation of both the large and small airways of the lung, characterized by symptoms of wheezing and coughing. Asthma causes 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.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries. Teva's Specialty Medicines businesses focus on CNS, respiratory, oncology, pain, and women's health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $20.3 billion in net revenues in 2013.
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This release contains forward-looking statements, which are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products; competition for our innovative products, especially COPAXONE® (including competition from orally-administered alternatives, as well as from potential purported generic equivalents); the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from the research and development efforts invested in our pipeline of specialty and other products; our ability to reduce operating expenses to the extent and during the timeframe intended by our cost reduction program; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; our potential exposure to product liability claims that are not covered by insurance; increased government scrutiny in both the U.S. and Europe of our patent settlement agreements; our exposure to currency fluctuations and restrictions as well as credit risks; the effectiveness of our patents, confidentiality agreements and other measures to protect the intellectual property rights of our specialty medicines; the effects of reforms in healthcare regulation and pharmaceutical pricing, reimbursement and coverage; governmental investigations into sales and marketing practices, particularly for our specialty pharmaceutical products; uncertainties related to our recent management changes; the effects of increased leverage and our resulting reliance on access to the capital markets; any failure to recruit or retain key personnel, or to attract additional executive and managerial talent; adverse effects of political or economical instability, major hostilities or acts of terrorism on our significant worldwide operations; interruptions in our supply chain or problems with internal or third-party information technology systems that adversely affect our complex manufacturing processes; significant disruptions of our information technology systems or breaches of our data security; competition for our generic products, both from other pharmaceutical companies and as a result of increased governmental pricing pressures; competition for our specialty pharmaceutical businesses from companies with greater resources and capabilities; decreased opportunities to obtain U.S. market exclusivity for significant new generic products; potential liability in the U.S., Europe and other markets for sales of generic products prior to a final resolution of outstanding patent litigation; any failures to comply with complex Medicare and Medicaid reporting and payment obligations; the impact of continuing consolidation of our distributors and customers; significant impairment charges relating to intangible assets and goodwill; potentially significant increases in tax liabilities; the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner; environmental risks; and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2013 and in our other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and we assume no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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